1
MEMORANDUM
DATE:
09/
29/
2005
SUBJECT:
Para­
tertiary
amylphenol,
and
its
Sodium
and
Potassium
Salts.
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
PC
Codes:
064101,
064111,
064112
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:
Killian
Swift,
Chemical
Review
Manager
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

DBARCODE:
D316295
2
I.
Introduction
Para­
tertiary
amylphenol
and
its
potassium
salt
are
antimicrobials
that
can
be
used
as
disinfectants
or
sanitizers
on
counter
tops,
tables,
refrigerators,
on
animal
premises
and
in
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
32
registered
products
that
contain
para­
tertiary
amylphenol
or
its
potassium
and
sodium
salts
as
active
ingredients
that
may
result
in
dietary
exposure
(
Tables
1,2,3,4,5).

The
use
of
antimicrobial
chemicals
on
food
or
feed
contact
surfaces,
in
animal
premises
and
poultry
premises
including
hatcheries
and
application
to
food­
grade
eggs
may
result
in
pesticide
residues
in
human
food.
These
antimicrobial
uses
are
considered
indirect
food
uses.
The
Agency
must
determine
the
risk
to
human
health
that
may
occur
from
exposure
to
these
chemicals.

4­
TERT­
TERIARY
AMYLPHENOL
USE
PATTERN
SUMMARY
I
Agricultural
Premises
and
Equipment
Includes
mushroom
houses,
poultry
houses,
hatching
facilities,
general
agricultural
premises
°
Hard
surfaces
and
equipment
(
e.
g.,
poultry
houses,
barns,
mushroom
houses)

°
Egg
handling
rooms
°
Egg
hatching
sanitizer
°
Shoebaths
II
Food
handling/
storage
establishments
premises
and
equipment
Includes
food
processing,
preparatory,
and
service
facilities,
restaurants
°
Hard
surfaces
and
equipment
(
e.
g.,
food
processing
plant
equipment,
counter
tops)
3
**
All
treated
food
contact
surfaces
must
be
rinsed
with
water
prior
to
use.

III
Commercial/
Institutional
Facilities
Includes
sites
such
as
schools,
hotels,
motels,
and
offices
°
Hard
surfaces
and
equipment
°
Air
deodorization
°
Carpet
cleaning
°
Immersion
of
instruments
IV
Residential
and
Public
Access
Premises
Includes
residential
homes,
commercial
animal
kennels
°
Hard
surfaces
and
equipment
(
e.
g.,
floors,
bedding,
carpet)

°
Air
deodorization
°
Carpet
cleaning
V
Medical
Premises
and
Equipment
Includes
hospitals,
medical
offices,
dental
offices,
hair
salons,
nursing
homes
°
Hard
surfaces
and
equipment
°
Ultrasonic
machine
°
Air
deodorization
°
Carpet
cleaning
°
Immersion
of
instruments
SODIUM
4­
TERT­
AMYLPHENATE
USE
PATTERN
SUMMARY
I
Agricultural
Premises
and
Equipment
Includes
mushroom
houses,
poultry
houses,
hatching
facilities,
general
agricultural
premises,
aquaculture
°
Hard
surfaces
and
equipment
(
e.
g.,
poultry
houses,
barns,
mushroom
houses)

°
Egg
handling
rooms
°
Egg
hatching
sanitizer
°
Shoebaths
II
Food
handling/
storage
establishments
premises
and
equipment
Includes
restaurants
°
Hard
surfaces
and
equipment
4
III
Commercial/
Institutional
Facilities
Includes
sites
such
as
schools,
hotels,
motels,
and
offices
°
Hard
surfaces
and
equipment
°
Immersion
of
instruments
V
Medical
Premises
and
Equipment
Includes
hospitals,
medical
offices,
dental
offices,
hair
salons,
nursing
homes
°
Hard
surfaces
and
equipment
°
Ultrasonic
machine
°
Immersion
of
instruments
POTASSIUM
4­
TERT­
AMYLPHENATE
AND
SODIUM
4­
TERT­
AMYLPHENATE
USE
PATTERN
SUMMARY
I
Agricultural
Premises
and
Equipment
Includes
mushroom
houses,
poultry
houses,
hatching
facilities,
general
agricultural
premises,
aquaculture
°
Hard
surfaces
and
equipment
(
e.
g.,
poultry
houses,
barns,
mushroom
houses)

