UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Zinc
Pyrithione
(
Zinc
Omadine
®
)
:
Occupational
and
Residential
Exposure
Assessment
for
the
RED
Document.
Chemical
No.
088002.
Case
No.
2480.
DP
Barcode:
D301370
DATE:
April
20,
2004.

TO:
Connie
Welch,
Chief
Benjamin
Chambliss,
Team
Leader,
Reregistration
Team
36
Regulatory
Management
Branch
I
Antimicrobials
Division
(
7510C)

FROM:
Doreen
Aviado,
Biologist,
Team
Two
and
Deborah
Smegal,
Toxicologist/
Risk
Assessor
Risk
Assessment
and
Science
Support
Branch
Antimicrobials
Division
(
7510C)

THRU:
Nader
Elkassabany,
Team
Leader,
Team
Two
Risk
Assessment
and
Science
Support
Branch
Antimicrobials
Division
(
7510C)

Norm
Cook,
Chief
Risk
Assessment
and
Science
Support
Branch
Antimicrobials
Division
(
7510C)

Attached
is
the
revised
Human
Exposure
Chapter
for
AD/
RASSB's
science
assessment
of
zinc
pyrithione
(
zinc
omadine
®
)
for
the
purpose
of
issuing
a
Reregistration
Eligibility
Decision
(
RED)
document.
Potential
nondietary
exposures
to
occupational
and
residential
handlers
are
addressed
in
this
document,
along
with
postapplication
exposure
from
contact
with
zinc
pyrithione­
treated
articles.
i
1.0
EXECUTIVE
SUMMARY
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1
2.0
OCCUPATIONAL
AND
RESIDENTIAL
EXPOSURE
AND
RISK
ASSESSMENT
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8
A.
Toxicological
Considerations
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8
(
1)
Criteria
for
Conducting
Exposure
Assessments
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8
(
2)
Summary
of
Toxicity
Concerns
Relating
to
Occupational
and
Residential
Non­
Dietary
Exposures
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8
(
a)
Acute
Toxicology
Categories
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8
(
b)
Summary
of
Toxicological
Endpoint
Selection
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9
(
c)
Dermal
Absorption
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12
B.
Occupational
and
Residential
Exposures
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12
(
1)
Handler
Exposures
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12
(
a)
Antifoulant
Use
Pattern
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13
(
b)
Materials
Preservation
Use
Pattern
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14
(
2)
Handler
Exposure
Data
and
Assumptions
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17
(
a)
Handler
Exposure
Data
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18
(
b)
Estimated
Amount
Handled
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22
(
3)
Handler
Risk
Assessment
and
Characterization
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26
(
a)
Handler
Exposure
and
Non­
Cancer
Risk
Calculations
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26
(
b)
Handler
Non­
Cancer
Risks
from
Exposure
to
Zinc
Pyrithione
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34
(
4)
Postapplication
Exposures
and
Risks
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36
(
a)
Primary
Occupational
Postapplication
Exposures
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37
(
b)
Secondary
Occupational
Postapplication
Exposures
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37
(
c)
Residential
Postapplication
Exposures
and
Risks
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38
(
5)
Aggregate
Postapplication
Residential
Risks
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43
(
6)
Data
Gaps,
Uncertainties,
and
Limitations
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44
3.0
REFERENCES
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45
1
1.0
EXECUTIVE
SUMMARY
Background
Zinc
pyrithione
(
Zinc
Omadine
®
)
is
used
as
an
industrial
preservative
to
prevent
microbial
deterioration
and
to
maintain
the
integrity
of
manufacturing
precursor
materials
and
finished
manufactured
articles.
Zinc
pyrithione
is
a
bacteriostat,
fungicide,
microbiocide/
microbiostat
registered
for
incorporation
into
food
packaging
adhesives
(
indoor
food),
incorporation
into
articles
made
from
or
coated
with
FDA
approved
food
contact
polymers
such
as
food
processing
equipment,
conveyor
belts,
utensils,
and
storage
containers
(
indoor
food),
antifoulant
paint
preservation
(
indoor/
outdoor
nonfood),
control
of
bacterial
growth
on
laundered
products
(
indoor
nonfood),
and
preservation
of
adhesives,
caulks,
patching
compounds,
sealants,
grouts,
latex
paints,
coatings,
dry
wall,
gypsum,
pearlite,
and
plaster
(
indoor
nonfood).
Zinc
pyrithione
is
used
for
the
control
of
mildew
in
nonfood
contact
polymers
and
control
of
mildew
and
bacteria
in
styrene
butadiene
rubber
and
thermoplastic
resins
(
e.
g.
carpets
and
other
floor
coverings,
textiles,
home
furnishings,
housewares,
sports
equipment,
automotive/
public
transport
systems,
mattress
liners,
air
ducts,
etc.).
Materials
preservation
extends
to
in­
can
preservation
of
clay,
mineral,
pigment
and
guar
gum
slurries,
latex
emulsions,
and
similar
high
solids
aqueous
media.
Zinc
pyrithione
is
also
conditionally
registered
as
an
antifoulant
for
incorporation
as
an
active
ingredient
into
boat
paints.
An
exposure/
risk
assessment
for
occupational
exposures
associated
with
this
use
pattern
is
not
included
in
the
current
Zinc
Pyrithione
RED.
The
registrant,
Arch
Chemicals
is
conducting
a
study
to
assess
exposures
of
workers
performing
painting
of
commercial
vessels
with
antifoulant
paints
containing
zinc
pyrithione.
This
study
is
expected
to
be
completed
and
submitted
in
2006,
and
will
be
used
to
assess
the
conditional
registrations
for
the
antifoulant
paint
use.
However,
the
occupational
use
on
commercial
vessels
will
be
evaluated
at
a
later
date.
The
registrant
has
submitted
a
protocol
to
AD
that,
when
accepted,

