Page
1
of
28
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
April
10,
2005
MEMORANDUM
SUBJECT:
2­
Phenylphenol,
and
salts
 
Conventional
Uses:
Revised
Occupational
and
Residential
Exposure
and
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
(
Case
2575).

FROM:
Matthew
Crowley,
Environmental
Protection
Specialist
Reregistration
Branch
4
Health
Effects
Division
THRU:
Susan
Hummel,
Branch
Senior
Scientist
Reregistration
Branch
4
Health
Effects
Division
TO:
Rebecca
Miller,
Chemical
Review
Manager
Antimicrobials
Division
Rosanna
Louie,
Chemical
Review
Manager
Reregistration
Branch
3
Special
Review
and
Reregistration
Division
DP
Barcode:
D328222
PC
Code(
s):
064103
 
o­
Phenylphenol
064104
 
o­
Phenylphenol,
sodium
salt
064108
 
o­
Phenylphenol,
potassium
salt
064116
 
o­
Phenylphenol,
ammonium
salt
EPA
MRID
No.:
43432901
The
following
document
is
the
revised
occupational
and
residential
exposure
assessment
and
recommendations
for
conventional
uses
(
postharvest
commodity
applications
only)
of
ortho­
Phenylphenol
(
OPP),
and
salts
for
the
RED
document
based
on
Phase
I
"
error­
correction"
comments.
Page
2
of
28
Executive
Summary
Short­
(
1­
30
days),
intermediate­
(
1­
6
months),
and
long­
term
(>
6
months)
dermal
and
inhalation
risks
for
occupational
handlers
using
OPP,
and
salts
as
a
conventional
post­
harvest
fungicide
for
citrus
and
pears
are
not
of
concern
when
workers
wear
baseline
personal
protective
equipment
(
PPE)
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes/
socks,
no
respirator)
plus
chemical­
resistant
gloves.
The
following
handler
scenarios
were
assessed:

 
Mixing/
loading
(
M/
L)
liquid
concentrate
solutions
for
automated
post­
harvest
foaming,
dipping,
drenching,
brushing,
spraying
treatments;
 
Loading
ready­
to­
use
(
RTU)
solutions
for
automated
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
thermofogging
applications
 
workers
are
not
present
within
the
storage
rooms
during
the
application
process;
 
Application
of
solutions
by
automated
foaming,
dipping,
drenching,
brushing,
spraying
(
inhalation
exposure
only
 
automated
application
process
results
in
negligible
dermal
exposure).

Postapplication
scenarios
assessed
following
automated
OPP,
and
salts
application
to
citrus
fruits
and
pears
include
pre­
sorting
(
citrus
only),
sorting,
and
packing.
Short­
(
1­
30
days)
and
intermediate­
(
1­
6
months)/
long­
(>
6
months)
term
postapplication
dermal
and
inhalation
risks
for
pre­
sorters
(
citrus
only),
sorters,
and
packers
are
not
of
concern
when
workers
wear
baseline
PPE
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes/
socks,
no
respirator,
no
chemical­
resistant
gloves).
All
dermal
risks
were
calculated
with
exposures
adjusted
to
the
highest
labelled
application
rate
(
2%
solution).

Based
on
the
incident
reports,
the
classification
of
OPP
and
its
sodium
salt
as
Category
I
and
II
acute
dermal
irritants,
respectively,
and
the
absence
of
acute
toxicity
data,
use
of
chemical­
resistant
gloves
should
be
considered
for
post­
harvest
activities.
Currently,
some
labels
require
handlers
to
wear
baseline
PPE
with
chemical­
resistant
gloves
and
goggles
or
a
faceshield.

Postapplication
dermal
and
inhalation
exposure
risks
are
not
of
concern
for
storage
room
re­
entry
workers
following
thermo­
fogging
applications
to
pears.
The
operating
instructions
for
the
thermo­
fogging
machine
require
application
of
a
self­
contained
breathing
apparatus
(
SCBA)
when
entering
the
cold
storage
room
shortly
after
application
due
to
low
oxygen
levels.
Use
of
SCBA
will
mitigate
any
potential
concerns
for
OPP,
and
salts
inhalation
exposure
for
workers
re­
entering
the
storage
room
at
this
time.
Additionally,
inhalation
exposure
is
considered
negligible
for
those
workers
entering
the
storage
room
months
after
the
application
for
pear
processing
and/
or
distribution
preparation.
The
aerosol
fog
has
likely
fully
dissipated
and
the
room
is
ventilated
to
return
it
to
ambient
atmospheric
conditions.
Postapplication
dermal
exposure
risks
for
these
re­
entry
workers
are
considered
negligible.
Page
3
of
28
1.0
Background
and
Purpose
This
RED
case
includes
four
active
ingredients:
o­
Phenylphenol
(
OPP)
and
its
salts
(
sodium,
potassium,
and
ammonium).
These
ingredients
have
a
variety
of
antimicrobial
uses
(
i.
e.,
cleaning/
disinfectant);
however,
this
assessment
only
addresses
conventional
uses
of
these
chemicals
 
specifically,
post­
harvest
agricultural
commodity
(
citrus
and
pears
only)
fungicide
applications.
There
are
no
residential
uses;
therefore
only
occupational
exposures
will
be
addressed.

For
the
purposes
of
this
assessment,
only
OPP
and
OPP­
sodium
salt
(
SOPP)
will
be
addressed.
OPP­
potassium
salt
solely
has
registered
antimicrobial
uses
and
OPP­
ammonium
salt
currently
has
no
active
registered
products.

2.0
Use
Information
Post­
Harvest
Automated
Applications
(
Dip
Tank,
Foam,
Spray)

OPP
and
SOPP
are
used
in
conventional
post­
harvest
fungicide
products
formulated
as
soluble
(
SC)
and
emulsifiable
concentrates
(
EC)
and
RTU
solutions.
Currently,
the
registrants
(
The
Dow
Chemical
Company
and
Lanxess,
Inc.)
plan
to
support
uses
only
for
citrus
fruits
(
citron,
sweet
orange,
tangerine,
lemon,
grapefruit,
lime,
and
kumquat)
and
pears
(
Louie,
2005).
Of
the
two
post­
harvest
fungicide
products
with
OPP
as
the
active
ingredient,
one
has
been
cancelled
(
2792­
35;
cancelled
21JUL05),
and
the
other
(
43410­
9)
is
not
labelled
for
use
on
citrus
or
pears.
As
such,
only
products
with
SOPP
as
the
active
ingredient
are
currently
labelled
for
these
uses
and
are,
therefore,
the
focus
of
this
assessment.

Typical
application
methods
were
derived
from
the
labels
and/
or
Agency
knowledge
of
use
practices
and
include
bin
drenching,
flooding,
dipping,
waxing,
foam
washing,
and
spraying
over
rolling
brushes.
Application
of
SOPP
solutions
are
typically
automated
with
commodities
passing
through
sprays/
foams/
brushes
on
conveyor
belts
or
bins
being
mechanically
dipped.
The
commodities
are
then
manually
sorted
and
packed
by
workers
at
the
end
of
the
process.

Thermo­
fogging
An
additional
end­
use­
product
(
EUP),
formulated
as
a
RTU
solution
is
labeled
for
use
on
pears
in
cold
storage
only
with
the
XEDA
®
Electrofogger,
a
thermo­
fogging
device.
The
label
indicates
that
applications
should
strictly
follow
the
machine's
operating
instructions.

Prior
to
treatment,
cooling
systems
and
humidifiers
and
circulation
fans
are
turned
off.
Tubing
suctions
the
product
directly
from
the
bung
or
spout
of
an
open
pail
to
the
machine,
which
is
outside
the
storage
room.
A
rigid
pipe
and
nozzle
extending
from
the
machine
is
attached
to
the
storage
room
through
an
access
hatch
and
further
sealed
with
plastic
sheeting
and
duct
tape.
The
machine
flash
heats
the
liquid
to
165
­
170
°
C
in
a
fast
flow
of
air
which
is
dispersed
as
a
fog
of
extremely
small
particles.
Once
the
fogger
is
operational,
an
operator/
monitor
stays
with
the
fogger
to
insure
it
is
working
properly.
At
no
time
during
the
application
process
is
anyone
permitted
inside
the
storage
room.
The
fogging
process
takes
Page
4
of
28
about
1
hour
to
treat
125
tons
and
approximately
3
hours
to
treat
400
tons
of
fruit.
An
operator
will
not
treat
more
than
two
rooms
per
day.
After
treatment,
the
storage
room
is
kept
at
32
 
36
°
F
and
1­
3%
oxygen
for
a
period
of
2
weeks
to
4
months,
at
which
time
the
fruit
is
scheduled
for
processing
and/
or
distribution
(
Collantes,
2005).