°
Egg
handling
rooms
°
Egg
hatching
sanitizer
°
Shoebaths
°
Vehicles
II
Food
handling/
storage
establishments
premises
and
equipment
Includes
restaurants
°
Hard
surfaces
and
equipment
III
Commercial/
Institutional
Facilities
Includes
sites
such
as
schools,
hotels,
motels,
and
offices
°
Hard
surfaces
and
equipment
°
Immersion
of
instruments
V
Medical
Premises
and
Equipment
Includes
hospitals,
medical
offices,
dental
offices,
hair
salons,
nursing
homes
°
Hard
surfaces
and
equipment
5
°
Immersion
of
instruments
°
Ultrasonic
machine
The
following
Tables
contain
uses
that
have
potential
dietary
exposure
for
humans.

Table
1:
4­
tert­
teriary
Amylphenol
Use
Patterns
for
Use
Site
Category
I
(
Agricultural
Premises
and
Equipment)
a
Target
of
Application
Representative
Exposure
Formulation
EPA
Reg.
#

Associated
with
Maximum
Exposure
Application
Rate
Associated
with
Maximum
Exposure
(
lb
a.
i.
/

dilute
gal)

Application
to
hard
surfaces
(
i.
e.,
walls,
floors,

barns
etc.),
equipment
(
i.
e.,
halters,
ropes,
forks,

etc)

Immersion
of
equipment
such
as
halters,
ropes,
etc.

Hatching
Egg
Sanitizer
Application
to
Hard
Surfaces
(
Handler
and
postapplication)

°
High
pressure
spray
°
Low
pressure
handwand
°
Mopping
°
Wiping
surfaces
°
Trigger
pump
spray
Soluble
Concentrate
11725­
00009
0.0033
lb
ai/
gal
Fog
rooms
Wet
mist
and
thermal
Soluble
Concentrate
65020­
00007
0.0542
lb
ai/
gal
(
Fog
1
gallon
for
each
6,000
to
8,000
ft2
floor
space)

a
Applications
are
made
in
agricultural
settings
including,
but
not
limited
to,
mushroom
houses,
poultry
facilities,
animal
facilities,
and
hatching
facilities.
6
Table
2:
4­
tert­
teriary
Amylphenol
Use
Patterns
for
Food
Handling
(
II)
and
Commercial/
institutional
(
III)

Uses
Representative
Exposure
Formulation
EPA
Reg.
#

Associated
with
Maximum
Exposure
(
specific
use
site
category)
Application
Rate
Associated
with
Maximum
Exposure
(
lb
a.
i./
diluted
gallon
product)

Application
to
hard
surfaces
(
i.
e.,
walls,

countertops,

floors,
etc.)

Automatic
Scrubbing
machines
Application
to
hard
surfaces
°
Low
pressure
handwand
Soluble
concentrate
1043­
00091
(
II)
0.00238
lb
ai/
gal
11725­
00009
(
III,
V)
0.00328
lb
ai/
gal
°
Mopping
°
Wiping
surfaces
(
representative
use
for
impregnated
wipes)
Soluble
Concentrate
1043­
00091(
II)
0.00238
lb
ai/
gal
49403­
00023
(
III,
V)
0.0069
lb
ai/
gal
°
Trigger
pump
Ready­
to­
Use
Solution
10088­
00105
(
II,
III,

IV)
0.0048
lb
ai/
gal
Soluble
Concentrate
1043­
00087
(
III,
V)
0.0048
lb
ai/
gal
°
Aerosol
spray
Pressurized
spray
44445­
00067
(
II)
0.0038
lb
ai/
gallon
1043­
00019
(
III,
V)
0.0062
lb
ai/
gallon
Fogging
rooms
Fogger
­
Wet
mist
Soluble
Concentrate
°
11725­
00009
(
II,

II,
IV)

°
66171­
00001
and
66171­
00002
II,
II,

IV)
°
0.00328
lb
ai/
gal
(
fog
6
minutes
for
every
1,000
ft3)

°
0.06408
lb
ai/
gal
(
fog
1
minute
to
reach
4000
cu
ft)
7
Table
3:
4­
tert­
teriary
Amylphenol
Use
Patterns
for
Residential
&
Public
Access
Uses
Representative
Exposure
Formulation
EPA
Reg.
#

Associated
with
Maximum
Exposure
Application
Rate
Associated
with
Maximum
Exposure
(
lb
a.
i./
diluted
gallon
product)

