1
MEMORANDUM
DATE:
04/
10/
2006
SUBJECT:
Ortho
Phenylphenol,
and
its
Sodium
and
Potassium
Salts.
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
PC
Codes:
064103,
064104,
064108
REVIEWER:
Robert
Quick,
Chemist
Risk
Assessment
&
Science
Support
Branch
Antimicrobials
Division
(
7510C)

THROUGH:
Norm
Cook,
Chief
Risk
Assessment
&
Science
Support
Branch
Antimicrobials
Division
(
7510C)

TO:
Rebecca
Miller,
Chemical
Review
Manager
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)
2
I.
Introduction
Ortho
phenylphenol(
OPP)
and
its
potassium
and
sodium
salts
are
antimicrobials
that
can
be
used
as
disinfectants
or
sanitizers
on
counter
tops,
tables,
refrigerators;
on
animal
premises;

as
a
preservative
in
papermaking;
as
a
preservative
in
adhesives
and
on
mushroom
premises.

There
are
other
registered
uses
for
these
chemicals
that
include
but
are
not
limited
to
odor
elimination
in
rooms,
beauty
parlors
and
medical
premises.
There
are
registered
products
that
contain
OPP
or
its
potassium
and
sodium
salts
as
active
ingredients
that
may
result
in
dietary
exposure.

These
uses
of
antimicrobial
chemicals
on
food
or
feed
contact
surfaces,
agricultural
commodities,
in
animal
premises
and
poultry
premises
including
hatcheries
and
application
to
food­
grade
eggs,
in
papermaking,
in
mushroom
houses,
in
hydroponic
growing
of
commodities,
in
plastics
and
polymers
and
in
adhesives
may
result
in
pesticide
residues
in
human
food.
These
uses
are
indirect
food
uses.
The
Agency
must
determine
the
risk
to
human
health
that
may
occur
from
exposure
to
these
chemicals.

Residue
Information
Review
of
the
Agency's
residue
chemistry
database
does
not
show
any
residue
data
for
ortho
phenylphenol
on
food
or
on
any
food
commodities
as
a
result
of
antimicrobial
use.

Note:
Agricultural
uses
for
ortho
phenylphenol
on
raw
agricultural
commodities
are
being
reviewed
by
the
Health
Effects
Division.
The
U.
S.
D.
A.
Pesticide
Data
(
PDP)
program
provides
some
residue
data
for
mushrooms,
presumably
from
an
antimicrobial
use.
No
other
residue
chemistry
data
and
analyses
are
available
for
inclusion
in
this
antimicrobial
dietary
exposure
chapter.
3
II.
Dietary
Exposure
and
Risks
to
Ortho
Phenylphenol
as
an
Indirect
Food
Additive
REFRIGERATORS,
COUNTER
TOPS,
SINKS
AND
STOVES
REFRIGERATORS,
COUNTER
TOPS,
SINKS
AND
STOVES
are
use
sites
on
registered
labels.
These
surfaces
that
have
been
treated
with
the
ortho
phenylphenol
products
may
bear
small
residues
of
the
ortho
phenylphenol
products
after
rinsing
with
potable
water;
i.
e.,
rinsing
with
potable
water
may
not
remove
all
residues
deposited
on
the
treated
surfaces
from
the
proposed
uses.
Note:
Historically
the
EPA
and
the
Food
&
Drug
Administration
have
taken
the
position
that
rinsing
treated
surfaces
with
potable
water
removes
all
residues.
The
Agency
recognizes
that
rinsing
treated
surfaces
with
potable
water
does
not
remove
all
residues
from
treated
surfaces
and
also
recognizes
that
not
all
users
do
rinse
treated
surfaces.
More
recent
information
shows
that
while
a
portion
of
the
residue
is
rinsed
from
treated
surfaces
by
a
potable
water
rinse,
some
residue
deposits
will
remain.
Residues
from
treated
surfaces
can
migrate
to
food
coming
into
contact
with
the
treated
and
rinsed
surfaces
and
can
be
ingested
by
humans.

The
maximum
rate
for
ortho
phenylphenol
in
sanitizer
end­
use
solutions
that
is
permitted
in
the
40
CFR
180.940
is
400
ppm.
The
maximum
concentration
in
an
end­
use
solution
in
a
product
registered
as
a
disinfectant
is
4200
ppm;
e.
g.
Reg.#
1270­
237
is
a
ready­
to­
use
disinfectant
product
containing
0.216%
OPP
(
2160
ppm
of
OPP)
and
Reg.#
777­
27
a
ready­
to­
use
disinfectant
product
containing
0.42%
OPP
(
4200
ppm
OPP).
Calculation:
%

A.
I.
in
formulation
x
10,000).
The
reason
for
this
is
probably
because
it
was
assumed
when
cleaning
and
disinfectant
products
were
registered
for
application
to
food
contact
surfaces,

rinsing
treated
surfaces
or
washing
treated
surfaces
with
soap
and
water
would
remove
residues
and
that
there
would
not
be
a
transfer
of
residues
to
food
that
contacts
treated
surfaces.

