Document ID: EPA-HQ-OPP-2004-0301-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-10T04:00Z

Page
1
of
5
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
05/
18/
2004
SUBJECT:
Phenol
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
PC
Code:

REVIEWER:
A.
Najm
Shamim,
Ph.
D,
Chemist
Regulatory
Management
Branch
I
Antimicrobials
Division
(
7510C)

THROUGH:
Tim
McMahon,
Ph.
D.,
Senior
Toxicologist
Antimicrobials
Division
(
7510C)

TO:
Ben
Chambliss,
Team
leader
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

And
Connie
Welch,
Chief
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)
Page
2
of
5
I.
Introduction
Phenol
and
sodium
phenate
are
antimicrobials
that
can
be
used
as
a
disinfectant
on
counter
tops
and
for
odor
elimination
in
rooms.
There
are
two
registered
products
that
contain
phenol
and
sodium
phenate
as
active
ingredients
that
may
result
in
dietary
exposure
(
Table
1).

Table
1.
Uses
With
Potential
Dietary
Exposure
Use
Formulation
Associated
Product
Registration
Numbers
Disinfectant
on
Counter
Tops
Towelette
wipe
8383­
7
Liquid
8383­
3
There
are
currently
two
products
registered
that
can
be
used
to
disinfect
counter
tops
in
kitchens,
among
other
areas.
One
product
is
a
ready­
to­
use
solution,
while
the
other
is
a
wettable
disposable
cloth
that
is
impregnated
with
phenol
and
sodium
phenate.
A
counter
top
that
has
been
treated
with
either
of
these
products
may
come
into
contact
with
food
prepared
on
the
counter
top,
which
in
turn
may
be
ingested.
Although
neither
product
label
states
that
it
should
be
used
on
food
preparation
equipment,
it
is
possible
that
food
could
be
prepared
or
placed
on
treated
kitchen
counter
tops
before
being
eaten.
No
residue
chemistry
data
were
submitted
by
registrants,
nor
were
any
data
asked
for
by
the
Agency,
as
these
uses
do
not
fall
under
the
guidelines
associated
with
residue
chemistry
(
OPPTS
GLN
860.1300,
OPPTS
GLN
860.1340,
OPPTS
GLN
860.1500).

Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
For
acute
and
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
the
acute
or
chronic
Reference
Dose
value
(
RfD).
In
general,
the
RfD
is
an
estimate
(
with
uncertainty
spanning
perhaps
an
order
of
magnitude)
of
a
daily
exposure
to
the
human
population
(
including
sensitive
subgroups)
that
is
likely
to
be
without
an
appreciable
risk
of
deleterious
effects
during
a
lifetime.
If
a
special
hazard­
based
factor
is
needed
under
the
Food
Quality
Protection
Act
(
FQPA
factor),
the
RfD
is
modified
by
division
of
the
RfD
value
by
the
special
FQPA
factor
to
obtain
a
Population
Adjusted
Dose,
or
PAD.
The
PAD
can
be
calculated
for
both
the
acute
RfD
(
aPAD)
and
chronic
RfD
(
cPAD).
Dietary
risk
is
then
expressed
as
a
percentage
of
the
aPAD
or
cPAD
in
this
case.
For
acute
and
chronic
dietary
exposures,
the
Agency
is
generally
not
concerned
if
the
estimated
dietary
risk
is
below
100%
of
the
calculated
RfD
or
PAD.

II.
Residue
Information
Review
of
the
Agency's
residue
chemistry
database
does
not
show
any
residues
on
food
or
on
any
RACs.
Therefore,
no
residue
chemistry
data
and
analyses
are
included
in
this
dietary
exposure
chapter.
Page
3
of
5
III.
Toxicological
Information
On
March
9,
2004,
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
reviewed
the
available
Toxicology
data
for
Phenol
and
discussed
endpoint
selection
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
phenol
was
also
evaluated
by
the
committee
in
order
to
meet
the
statutory
requirements
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

The
ADTC
determined
that
for
acute
dietary
risk,
there
was
no
appropriate
endpoint
for
assessment
of
acute
dietary
exposure.
This
conclusion
was
based
upon
examination
of
the
hazard
data
which
might
be
used
in
support
of
such
an
endpoint.
Body
weight
effects
observed
were
not
felt
to
be
the
result
of
a
single
exposure,
and
there
were
no
other
effects
from
the
data
that
were
considered
reflective
of
an
adverse
effect
from
a
single
exposure.
An
Acute
RfD
value
was
not
selected.