Application
to
hard
surfaces
(
e.
g.,

walls,
countertops,

floors,
etc.)
Application
to
Hard
Surfaces
°
Trigger
pump
spray
Ready­
to­
use
10088­
00105
0.0048
lb
ai/
gal
°
Aerosol
spray
Pressurized
spray
1043­
00019
0.0062
lb
ai/
gal
Table
4:
Sodium
para­
tertiary­
amylphenate
(
PC
Code
064111)
Use
Patterns
for
Use
Site
Categories
I
(
Agricultural),

II
(
Food
Handling),
III
(
Commercial/
Institutional)

Uses
Use
Site
Category
Representative
Exposure
Formulation
EPA
Reg.

#

Associated
with
Maximum
Exposure
Application
Rate
Associated
with
Maximum
Exposure
(
lb
a.
i./
dilute
gallon)

Application
to
hard
surfaces
(
i.
e.,
walls,
floors,
barns
etc.),
equipment
(
i.
e.,
halters,

ropes,
forks,
etc)
Application
to
Hard
Surfaces
(
Handler
and
postapplication)

I
°
mopping
°
wiping
surfaces
°
low
pressure
spray
°
high
pressure
spray
°
trigger
pump
Soluble
Concentrate
211­
00036
0.0016
lb
ai/
gal
Application
to
hard
surfaces
(
i.
e.,
walls,
counter
tops,

floors,
etc.)
II,
III,
V
°
mopping
°
wiping
surfaces
°
trigger
pump
°
liquid
pour
Soluble
Concentrate
211­
00036
0.0016
lb
ai/
gal
8
Table
5:
Potassium
para­
tertiary­
amylphenate
(
PC
Code
064111)
Use
Patterns
for
Use
Site
Categories
I
(
Agricultural),
II
(
Food
Handling),
III
(
Commercial/
Institutional)

Uses
Use
Site
Category
Representative
Exposure
Formulation
EPA
Reg.
#

Associated
with
Maximum
Exposure
Application
Rate
Associated
with
Maximum
Exposure
(
lb
a.
i./
dilute
gallon)

Application
to
hard
surfaces
(
i.
e.,
walls,
floors,
barns
etc.),
equipment
(
i.
e.,

halters,
ropes,
forks,
etc)
Application
to
Hard
Surfaces
(
Handler
and
postapplication)

I
°
mopping
°
wiping
surfaces
°
low
pressure
spray
°
high
pressure
spray
°
trigger
pump
Soluble
Concentrate
211­
00025
0.0013
lb
ai/
gal
Fog
rooms
I
°
fogger
Soluble
Concentrate
211­
00025
0.012
lb
ai/
gal
(
Fog
1
gallon
for
each
6000
to
8000
sq
ft
of
floor
area)

Application
to
hard
surfaces
(
i.
e.,
walls,
counter
tops,

floors,
etc.)
II,
III,
V
°
mopping
°
wiping
surfaces
°
trigger
pump
Soluble
Concentrate
2212­
00005
(
III,
V
only)
0.0023
lb
ai/
gal
211­
00025
(
II
only)
0.0013
lb
ai/
gal
°
low
pressure
spray
Soluble
Concentrate
2212­
00005
(
III,
V
only)
0.0023
lb
ai/
gal
There
are
currently
32
products
registered
that
can
be
used
to
disinfect
counter
tops
in
food
preparation
areas,
farm
premises
among
other
areas.
Some
products
are
ready­
to­
use
solutions,
while
others
are
products
that
are
to
be
diluted
with
water
before
use.

II.
DIETARY
EXPOSURE
Residue
Information
9
Review
of
the
Agency's
residue
chemistry
database
does
not
show
any
residue
data
for
para­
tertiary
amylphenol
on
food
or
on
any
RACs.
Therefore,
no
residue
chemistry
data
and
analyses
are
available
for
inclusion
in
this
dietary
exposure
chapter.

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
p­
tertiary
amylphenol
products
may
bear
small
residues
of
the
p­
tertiary
amylphenol
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
para­
tertiary
amylphenol
in
sanitizer
end­
use
solutions
that
is
permitted
in
the
40CFR
180.940
is
80
ppm.
The
end­
use
solutions
in
products
registered
as
a
disinfectant
is
540
ppm.
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
p­
tertiary
amylphenol
on
treated
food
contact
surfaces
and
in
the
absence
of
data
to
show
the
efficiency
of
washing
or
rinsing
treated
surfaces
to
remove
residues,
the
Agency
can
calculate
residue
levels
that
may
occur
in
food
from
the
application
rates
on
food
contact
surfaces.