In
the
absence
of
residue
data
for
residues
of
ortho
phenylphenol
on
treated
food
contact
surfaces,

the
Agency
can
calculate
residue
levels
that
may
occur
in
food
from
the
application
rates
on
food
contact
surfaces.
4
To
estimate
the
Estimated
Daily
Intake
(
EDI),
the
Agency
has
used
the
following
model
calculation.
This
model
is
taken
from
FDA
Guidelines.

1.
The
maximum
ingredient
percentage
for
ortho
phenylphenol
in
a
ready­
to­
use
product
registered
for
use
on
drain
boards,
cabinets,
counters,
refrigerators
and
stoves
is
0.42%

(
EPA
Reg.
777­
27).

The
concentration
of
ortho
phenylphenol
in
the
one
product
is
4200
ppm(
0.42%
x
10,000)

EDI
from
Equation
1
=
4200
µ
g/
1000
mg(
ppm)
x
0.10
mg/
cm2
x
2000
cm2
/
kg
BW
=
840
µ
g
a.
i./
BW
Assuming
that
an
average
adult
consumes
3000
gm
of
food
per
day,

840
µ
g
a.
i./
3000
gm
food
=
0.28
µ
g
a.
i./
gm
(
ppm)
of
food
840
µ
g
a.
i./
70
kg
BW
=
12
µ
g
ortho
phenylphenol/
kg/
day
for
male
adult
840
µ
g
a.
i./
60
kg
BW
=
14
µ
g
ortho
phenylphenol/
kg/
day
for
female
adult
840
µ
g
a.
i./
15
kg
BW
=
56
µ
g
ortho
phenylphenol/
kg/
day
for
child
2.
The
maximum
application
rate
for
ortho
phenylphenol
in
food
handling
establishments
from
the
various
labeled
products
that
are
diluted
with
water
prior
to
use
is
0.5
fl
oz/
gallon
for
a
product
containing
10.5%
a.
i.(
EPA
Reg.#
70627­
6)

Calculation:

0.5
oz
of
product/
gal
of
water
5
0.5
oz
product/
128
fl
oz
of
water
=
0.39%
solution
of
product
in
water
ortho
phenylphenol
in
formulation
is
10.5%

0.105
x
0.0039
x
1,000,000
=
410
ppm
of
ortho
phenylphenol
in
treatment
water
EDI
from
Equation
1
=
410
µ
g/
1000
mg(
ppm)
x
0.10
mg/
cm2
x
2000
cm2
/
kg
BW
=
82
µ
g
a.
i./
BW
Assuming
that
an
average
person
consumes
3000
gm
of
food
per
day,

82
µ
g
a.
i./
3000
gm
food
=
0.027
µ
g
a.
i./
gm
(
ppm)
of
food
82
µ
g
a.
i./
70
kg
BW
=
1.2
µ
g
ortho
phenylphenol/
kg/
day
for
male
adult
82
µ
g
a.
i./
60
kg
BW
=
1.4
µ
g
ortho
phenylphenol/
kg/
day
for
female
adult
82
µ
g
a.
i./
15
kg
BW
=
5.5
µ
g
ortho
phenylphenol/
kg/
day
for
a
child
*
The
10%
transfer
rate
for
residues
is
taken
from
the
Agency
Residential
SOPs.
The
use
of
the
10%
transfer
rate
instead
of
the
use
of
a
100%
transfer
rate
that
is
used
in
the
FDA
Sanitizer
Solution
Guidelines
requires
the
submission
of
confirmatory
data
to
establish
the
reliability
of
the
use
of
the
10%
transfer
rate.

Dishwashing
Liquid
Use
Ortho
phenylphenol
is
registered
as
a
preservative
in
a
dishwashing
liquid.
The
use
is
to
formulate
a
dishwashing
liquid
containing
0.01­
0.08
lbs
of
the
antimicrobial
formulation
containing
sodium
ortho
phenylphenate
to
100
lbs
of
dishwashing
liquid.
The
antimicrobial
formulation
contains
25.3%
active
ingredient
(
EPA
Reg.#
464­
656)(
equivalent
to
22.4%
ortho
phenylphenol).
A
dishwashing
liquid
could
be
used
on
dishes,
glassware,
utensils
pots
and
pans,
counter
tops,
6
stoves.
This
would
be
equivalent
to
exposing
the
human
dietary
intake
to
at
least
4,000
cm2
per
day
of
treated
surface
The
Agency
does
not
have
a
model
for
estimating
residues
in
food
resulting
from
a
dishwashing
use.
We
are
using
a
model
that
appears
on
the
internet
as
http://
www.
scienceinthebox.
com/
en­

UK/
safety/
imgestionfromsurface­
en.
html.
This
model
uses
a
dishware
surface
area
of
5400
cm2/
day.

The
equation
cited
is:

Oral
exposure
from
residue
on
dishware
=
(
amount
of
liquid
product
used
in
wash
cycle)
x
(
amt.

of
a.
i.
in
a
formulation)
x
(
rinse
water
in
contact
with
dishware
surface)
x
(
portion
of
product
in
final
rinse
cycle)
x
dishware
surface
area
per
day)]/
(
mean
body
weight
for
consumers)
=

gm/
kg/
day
In
the
case
of
this
ortho
phenylphenol
preservative
added
to
the
dishwashing
product,
the
calculation
would
use
a
figure
of
0.018%
a.
i.
in
the
product
formulation.