Chemical­
specific
information
regarding
daily
amount
treated
(
i.
e.,
pounds
of
fruit
treated
per
day)
is
not
available.
However,
use
information
from
similar
post­
harvest
active
ingredients
previously
assessed
(
i.
e.,
imazalil,
thiabendazole,
ethoxyquin,
and
diphenylamine)
will
be
used
in
this
assessment.

There
are
currently
9
active
SOPP
labels.
Label
directions
for
the
liquid
concentrate
formulations
call
for
dilution
in
water.
Application
rates
are
calculated
as
pounds
of
active
ingredient
per
gallon
of
dilute
solution
(
i.
e.,
lb
ai/
gal
soln)
ranging
from
0.0066
to
0.19
lb
ai/
gal
soln
(
0.05
 
2%
solution
by
weight).
Other
labels
further
list
the
amount
of
fruit
per
gallon
of
dilute
solution
(
i.
e.,
lbs
fruit/
gal
soln);
this
ranges
from
3,000­
10,000
pounds
lbs
fruit/
gal
soln
depending
on
the
concentration.
The
RTU
thermo­
fogging
product
has
an
application
rate
of
0.0633
lb
ai/
2200
lbs
fruit.
Appendix
A
has
a
more
detailed
summary
of
these
products.

3.0
Hazard
Identification
Note:
Hazard
Identification
section
was
provided
by
the
Antimicrobials
Division
(
AD).

The
acute
toxicity
database
for
OPP,
and
salts
is
considered
incomplete.
Acute
dermal
toxicity
(
870.1200),
acute
inhalation
toxicity
(
870.1300),
and
primary
eye
irritation
studies
must
be
submitted.
OPP
has
a
moderate
order
of
acute
toxicity
via
the
oral
route
of
exposure
(
Toxicity
Category
III).
For
dermal
irritation,
OPP
and
its
sodium
salt
are
severe
(
Toxicity
Cateogry
I)
and
moderate
to
severe
(
Toxicity
Category
II)
irritants,
respectively.
OPP
and
its
sodium
salt
are
not
dermal
sensitizers.
The
acute
toxicity
data
for
OPP
and
salts
is
summarized
below
in
Table
1.

Table
1:
Acute
Toxicity
Profile
for
OPP,
and
salts
Guideline
Number
Study
Type/
Test
substance
(%
a.
i.)
MRID
Number/
Citation
Results
Toxicity
Category
870.1100
(
§
81­
1)
Acute
Oral
Toxicity
­
Rat
2­
phenylphenol,
purity
99.9%
43334201
LD50
=
2733
mg/
kg
III
870.1100
(
§
81­
1)
Acute
Oral
Toxicity
­
Rat
2­
phenylphenol,
sodium
salt
purity
99.1%
433342402
LD50
=
846
mg/
kg
(
male)
LD50
=
591
mg/
kg
(
female)
III
870.1200
(
§
81­
2)
Acute
Dermal
Toxicity
NS
NS
­­­

870.1300
(
§
81­
3)
Acute
Inhalation
Toxicity
NS
NS
­­­

870.2400
(
§
81­
4)
Acute
Eye
Irritation
NS
NS
­­­
Page
5
of
28
Table
1:
Acute
Toxicity
Profile
for
OPP,
and
salts
Guideline
Number
Study
Type/
Test
substance
(%
a.
i.)
MRID
Number/
Citation
Results
Toxicity
Category
870.2500
(
§
81­
5)
Acute
Dermal
Irritation­
Rabbit
2­
phenylphenol
purity
99.9%
43334202
Dermal
irritant
I
870.2600
(
§
81­
6)
Dermal
Sensitization
­
Guinea
pig
2­
phenylphenol,
purity
99.9%
43334203
Non
sensitizer.
NA
870.2600
(
§
81­
6)
Dermal
Sensitization
­
Guinea
pig
2­
phenylphenol,
sodium
salt
purity
99.1%
43334205
Non
sensitizer.
NA
Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
OPP,
and
salts
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
FQPA
SF
=
1
UF
=
100
(
10x
interspecies
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
interspecies
extrapolation,
10x
intra­
species
variation)
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.

Incidental
Oral
Intermediate­
Term
NOAEL
=
Target
MOE
=
100
FQPA
SF
=
1
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)
Page
6
of
28
Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
OPP,
and
salts
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
(
1
­
6
months)
39
mg/
kg/
day
UF
=
100
(
10x
interspecies
extrapolation,
10x
intra­
species
variation)
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
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
interspecies
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/
daya
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
interspecies
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/
dayb
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
interspecies
extrapolation,
10x
intra­
species
variation)
DB
UF
=
an
additional
10x
is
necessary
for
route
extrapolation.
If
results
are
below
an
MOE
of
1,000,
a
confirmatory
inhalation
study
is
warranted.
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.

Inhalation
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
interspecies
extrapolation,
10x
intra­
species
variation)
DB
UF
=
an
additional
10x
is
necessary
for
route
extrapolation.
If
results
are
below
an
MOE
of
1,000,
a
confirmatory
inhalation
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.
Page
7
of
28
Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
OPP,
and
salts
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
study
is
warranted.

Cancer
(
oral,
dermal,
inhalation)
Classification:
ortho­
Phenylphenol
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
aA
human
dermal
absorption
factor
of
43%
is
used
because
an
oral
endpoint
was
selected
for
the
intermediate­
and
long­
term
dermal
exposure
scenarios.
bThe
inhalation
absorption
factor
of
100%
(
default
value,
assuming
oral
and
inhalation
absorption
are
equivalent)
should
be
used
since
an
oral
endpoint
was
selected
for
the
inhalation
exposure
scenarios.

Short­
term
dermal
and
inhalation
risks
are
calculated
separately.
Intermediate­
and
longterm
dermal
and
inhalation
risks
can
be
combined
due
to
a
common
toxicological
endpoint;
however,
they
are
presented
separately
so
a
determination
can
be
made
for
additional
inhalation
toxicity
data.
Table
2
notes
that
for
inhalation
risks,
MOEs
below
1000
warrant
additional
toxicity
data.
Table
3
below
shows
a
summary
of
the
levels
of
concern
for
each
route
of
exposure
and
exposure
duration.

Table
3:
Levels
of
Concern
for
OPP,
and
salts
Occupational
(
Worker)
Exposure
Short­
Term
Intermediate­
and
Long­
Term
Route
MOE
MOE
Dermal
100
100
Inhalation
100*
100*

*
MOEs
below
1000
may
warrant
confirmatory
inhalation
toxicity
data.
See
Table
2.

4.0
Incident
Report
No
post­
harvest
commodity
fungicide
application­
related
incidences
were
reported
in
the
incident
report.
All
reports
were
associated
with
surface
disinfectants.
However,
all
reports
indicated
dermal,
oral,
and
ocular
irritation.
The
report
notes
that
because
the
effects
are
reported
with
products
containing
ingredients
other
than
OPP,
and
salts,
it
cannot
rule
out
the
possibility
that
some
of
the
effects
are
caused
by
other
ingredients
(
Chen,
2005).

5.0
Occupational
Exposure
and
Risk
Assessment
It
has
been
determined
that
there
is
the
potential
for
exposure
in
occupational
scenarios
from
handling
SOPP/
OPP
products
during
the
application
process
and
from
conducting
activities
in
areas
previously
treated
with
SOPP/
OPP.
As
a
result,
risk
assessments
have
been
completed
for
both
handler
and
postapplication
scenarios.
Page
8
of
28
5.1
Criteria
for
Conducting
Exposure
Assessments
An
occupational
and/
or
residential
exposure
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
a
potential
for
exposure
to
handlers
(
mixers,
loaders,
applicators,
flaggers,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
Toxicological
endpoints
were
selected
for
short­,
intermediate­,
and
long­
term
exposures
to
SOPP.
Risk
assessments
are
required
for
occupational
handlers
and
occupational
postapplication
exposures
that
can
occur
as
a
result
of
OPP,
and
salts
use.