To
estimate
the
Estimated
Daily
Intake
(
EDI),
the
Agency
has
used
the
following
model
calculation.
This
model
is
taken
from
FDA
Guidelines.
10
EDI
=
(
1
mg/
cm2)
x
wt.
fraction
of
wash
solution
(
AR)
x
SA
x
FMF/
BW
Equation
1
Where:

AR
=
Application
rate
SA
=
surface
to
which
food
is
exposed,
assume
2000
cm2
FMF
=
Fraction
of
pesticide
migrating
to
food,
assume
10%*

BW
=
70
for
male
adults,
60
kg
for
female
adults
and
15
kg
for
children
1.
The
maximum
ingredient
percentage
for
p­
tertiary
amylphenol
in
a
ready­
to­
use
product
registered
for
use
in
food
handling
establishments
in
kitchens,
cafeterias,
supermarkets
and
meat
and
poultry
plants
is
0.054%(
EPA
Reg.
1270­
237).
A
label
for
a
ready
to
use
product
containing
0.058%
p­
tertiary
amyphenol
is
registered
but
is
only
for
use
in
food
marketing,
storage
and
distribution
facilities(
EPA
Reg.
10088­
105).

The
concentration
of
p­
tertiary
amylphenol
in
the
one
product
is
540
ppm(
0.054%
x
10,000)

EDI
from
Equation
1
=
540
µ
g/
1000
mg(
ppm)
x
0.10
x
2000
cm2
/
kg
BW
=
108
µ
g
a.
i./
BW
108
µ
g
a.
i./
70
kg
BW
=
1.5
µ
g
p­
tertiary
amylphenol/
kg/
day
for
male
adult
108
µ
g
a.
i./
60
kg
BW
=
1.8
µ
g
p­
tertiary
amylphenol/
kg/
day
for
female
adult
108
µ
g
a.
i./
15
kg
BW
=
7.2
µ
g
p­
tertiary
amylphenol/
kg/
day
for
a
child
Calculation
to
Estimate
4­
t­
Amylphenol
Residues
in
Food:

Assumptions:
1
in2
=
6.45
cm2,
then
6.45
cm2
has
a
deposit
of
6.45
mg
residue
1
in2
holds
10
gm
food
6.45
mg
deposit/
in2
surface
*
540
ug
chemical/
1000
mg
=
0.34
ug
chemical/
gm
food
=
340
ug/
kg
(
ppb)

Assuming
10%
residue
transfer
=
340
ug
chemical/
kg
food
*
0.1
=
34
ug/
kg
or
34
ppb
11
Assuming
an
adult
ingests
3000
g
food/
day
and
a
child
ingests
1500
g
food/
day:

EDI
=
34
ug/
kg
*
3000
g/
day
(
adults)
or
1500
g/
day
(
children)
*
1/
BW
=
1.46
ug/
kg
males
(
70
kg)

1.7
ug/
kg
females
(
60
kg)

6.8
ug/
kg
children
(
15
kg)

2.
The
maximum
application
rate
for
p­
tertiary
amylphenol
in
food
handling
establishments
from
the
various
labeled
products
that
are
diluted
with
water
prior
to
use
is
1.0
fl
oz/
gallon
for
a
product
containing
7.6%
a.
i.(
EPA
Reg.#
11725­
9)

Calculation:

1.0
oz
of
product/
gal
of
water
1.0
oz
product/
128
fl
oz
of
water
=
0.78%
solution
of
product
in
water
p­
tertiary
amylphenol
in
formulation
is
5.25%

0.0525
x
0.0078
x
1,000,000
=
410
ppm
of
p­
tertiary
amylphenol
in
treatment
water
EDI
from
Equation
1
=
410
µ
g/
1000
mg(
ppm)
x
0.10
x
2000
cm2
/
kg
BW
=
82
µ
g
a.
i./
BW
82
µ
g
a.
i./
70
kg
BW
=
1.2
µ
g
p­
tertiary
amylphenol/
kg/
day
for
male
adult
82
µ
g
a.
i./
60
kg
BW
=
1.4
µ
g
p­
tertiary
amylphenol/
kg/
day
for
female
adult
82
µ
g
a.
i./
15
kg
BW
=
5.5
µ
g
p­
tertiary
amylphenol/
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
12
10%
transfer
rate.