will
allow
the
registrant
to
gather
experimental
data
on
exposures
of
workers
performing
painting
of
commercial
vessels
with
antifoulant
paints
containing
zinc
pyrithione.
Residential
exposures
and
risks
from
use
of
antifoulant
paint
containing
zinc
pyrithione
are
assessed
in
this
chapter.

There
are
five
registered
industrial
end­
use
products
containing
zinc
pyrithione
that
are
eligible
for
reregistration
under
Case
2480
as
materials
preservatives.
They
range
in
active
ingredient
concentration
from
5%
a.
i.
to
95%
a.
i.
and
are
sold
as
powder,
liquid,
and
aqueous
dispersion
(
solids
in
liquid)
formulations.
The
end­
use
products
are
applied
during
the
manufacturing
process
of
the
incorporated
treated
articles
and
treated
article
precursor
materials.
Zinc
Pyrithione
formulations
are
added
at
rates
typically
up
to
5000
ppm
using
both
open
pouring
and
closed
delivery
systems.
They
are
added
at
a
point
where
thorough
mixing
takes
place.

Variations
in
formulations,
conditions
of
use,
and
desired
degree
of
protection
for
the
manufactured
articles/
substrates
determines
the
pesticide
use
rates.
2
The
resulting
manufactured
zinc
pyrithione­
treated
end
products
which
are
sold
or
distributed
are
exempt
from
pesticide
registration
requirements
under
FIFRA
if
they
qualify
as
treated
articles
under
the
"
treated
articles
exemption"
[
40
CFR,
Part
152.25(
a)].
The
"
treated
articles
exemption"
provides
an
exemption
from
FIFRA
requirements
for
qualifying
articles
or
substances
treated
with,
or
containing
a
registered
pesticide
if
(
1)
the
incorporated
pesticide
is
registered
for
use
in
or
on
the
article
or
substance
itself,
and
(
2)
the
sole
purpose
of
the
treatment
is
to
protect
the
article
or
substance
itself,
not
to
provide
additional
pesticidal
(
antimicrobial)
benefits.