Calculation
for
Dishwashing
Use:

0.08
lb
a.
i.
0.224(%
of
ortho
phenylphenol
in
the
formulation/
100
lb
of
dishwashing
product)
x
100
=
0.018%
ortho
phenylphenol
in
the
dishwashing
product
Then:

(
105
gm
(
amount
of
liquid
product
used
in
wash
cycle)
x
0.018%
(
amt.
of
a.
i.
in
a
formulation)
x
0.0023
gm/
cm2
(
rinse
water
in
contact
with
dishware
surface)
x
0.39%
(
portion
of
product
in
final
rinse
cycle)
x
5400
cm2/
day
dishware
surface
area
per
day)]/
BW
(
mean
body
weight
for
consumers)
=
0.0000915
gm
a.
i./
BW/
day
or
91.5
µ
g/
BW/
day
91.5
µ
g/
a.
i.
per
day/
3000
gm
food
per
day
=
0.0305
µ
g
a.
i/
gm
of
food
or
0.0305
ppm
7
91.5
µ
g
a.
i./
70
kg
BW
=
1.3
µ
g
ortho
phenylphenol/
kg/
day
for
male
adult
91.5
µ
g
a.
i./
60
kg
BW
=
1.5
µ
g
ortho
phenylphenol/
kg/
day
for
female
adult
91.5
µ
g
a.
i./
15
kg
BW
=
6.1
µ
g
ortho
phenylphenol/
kg/
day
for
a
child
The
registered
uses
for
counter
tops
and
food
preparation
surfaces
provides
a
higher
dietary
exposure
for
ortho
phenylphenol
than
the
dishwashing
use
and
the
two
uses
could
be
additive.

Mushroom
Houses
Use
Potassium
ortho
phenylphenate
and
ortho
phenylphenol
formulations
can
be
used
in
mushroom
houses.
Mushrooms
are
a
food
crop
(
See
40
CFR
158,
App.
A,
1.
Agricultural
crops).
The
label
use
is
for
the
purpose
of
cleaning
and
sanitizing
non­
food
contact
surfaces
between
crops
in
mushrooms.
Surfaces
that
are
treated
include
tanks,
air
conditioners,
air
ducts,
fans
and
breezeways,
compost
wharf,
concreted
surfaces,
inside
and
outside
walls
of
mushroom
houses,

lofts,
floors,
spawning
machines,
tampers,
casing
rings,
storage
sheds
and
track
alleys
before
spawning.
Application
is
made
only
to
surfaces
that
do
not
come
into
contact
with
the
crop.

There
is
a
restriction
against
application
to
the
crop,
compost
or
casings.
Some
labels
do
not
require
rinsing
treated
or
washing
treated
surfaces
with
water
before
use.
Other
labels
specify
that
treated
surfaces
are
to
be
rinsed
with
potable
water
before
they
contact
the
crop,
compost
or
casing.

The
USDA
Pesticide
Data
Program
(
PDP)
provides
residue
monitoring
data
for
pesticide
chemicals
of
interest
on
various
agricultural
commodities.
The
monitoring
data
for
years
2001,

2002
and
2003
were
made
available
to
the
Antimicrobials
Division.
The
monitoring
data
for
these
years
reports
OPP
residues
in
mushrooms.
There
are
no
EPA
pesticide
tolerances
for
residues
of
OPP
in
mushrooms
(
40
CFR
180.129)
and
there
are
no
crop
groupings
for
mushrooms
in
the
40
CFR
180.41
under
which
mushrooms
could
be
included.
Mushrooms
are
specifically
excluded
from
crop
groupings
under
that
Regulation.
8
The
PDP
residue
monitoring
data
reports
residues
ranging
of
up
to
0.75
ppm
OPP
in/
on
mushrooms
over
the
2001­
2003
timeframe.
The
2001
data
showed
OPP
residues
in
63
of
184
samples
analyzed.
Residues
in
mushrooms
had
declined
to
reports
of
OPP
in
35
of
552
samples
in
2003
but
the
highest
OPP
residue
reported
that
year
was
0.75
ppm.
(
Health
Effects
Division
notes
that
the
likely
cause
of
these
residues
involved
disinfection
and
sanitization
in
the
mushroom
houses).

It
is
likely
that
the
occurrence
of
OPP
residues
in
mushrooms
grown
in
mushroom
houses
that
have
been
disinfected
with
OPP
is
because
the
mushroom
houses
have
not
been
adequately
cleaned
after
the
disinfection
process.
The
cleaning
of
mushroom
houses
after
OPP
disinfection
involves
rinsing
with
water.
The
interiors
of
mushroom
houses
are
constructed
of
wood
and
it
is
difficult
to
totally
eliminate
OPP
residues
from
the
treated
wood
with
a
washing
process.
The
OPP
is
likely
absorbed
into
the
wood
and
then
slowly
released
into
the
mushroom
compost
and
is
available
for
uptake
by
the
mushrooms
grown
in
the
treated
house.