5.2
Occupational
Handler
Exposures
and
Risks
The
Agency
uses
the
term
"
handlers"
to
describe
those
individuals
who
are
involved
in
the
pesticide
application
process.
The
agency
believes
that
there
are
distinct
job
functions
or
tasks
related
to
applications
and
that
exposures
can
vary
depending
on
the
specifics
of
each
task.
Job
requirements
(
e.
g.,
amount
of
chemical
to
be
used
in
an
application),
the
kinds
of
equipment
used,
the
crop
or
target
being
treated,
and
the
circumstances
of
the
user
(
e.
g.,
the
level
of
protection
used
by
an
applicator)
can
cause
exposure
levels
to
differ
in
a
manner
specific
to
each
application
event.
Handler
tasks
can
generally
be
categorized
using
one
of
the
following
terms:

 
Mixer/
loaders
 
Applicators
 
Mixer/
loader/
applicators
 
Flaggers
5.2.1
Occupational
Handler
Exposure
Scenarios
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
thermofogging
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
9
of
28
5.2.2
Data
and
Assumptions
for
Occupational
Handler
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
handler
risk
assessments.
Each
assumption
and
factor
is
detailed
below.

 
It
is
anticipated
that
most
of
the
occupational
OPP,
and
salts
exposure
will
generally
occur
in
a
short­
and
intermediate­
term
pattern,
given
that
most
uses
are
for
controlling
disease
outbreaks
after
the
harvest
and
most
crops
are
not
harvested
longer
than
6
months.
There
may
be
potential
for
long­
term
exposures
due
to
some
citrus
harvests
lasting
over
6
months
(
California
Citrus
Quality
Council,
California
Citrus
Crop
Profile,
2003).
However,
the
endpoint
is
the
same
for
intermediate­
and
long­
term
dermal
and
inhalation
exposures,
respectively,
and
the
assessment
of
intermediate­
term
risk
is
considered
protective
for
long­
term
risk.
 
The
Agency
always
considers
the
maximum
application
rates
allowed
by
labels
in
its
short­,
intermediate­,
and
long­
term
risk
assessments
in
order
to
consider
what
is
legally
possible
based
on
the
label.
 
A
typical
workday
is
assumed
to
be
8
hours
per
day.
 
Adult
breathing
rate
is
assumed
1.6
m3
per
hour
(
for
moderate
activities).
 
Adult
body
weight
used
in
risk
calculations
is
70
kg;
 
Assumptions
for
amount
treated
per
day
(
i.
e.,
lbs
fruit/
day
or
gal
soln/
day)
values
were
taken
from
previously
assessed
active
ingredients
(
i.
e.,
imazalil,
thiabendazole,
ethoxyquin,
and
diphenylamine)
used
in
similar
post­
harvest
applications.
Further
refinement
of
this
assessment
is
possible
with
crop/
chemical­
specific
information.

o
Citrus:
1,440,000
lbs/
day

2000
boxes/
hr
*
90
lbs/
box
*
8
hrs/
day
o
Pears:
500,000
lbs/
day

amount
of
citrus
treated
per
day
is
assumed
to
be
more
conservative
and
is
used
in
risk
calculations;
however
the
assessment
for
diphenylamine
assumed
500,000
lbs
pears/
day
for
a
truck
drencher
application
 
Baseline
PPE:
includes
typical
work
clothing
(
i.
e.,
a
long­
sleeved
shirt,
long
pants,
shoes,
socks,
and
no
respiratory
protection).
It
does
not
include
chemical­
resistant
gloves.
 
Baseline/
Gloves
PPE:
includes
chemical­
resistant
gloves
in
addition
to
baseline
PPE.
Note:
most
labels
call
for
handlers
to
don
at
least
this
level
of
protection.

Unit
Exposure
Data
Sources
Many
of
the
unit
exposures
used
in
this
assessment
were
based
on
the
PHED
Version
1.1
of
August
1998.
The
unit
exposures
from
PHED
that
were
used
to
complete
all
of
the
aspects
of
this
risk
assessment
are
discussed
below.

Pesticide
Handler
Exposure
Database
(
PHED)
Version
1.1
(
August
1998):
It
is
the
policy
of
HED
to
utilize
the
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1
to
Page
10
of
28
assess
handler
exposures
for
regulatory
actions
when
no
chemical­
specific
data
are
provided.
Data
from
PHED
were
used
to
complete
this
assessment.

PHED
was
designed
by
a
task
force
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
PHED
is
a
software
system
consisting
of
two
parts
 
a
database
of
measured
exposure
values
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(
i.
e.,
replicates)
and
HED
has
developed
a
series
of
tables
of
standard
unit
exposures
for
many
occupational
scenarios
that
can
be
utilized
to
ensure
consistency
in
exposure
assessments.
These
values
are
included
in
the
"
PHED
Surrogate
Exposure
Guide".

The
unit
exposures
calculated
by
PHED
generally
range
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
To
add
consistency
and
quality
control
to
the
values
produced
from
this
system,
the
PHED
Task
Force
has
evaluated
all
data
within
the
system
and
has
developed
a
set
of
grading
criteria
to
characterize
the
quality
of
the
original
study
data.
The
assessment
of
data
quality
is
based
on
the
number
of
observations
and
the
available
quality
control
data.
While
data
from
PHED
provide
the
best
available
information
on
handler
exposures,
it
should
be
noted
that
some
aspects
of
the
included
studies
(
e.
g.,
duration,
acres
treated,
pounds
of
active
ingredient
handled)
may
not
accurately
represent
labeled
uses
in
all
cases.

Chemical­
specific
Data
Sources
for
Handler
Activities
A
study
designed
to
evaluate
potential
postapplication
exposures
of
workers
to
SOPP/
OPP
during
post­
harvest
pear
and
citrus
fruit
handling
activities
was
conducted
by
The
Dow
Chemical
Company
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
SOPP/
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.
Page
11
of
28
The
following
is
an
overall
description
of
the
study
including
a
detailed
review
of
the
results
of
area
air
monitoring.
Discussion
and
review
of
postapplication
dermal
and
inhalation
exposure
data
is
in
Section
5.3.1.

 
MRID
43432901:
Evaluation
of
Post­
Application
Exposures
to
Sodium
o­
Phenylphenate
Tetrahydrate/
o­
Phenylphenol
to
Workers
During
Post­
Harvest
Activities
at
Pear
and
Citrus
Fruit
Packaging
Facilities,
1994.

This
study
was
conducted
to
determine
postapplication
dermal
and
inhalation
exposures
to
workers
following
the
application
of
SOPP/
OPP
solutions
to
citrus
fruits
and
pears.
A
total
of
62
participants
in
6
facilities
(
located
in
Washington,
Florida,
and
California)
were
monitored
for
dermal
and
inhalation
exposure
in
this
study.
The
following
table
details
the
breakdown
of
replicates.

Table
4:
MRID
43432901
 
Replicate
Breakdown
Facility
#
Location(
s)
Automated
Application
Type
Application
Rate
(%
soln)
Activities
Monitored
(
at
each
facility)
Total
#
Replicates
1,
2,
3
Peshatin,
Cashmere
(
WA)
Dip
Tank
0.204%
(
avg)
0.238%
(
max,
Facility
3)
5
Pear
Sorters
5
Pear
Packers
30*
*
two
alternate
replicates
at
Facility
2
with
some
uncollected
data
4
Ft.
Pierce
(
FL)
Foam
0.543%
2
Citrus
Pre­
Sorters
3
Citrus
Sorters
5
Citrus
Packers
10
5,
6
Orange,
Redlands
(
CA)
Spray
1.03%
(
avg)
1.29%
(
max,
Facility
6)
2
Citrus
Pre­
Sorters
3
Citrus
Sorters
5
Citrus
Packers
20
All
application
solutions
were
prepared
using
SOPP
formulations;
however,
different
concentrations
(
i.
e.,
application
rates)
were
used
in
each
facility.
Samples
of
formulations
were
analyzed
at
each
facility
and
showed
a
range
of
0.140
to
1.29%
(
averages,
expressed
as
%
OPP
by
weight).
The
maximum
labeled
application
rate
is
2%.

After
treatment
(
by
automated
dip,
foam,
or
spray)
the
citrus
or
pears
were
conveyed
to
a
pre­
sort
station
where
workers
would
pull
out
culls
(
i.
e.,
damaged
fruit).
It
should
be
noted
that
only
workers
performing
pre­
sorting
activities
for
citrus
fruits
were
monitored.
Fruits
finally
reached
the
sorters
and
packers
after
being
cleaned,
waxed,
and
dried.