Occupational
and
Residential
Exposures
The
Occupational
and
Residential
Exposure
Chapter
of
the
Zinc
Pyrithione
Reregistration
Eligibility
Decision
Document
(
RED)
addresses
potential
exposures
and
risks
to
humans
who
may
be
exposed
to
zinc
pyrithione
in
both
"
occupational"
and
"
residential"
settings.
Specifically,
in
support
of
the
materials
preservation
use
patterns,
this
RED
Chapter
estimates
non­
dietary
exposures
and
non­
cancer
risks
to:
primary
occupational
handlers
(
mixers,
loaders,
applicators)
of
registered
zinc
pyrithione
pesticide
product
concentrates
in
industrial
settings;
and
secondary
occupational/
residential
handlers
of
zinc
pyrithione­
treated
end
products
(
e.
g.,
paints)
in
residential
settings.
In
addition,
the
use
of
zinc
pyrithione
as
an
antifoulant
paint
applied
to
recreational
crafts
(
i.
e.,
boats)
was
assessed
for
residential
handlers.

Also
addressed
are
postapplication
exposures
which
can
occur
to
individuals
who
are
involved
in
industrial
activities
following
application
of
zinc
pyrithione
pesticides,
and
those
in
contact
with
zinc
pyrithione­
treated
end
products
in
residential
sites.
Estimates
of
postapplication
exposure
to
the
chemical
compound
from
contact
with
zinc
pyrithione­
treated
articles
are
presented
for
residential
adults
and
children,

including
child
incidental
non­
dietary
oral
ingestion
pathways.
Potential
dietary
exposures
from
indirect
food
contact
are
not
addressed
in
this
chapter
and
are
presented
as
part
of
the
human
health
risk
assessment
document.

The
exposure
scenarios
developed
for
this
RED
Chapter
are
representative
of
potential
occupational
and
residential
exposures
to
zinc
pyrithione
preservative
over
short­
term
(
1
day
to
1
month
),
intermediate­
term
(
1­
6
months),
and
long­
term
(
>
6
months)
exposure
durations.
The
target
MOE
is
100
for
occupationally
exposed
workers,
while
the
target
MOE
is
300
for
residential
exposures.

At
present,
there
are
no
available
chemical­
specific
occupational
exposure
monitoring
studies
meeting
Agency
guidelines
that
can
be
relied
upon
to
assess
handler
and
postapplication
exposures
to
zinc
pyrithione.

Therefore,
inhalation
and
dermal
exposure
dose
estimates
were
developed
for
occupational
handler
populations
using
surrogate
data
from
the
Chemical
Manufacturers
Association
(
CMA)
Antimicrobial
Exposure
3
Assessment
Study
(
CMA,
1992),
the
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1
(
PHED,

1997),
and
a
literature
exposure
study
on
antifoulant
paints
(
Garrod
et
al.
2000).
CMA
surrogate
data
and
approaches
derived
from
the
EPA
Residential
Exposure
Assessment
Standard
Operating
Procedures
(
SOPs)

(
U.
S.
EPA,
1997a,
2001)
were
used
for
handler
and
postapplication
assessments
for
residential
populations.

In
addition,
several
studies
which
relate
to
the
use
patterns
of
zinc
pyrithione
were
used
to
estimate
postapplication
exposure.
These
studies,
combined
with
guidance
from
EPA
SOPs,
were
used
to
develop
the
postapplication
section.
Most
notably,
an
exposure
assessment
submitted
to
EPA
in
support
of
the
reregististration
requirements
of
zinc
pyrithione
entitled
"
Health
Assessment
of
the
Use
of
Zinc
Pyrithione
Incorporated
Into
Polyurethane
Sole
Liners
of
Shoes"
(
MRID
441086­
01)
(
Olin
Corporation,
1996)
was
used
in
conjunction
with
leach
rate
data
from
an
FDA
Migration
Study
(
MRID
441086­
02)
(
U.
S.
EPA,
2000)
as
"
surrogate"
data
to
calculate
dermal
exposures
to
the
preservative
incorporated
into
polymeric
materials.

Potential
non­
dietary
exposures
via
oral
ingestion
of
residues
from
treated
toy
surfaces
(
i.
e.,
infant
toyto
mouth
and
hand­
to­
mouth
contact)
were
addressed
using
"
surrogate"
exposure
information
from
"
Risk
Analysis
For
Microban
Additive
"
B"
(
Triclosan
or
Irgasan
DP300)
Treated
Toys
For
Infants
(
Dang,
1997),

MRIDs
441086­
01
and
441086­
02
and
the
Residential
SOPs
(
2001).

