Document ID: EPA-HQ-OPP-2005-0487-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-25T05:00Z

Page
1
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
August
29,
2003
MEMORANDUM
SUBJECT:
Tolerance
Reassessment
Decisions
Completed
by
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
FROM:
Peter
Caulkins,
Associate
Director
Registration
Division
TO:
Richard
Keigwin,
Acting
Associate
Director
Special
Review
and
Reregistration
Division
Please
find
attached
the
Focus
Group
Decision
Documents
for
(
1)
beeswax
and
(
2)
carnauba
wax.
The
two
tolerance
exemptions
for
these
chemicals
in
40
CFR
180.1001
are
reassessed.

If
you
have
any
comments
or
questions,
please
contact
Kathryn
Boyle
at
703­
305­
6304.

Attachments
(
2)
Page
2
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
27,
2003
MEMORANDUM
FROM:
Kathryn
Boyle,
Chair
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Registration
Division
TO:
Susan
Lewis,
Acting
Chief
Minor
Use,
Inerts,
and
Emergency
Response
Branch
Registration
Division
SUBJECT:
Recommendation
for
Tolerance
Reassessment
The
attached
science
assessment
discusses
the
toxicity
of
beeswax.
Based
on
its
long
history
of
safe
use
as
a
food
additive
and
in
cosmetics,
and
on
the
low
toxicity
of
beeswax,
a
qualitative
assessment
was
performed.

Based
on
its
review
and
evaluation
of
the
available
information,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
residues
of
beeswax
from
its
uses
as
an
inert
ingredient
in
pesticide
products.
The
beeswax
exemption
from
the
requirement
of
a
tolerance
as
established
in
40
CFR
180.1001
(
c)
is
reassessed.
Based
on
its
low
toxicity,
the
classification
of
beeswax
as
List
4A
is
confirmed.
Page
3
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
22,
2003
Memorandum
Subject:
Beeswax:
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Document
for
Inert
Tolerance
Reassessment
CAS
No.:
8012­
89­
3
PC
Code:
900031
From:
Mark
Perry
Special
Review
and
Reregistration
Division
(
7508C)

To:
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Kathryn
Boyle,
Chair
Registration
Division
(
7505C)

Background:

Attached
is
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group's
assessment
for
beeswax.
This
assessment
summarizes
the
available
information
on
use,
physical/
chemical
properties,
toxicological
effects
and
exposure
potential
of
beeswax.
Page
4
of
10
I.
Executive
Summary:

Beeswax
is
a
complex
mixture
composed
of
a
variety
of
monoesters,
diesters,
hydroxylated
esters,
hydrocarbons,
and
free
fatty
acids.
It
is
a
wax,
not
a
fat,
as
it
is
composed
primarily
of
esters
and
long
chained
hydrocarbons
which
are
classic
wax
components.
Honey
bees
synthesize
beeswax
in
four
pairs
of
glands
located
on
the
ventral
side
of
their
abdomen.
The
wax
is
used
by
the
bees
as
their
primary
building
material
for
making
combs,
in
which
they
rear
their
brood
and
store
honey
and
pollen.
It
is
resistant
to
hydrolysis
and
natural
oxidization,
and
is
completely
insoluble
in
water.
Yellow
beeswax
is
produced
by
melting
strained
combs
in
hot
water
and
using
acid
or
alkali
to
extract
impurities.
White
beeswax
is
produced
by
bleaching
the
pigments
in
yellow
beeswax
with
sunlight
or
peroxides.

Beeswax
has
many
commercial
uses.
It
is
used
in
wood
polishes,
cosmetics,
baby
products,
bath
preparations,
adhesives,
sizing
and
finishing
textiles,
candles,
chewing
gum,
confections,
and
on
fresh
&
frozen
fruit.
The
Food
and
Drug
Administration
(
FDA)
has
classified
beeswax
as
a
Generally
Recognized
As
Safe
(
GRAS)
direct
food
additive
with
limitations
(
21
CFR
184.1973).
The
only
significant
effects
noted
in
the
available
toxicology
data
on
beeswax
are
minimal
eye
and
dermal
irritation
observed
in
a
relatively
small
number
of
animals
in
certain
irritation
studies.

Based
on
available
information
on
beeswax,
its
safe
history
of
use
as
a
food
additive,
its
extensive
use
in
cosmetics,
and
its
low
toxicity,
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
has
determined
that
a
screening­
level
quantitative
risk
assessment
is
not
required
for
this
compound.

II.
Use
Information:

The
pesticidal
and
non­
pesticidal
uses
of
beeswax
are
summarized
briefly
below.