Sorters
separated
the
citrus/
pears
into
different
grades
based
on
appearance,
quality,
and
size.
Packers
in
the
pear
facilities
performed
all
activities
(
i.
e.,
wrapping,
boxing)
manually,
while
packers
in
two
citrus
facilities
operated
packing
machines
and
performed
manual
work.
Approximately
180­
300
boxes
(
40­
50
pounds
per
box)
of
pears
are
packaged
per
day.
Similar
information
was
not
provided
for
citrus
packers.

Area
air
monitoring
was
conducted
only
in
the
three
citrus
facilities
using
a
polyvinyl
chloride
(
PVC)
filter
in
a
plastic
cassette
and
a
silica
gel
sorbent
tube.
This
data
was
conducted
to
evaluate
ambient
air
concentrations
of
SOPP/
OPP
in
areas
occupied
by
postapplication
workers;
the
data
was
intended
to
augment
the
actual
worker
exposure
data.
Preliminary
data
Page
12
of
28
from
the
pear
segment
of
the
study
(
conducted
prior
to
the
citrus
segment)
suggested
that
additional
area
monitoring
data
might
better
define
sources
of
potential
exposure.
It
is
noted
that
the
intention
of
this
data
was
not
to
represent
worker
exposure
data.
However,
it
is
believed
that
because
the
application
process
is
automated,
but
workers
are
present
in
the
vicinity
of
the
process,
this
data
represents
the
best
approximation
for
exposure
during
the
application
process.

The
following
table
presents
a
summary
of
the
results
of
the
area
monitoring
in
the
citrus
facilities.
Results
have
been
corrected
for
field
fortification
recoveries
below
100%
and
are
expressed
as
a
time­
weighted
average
(
TWA)
in
micrograms
per
cubic
meter
(
ug/
m3).

Table
5:
Area
Monitoring
in
Citrus
Facilities
Facility
#
Concentration
(
ug/
m3)
1
4
23.1
5
11.8
6
90.3
All
38.6
1
All
concentrations
are
arithmetic
means
expressed
as
a
TWA.

5.2.3
Occupational
Handler
Exposure
and
Risk
Calculation
Methods
Calculation
Methods
using
Unit
Exposures
The
Agency
uses
a
concept
known
as
unit
exposure
as
the
basis
for
assessing
handler
exposures.
The
unit
exposure
is
amount
of
exposure
that
occurs
while
handling
a
pound
of
active
ingredient.
Daily
exposures
are
calculated
by
considering
application
parameters
(
i.
e.,
rate
and
area
treated)
along
with
unit
exposure
levels.
Exposures
are
then
normalized
by
body
weight
to
calculate
dose
levels
and
the
Margin
of
Exposure
(
MOE).

Daily
Exposure:
The
daily
exposures
to
handlers
are
calculated
as
described
below.
The
first
step
is
to
calculate
daily
exposure
(
dermal
or
inhalation)
using
the
following
formula:

Daily
Exposure
=
Unit
Exposure
x
Application
Rate
x
Amount
Treated
Where:

Daily
Exposure
=
Amount
deposited
on
the
surface
of
the
skin
or
amount
that
is
inhaled
(
mg
ai/
day);
Unit
Exposure
=
Normalized
exposure
value,
derived
from
August
1998
PHED
Surrogate
Exposure
Table
and
various
referenced
exposure
studies
(
mg
ai/
lb
ai);
Application
Rate
=
Amount
of
a.
i.
applied
per
unit
treated
such
as
acres
or
pounds
of
seed
Amount
Treated
=
Typically
expressed
as
acres/
day
for
crops
and
pounds/
day
for
seed.

Inhalation
exposure
values
(
for
mixers/
loaders,
only)
are
calculated
in
a
similar
manner.
The
only
difference
is
that
unit
exposures
representing
the
inhalation
route
are
calculated
using
PHED
and
standard
human
breathing
rates
(
29
liters/
minute
and
an
8
hour
exposure).

Daily
Dose:
Daily
dose
(
inhalation
or
dermal)
are
then
calculated
by
normalizing
the
daily
dermal
exposure
value
by
body
weight.
It
should
be
noted
that
short­
term
dermal
Page
13
of
28
exposures
need
not
be
corrected
for
dermal
absorption
(
i.
e.,
dermal
absorption
factor)
because
the
dermal
endpoint
was
based
upon
a
dermal
study.
Intermediate­/
long­
term
dermal
exposure/
risk
calculations
are
based
on
an
oral
endpoint,
and
are
corrected
for
absorption
using
a
43%
dermal
absorption
factor.
The
inhalation
absorption
factor
is
assumed
to
be
100
percent
because
the
inhalation
endpoint
was
based
upon
an
oral
study.
Daily
dose
is
calculated
using
the
following
formula:

Average
Daily
Dose
 
 

 
 

 
 

 
 

day
kg
mg
/
=
Daily
Exposure
 
 

 
 

 
 

 
 

day
ai
mg.
x
 
 

 
 

 
 

 
 

)
(
)
100
/
(%

kg
Bodyweight
factor
absorbtion
Where:

Average
Daily
Dose
=
The
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
Daily
Exposure
=
Amount
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
that
is
inhaled
(
mg
ai/
day);
Absorption
Factor
=
43%
dermal
absorption
factor
for
int/
long­
term
calculations
100%
for
inhalation
exposures
(
all
durations)
Body
Weight
=
70
kg
representing
the
general
adult
population.

Margins
of
Exposure:
Finally,
the
daily
dermal
dose
and
daily
inhalation
dose
received
by
handlers
are
compared
to
the
appropriate
endpoint
(
i.
e.,
NOAEL
or
LOAEL)
to
obtain
a
Margin
of
Exposure
(
MOE).
All
MOE
values
were
calculated
separately
for
dermal
and
inhalation
exposures
using
the
formula
below:

MOE
=
NOAEL/
ADD
Where:

MOE
=
Margin
of
exposure
ADD
=
Average
Daily
Dose
(
mg
ai/
kg/
day)
or
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
NOAEL
=
No
Observed
Adverse
Effects
Level
(
mg
ai/
kg/
day).

Calculation
Methods
using
Chemical­
Specific
Data
Ambient
area
monitoring
was
used
to
quantitatively
assess
exposure
to
workers
during
the
application
process.
As
discussed
previously,
this
data
best
represents
exposure
to
workers
in
the
vicinity
of
the
automated
application
process,
although
the
samples
collected
were
in
the
area
where
workers
conduct
postapplication
activities
(
i.
e.,
sorting
and
packing).

The
study
data
presents
exposure
as
a
TWA
concentration
in
micrograms
per
cubic
meter.
This
concentration
must
be
converted
into
an
average
daily
exposure
(
mg/
kg/
day)
to
be
used
in
the
MOE
calculation
described
above.
To
present
the
area
monitoring
data
as
an
average
daily
dose,
the
following
calculation
is
used.

Avg
Daily
Dose
  

 

  
 

day
kg
mg
/
=
Daily
Exp.

  

 

  
 

3
m
ug
x
Inhl.
Rate
  

 

  
 

day
m3
x
  

 

  
 

)
(
)
100
/
(%

kg
Bodyweight
absfactor
x
  

 

  
 

)
1000
(
)
1
(

ug
mg
Where:
Page
14
of
28
Average
Daily
Dose
=
The
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
Daily
Exposure
=
Area
monitoring
TWA
concentration
(
ug/
m3);
Inhalation
Rate
=
Adult
daily
inhalation
rate:
8
hrs/
day
*
1.6
m3/
hr
=
12.8
m3/
day;
Absorption
Factor
=
100%
for
inhalation
exposures
(
all
durations);
Body
Weight
=
70
kg
representing
the
general
adult
population.

5.2.4
Occupational
Handler
Risk
Estimates
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
6
and
7
below
summarize
the
handler
risk
estimates.
Detailed
exposure
and
risk
calculations
are
in
Appendix
B.

Table
6:
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
Post­
harvest
Applications
Citrus
only
0.0000133
130
16000
300000
Loading
RTU
for
Thermofogging
applications
Pears
only
0.0000288
58
7300
140000
Automated
Application
Process
Citrus
&
Pears
Activities
during
automated
application
(
i.
e.,
operations
monitoring)
Citrus
only
NA
Negligible
6100
*
MOEs
below
1000
may
warrant
confirmatory
inhalation
toxicity
data.
See
Table
2.

Table
7:
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
Post­
harvest
Applications
Citrus
only
0.0000133
110
14000
120000
Page
15
of
28
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
*
MOEs
below
1000
may
warrant
confirmatory
inhalation
toxicity
data.
See
Table
2.