Using
surrogate
unit
exposure
data,
use
application
rates
from
EPA­
registered
product
labels,
and
Agency­
derived
estimates
of
daily
amounts
handled,
a
variety
of
handler
and
postapplication
exposures
and
risks
were
assessed.

Handlers
Based
on
the
EPA­
registered
use
patterns,
appropriate
primary
and
secondary
handler
exposure
scenarios
were
identified
for
zinc
pyrithione.
In
general
terms,
EPA
defines
"
primary"
handler
exposure
as
direct
exposure
to
the
pesticide
formulation
during
mixing/
loading/
applying
operations.
"
Secondary"
handler
exposure
is
defined
as
exposure
to
a
pesticide
active
ingredient
as
a
direct
result
of
its
incorporation
into
an
end
product.

Primary
Occupational
Handlers.
The
exposure
and
risk
assessment
for
primary
occupational
handlers
was
conducted
using
product
label
maximum
application
rates,
related
use
information
from
Arch
Chemicals,
Inc.,
Agency
standard
values
for
industrial
practices,
and
CMA
unit
exposure
data.
For
mixing/
loading
liquids
and
powders
in
closed
systems
(
i.
e.,
using
a
metered
pump,
or
automatic­
dispensing
techniques),
the
margin
of
exposure
(
MOE)
calculations
indicate
risks
(
i.
e.,
target
MOEs

100)
not
exceeding
the
Agency's
level
of
concern
for
the
dermal
and
inhalation
exposure
scenarios
assessed.
The
"
dermal"
4
exposure
risks
are
not
of
concern
(
i.
e.,
MOE

100)
for
potential
short­
term,
intermediate­
term,
and
long­
term
exposures
during
open
mixing/
loading
of
powders
and
liquids
for
all
the
scenarios
assessed.
Also,
the
dermal
and
inhalation
MOEs
for
the
laundered
fabrics
scenarios
were
not
of
concern.
However,
MOEs
from
inhalation
exposures
exceed
the
Agency's
level
of
concern
(
i.
e.,
MOEs
<
100)
for
short­
term,
intermediate­
term,
and
longterm
exposure
scenarios
during:

°
mixing/
loading/
applying
powders
and
liquids
for
general
preservative
use
patterns
using
open
pour
methods
(
MOE=
50
for
liquid
formulations;
MOE=
15
for
powder
formulation);
and
°
mixing/
loading/
applying
powders
and
liquids
for
paint
preservation
using
open
pour
methods
(
MOE=
50
for
liquid
formulations;
MOE=
15
for
powder
formulation).

The
Agency
may
consider
requiring
risk
mitigation
steps,
such
as
closed
delivery
systems
or
use
of
a
respirator
during
open
pouring.

Secondary
Occupational
Handlers.
Secondary
occupational
handler
exposures
could
occur
through
the
application
of
treated
paints
and
coatings,
and
building
materials
such
as
caulks,
adhesives,
spackling,

groutings,
sealants,
stucco
and
joint
cements.
Based
on
end­
use
product
application
methods
and
use
amounts,

it
is
assumed
that
exposures
while
applying
paints
will
be
equal
to
or
greater
than
exposures
while
applying
building
materials.
Therefore,
occupational
handler
exposures
were
assessed
for
the
application
of
paint,
as
this
scenario
represents
maximum
possible
exposure
to
the
chemical.
Under
this
scenario,
dermal
and
inhalation
exposures
were
assessed
for
brush,
airless
sprayer,
and
aerosol
application
methods
using
PHED
Version
1.1
data.

Using
product
label
maximum
application
rates,
related
use
information,
Agency
standard
values,
and
PHED
unit
exposure
data,
the
secondary
handler
potential
short­
term,
intermediate­
term,
and
long­
term
MOEs
exceed
the
Agency's
level
of
concern
(
MOEs
<
100)
for:

$
handling
zinc
pyrithione­
containing
paint
products
using
an
airless
sprayer
application
method
(
inhalation
MOEs=
4.4
and
44
without
and
with
the
use
of
a
respirator
as
PPE,
respectively,

and
dermal
MOE=
74
without
the
use
of
gloves
as
PPE).