The
establishment
of
a
tolerance
for
indirect
residues
of
OPP
in
mushrooms
under
a
40
CFR
180.129
subsection
should
be
considered.

General
Agricultural
Premise
Use
Agricultural
premise
uses
involve
the
application
of
a
pesticide
chemical
to
the
hard
surface
interior
surfaces
of
the
interior
of
barns
and
poultry
houses.
These
uses
involve
application
to
the
physical
structure
of
the
premises
(
including
floors
and
walls)
and
also
include,
but
not
limited
to,

watering
troughs,
feed
troughs,
animal
halters,
ropes
and
forks.
(
See
40
CFR
158,
App.
A,
5.
Pets
and
Domestic
Animals­
animals
and
their
man­
made
premises
which
includes
dairy
and
meat
animals;
and
40CFR
158.
A,
4.
Processed
and
manufactured
products,
and
food
or
feed
containers
or
dispensers.)

The
ortho
phenylphenol
labels
also
include
either
a
potable
water
rinse
or
a
soap/
detergent
scrubbing
following
a
ten
minute
wait
after
application.
Historically
a
scrubbing
or
a
potable
rinse
after
pesticidal
application
has
been
considered
a
non­
food
use.
This
was
because
it
was
assumed
9
that
the
wash
or
scrub
or
rinse
was
assumed
to
eliminate
all
residues
from
the
treated
surfaces.

However
with
the
advent
of
improved
and
more
sensitive
analytical
methods,
it
has
been
found
that
small
residues
would
be
expected
to
remain
after
scrubbing
or
rinsing.
This
would
be
especially
true
of
treated
wood
surfaces.
Wood
is
porous
and
residues
would
likely
be
absorbed
into
the
treated
surfaces.
This
would
also
be
true
to
a
lesser
extent
on
concrete
surfaces.
Metal
surfaces
would
not
be
porous
and
rinsing
well
or
scrubbing
would
likely
remove
most
or
all
pesticide
residues.
Livestock
feed
and
watering
troughs
would
be
filled
with
feed
and
water
and
would
be
expected
to
absorb
some
of
the
remaining
residue
from
the
treated
surfaces.

Consumption
by
livestock
of
feed
and
water
bearing
pesticide
residues
may
result
in
pesticide
residues
in
animal
tissues,
milk,
poultry
tissues
and
eggs.
This
would
necessitate
the
establishment
of
pesticide
animal
commodity
tolerances
under
the
Food,
Drug
&
Cosmetic
Act.
Tolerances
for
these
commodities
would
be
inserted
into
the
EPA
Title
40
CFR
180
along
with
other
pesticide
tolerances.

Note:
The
establishment
of
tolerances
for
animal
commodities
also
occurs
in
those
cases
in
which
an
agricultural
pesticide
is
used
in
livestock
premises.
In
those
cases,
there
are
generally
other
pesticidal
uses
from
either
animal
feed
or
dermal
treatment
uses
for
the
agricultural
chemical
that
result
in
higher
pesticide
residues
in
animal
commodities
that
necessitate
the
establishment
of
livestock
commodity
tolerances.
The
need
for
livestock
tolerance
commodity
tolerances
for
those
pesticide
uses
in
agricultural
premises
is
encompassed
by
other
animal
feed
or
dermal
treatment
uses
that
result
in
animal
commodity
tolerances.

In
addition
to
animals
consuming
feed
and
water
from
treated
troughs,
livestock
would
also
ingest
residues
from
chewing
on
treated
wood
in
livestock
structures.

Livestock
would
also
likely
inhale
residues
from
the
air
in
treated
farm
structures
and
would
also
be
exposed
dermally
to
residues
in
treated
farm
structures
through
rubbing
themselves
on
the
treated
surfaces.
These
residues
could
also
appear
as
secondary
residues
in
animal
tissues
and
milk
and
in
poultry
tissues
and
eggs.
10
There
are
no
residue
data
for
livestock
and
poultry
reflecting
the
application
of
ortho
phenylphenol
or
its
potassium
and
sodium
salts
to
agricultural
premises.

The
labels
do
not
bear
any
restrictions
for
the
farm
premises
uses
that
would
prohibit
treatment
of
wood
feed
and
water
troughs,
racks
and
other
feeding
and
watering
devices.
Residues
would
likely
be
absorbed
into
the
wood
surfaces
of
farm
premises
and
would
not
be
completely
removed
by
soap/
detergent
scrubbing
and
potable
water
rinses.
Wood
is
a
likely
construction
material
that
would
be
used
in
construction
of
farm
premise
equipment,
especially
on
smaller
farms.

These
residues
would
be
ingested
in
the
human
diet.
The
label
uses
for
agricultural
premises
would
not
be
a
non­
food
use.