5.2.5
Occupational
Handler
Risk
Characterization
The
exposure
data
that
were
used
in
the
SOPP/
OPP
occupational
handler
risk
assessment
represents
the
best
data
currently
available.
In
many
cases,
the
Pesticide
Handlers
Exposure
Database
(
PHED)
was
used
to
develop
the
unit
exposures.
In
addition
to
PHED,
the
Agency
used
a
few
literature
and
registrant
submitted
studies
to
define
unit
exposures.
Generally,
the
quality
of
these
studies
is
excellent.
PHED
unit
exposures
represent
a
central
tendency
of
the
data
that
ranges
from
the
geometric
mean
to
the
median
or
arithmetic
mean
of
the
data
(
it
depends
upon
the
distribution
of
the
data).
As
such,
the
values
based
on
the
recent
studies
also
are
measures
of
central
tendency
(
e.
g.,
the
geometric
means
were
selected
from
each
study
for
assessment
purposes
in
most
cases).

Other
inputs
for
this
assessment
included
chemical­
specific
data,
application
rates,
and
daily
amount
treated
(
i.
e.,
lbs
fruit
treated/
day).
The
application
rate
used
was
the
maximum
labeled
rate.
The
daily
amount
treated,
as
seen
in
other
post­
harvest
commodity
assessments,
was
based
on
a
typical
citrus
fruit
facility
 
and
is
considered
a
conservative
estimate.
The
inhalation
exposure
used
for
"
application"
exposure
was
ambient
area
monitoring
data
from
a
submitted
study,
not
personal
monitoring
data.
Because
the
application
process
is
automated,
workers
do
not
perform
application
activities
per
se;
this
data
was
considered
a
reasonable
estimate
of
inhalation
exposure
to
workers
in
the
vicinity
of
the
application
process.
Additionally,
the
value
used
(
90.3
ug/
m3)
was
the
maximum
average
exposure
concentration
from
a
California
citrus
facility
(
Facility
#
6).
The
overall
average
concentration
for
citrus
facilities
was
much
lower
(
38.6
ug/
m3).
Ambient
area
monitoring
was
not
conducted
in
pear
facilities.

A
summary
of
the
input
values
is
given
in
Table
8.

Table
8:
Summary
of
Handler
Input
Values
Input
Value
Source
Comments
Daily
Amt.
Treated
(
lbs
citrus/
day)
From
previously
assessments
of
chemicals
with
post­
harvest
applications
(
i.
e.,
imazalil,
thiabendazole,
ethoxyquin,
and
diphenylamine)
Citrus
value
is
assumed
to
be
a
conservative
estimate.

Unit
Exposure
Data
PHED
Most
values
are
geometric
mean,
not
upper
percentile.

Automated
Postharvest
Application
Inhalation
Exposure
MRID
43432901
The
data
for
area
monitoring
was
used
as
a
reasonable
surrogate
of
inhalation
exposures
during
the
automated
application
process.
The
highest
average
(
from
Facility
6)
was
used
to
Page
16
of
28
Table
8:
Summary
of
Handler
Input
Values
Input
Value
Source
Comments
provide
the
most
conservative
estimate.

Application
Rate
EPA
Registration
#
64864­
54
This
was
the
highest
application
rate
of
the
two
liquid
concentrate
products
that
specified
the
amount
of
fruit
to
treat
with
said
rate.
It
is
also
the
highest
%
soln
of
all
labels
(
2%).

5.2.6
Recommendations
for
Occupational
Handler
Assessment
All
labels
should
require
the
use
of
chemical­
resistant
gloves
when
handling
SOPP/
OPP.
As
noted
in
Section
3.0,
there
is
currently
no
acute
eye,
dermal,
or
inhalation
toxicity
studies,
so
application
of
protective
equipment
based
on
acute
toxicity
categories
cannot
be
determined
(
although
it
is
recognized
that
this
use
does
not
fall
under
Worker
Protection
Standard
(
WPS)
provisions).
Based
on
this
handler
assessment,
however,
chemical­
resistant
gloves
are
warranted.
Currently
4
of
the
9
active
labels
require
chemical­
resistant
gloves.
See
Appendix
A
for
more
label
information.

Additionally,
labels
should
specify
the
amount
of
fruit
to
treat
with
the
specified
application
rates.
Currently
3
of
the
9
active
labels
have
this
additional
statement.

5.3
Occupational
Postapplication
Exposure
and
Risk
Assessment
The
Agency
uses
the
term
"
postapplication"
to
describe
exposures
to
individuals
that
occur
as
a
result
of
working
in
an
environment
that
has
been
previously
treated
with
a
pesticide.
The
Agency
believes
that
there
are
distinct
job
functions
or
tasks
related
to
the
kinds
of
activities
that
occur
in
previously
treated
areas
such
as
harvesting
vegetables
in
a
treated
field.

In
the
case
of
SOPP/
OPP
post­
harvest
commodity
applications,
workers
performing
sorting
and
packing
activities
are
potentially
exposed
to
SOPP/
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.

5.3.1
Data
Used
for
Occupational
Postapplication
Exposure
Scenarios
Postapplication
data
has
been
submitted
for
use
in
determining
postapplication
exposures
and
risks
for
workers
performing
sorting
and
packing
activities.
No
data
is
currently
available
to
quantitatively
assess
postapplication
exposures
to
storage
room
re­
entry
workers
following
thermo­
fogging
applications.

The
study
previously
summarized
in
Section
5.2.2
determined
dermal
and
inhalation
exposure
monitoring
through
passive
dosimetry
for
workers
performing
sorting
and
packing
activities
following
application
of
SOPP/
OPP
solutions
to
citrus
fruits
and
pears.
The
following
is
a
summary
and
discussion
of
results
of
the
postapplication
dermal
and
inhalation
exposures.
Page
17
of
28
As
previously
discussed,
the
citrus
fruits
and
pears
reach
the
sorters
and
packers
following
application
of
the
SOPP/
OPP
solution,
a
pre­
sorting
phase,
a
cleaning/
waxing
phase,
and
a
drying
phase.
The
sorters
then
separate
the
citrus/
pears
into
grades
which
the
packers
package
both
manually
(
in
the
case
of
both
citrus
fruits
and
pears)
and
mechanically
(
in
the
case
of
citrus
only).
The
study
conducted
dermal
(
arms,
hands,
torso)
and
inhalation
(
personal
breathing
zone)
exposure
monitoring
during
these
activities.
The
study
noted
that
during
presurvey
observations,
it
was
visually
apparent
that
there
was
a
lack
of
contact
with
treated
fruit
with
lower
portions
of
the
body;
therefore
only
upper­
body
exposures
were
determined.

Dermal
exposure
to
the
torso
region
(
stomach,
back,
chest,
shoulders,
and
upper
arms)
was
quantified
by
extraction
of
SOPP/
OPP
from
an
inner,
short­
sleeve,
100%
cotton
t­
shirt
using
acetonitrile.
Because
workers
typically
wear
short­
sleeve
shirts,
arm
dosimeters
cut
from
an
outer,
long­
sleeve,
65%
polyester/
35%
cotton
shirt
long­
sleeve
shirt,
combined
as
one
sample,
represent
exposure
to
bare
arms.
A
penetration
factor
(
i.
e.,
the
ratio
between
the
outer­
shirt
torso
dosimeter
and
the
inner­
shirt
torso
dosimeter)
was
also
derived
 
this
factor
was
not
used
in
the
dermal
exposure
calculation,
but
could
be
used
to
determine
protection
offered
by
additional
clothing
layers.
Analysis
of
the
three
dosimeters
(
arms,
outer­
torso,
and
inner­
torso)
was
done
by
gas
chromatography
with
flame­
ionization
detection
(
GC/
FID).
Laboratory
recoveries
averaged
approximately
92%
and
99%
for
the
long­
sleeve
cotton­
blend
shirt
and
the
short­
sleeve
cotton
t­
shirt,
respectively.