It
is
assumed
that
in
real­
use
situations
for
airless
sprayer
applications,
the
occupational
handlers
will
have
adequate
respiratory
protection
by
wearing
either
a
dust/
mist
or
organic
vapor
respirator
as
PPE
recommended
by
paint
manufacturers
for
spray
equipment
applications.
Although
the
dermal
MOE
for
airless
spray
painting
operations
is
of
concern
(
MOE=
74)
without
gloves,
the
MOE
is
not
of
concern
(
MOE=
200)

when
gloves
are
worn
as
protective
equipment.
It
is
assumed
that
in
real­
use
situations
for
airless
sprayer
applications,
the
occupational
handlers
will
have
adequate
dermal
protection
by
wearing
gloves
as
may
be
5
recommended
by
paint
manufacturers
during
spray
equipment
applications.
Dermal
and
inhalation
MOEs
obtained
for
the
painting
scenarios
involving
use
of
paint
brush
and
aerosol
spray
can
application
methods
were
found
to
be
of
no
risk
concern.

Primary
Residential
Handlers.
Zinc
Pyrithione
is
an
antifouling
agent
used
to
control
slime
and
algae
growth
below
the
water
line
of
recreational
and
commercial
boat
hulls
in
fresh,
salt,
or
brackish
water.

Recreational
boat
owners
have
several
techniques
they
can
use
to
paint
their
hulls
including
paint
brush,
roller,

and
airless
sprayer.
There
are
no
chemical­
specific
exposure
data
to
assess
these
techniques.
However,

surrogate
data
are
available
for
painting
with
a
brush
and
an
airless
sprayer.
The
surrogate
data
are
based
on
test
subjects
painting
a
bathroom
with
a
paint
brush
and
staining
the
outside
of
a
house
with
an
airless
sprayer.

The
dermal
and
inhalation
exposures
from
these
techniques
have
been
normalized
by
the
amount
of
active
ingredient
handled
and
reported
as
unit
exposures
(
UE)
expressed
as
mg/
lb
ai
handled.
Although
the
exposures
while
painting
a
boat
hull
may
differ
slightly,
the
data
are
judged
to
be
representative
of
painting
and
are
used
in
this
assessment.
In
addition,
Garrod
et
al
(
2000)
measured
both
inhalation
and
dermal
exposures
during
the
painting
of
recreational
boat
hulls.
However,
the
dermal
portion
of
this
study
only
measured
a
limited
number
of
outside
patches
on
the
test
subject's
clothing.
Therefore,
only
the
air
concentration
measurements
from
Garrod
et
al
(
2000)
are
used
to
estimate
MOEs.

Calculation
of
dermal
and
inhalation
MOEs
for
residential
use
of
antifoulant
boat
paint
showed
that
dermal
and
inhalation
MOEs
were
of
concern
(
i.
e.
<
300)
for
all
boat
sizes
when
using
a
paint
brush.
Dermal
and
inhalation
MOEs
were
also
of
concern
when
using
an
airless
sprayer
for
all
boat
sizes,
except
dermal
MOEs
were
not
of
concern
for
the
smallest
boat
size.
It
is
important
to
note
that
the
inhalation
exposure
risk
estimates
are
conservative
because
the
toxicity
endpoint
used
in
the
assessment
is
based
on
a
whole­
body
rat
90­
day
inhalation
study.

Secondary
Residential
Handlers.
An
assessment
for
primary
residential
handlers
was
not
conducted
in
support
of
reregistration
for
the
materials
preservative
use
patterns
because
only
industrial
workers
handle
the
EPA­
registered
zinc
pyrithione
pesticides;
rather,
residential
populations
are
secondary
handlers
of
consumer
end
products
for
which
zinc
pyrithione
has
been
incorporated
during
the
manufacturing
process
(
i.
e,

zinc
pyrithione­
treated
articles).