Confirmatory
data
are
needed
to
show
whether
residues
would
be
absorbed
into
treated
surfaces,

especially
wood
surfaces,
of
feeding
devices
and
not
be
removed
by
scrubbing
with
soap
and
rinsing
with
water.
If
the
antimicrobial
residues
are
absorbed
into
the
wood,
these
residues
would
be
available
for
livestock
ingestion.
This
finding
could
entail
the
need
to
generate
data
for
large
animals
including
livestock
and
poultry
metabolism
studies,
analytical
methods
for
livestock
and
poultry
tissues
and
residue
data
for
livestock
and
poultry.

Poultry
Hatcheries
Use
Poultry
hatcheries
are
not
used
in
the
production
of
eggs
for
food­
grade
eggs
for
human
consumption.
Hatchery
eggs
are
used
for
the
production
of
chicks.

Sanitizer
chemicals
could
penetrate
the
egg
shell
and
become
a
residue
in
the
developing
chick.

Any
residues
that
did
penetrate
the
egg
shell
and
occur
in
the
chick
would
not
be
expected
to
be
detectable
in
birds
that
are
ready
for
consumption
because
of
growth
dilution
in
the
growing
birds.

The
use
of
ortho
phenylphenol
products
in
poultry
hatcheries
appears
to
be
a
non­
food
use.
11
Poultry
Laying
Facilities
Use
A
registered
use
exists
for
application
in
a
poultry
laying
operation
(
e.
g.,
EPA
Reg.#
11725­
7).

The
use
is
not
an
egg
sanitizer
use.
Residues
could
remain
on
treated
layer
facilities
after
treatment
and
rinsing
with
potable
water
or
after
scrubbing
with
soap
and
water.
As
a
result,
trace
residues
could
occur
on
egg
shells
that
contact
treated
and
rinsed
surfaces.
However
these
would
be
minimal
and
would
not
likely
penetrate
the
egg
shell.
Measurable
residues
would
not
be
expected
to
occur
in
the
egg
content
from
this
type
of
use.

Greenhouse
and
Hydroponic
Uses
Food
commodities
can
be
grown
in
greenhouses
(
See
40
CFR
158,
App.
A,
1.
Agricultural
crops,

includes
commercial
greenhouses
for
greenhouse
food
crops)
and
on
hydroponic
farms.
The
food
commodities
can
be
grown
in
a
growing
media
or
hydroponically
in
water.

There
is
a
label
restriction
against
application
to
crop,
soil
or
growing
media
in
which
a
crop
grows
or
will
be
grown.
There
is
also
a
label
instruction
that
requires
a
potable
water
rinse
before
treated
surfaces
contact
the
crop
or
the
substrate
in
which
the
crop
is
or
will
be
grown.

A
potable
water
rinse
for
treated
surfaces
will
likely
remove
a
part,
but
not
all
of
the
residues
from
treated
surfaces.
The
growing
structures
could
be
made
of
wood,
plastic,
concrete
or
metal.

The
greatest
potential
for
residues
adhering
to
treated
surfaces
would
be
expected
to
be
from
the
use
of
wood
structures.
Wood
is
porous
and
residues
would
likely
be
absorbed
into
the
treated
surfaces.
This
would
also
be
true
to
a
lesser
extent
on
concrete
surfaces.
Metal
surfaces
would
not
be
porous
and
rinsing
well
or
scrubbing
would
likely
remove
most
or
all
pesticide
residues.

Confirmatory
data
are
needed
to
show
whether
ortho
phenylphenol
residues
would
be
absorbed
into
treated
surfaces,
especially
wood
surfaces,
of
feeding
devices
and
not
be
removed
by
scrubbing
with
soap
and
rinsing
with
water.
If
the
antimicrobial
residues
are
absorbed
into
the
growing
structures
these
residues
would
be
available
for
plant
uptake
with
residues
occurring
in
the
food
plants.
12
Polymers
and
Plastics
Use
There
is
a
registered
use
for
ortho
phenylphenol
in
polymers
and
plastics:
0.1­
0.5%
by
weight
of
material
to
be
protected
(
e.
g.,
EPA
Reg.#
464­
126).

This
formulation
can
be
formulated
into
polymers
and
plastics
which
could
have
contact
with
both
food
and
water.
The
use
of
label
restrictions
to
preclude
food
contact
with
impregnated
plastics
and
polymers
would
not
be
practical
because
the
end
use
of
treated
plastics
would
be
difficult
to
control.
This
is
an
indirect
food
use.
The
antimicrobial
chemical
can
migrate
out
of
the
polymer/
plastic
into
food
and
water
and
be
ingested
by
humans.
The
use
of
ortho
phenylphenol
under
21
CFR
177.1632
for
articles
with
repeated
contact
with
food
is
for
the
ortho
phenylphenol
to
be
included
at
0.01%
of
base
polymer.

There
are,
to
our
knowledge,
no
migration
studies
for
ortho
phenylphenol
from
plastics
and
polymers.
If
the
registrant(
s)
has
submitted
migration
data
to
the
FDA,
the
Agency
should
receive
a
copy
of
the
study
so
that
those
data
can
be
included
in
our
risk
assessment.

Otherwise,
a
migration
study
should
be
generated
for
OPP
and
submitted
to
the
Agency.