Dermal
exposure
to
the
hands
was
assessed
by
hand
rinses
conducted
throughout
the
day
when
workers
would
normally
wash
their
hands
after
coming
off
the
line
(
i.
e.,
bathroom
and
lunch
breaks).
Although
thin
cotton
gloves,
finger
cots,
or
fingernail
tape
are
typically
worn
as
an
industry
practice
by
sorters
and
packers
to
protect
their
hands
from
cuts
and
punctures
and
to
protect
the
fruit
from
damage,
the
study
directors
asked
workers
not
to
wear
any
hand
coverings.
Packers
at
all
the
pear
packing
facilities
wore
thin
cotton
gloves,
finger
cots,
or
fingernail
tape,
sorters
did
not;
citrus
facility
#
4
was
the
only
facility
to
have
all
sorter
and
packer
samples
(
including
pre­
sorters)
without
hand
coverings;
at
citrus
facilities
5
and
6,
only
packers
wore
cotton
gloves
 
sorters
and
pre­
sorters,
with
the
exception
of
fingernail
tape,
did
not
wear
hand
coverings.
Cotton
gloves,
when
used,
were
removed
prior
to
the
hand
rinse
procedure
(
and
not
included
in
the
sample);
fingernail
tapes
remained.
The
study
notes
that
the
cotton
gloves
were
not
intended
to
nor
were
effective
as
a
chemical
barrier.
Hand
rinses
were
collected
by
rinsing
with
soap
and
water
over
a
stainless
steel
bowl
and
transferring
the
solution
to
a
bottle
containing
sodium
chloride.
Ethyl
acetate
was
then
added
to
extract
the
SOPP/
OPP.
Like
the
torso
and
arm
dosimeters,
analysis
was
done
by
GC/
FID,
with
an
average
laboratory
recovery
of
approximately
112%.

The
following
table
presents
a
summary
of
the
results
for
total
dermal
exposure
by
facility,
crop,
and
postapplication
activity.
Results,
both
the
arithmetic
mean
and
the
maximum
reported
exposure,
are
presented
in
micrograms
and
represent
exposure
over
an
8­
hour
workday.
Results
shown
have
been
corrected
for
field
fortification
recoveries
below
100%
(
including
those
above
90%).
Page
18
of
28
Table
9:
MRID
43432901
 
Dermal
Exposure
Results
for
Sorters
and
Packers
in
Citrus
Fruit
and
Pear
Facilities
Dermal
Exposure
(
ug)
Facilities
(
State)
Crop
Activity
Arithmetic
Mean
Maximum
Sorter
6134
14102
1,
2,
3
(
WA)
Pears
Packer
4022
6147
Sorter
2460
3448
Pre­
sorter
7873
12693
4
(
FL)
Citrus
Packer
1500
3088
Sorter
1934
5153
Pre­
sorter
4513
7784
5,
6
(
CA)
Citrus
Packer
720
1845
Inhalation
exposure
was
monitored
using
a
PVC
filter
in
a
plastic
cassette,
followed
in
series
by
a
silica
gel
sorbent
tube.
The
filter
and
tube
sample
train,
placed
in
the
worker's
breathing
zone
on
the
lapel
of
their
work
shirt,
was
used
to
collect
both
particulate
and
vapor
components
of
SOPP
and
OPP
in
the
air.
The
air
flow
rate
was
approximately
1
liter
per
minute
using
vacuum
pumps.
Both
the
filter
and
tube
were
desorbed
with
acetonitrile
and
analyzed
by
GC/
FID.
Laboratory
recovery
for
this
method
averaged
approximately
92%.

The
following
table
presents
a
summary
of
the
results
of
the
personal
air
monitoring
in
all
facilities.
Results
have
been
corrected
for
field
fortification
recoveries
below
100%
(
including
those
above
90%)
and
are
expressed
as
a
time­
weighted
average
(
TWA)
in
micrograms
per
cubic
meter
(
ug/
m3).
Like
dermal
exposure,
both
the
arithmetic
mean
and
maximum
reported
exposure
are
shown.

Table
10:
MRID
43432901
 
Inhalation
Exposure
Results
for
Sorters
and
Packers
in
Citrus
Fruit
and
Pear
Facilities
Inhalation
Exposure
(
ug/
m3)
Facilities
(
State)
Crop
Activity
Arithmetic
Mean
Maximum
Sorter
95.1
154
1,
2,
3
(
WA)
Pears
Packer
75.4
96.4
Sorter
19.8
29.8
Pre­
sorter
43.7
50
4
(
FL)
Citrus
Packer
4.6
5.4
Sorter
7.6
27.4
Pre­
sorter
93.2
197
5,
6
(
CA)
Citrus
Packer
6.6
16.7
5.3.2
Postapplication
Exposure
Assumptions,
Factors,
and
Calculation
Methods
The
following
assumptions
and
factors
were
used
for
assessing
the
occupational
postapplication
risks:

 
Body
weights,
dermal
and
inhalation
absorption
factors,
inhalation
rates,
hours
worked
per
day,
and
toxicological
endpoints
are
the
same
as
those
used
for
the
occupational
handler
assessments.
 
As
with
the
handler
assessment,
all
exposure
durations
(
short­
term
and
intermediate­
/
long­
term)
will
be
assessed.
Page
19
of
28
 
Chemical­
specific
dermal
and
inhalation
exposure
data
from
MRID
43432901
was
used
to
assess
all
postapplication
risks.
 
The
cotton
gloves
described
in
the
study
were
not
chemical­
resistant,
nor
were
they
intended
to
be
a
chemical
barrier.
Calculation
corrections
for
these
gloves
were
not
performed,
nor
were
the
gloves
analyzed
for
chemical
residue/
content.

Dermal
and
inhalation
exposure
data
was
used
to
quantitatively
assess
exposure
to
sorters
and
packers
following
SOPP/
OPP
application.
The
study
data
presents
inhalation
exposure
as
a
TWA
concentration
in
micrograms
per
cubic
meter
(
ug/
m3)
and
dermal
exposure
as
a
work­
day
total
(
8
hours)
in
micrograms
(
ug).
These
concentrations
must
be
converted
into
an
average
daily
exposure
(
mg/
kg/
day)
to
be
used
in
the
MOE
calculations
described
in
Section
5.2.3.

To
present
the
inhalation
monitoring
data
as
an
average
daily
dose,
the
following
calculation
is
used.

Avg
Daily
Dose
  

 

  
 

day
kg
mg
/
=
Daily
Exp.

  

 

  
 

3
m
ug
x
Inhl.
Rate
  

 

  
 

day
m3
x
  

 

  
 

)
(
)
100
/
(%

kg
Bodyweight
absfactor
x
  

 

  
 

)
1000
(
)
1
(

ug
mg
Where:

Average
Daily
Dose
=
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
Daily
Exposure
=
Personal
air
monitoring
TWA
concentration
(
ug/
m3);
Inhalation
Rate
=
Adult
daily
inhalation
rate:
8
hrs/
day
*
1.6
m3/
hr
=
12.8
m3/
day;
Absorption
Factor
=
100%
for
inhalation
exposures
(
all
durations);
Body
Weight
=
70
kg.

To
present
the
dermal
exposure
data
as
an
average
daily
dose,
the
following
calculation
is
used.

Avg
Daily
Dose
  

 

  
 

day
kg
mg
/
=
Daily
Exp.

  

 

  
 

day
ug
x
  

 

  
 

)
(
)
100
/
(%

kg
Bodyweight
absfactor
x
  

 

  
 

)
1000
(
)
1
(

ug
mg
Where:

Average
Daily
Dose
=
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
Daily
Exposure
=
Dermal
exposure
during
a
typical
workday
(
ug/
day);
Absorption
Factor
=
43%
for
intermediate­/
long­
term
duration;
Body
Weight
=
70
kg.

5.3.3
Occupational
Postapplication
Risk
Estimates
Table
11
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).
See
Table
4
for
actual
application
solutions
used
in
each
facility.
Page
20
of
28
There
are
risks
of
concern
for
the
following
scenarios.
Detailed
exposure
and
risk
calculations
are
in
Appendix
B.

Sorters
 
Short­
term
dermal
risk
for
sorting
in
pear
facilities
(
MOE
=
51).
Note:
this
risk
is
calculated
with
the
maximum
reported
dermal
exposure.

Table
11:
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
Note:
Dermal
risks
are
calculated
with
exposures
adjusted
to
the
maximum
labeled
application
rate
(
2%
solution).
See
Table
4
for
actual
rates
used
in
the
study.
*
Inhalation
MOEs
below
1000
may
warrant
confirmatory
inhalation
toxicity
data.
See
Table
2.

Postapplication
inhalation
exposure
risks
are
not
of
concern
for
storage
room
re­
entry
workers
following
thermo­
fogging
applications
to
pears.
Workers
performing
post­
treatment
residue
sampling
likely
will
enter
the
storage
room
shortly
after
application
(
i.
e.,
a
few
hours
to
a
couple
of
days).
At
this
time,
the
oxygen
level
in
the
storage
rooms
is
1­
3%
and
the
machine's
operating
instructions
require
application
of
a
self­
contained
breathing
apparatus
(
SCBA).
Use
of
SCBA
will
mitigate
any
potential
concerns
for
SOPP/
OPP
inhalation
exposure.
Additionally,
inhalation
exposure
is
considered
negligible
for
those
workers
entering
the
storage
room
months
after
the
application
for
processing/
distribution
preparation.
The
aerosol
fog
has
likely
fully
dissipated
and
the
room
is
ventilated
to
return
it
to
ambient
atmospheric
conditions.