For
chronic
dietary
risk,
the
ADTC
cited
the
published
chronic
RfD
value
in
EPA's
Integrated
Risk
Information
System
(
IRIS)
database.
This
Reference
Dose
value
is
based
upon
an
unpublished
developmental
toxicity
study
conducted
according
to
GLP
guidelines
(
Argus
Research
Laboratories,
1997).
In
this
study,
pregnant
Crl:
CDRBR
VAF/
Plus
Sprague­
Dawley
rats
(
25
per
group)
received
phenol
by
oral
gavage
on
GDs
6
through
15.
Dosing
was
three
times
daily
with
0,
20,
40,
or
120
mg
phenol/
kg/
dosage
using
a
dosing
volume
of
10
mL/
kg.
The
corresponding
daily
doses
were
0,
60,
120,
and
360
mg/
kg­
day.
The
authors
noted
that
the
test
material
was
90%
phenol
United
States
Pharmacopeia
(
USP);
the
authors
adjusted
the
dosage
calculations
for
test
material
purity.

The
chronic
RfD
value
was
calculated
to
be
0.6
mg/
kg/
day,
using
the
developmental
NOAEL
value
of
60
mg/
kg/
day
and
an
uncertainty
factor
of
100
(
10x
interspecies
extrapolation,
10x
intraspecies
variation).
The
ADTC
determined
that
a
special
FQPA
hazard­
based
safety
factor
was
not
required
for
phenol,
and
could
be
reduced
to
1x.

IV.
Calculations
Determining
Estimated
Daily
Intake
(
EDI)
of
a
Pesticide
Used
as
a
Disinfectant
The
Agency
has
used
the
following
equation
to
estimate
the
Estimated
Daily
Intake
(
EDI)
for
Phenol
and
Sodium
Phenate
use
as
a
disinfectant
solution
(
end
use).

EDI
=
(
wash
solution,
mg/
cm2)
x
(
AR)
(
wt.
fraction
of
wash
solution
)
x
MF(
fraction
of
pesticide
migrating
to
food)
x
SA(
surface
area
of
exposure)/
BW­­­­­­­­­­­­­­­­­­­­­­­­(
1)

Where
EDI
=
Estimated
Daily
Intake,
mg/
kg/
day)
AR
=
Application
Rate
Page
4
of
5
SA
=
Surface
area
to
containing
the
pesticide
to
which
food
is
exposed
MF
=
Fraction
of
pesticide
migrating
to
food,
assuming
10%
BW
=
Body
weight,
adult
male
=
70
kg,
adult
female
=
60
kg
and
a
child
=
15
kg
Assuming
the
end­
use
formulation
contains
1.62%
of
Phenol
and
Sodium
Phenate,
using
equation
1,
the
EDI
will
be:

EDI
=
(
mg/
cm2
)
x
1.62
%
x
0.10
x
2000
cm2
/
BW
=
3.24/
BW
=
3.24/
70kg
=
0.046
mg/
kg/
day
for
male
adult
=
3.24/
60
kg
=
0.054
mg/
kg/
day
for
a
female
adult
=
3.24/
15
kg
=
0.216
mg/
kg/
day
for
a
child
In
equation
1,
if
we
assume
that
MF
(
migration
of
pesticide
to
food)
is
100%,
the
EDI's
will
be:

EDI
=
(
mg/
cm2)
x
1.62
%
x
100/
100
x
2000
cm2
/
BW
=
32.4/
BW
=
32.4/
70kg
=
0.46
mg/
kg/
day
for
a
male
adult
=
32.4/
60
kg
=
0.54
mg/
kg/
day
for
a
female
adult
=
32.4/
15kg
=
2.16
mg/
kg/
day
for
a
child
The
Agency
has
determined
that
the
disinfectant
use
of
Phenol
and
Sodium
Salt
of
Phenol
as
a
room
deodorizer
(
second
scenario)
will
not
result
in
any
dietary
exposure
and
any
adverse
effect
is
not
likely
to
occur.

For
scenario
3,
where
phenol
and
sodium
phenate
are
used
in
towelette,
EPA
contacted
for
Reg#:
8383­
7
(
use
of
the
product
as
a
towelette).
(
Sporicidin
International,
May
26,
2004).
Industry
has
informed
EPA
that
one
towelette
is
used
only
once.
Hence
based
on
this
information,
the
EDI
and
total
dietary
exposure/
person/
day
will
be
the
same
as
scenario
1
V.
Discussion
of
Uncertainties
The
Agency
has
determined
that
by
using
10%
migration
factor
(
MF
in
equation
1),
any
adverse
effect
is
indicated,
the
Agency
will
ask
for
a
confirmatory
data.
Page
5
of
5
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.

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.