Use
Pattern
(
pesticidal
­
inert
ingredient)

Chemical
Name
Inert
PC
Code
40
CFR
180.1001
Inert
Use
Pattern
(
Pesticidal)
Current
Inert
List
Beeswax
900031
(
c)
coating
agent
4A
Use
Pattern
(
non­
pesticidal):

The
beeswax
GRAS
classification
allows
limited
(
levels
not
to
exceed
good
manufacturing
practice)
use
in
foods
as
a
flavoring
agent
and
adjuvant,
as
a
lubricant
and
as
a
surface­
finishing
agent.
The
classification
allows
use
in
chewing
gum,
in
confections
and
frostings,
in
hard/
soft
Page
5
of
10
candy
and
in
other
food
categories
at
reduced
levels.
Cosmetic
uses
of
beeswax
include
eye/
facial
makeup,
lipstick,
hair/
skin/
nail
products,
shaving
products
and
in
baby
lotions,
oils
and
bath
products
at
concentrations
ranging
from
less
than
0.1%
to
greater
than
50%.
Other
non­
food
uses
include
sizing/
finishing
textiles,
leather
polishing,
candle
making
and
as
a
vehicle
for
drug
administration.

III.
Physical/
Chemical
Properties:

Table
1.
Physical/
Chemical
Properties.

Beeswax
Melting
range
62­
65
C
Solubility
in
water
insoluble
Density
0.95
Physical
state
wax
IV.
Hazard
Assessment:

As
mentioned
above,
beeswax
is
classified
by
the
U.
S.
FDA
as
Generally
Recognized
as
Safe
for
use
as
a
direct
food
additive
at
levels
not
to
exceed
good
manufacturing
practice
(
21
CFR
184.1973).
It
is
believed
that
beeswax
is
not
digested
or
absorbed
by
humans
since
the
structural
components
of
beeswax
are
not
susceptible
to
hydrolysis
in
the
mammalian
digestive
tract.
Furthermore,
it
is
prevented
from
dissolution
within
the
body
due
to
its
insolubility
in
water
and
high
melting
point.
As
an
ingredient
of
comb
honey,
beeswax
has
a
long
history
of
consumption
without
evidence
of
adverse
effects.

The
1975
FDA
evaluation
of
beeswax
as
a
food
ingredient
by
the
Select
Committee
on
GRAS
Substances
concluded
that
"(
T)
here
is
no
evidence
in
the
available
information
on
beeswax
(
yellow
or
white)
that
demonstrates,
or
suggests
reasonable
grounds
to
suspect,
a
hazard
to
the
public
when
it
is
used
at
levels
that
are
now
current
or
might
reasonably
be
expected
in
the
future."
The
Select
Committee
based
this
decision
on
considerations
such
as
history
of
use,
consumer
exposure
information
and
the
experimental
data
available
at
the
time.
The
consumer
exposure
information
used
by
the
Committee
included
estimates
that
beeswax
is
added
to
soft
candy
and
chewing
gum
at
levels
ranging
from
389
to
446
ppm.

The
International
Programme
on
Chemical
Safety
(
IPCS)
in
conjunction
with
the
World
Health
Organization
(
WHO)
addressed
beeswax
in
a
1993
evaluation
performed
to
determine
acceptable
daily
intakes
of
certain
food
additives
(
Food
Additive
Series
30).
This
evaluation
considered
the
biochemical
aspects
of
beeswax
in
human
digestion,
available
toxicity
data,
history
of
use
without
apparent
adverse
effect
and
current
food­
uses.
The
uses
cited
in
this
evaluation
Page
6
of
10
included
use
in
bakery
products,
on
fresh/
frozen
fruit,
in
candy
and
as
a
chewing
gum
base.
The
evaluation
concluded
that
the
present
uses
of
beeswax
are
not
of
toxicological
concern.

Toxicological
Profile:

The
Cosmetic
Ingredient
Review
(
CIR)
performed
a
safety
assessment
of
beeswax
in
1984
which
references
data
performed
with
undiluted
beeswax
resulting
in
an
oral
LD50
(
rat)
greater
than
5
g/
kg,
and
studies
on
products
containing
0.3%
to
13%
beeswax
which
produced
no
oral
toxicity
in
rats
at
doses
up
to
15
g/
kg.
This
assessment
also
reports
that
skin
(
100%
beeswax)
and
eye
irritation
(
50%
beeswax)
studies
in
the
rabbit,
resulted
in
little
or
no
irritation;
that
two
13%
formulations
tested
for
subchronic
dermal
toxicity
(
rabbit/
rat)
demonstrated
no
topical
or
systemic
effects;
and
that
beeswax
was
not
mutagenic
when
tested
with
Salmonella
typhimurium
and
Saccharomyces
cerevisiae
with
and
without
activation.
The
CIR
assessment
referenced
human
dermal
patch
studies
as
well,
which
resulted
in
minimal
or
no
irritation
at
concentrations
of
6.4%,
13%
and
100%
beeswax.
Overall,
the
assessment
concluded
that
beeswax
is
safe
as
used
in
cosmetics
under
present
practices
of
concentration
and
use.