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.

The
p­
tertiary
amylphenol
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
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
could
result
in
pesticide
residues
in
food
animals.

Note:
This
consideration
also
arises
in
those
cases
in
which
an
agricultural
pesticide
is
used
in
livestock
premises.
In
those
cases,
agricultural
premise
uses
are
considered
food
uses
but
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.
13
The
p­
tertiary
amylphenol
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
may
not
be
"
completely"
removed
by
soap/
detergent
scrubbing
and
potable
water
rinses.

(
Note:
Recent
PDP
data
have
shown
that
residues
for
a
phenolic
antimicrobial
chemical
used
in
mushroom
houses
(
when
compost
and
mushrooms
were
not
present)
remained
in/
on
treated
wood
after
a
potable
water
wash
or
rinse.
Residues
of
the
chemical
occurred
in
the
mushrooms
grown
in
the
treated
and
washed
mushroom
houses.)

The
issue
of
whether
antimicrobial
uses
used
on
agricultural
premises
is
an
indirect
food
use
or
a
non­
food
use
can
be
addressed
after
either
the
issuance
of
the
proposed
EPA
158W
Guidelines
or
through
a
data
call­
in.

Poultry
Hatcheries
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
para­
tertiary
amylphenol
products
in
poultry
hatcheries
appears
to
be
a
non­
food
use.

Mushroom
Houses
Para­
tertiary
amylphenol
formulations
can
be
used
in
mushroom
houses.
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
14
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.
These
uses
have
been
considered
as
non­
food
uses.

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,
20002
and
2003
were
made
available
to
the
Antimicrobials
Division.
The
monitoring
data
for
these
years
reports
residue
data
for
another
phenol
antimicrobial
chemical
for
residues
in
mushrooms.
That
antimicrobial
chemical
can
also
be
present
in
formulations
containing
para­
tertiary
amylphenol.

(
The
PDP
residue
monitoring
data
reports
residues
ranging
of
up
to
0.75
ppm
for
that
phenol
chemical
in/
on
mushrooms
over
the
2001­
2003
time
frame.
Health
Effects
Division
notes
that
the
likely
cause
of
these
residues
for
that
chemical
involved
disinfection
and
sanitization
in
the
mushroom
houses).

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

Depending
on
the
resolution
of
the
residue
problem
on
mushrooms
that
occurred
for
that
phenol
chemical,

the
question
of
whether
the
use
of
para­
tertiary
amylphenol
in
mushroom
houses
will
continue
to
be
considered
a
non­
food
use
will
need
to
be
addressed.
Mushroom
residue
data
may
need
to
be
generated
reflecting
the
label
use
of
para­
tertiary
amylphenol
in
mushroom
houses.
15
Greenhouse
and
Hydroponic
uses
Food
commodities
can
be
grown
in
greenhouses
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.
Historically
a
scrubbing
or
a
potable
rinse
after
pesticidal
application
has
been
considered
a
non­
food
use.
This
was
because
it
was
assumed
that
the
wash
or
scrub
or
rinse
was
assumed
to
eliminate
all
residues
from
the
treated
surfaces.

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.
There
is
the
possibility
that
residues
could
remain
on
treated
wood
surfaces
after
a
wash
or
rinse.
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.
Any
remaining
residues
on
treated
surfaces
could
be
taken
up
by
crops/
plants
grown
in
the
greenhouse
or
hydroponically.

The
issue
of
whether
antimicrobial
uses
in
greenhouse/
hydroponic
premises
is
an
indirect
food
use
or
a
non­
food
use
can
be
addressed
after
either
the
issuance
of
the
proposed
EPA
158W
Guidelines
or
through
a
data
call­
in.

REFERENCES
EPA,
1997.
"
Exposure
Factors
Handbook,
Volume
III:
Activity
Factors."
EPA/
600/
P­
95/
002Fc
August
1997.

EPA,
1999.
"
Available
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.
16
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.
"
Sanitizing
Solutions:
Chemistry
Guidelines
for
Food
Additive
Petitions."
January,
1993.

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

U.
S.
D.
A
Pesticide
Data
Program
for
residues
in
agricultural
crops,
2001­
2003.