Postapplication
dermal
exposure
risks
for
the
re­
entry
workers
are
considered
negligible.
Post­
treatment
residues
samplers
will
contact
very
few
pears
and
workers
preparing
the
pears
for
processing
and/
or
distribution
will
contact
the
pears
months
after
the
application.

5.3.4
Occupational
Postapplication
Risk
Characterization
The
data
used
from
the
postapplication
exposure
study
is
the
best
available
representation
of
dermal
and
inhalation
exposure
to
sorters
and
packers
of
citrus
fruits
and
pears.
Risk
calculations
using
both
the
arithmetic
mean
and
maximum
reported
dermal
and
inhalation
exposures
for
each
crop/
geographic
location
are
the
most
conservative
estimates.
Other
statistical
manipulations
(
i.
e.,
median
or
geometric
mean
of
exposures)
may
be
more
representative
of
actual
exposure.
Page
21
of
28
The
short­
term
dermal
risk
for
pear
sorters
was
reported
to
be
a
risk
of
concern
(
MOE
=
51)
when
the
maximum
reported
dermal
exposure
for
pear
sorters
was
used.
However,
it
should
be
noted
that
it
is
unlikely
that
this
level
of
dermal
exposure
would
persist
over
the
entire
shortterm
exposure
duration
(
i.
e.,
up
to
30
days),
and
is
a
conservative
risk
estimate.
The
short­
term
dermal
risk
using
the
average
of
dermal
exposure
for
pear
sorters
(
MOE
=
120)
may
be
a
more
appropriate
estimate.

It
is
recognized
that
the
adjustment
of
the
dermal
exposure
data
for
the
maximum
labeled
application
rate
(
2%
solution),
though
typical
in
HED
assessments,
is
conservative.
For
some
data
points
this
adjustment
yields
a
result
approximately
14
times
greater
than
the
reported
exposure.
However,
because
of
a
wide
variety
of
uncertainty
regarding
potential
factors
influencing
exposure,
it
was
assumed
that
a
higher
solution
concentration
would
correlate
to
higher
dermal
exposures
 
although,
in
some
cases
the
data
did
not
exhibit
this
trend.
For
example,
the
data
showed
that
post­
harvest
workers
at
pear
facilities,
while
exposed
to
lower
solution
concentrations
than
citrus
facility
workers
in
California
(
0.204%
average
solution
in
pear
facilities
versus
1.03%
average
solution
in
the
California
citrus
facilities),
the
workers
in
the
pear
facilities
reported
higher
dermal
exposures.
This
appears
to
hold
true
when
holding
certain
observable
parameters
equal,
such
as
wearing
cotton
gloves
during
packing
activities
(
i.
e.,
pear
packers
wearing
gloves
exposed
to
lower
concentration
solutions
reported
higher
dermal
exposures
than
citrus
packers
wearing
cotton
gloves).
Additionally,
this
holds
true
even
when
comparing
sorters
and
packers
in
the
pear
facilities
with
pre­
sorters
in
the
citrus
facilities
 
because
pre­
sorters
handle
the
fruits
prior
to
the
drying/
waxing
phase,
one
may
intuitively
assume
they
would
have
the
highest
exposures,
but
they
do
not.
Data
for
pre­
sorters
in
pear
facilities
might
help
refine
this
discrepancy.

The
reasons
for
these
patterns
in
the
data
are
unclear.
As
mentioned
before,
there
may
be
factors
influencing
the
data
that
were
not
reported
in
the
study
and
cannot
be
determined
simply
by
data
observation.
Factors
such
as
the
ventilation
rates
within
each
facility,
chemical
absorption
by
cotton
gloves,
the
influence
of
application
method
(
dip
tank,
foam,
or
spray)
on
chemical/
fruit
residue,
the
influence
of
ambient
temperature
on
the
application
solutions,
the
effectiveness
of
the
drying
and
waxing
phases,
and
the
amount
of
fruit
treated
(
which
influences
the
solution
concentration)
all
may
affect
exposure,
but
are
indeterminable.

5.3.5
Recommendations
for
Occupational
Postapplication
Assessment
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.

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/
SOPP's
classifications
as
Category
I
and
II
acute
dermal
irritants,
Page
22
of
28
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.

6.0
References
Chen,
J.
2005.
Draft
Incident
Reports
Associated
With
o­
Phenylphenol
&
Salts.
USEPA/
OPPTS/
OPP/
AD.
Dated
May
10,
2005.

California
Citrus
Quality
Council,
Citrus
Research
Board.
Crop
Profile
 
Citrus
in
California.
Dated
December,
2003.

Collantes,
M.
2005.
Memorandum:
Diphenylamine:
Occupational
and
Residential
Exposure
Assessment
for
Proposed
Section
3
Registration
for
Post­
harvest
Use
on
Apples
and
Pears
(
Petition
No.
06987).
Dated
8/
8/
2005.

Jaquith,
D.
2002.
Memorandum:
Revision
to
Occupational
and
Residential
Exposure
Assessment
for
Thiabendazole
Use
for
Post
Harvest
Treatment.
Dated
February
7,
2002.

Jaquith,
D.
2004.
Memorandum:
Occupational
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
Ethoxyquin.
Dated
June
30,
2004.

Louie,
R.
2005.
Memorandum:
Use
Closure
Memorandum
for
Conventional
Uses
of
2­
phenyphenol
Salts
Case
#
2575:
2­
phenyphenol
PC
#
064103;
Sodium
2­
phenyphenate
PC
#
064104
to
Support
the
Reregistration
Eligibility
Decision
(
RED).
Dated
July
18,
2005.

Maxey,
S.
W.,
and
Murphy,
P.
G.
1994.
Evaluation
of
Post­
Application
Exposures
to
Sodium
o­
Phenylphenate
Tetrahydrate/
o­
Phenylphenol
to
Workers
During
Post­
Harvest
Activities
at
Pear
and
Citrus
Fruit
Packaging
Facilities.
Dated
10/
19/
1994.
MRID
No.
43432901.
The
Dow
Chemical
Company.

Morris,
L.
1993.
Memorandum:
Review
of
Protocol
for
Post­
Application
Exposure
to
Sodium
o­
Phenylphenate
Tetrahydrate.
Dated
June
15,
1993.

Tadayon,
S.
2000.
Memorandum:
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Documents
for
Imazalil.
Dated
December
25,
2000.
Page
23
of
28
APPENDIX
A
Summary
of
Registered
Products
Label
Extractions
Page
24
of
28
o­
Phenylphenol
(
PC#
064103)

Registered
Product
(%
ai)
Crop/
Use
App
Equipment
Max
App
Rate
(
ai)
Max
Exposure
Time
Comments/
Description
The
following
two
products
were
initially
listed
for
conventional
use:

$
2792­
35:
canceled
as
of
21JUL05
$
43410­
9:
not
labeled
for
use
on
citrus
or
pears
(
labeled
for
tomatoes,
cucumbers,
and
peppers
only)

o­
Phenylphenol,
sodium
salt
(
PC#
064104)

Wash
tank
0.0463
lb
ai/
gal
soln
(
0.35%
soln)

Citrus
Bin
drencher
0.0066
lb
ai/
gal
soln
(
0.05%
soln)
5
minutes
Deccosol
122
Concentrate
Reg
No.
2792­
28
(
14.5%)
Pears
Wash
tank
Bin
drencher
0.0422
lb
ai/
gal
soln
(
0.05%
soln)
4
minutes
Liquid
(
SC)

PPE
­
Baseline,
gloves,

goggles/
faceshield
Citrus
Mechanical
washer
0.0592
lb
ai/
gal
soln
(
0.6%
soln)
4
minutes
Stop­
Mold
AF@

Reg
No.
43553­
20
(
22.6%)
Pears
Mechanical
washer
0.0485
lb
ai/
gal
soln
(
0.5%
soln)
20
seconds
Liquid
(
SC)

PPE
­
not
on
label
Spray­
type
application;

apply
by
spraying
over
rolling
brushes
0.19
lb
ai/
gal
soln/
3000
lbs
fruit
(
2%
soln)
3
minutes
Foamex
Reg
No.
64864­
54
(
14.52%)
Citrus
Bin
drenchers
0.0285
lb
ai/
gal
soln
(
0.3%
soln)
3
minutes
Liquid
(
SC)