The
Agency
is
aware
that
some
beeswax
may
contain
environmental
contaminants
(
chemical
residues)
or
impurities
such
as
pollen
which
could
effect
its
toxic/
allergenic
potential.
The
presence
and
levels
of
such
contaminants
are
extremely
difficult
to
predict
for
a
natural
product
like
beeswax,
and
due
to
the
refinement
process,
it
is
considered
unlikely
that
significant
contaminant
levels
would
persist
in
commercial­
grade
beeswax.
Therefore,
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
does
not
consider
it
feasible
to
account
for
these
potential
impurities
in
an
assessment
of
risk
for
generic
beeswax
.

Special
Considerations
for
Infants
and
Children:

At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

Hazard
Characterization:

Taking
into
consideration
all
available
information
on
beeswax,
including
FDA's
GRAS
designation,
its
use
in
food
products
and
cosmetics,
the
history
of
use
without
incident
and
its
apparent
indigestible
nature,
use
of
beeswax
as
an
inert
ingredient
in
pesticide
products
is
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup.

V.
Risk
Characterization:

Exposure
to
beeswax
would
result
from
its
FDA­
approved
GRAS
use
as
a
food
additive
and
through
its
use
in
the
numerous
cosmetic
products
mentioned
above.
The
use
of
beeswax
in
Page
7
of
10
pesticide
products
is
expected
to
result
in
much
lower
exposure
than
through
the
food
and
cosmetic
uses
of
this
material.
Exposures
from
pesticide
inert
uses
are
expected
to
result
in
human
exposure
below
any
dose
level
that
could
possibly
produce
an
adverse
effect.
Therefore,
a
screening­
level
quantitative
exposure
assessment
has
not
been
conducted.
Page
8
of
10
VI.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

The
natural
waxes,
such
as
beeswax,
are
naturally
occurring
and,
as
a
result
it
is
believed
that
there
is
no
concern
for
exposures
to
non­
target
organisms
and
the
environment
from
releases
through
approved
uses.

Natural
waxes,
including
beeswax,
unlike
most
synthetic
waxes
(
i.
e.,
paraffins)
are
ester
of
the
general
formula:

O
5
R­
C­
C­
O­
R
0
These
compounds
are
insoluble
in
water,
non­
volatile,
have
a
low
air:
water
partitioning
coefficient
(
Henry's
Law
Coefficient)
and
are
poorly
mobile
in
soils
and
sediments.
The
ultimate
sink
for
beeswax
released
into
the
environment
is
soil
and
sediments.
Beeswax
will
undergo
primary
biodegradation
of
various
components
in
days
to
weeks
aerobically
and
longer
anaerobically.
Because
beeswax
is
a
"
mixture"
of
compounds,
component
analysis
is
considered
the
optimal
approach
to
understanding
the
behavior
and
toxicity
in
the
environment.

The
primary
component
of
beeswax
is
myricyl
palmitate
(
CH
3
­(
CH
2
)
14
­
CO
2
­(
CH
2
)
29
­
CH
3
).
This
component,
like
its
parent,
is
insoluble
in
water
(
est.
water
solubility:
2.2E­
17),
non­
volatile
(
est.
vapor
pressure
2.2E­
15
mmHg),
and
poorly
mobile
in
soils
and
sediments
(
est.
Log
K
oc
:
11).
Primary
degradation
occurs
in
days
to
weeks
and
ultimate
degradation
in
weeks
to
months.
The
principle
sink
in
the
environment
for
myricyl
palmitate
is
also
soil
and
sediments.
It
is
unlikely
to
undergo
hydrolysis
and
photolysis,
but
will
react
in
the
atmosphere
with
hydroxyl
radicals
with
a
half­
life
of
hours.
Bioconcentration
and/
or
biomagnification
is
unlikely
for
both
compounds
based
on
estimated
K
ow
s
greater
than
the
analytical
stability
of
available
models
(
est.
Log
K
ow
:
>
20).

Toxicity
of
beeswax
and
the
primary
component
to
aquatic
organisms
is
not
expected
due
the
low
water
solubility
and
high
log
K
ow.
Toxicity
to
wild
mammals,
using
the
rat
as
a
surrogate
species,
is
likewise
not
expected.
By
analogy,
birds
and
other
terrestrial
organisms
are
unlikely
to
exhibit
adverse
effects
when
exposed.

VII.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
Page
9
of
10
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
beeswax
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
beeswax
and
any
other
substances
and
beeswax
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
beeswax
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website.
Page
10
of
10
References:

(
Note
to
the
Reader:
MRID
(
Master
Record
Identification)
Numbers
were
added
to
the
references
on
October
17,
2003.
These
numbers
were
not
available
at
the
time
of
document
signature.
No
other
changes
were
made
to
the
document.)

U.
S.
Food
and
Drug
Administration
(
FDA).
1975.
Evaluation
of
the
Health
Aspects
of
Beeswax
(
yellow
and
white)
as
Food
Ingredients.
Federation
of
American
Societies
for
Experimental
Biology,
Available
through
National
Technical
Information
Service
(
Doc.
PB262656).
(
MRID
No.
46067501)

Cosmetic
Ingredient
Review
(
CIR).
1984.
Final
Report
on
the
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