Secondary
residential
handler
exposures
could
occur
through
the
application
of
treated
paints
and
coatings,
and
building
materials
such
as
caulks,
adhesives,
spackling,
groutings,
sealants,
stucco
and
joint
cements.
Based
on
end­
use
product
application
methods
and
use
amounts,
it
is
assumed
that
exposures
while
applying
paints
will
be
equal
to
or
greater
than
exposures
while
applying
building
materials.
Therefore,

residential
handler
exposures
were
assessed
for
the
application
of
paint,
as
this
scenario
represents
maximum
possible
exposure
to
the
chemical.
Under
this
scenario,
dermal
and
inhalation
exposures
were
assessed
for
6
brush,
airless
sprayer,
and
aerosol
application
methods
using
PHED
Version
1.1
values
found
in
the
Residential
Exposure
SOPs
(
U.
S.
EPA,
1997a,
2001).
The
surrogate
exposure
data
in
PHED
are
based
on
test
subjects
painting
a
bathroom
with
a
paint
brush
and
staining
the
outside
of
a
house
with
an
airless
sprayer.

The
dermal
and
inhalation
exposures
from
these
techniques
have
been
normalized
by
the
amount
of
active
ingredient
handled
and
reported
as
unit
exposures
(
UE)
expressed
as
mg/
lb
ai
handled.
The
residential
scenarios
are
similar
to
those
developed
for
secondary
occupational
handlers,
only
the
use
rates
and
residential
PHED
data
are
modified.

Using
product
label
maximum
application
rates,
related
use
information,
Agency
standard
values,
and
PHED
unit
exposure
data,
the
secondary
handler
short­
term,
intermediate­
term,
and
long­
term
MOEs
exceed
the
Agency's
level
of
concern
(
MOEs
<
300)
for
the
following
scenarios:

°
handling
zinc
pyrithione­
containing
paint
products
using
an
airless
sprayer
application
method
(
Dermal
MOE=
118
inhalation
MOE=
15);
and
°
handling
zinc
pyrithione­
containing
paint
products
using
an
aerosol
spray
can
application
method
(
inhalation
MOE=
271).

It
is
assumed
that
in
real­
use
situations
for
airless
sprayer/
aerosol
spray
can
paint
applications,
the
residential
handlers
will
have
adequate
respiratory
protection
by
wearing
either
a
dust/
mist
or
organic
vapor
respirator
as
may
be
recommended
by
paint
manufacturers
for
spray
applications,
and
adequate
dermal
protection
by
wearing
gloves
while
painting.
Dermal
MOEs
were
not
of
concern
for
the
painting
scenarios
involving
use
of
a
paint
brush
and
aerosol
spray
can.

Postapplication
Exposures
Postapplication
exposures
refer
to
those
potential
exposures
which
may
occur
to
handlers
while
involved
in
postapplication
or
reentry
activities
following
application
of
the
pesticide
concentrate
or
formulated
end­
use
product.
Postapplication
exposures
also
result
from
bystander
contact
with
treated
surfaces/
articles
and
while
occupying
areas
where
pesticide
end­
use
products
have
recently
been
applied
(
e.
g.
treated
duct
work).

Zinc
pyrithione
has
a
low
vapor
pressure
(
i.
e.,<
1.87x10­
9
torr
@
25

C)
and
is,
therefore,
not
likely
to
generate
sufficient
vapor
to
cause
an
inhalation
concern
to
occupational
and
residential
populations
performing
postapplication
tasks,
or
occupying
recently
treated
areas,
or
from
bystander
contact
with
treated
articles.

Therefore,
postapplication
inhalation
exposures
were
not
assessed.

Primary
Occupational
Postapplication.
Primary
occupational
postapplication
inhalation
exposures
are
limited
to
mists,
steams,
or
vapors
resulting
from
manufacturing
process
operations.
Occupational
postapplication
dermal
and
inhalation
exposures
to
zinc
pyrithione
are
likely
to
be
minimal
compared
to
handler
7
exposure
because
of
the
dilution
of
the
biocide
during
processing.
Since
primary
occupational
postapplication
exposures
are
likely
to
be
brief
and
pesticide
concentrations
are
expected
to
be
more
diluted,
a
risk
assessment
is
not
required.