Wood
and
Wood
Product
Use
There
is
a
registered
use
for
ortho
phenylphenol
on,
Apallets,
fruit
and
vegetable
pallets:
1­
3%
by
wt
of
solution@,
(
e.
g.,
EPA
Reg.#
464­
126).
The
definition
of
a
pallet
is:
Aa
portable
platform
for
handling,
storing,
or
moving
materials
and
packages@.
The
registrant(
s)
should
clarify
whether
this
use
includes
packing
crates
for
fruits
and
vegetables
and
whether
the
use
will
permit
contact
between
treated
wood
and
fruits
and
vegetables.
Note:
Dow
Chemical
believes
that
the
residues
of
ortho
phenylphenol
on
mushrooms
may
be
attributed
to
the
use
of
ortho
phenylphenol
on
treated
wood
used
in
the
construction
of
containers
that
were
used
to
ship
mushrooms.

There
is
also
a
registered
use
for
ortho
phenylphenol
as
a
temporary
sapstain
control
for
fresh
cut
lumber
and
other
lumber
in
fruit
and
vegetable
containers
at
a
rate
of
5.7­
17.0%(
e.
g.,
EPA
Reg.#
13
39967­
11).
It
is
unclear
what
the
dosage
applies
to.
This
appears
to
be
a
use
for
ortho
phenylphenol
intended
for
use
in
wood
for
fruit
and
vegetable
crates.
This
use
has
the
potential
for
transfer
of
residues
to
the
agricultural
produce
packed
in
the
containers.
Residue
data
are
needed
to
show
the
residual
level
of
residue
that
could
transfer
from
the
treated
wood
crate
to
fruits
and
vegetables
in
contact
with
the
treated
wood.

Paper
Slurry
Uses
The
Food
&
Drug
Administration
establishes
the
21
CFR
Regulations
and
or
the
FDA
Notifications
for
food
contact
paper
uses
for
antimicrobial
chemicals.
There
are
no
paper
uses
listed
for
slimicide
use
in
the
21
CFR
176.300
or
in
the
FDA
Notifications
for
Food
Contact
Substances.
Sodium
o­
phenylphenate
is
cleared
for
use
in
paper
coatings
in
21
CFR
176.170(
b)(
2)
and
21
CFR
176.180(
b)(
1).
There
is
also
a
use
for
ortho
phenylphenol
as
a
defoamer
in
the
21
CFR
176.200.

It
is
unclear
to
us
from
the
labels
whether
o­
phenylphenol
is
intended
for
use
as
a
slimicide.

The
use
purpose
on
some
labels
is
to
protect
from
deterioration
during
manufacture,
storage
and
service
life.
The
ortho
phenylphenol
registrants
should
clarify
the
label
uses
for
paper
auxiliaries
and
paper
slurries.
In
the
absence
of
other
information,
we
are
assuming
that
this
is
a
slimicide
use.
If
use
is
intended
as
a
paper
slimicide
or
as
a
paper
coating,
clearance
from
the
FDA
must
be
sought.

The
maximum
label
use
rate
proposed
on
the
labels
with
a
paper
slurry
use
(
presumably
a
slimicide
use)
is
0.6%
of
the
product
(
0.12%
active
ingredient).
It
is
unclear
from
the
label
whether
this
concentration
is
for
the
paper
slurry
or
for
the
end
paper
product.
We
will
consider
that
the
use
rate
is
for
the
paper
slurry
at
the
wet
end
of
the
papermaking
process.
(
Note:
0.12%

is
1200
ppm).
The
registrant(
s)
must
clarify
the
use
pattern.

Paper
Slimicide
Use
RASSB
calculations
based
on
FDA
modeling
for
the
slimicide
use:
14
If
RASSB
uses
the
FDA
model
to
calculate
residue
levels
in
paper
and
in
food,
the
following
assumptions
would
be
used:

$
The
maximum
label
use
rate
proposed
on
the
labels
with
a
paper
slurry
use
is
0.6%
of
the
product
(
0.12%
active
ingredient).
It
is
unclear
from
the
label
whether
this
concentration
is
for
the
paper
slurry
or
for
the
end
paper
product.
We
will
consider
that
the
use
rate
is
for
the
paper
slurry
at
the
wet
end
of
the
papermaking
process.
(
Note:
0.12%
is
1200
ppm).

$
Prior
to
entering
the
driers,
the
pulp
slurry
is
33%
pulp
and
67%
water.

$
The
standard
basis
weight
for
paper
is
that
the
paper
weighs
50
mg/
in2.

$
Finished
paper
(
after
paper
making)
contains
approximately
92%
pulp
and
8%
water.

$
Food
mass
to
surface
area
of
treated
paper
is
10
gm
food/
in2.

$
There
is
100%
migration
of
the
ortho
phenylphenol
residue
from
the
treated
paper
into
food.
The
consumption
factor
is
10%
(
from
the
FDA
guidance
document
for
indirect
food
additives.

Many
of
the
above
assumptions
are
from
the
FDA
document
entitled,
Recommendations
For
Chemistry
Data
For
Indirect
Food
Additive
Petitions.