PPE
­
not
on
label
Citrus
spray,
flood,
dip
0.17
lb
ai/
gal
soln
(
2%
soln)
60
seconds
SOPP
Soap/
SOPP
Tank
Reg
No.
64864­
45
(
13%)
Pears
spray,
flood,
dip
0.17
lb
ai/
gal
soln
30
seconds
Liquid
(
SC)

PPE
­
Baseline,
gloves,

goggles/
faceshield
Page
25
of
28
(
2%
soln)

Tank/
spray
washer
0.0411
lb
ai/
gal
soln
(
0.5%
soln)
4
minutes
Citrus
Waxing
0.0812
lb
ai/
gal
soln/
10000
lbs
fruit
(
1%
soln)
Not
on
label
Freshguard
25
Reg
No.
8764­
1
(
25%)
Pears
flood
or
dip
0.0411
lb
ai/
gal
soln
(
0.5%
soln)
Not
on
label
Liquid
(
SC)

PPE
­
Baseline,
gloves,

goggles/
faceshield
Sta­
Fresh
401
Reg
No.
8764­
24
(
1.0%)
Citrus
spray
brush
applicator
0.133
lb
ai/
gal
soln/
10000
lbs
fruit
RTU
Product
conc
=

0.133
lb
ai/
gal
(
1%

ai);
apply
1
gal/
10000
lbs
fruit
Not
on
label
Liquid
(
SC)

PPE
­
not
on
label
Citrus
Foam
generator,
foam
washing
solution
0.1676
lb
ai/
gal
soln
(
2%
soln)
1
minute
Freshguard
5
Reg
No.
8764­
16
(
24%)
Pears
Foam
generator,
foam
washing
solution
0.155
lb
ai/
gal
soln
(
1.86%
soln)
30
seconds
Liquid
(
SC)

PPE
­
not
on
label
Fresh
Foam
26F
Foam
Cleaner
Reg
No.
33354­
2
(
14.15%)
Citrus
Foaming
or
brushing
0.185
lb
ai/
gal
soln
(
1.94%
soln)
30
seconds
Liquid
(
SC)

PPE
­
not
on
label
Steri­
Seal
AD@

Reg
No.
57227­
7
(
22.6%)
Pears
XEDA
Fogging
machine
0.0633
lb
ai/
2200
lbs
fruit;
0.0234
gal/
2200
lbs
fruit
RTU
Product
conc
=

2.7
lb
ai/
gal
(
22.6%

ai);
apply
3
fl
oz/
2200
lbs
fruit
Not
on
label
Liquid
(
SC)

PPE
­
Baseline,
gloves,

goggles/
faceshield
Page
26
of
28
APPENDIX
B
Exposure
and
Risk
Calculation
Page
27
of
28
OPP,
and
salts
Short­
and
Intermediate­/
Long­
Term
Dermal
and
Inhalation
Postapplication
Exposure
Calculations
Adult
Body
Weight
­
Gen
Pop
(
kg)
70
100**
Target
MOE
Exposure
Factors
ST
Dermal
NOAEL
(
mg/
kg/
day)
100
ST
Inhalation
NOAEL
(
mg/
kg/
day)
100
IT/
LT
Dermal/
Inhalation
NOAEL
(
mg/
kg/
day)
39
100**

Dermal
absorption
factor
(
use
for
IT/
LT
risk
only)
43%

Adult
Inhalation
rate
(
m3/
hr)
1.6
Typical
work
day
(
hrs/
day)
8
Inhalation
absorption
factor
100%

Conversion
Factor
(
ug/
mg)
1000
Postapplication
Activity
Location
Crop
Dermal
MOE
Inhalation
MOE**

Mean
Max
Mean
Max
Mean
Max
Mean
Max
Mean
Max
Mean
Max
Mean
Mean
WA
Pears
59071.28
136251.21
95.10
154.00
0.84388
1.9464
0.01739
0.0282
120
51
5800
3600
110
2200
FL
Citrus
9060.77
12699.82
19.80
29.80
0.12944
0.1814
0.00362
0.0054
770
550
28000
18000
700
11000
CA
Citrus
3237.94
7989.15
7.58
27.40
0.04626
0.1141
0.00139
0.005
2200
880
72000
20000
2000
28000
WA
Pears
37419.93
53452.174
75.39
96.40
0.53457
0.7636
0.01378
0.0176
190
130
7300
5700
170
2800
FL
Citrus
5525.672
11373.849
4.56
5.43
0.07894
0.1625
0.00083
0.001
1300
620
120000
100000
1100
47000
CA
Citrus
1271.112
2860.4651
6.75
16.70
0.01816
0.0409
0.00123
0.0031
5500
2400
81000
33000
5000
32000
FL
Citrus
28996.32
46751.381
26.95
50.00
0.41423
0.6679
0.00493
0.0091
240
150
20000
11000
220
7900
CA
Citrus
8029.353
12068.217
93.23
197.00
0.11471
0.1724
0.01705
0.036
870
580
5900
2800
790
2300
*
Dermal
exposures
are
adjusted
to
the
maximum
labeled
application
rate
of
2%
solution
**
Inhalation
MOEs
below
1000
may
warrant
confirmatory
inhalation
tox
data
IT/
LT
Risk
Pre­
sorter
Dermal
MOE
Inhalation
MOE**

ST
Risk
Packer
Inhalation
(
ug
ai/
m3)

Sorter
(
mg/
kg/
day)
(
mg/
kg/
day)

Inhalation
Daily
Dose
Dermal
Exposure
Dermal*

(
ug
ai/
day)
Page
28
of
28
OPP,
and
salts
Short­
and
Intermediate­/
Long­
Term
Dermal
and
Inhalation
Handler
Exposure
Calculations
Adult
Body
Weight
­
Gen
Pop
(
kg)
70
Exposure
Factors
Targe
t
MOE
ST
Dermal
NOAEL
(
mg/
kg/
day)
100
ST
Inhalation
NOAEL
(
mg/
kg/
day)
100
IT/
LT
Dermal/
Inhalation
NOAEL
(
mg/
kg/
day)
39
100*

Dermal
absorption
factor
(
use
for
IT/
LT
risk
only)
43%

Adult
Inhalation
rate
(
m3/
hr)
1.6
Typical
work
day
(
hrs/
day)
8
Inhalation
absorption
factor
100%

Conversion
Factor
(
ug/
mg)
1000
App
Equipment
Crop(
s)
Formulation
Daily
Area
Treated
Max
App
Rate
Handler
Scenario
(
lbs
fruit/
day)
(
lb
ai/
lb
fruit)
Inhalation
Inhalation
Inhalation
MOE
Inhalation
MOE
(
ug/
lb
ai)
(
mg/
kg/
day)

Baseline
Baseline/
Gloves
Baseline
Baseline
Baseline/
Gloves
Baseline
Baseline
Baseline/
Gloves
Baseline
Baseline
Baseline/
Gloves
Baseline
Thermofogger
Pears
RTU
1440000
0.0000288
M/
L
2.9
0.023
1.2
1.718126
0.013626514
0.000710949
58
7300
140000
53
6700
55000
M/
L
2.9
0.023
1.2
3.776297
0.029949943
0.001562606
26
3300
64000
24
3000
25000
A
**
see
below
0.016504686
6100
2400
M/
L
2.9
0.023
1.2
0.79344
0.0062928
0.00032832
130
16000
300000
110
14000
120000
A
**
see
below
0.016504686
6100
2400
*
Inhalation
MOEs
below
1000
may
warrant
confirmatory
inhalation
tox
data
**
Inhalation
Exposure
from
MRID
43432901
Area
(
ambient)
air
monitoring
TWA
(
ug/
m3)

Avg
(
arithmetic
mean)
from
all
data
points
38.6
Avg
(
arithmetic
mean)
from
Facility
6
(
highest
avg)
90.26
IT/
LT
Risk
NA
NA
Dermal
MOE
Negligible
Negligible
Negligible
1440000
0.0000133
Negligible
Negligible
Negligible
Unit
Exposure
Dermal
(
mg/
kg/
day)

(
mg/
lb
ai)
Dermal
MOE
Dermal
ST
Risk
Daily
Dose
Citrus
&
Pears
1440000
0.0000633
SC/
EC
Automated
spraying,
dipping,

brushing,
foaming
100*

Citrus
RTU