Secondary
Occupational
Postapplication.
Secondary
occupational
postapplication
exposures
result
when
bystanders
come
in
contact
with
zinc
pyrithione
in
areas
where
pesticide­
treated
end­
use
products
have
recently
been
applied
(
e.
g.,
freshly
painted
walls).
Workers
could
have
dermal
and
inhalation
exposures
to
zinc
pyrithione­
treated
adhesives,
caulks,
sealants,
and
paints.
However,
since
the
paint,
caulks
and
sealants
are
expected
to
dry
within
a
day,
potential
dermal
and
inhalation
exposures
are
expected
to
be
minimal.
In
addition,
the
short­
term
dermal
endpoint
is
based
on
a
90
day
dermal
study,
rather
than
a
one­
day
study,
and
would
significantly
overestimate
the
risks
associated
with
this
scenario.
Exposures
resulting
from
contact
with
treated
fabrics/
textiles,
polymeric
materials
and
related
treated
substances
are
expected
to
be
negligible
because
of
limited
transfer
of
product
residues
and
product
dilution.
Consequently,
postapplication
dermal
exposures
were
not
quantitatively
evaluated
in
this
report.

Residential
Postapplication.
Residential
postapplication
exposures
result
when
bystanders
(
adults
and
children)
come
in
contact
with
zinc
pyrithione
in
areas
where
pesticide­
treated
end­
use
products
have
recently
been
applied
(
e.
g.,
freshly
painted
walls
or
boat
hulls
of
recreational
craft),
or
when
children
incidentally
ingest
the
pesticide
residues
through
mouthing
the
treated
end
products/
treated
articles
(
i.
e.,

handto
mouth
or
object­
to­
mouth
contact).
As
noted
previously
for
the
occupational
scenarios,
postapplication
dermal
exposures
are
expected
to
be
minimal
because
the
paint
is
expected
to
dry
within
a
day.
Thus,

postapplication
dermal
exposures
to
paint
were
not
quantitatively
evaluated
in
this
report.
Dermal
exposures
to
plastic
treated
with
zinc
pyrithione,
such
as
shoe
liners,
were
evaluated
and
determined
not
to
be
of
concern
(
MOEs
=
4,500­
7,700).
In
addition,
non­
dietary
incidental
ingestion
exposures
of
children
via
toy­
to­
mouth
and
hand­
to­
mouth
activities
did
not
exceed
the
Agency's
level
of
concern
(
MOE
>
300).
Aggregate
postapplication
residential
exposures
for
a
young
child
were
also
greater
than
the
target
MOE
of
300,
and
are
not
of
concern.

Occupational
and
Residential
Risk
Characterization
The
exposure
and
risk
assessment
conducted
for
occupational
and
residential
populations
and
use
patterns
indicated
the
following:

°
Primary
occupational
handlers
of
registered
zinc
pyrithione
industrial
pesticides
are
best
protected
under
conditions
where
automated
pesticide
delivery
systems
are
used;
8
°
Inhalation
exposure
to
zinc
pyrithione
is
of
concern
for
primary
occupational
handlers
using
"
open
pour"
methods
(
assessed
as
wearing
no
respiratory
PPE
as
typical
work
conditions).

The
Agency
may
need
to
require
product
labeling
statements
for
adequate
respiratory
protection
in
the
form
of
respirator
PPE;

°
Dermal
exposure
to
zinc
pyrithione
is
not
a
concern
for
primary
occupational
handlers
(
assessed
as
wearing
gloves
under
typical
work
conditions);

°
Secondary
occupational
and
residential
handlers
of
zinc
pyrithione­
treated
products
(
e.
g.,

paints,
caulks)
are
best
protected
under
conditions
where
adequate
dermal
and
inhalation
protection
occur
in
the
form
of
PPE
(
especially
respiratory
protection
during
paint
spraying
applications).
The
Agency
has
no
regulatory
purview
over
consumer
goods
which
meet
the
FIFRA
"
treated
articles
exemption";

°
Postapplication
inhalation
and
dermal
exposures
to
occupational
and
residential
adult
populations
are
not
a
concern;

°
Postapplication
exposures
to
child
populations
handling
and
mouthing
treated
objects
(
i.
e.,

toys)
are
not
a
risk
concern.