The
proposed
use
is
for
application
of
otho
phenylphenol
to
be
added
to
the
paper
slurry
at
a
rate
of
0.12%
of
the
slurry.

Then
the
concentration
of
active
ingredient
(
a.
i.)
in
the
pulp
prior
to
entering
the
driers
is:

(
Application
rate)
x
(
water/
pulp
ratio)

(
1200
µ
g
a.
i./
gm
of
pulp
slurry)
(
0.67
gm
water/
0.33
gm
pulp)
=
2436
µ
g
ortho
phenylphenol/
gm
15
pulp
Then,
the
dietary
concentration
is:

(
µ
g
of
a.
i./
gm
of
pulp)
(
gm
of
pulp/
gm
of
paper)
(
basis
weight
of
paper)
(
food
mass
to
surface
area)

(
2436
µ
g
a.
i
/
gm
pulp)
(
0.92
gm
pulp/
gm
of
paper)
(
0.05
gm/
in.
2)
(
1
in.
2/
10
gm
food)
=

11.2
µ
g
of
ortho
phenylphenol/
gm.
food.

Using
a
Consumption
Factor
of
0.1(
from
the
FDA
Recommendations
for
Chemistry
Data
For
Indirect
Food
Additive
Petitions)
for
uncoated
paper,
the
concentration
of
ortho
phenylphenol
in
the
daily
diet
is
then;

11.2
µ
g.
a.
i./
gm.
of
food
x
0.1
=
1.12
µ
g
of
ortho
phenylphenol/
gm.(
1.12
ppm)
of
food.

Assuming
3
kg
of
food
in
the
daily
diet
for
an
adult
and
1500
gm
for
a
child,
then:

1.12
µ
g
of
ortho
phenylphenol/
gm
of
food
x
3000
gm
=
3360
µ
g
ortho
phenylphenol/
adult/
day
1.12
µ
g
of
ortho
phenylphenol/
gm
of
food
x
1500
gm
=
1680
µ
g
ortho
phenylphenol/
child/
day
3360
µ
g
a.
i./
70
kg
BW
=
48
µ
g
ortho
phenylphenol/
kg/
day
for
male
adult
3360
µ
g
a.
i./
60
kg
BW
=
56
µ
g
ortho
phenylphenol/
kg/
day
for
female
adult
1680
µ
g
a.
i./
15
kg
BW
=
112
µ
g
ortho
phenylphenol/
kg/
day
for
a
child
We
understand
that
industry
residue
data
are
available
to
show
the
migration
level
of
OPP
from
OPP­
treated
paper
to
food.
These
data
will
be
submitted
to
the
Agency
to
support
registration.
16
Paper
Coating
Preservative
Use
RASSB
calculations
based
on
FDA
modeling
for
a
coating
use:

The
maximum
label
use
rate
proposed
on
the
labels
with
a
paper
auxiliary
use
is1.7%
of
the
product
(
0.34%
active
ingredient).
We
are
assuming
that
the
coating
use
and
that
the
slimicide
use
are
additive.

The
coating
use
for
Reg#
464­
78,
Dowicide
A,
contains
71.7%
sodium
ortho
phenylphenate
and
the
suggested
concentration
of
product
in
the
coating
is
0.1­
1.0%
or
0.717%
active
ingredient
in
the
coating
(
equivalent
to
0.63%
orthophenylphenol).
(
EPA
Reg.#
464­
78)

$
The
preservative
is
added
to
paper
coating
formulations
at
a
maximum
application
rate
of
6300
ppm
$
The
paper
coating
is
approximately
10%
by
weight
of
paper
$
The
standard
basis
weight
for
paper
is
that
the
paper
weighs
50
mg/
in2
$
Food
mass
to
surface
area
of
treated
paper
is
10
gm
food/
in2.

$
There
is
100%
migration
of
the
ortho
phenylphenol
residue
from
the
treated
paper
into
food.
The
consumption
factor
is
10%
(
from
the
FDA
guidance
document
for
indirect
food
additives.

Then,
the
dietary
concentration
is:

Calculations:

Application
rate
x
%
of
paper
that
is
coating
x
basis
weight
of
paper
x
food
mass
to
surface
area
x
%
migration
(
6300
µ
g
a.
i./
g
of
coating)
(
0.1
gm
coating/
gm
of
paper)
(
0.05
gm/
in2)
(
1
in2/
10
gm
of
food
=
3.15
17
µ
g
a.
i./
gm
of
food
Using
a
Consumption
Factor
of
0.1
(
from
the
FDA
guidance
document
for
indirect
food
additives.

3.15
µ
g.
a.
i./
gm.
of
food
x
0.1
=
0.315
µ
g
of
ortho
phenylphenol/
gm
of
food
Assuming
3
kg
of
food
in
the
daily
diet,
then:

0.32
µ
g
of
ortho
phenylphenol/
gm
of
food
x
3000
gm
=
960
µ
g
ortho
phenylphenol/
adult/
day
0.32
µ
g
of
ortho
phenylphenol/
gm
of
food
x
1500
gm
=
480
µ
g
ortho
phenylphenol/
child/
day
960
µ
g
a.
i./
70
kg
BW
=
13.7
µ
g
ortho
phenylphenol/
kg/
day
for
male
adult
960
µ
g
a.
i./
60
kg
BW
=
16.0
µ
g
ortho
phenylphenol/
kg/
day
for
female
adult
480
µ
g
a.
i./
15
kg
BW
=
32
µ
g
ortho
phenylphenol/
kg/
day
for
a
child
Adhesives
Use
Ortho
phenylphenol
is
cleared
for
use
by
the
Food
&
Drug
Administration
as
an
adhesive
component
(
21
CFR
175.105).
The
Food
&
Drug
Administration
provides
a
calculated
dietary
estimate
for
residues
resulting
from
use
of
an
adhesive
in
food
packaging
material
at
7
ppb.
(
April
2002.:
Guidance
for
Industry
Preparation
of
Food
Contact
Notifications
and
Food
Additive
Petitions
for
Food
Contact
Substances:
Chemistry
Recommendations.
Final
Guidance).
18
Table
1.
Cumulative
Estimated
Dietary
Intake/
Daily
Dietary
Dose
and
%
cPADs
for
Ortho
Phenylphenol
Use
Dietary
Conc.

(
ppb)
Estimated
Daily
Intake
(
µ
g/
person/
day)
Daily
Dietary
Dose
(
mg/
kg
bw/
day)
%
cPAD
Countertop
Disinfectant
280
840
(
adult)

420(
child)
0.012(
adult)

0.056(
child)
3.08
14.4
Dishwashing
Disinfectant
91.5
274(
adult)

137.5(
child)
0.004(
adult)

0.0092(
child)
1.03
2.36
Paper
Slimicide
Use
1120
3360(
adult)

1680(
child)
0.048(
adult)

0.017(
child)
12.3
4.36
Paper
Coating
Preservative
3200
960(
adult)

480(
child)
0.014(
adult)

0.032(
child)
3.59
8.21
Paper
Adhesive
Preservative
7
21(
adult)

10.5(
child)
0.0003(
adult)

0.0007(
child)
0.08
0.18
Cumulative
4978
5455(
adult)

2728(
child)
0.078(
adult)

0.11(
child)
20.1
29.5
19
4.4
DIETARY
EXPOSURE
ASSESSMENT
FOR
CONVENTIONAL
(
AGRICULTURAL)
PESTICIDES
This
part
of
the
non­
cancer
dietary
risk
assessment
was
carried
out
by
OPPs
Health
Effects
Division
(
David
Hrdy,
Barcode:
D319639).
It
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FDIC
J
),
Version
2.03
as
well
as
Lifeline
Model
Version
3.0
which
uses
food
consumption
data
from
the
USDAs
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
levels
tolerances
were
used
as
point
estimates.

The
chronic
analyses
were
below
the
Agencys
level
of
concern
for
the
general
US
Population
(
7.1%
of
cPAD)
and
all
other
population
subgroups
(
the
most
highly
exposed
being
children
1­
2
years
old
with
a
24.6%
of
the
cPAD).

Table
2.
(
attachment
from
Dave
Hrdys
document)
summarizes
the
Dietary
Exposure
for
OPP/
SOPP/
KOPP
based
on
DEEM­
FCID
J
and
Lifeline
Model
results.

====================================================
Table
2.
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%
20
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%
Males
20+
yrs
0.018416
4.7%
Seniors
55+
0.020089
5.2%

Children
1­
2
yrs
0.096127
24.6%
Children
3­
5
yrs
0.072170
18.5%
Children
6­
12
yrs
0.043942
11.3%
Youth
13­
19
yrs
0.027479
7.0%
Adults
20­
49
yrs
0.018780
4.8%
Adults
50+
yrs
0.019974
5.1%
Females
13­
49
yrs
0.020530
5.3%

III.
Discussion
of
Uncertainties
The
Agency
has
determined
that
a
10%
migration
factor
(
MF
in
equation
1)
will
be
used.
The
Agency
will
ask
for
confirmatory
data
to
support
the
10%
migration
factor.

REFERENCES
21
EPA,
1997.
AExposure
Factors
Handbook,
Volume
III:
Activity
Factors.@
EPA/
600/
P­
95/
002Fc
August
1997.

EPA,
1999.
AAvailable
Information
on
Assessing
Exposure
from
Pesticides,
A
User=
s
Guide.@

http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf.
Last
accessed
June
9,
2003.

FDA,
2003a.
Guidance
For
Industry:
Preparation
of
Food
Contact
Notifications
and
Food
Additive
Petitions
for
Food
Contact
Substances:
Chemistry
Recommendations.
Final
Guidance.

April,
2003.
http://
www.
cfsan.
fda.
gov/~
dms/
opa2pmnc.
html.
Last
accessed
June
9,
2003.

FDA,
2003b.
ASanitizing
Solutions:
Chemistry
Guidelines
for
Food
Additive
Petitions.@

January,
1993.
http://
www.
cfsan.
fda.
gov/~
dms/
opa­
cg3a.
html.
Last
accessed
June
9,
2003.