2.0
OCCUPATIONAL
AND
RESIDENTIAL
EXPOSURE
AND
RISK
ASSESSMENT
A.
Toxicological
Considerations
(
1)
Criteria
for
Conducting
Exposure
Assessments
An
occupational
and/
or
residential
exposure
and
risk
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
potential
exposure
to
handlers
(
mixers,
loaders,

applicators)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
zinc
pyrithione,

both
criteria
are
met.

(
2)
Summary
of
Toxicity
Concerns
Relating
to
Occupational
and
Residential
Non­
Dietary
Exposures
(
a)
Acute
Toxicology
Categories
Acute
toxicity
categories
for
zinc
pyrithione
are
shown
in
Table
1.
9
Table
1.
Acute
Toxicity
Categories
for
Zinc
Pyrithione
Test
Results
Toxicity
Category
Acute
Oral
Toxicity
LD50=
267
mg/
kg
II
Acute
Dermal
Toxicity
LD50
>
2000
mg/
kg
III
Acute
Inhalation
Toxicity
LC50
>
0.61
mg/
L
III
Primary
Eye
Irritation
Severe
Irritant
I
Primary
Dermal
Irritation
Slight
Erythema
and
Edema
IV
Dermal
Sensitization
No
Dermal
Sensitization
Observed
NA
As
indicated
above,
zinc
pyrithione
is
moderately
toxic
by
the
oral
route,
but
acute
toxicity
by
the
dermal
route
is
not
as
significant.
Acute
toxicity
by
the
inhalation
route
is
also
relatively
low.
Zinc
pyrithione
is
a
severe
eye
irritant
(
Toxicity
category
I)
but
does
not
appear
to
demonstrate
significant
dermal
irritation
nor
dermal
sensitization
potential.
Non­
acute
toxicity
studies
with
zinc
pyrithione
demonstrate
developmental
toxicity
as
well
as
neurotoxicity.

(
b)
Summary
of
Toxicological
Endpoint
Selection
OPP's
Antimicrobial
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
(
2004)
has
identified
toxicological
endpoints
of
concern
(
EPA,
2004).
Table
2
summarizes
these
endpoints.
Dermal
endpoints
of
concern
have
been
identified
for
short­,
intermediate­,
and
long­
term
dermal
exposures.
The
noobserved
adverse­
effect
level
(
NOAEL)
selected
for
short­,
intermediate­,
and
long­
term
dermal
exposures
was
100
mg/
kg/
day,
based
on
a
90
day
dermal
toxicity
study
in
which
toxic
effects
were
observed
in
rats
causing
decreased
body
weight
gain
and
food
consumption/
food
efficiency
(
MRID
428279­
02).

In
addition
to
the
dermal
endpoints
of
concern,
inhalation
endpoints
of
concern
have
also
been
identified
for
short­,
intermediate­,
and
long­
term
inhalation
exposures.
The
NOAEL
selected
for
short­,

intermediate­,
and
long­
term
inhalation
exposures
was
0.0005
mg/
L/
day
based
on
toxic
effects
including
labored
breathing,
rales,
increased
salivation,
decreased
activity,
dry
red­
brown
material
around
the
nose,

increased
absolute
and
relative
lung
weights,
and
death
of
undetermined
cause
(
MRID
428279­
03).
Since
the
NOAEL
was
presented
in
mg/
L/
day,
it
was
necessary
to
convert
the
dose
to
mg/
kg/
day
because
exposure
doses
are
presented
in
these
units.
A
route­
to­
route
extrapolation
equation
was
used
to
convert
human
and
animal
values
from
"
mg/
L/
day"
concentrations
to
"
mg/
kg/
day."
Using
the
"
Route­
to­
Route
Extrapolation"
presented
by
EPA,
the
dose
of
0.0005
mg/
L/
day
converts
to
0.13
mg/
kg/
day
(
U.
S.
EPA,
1998).
10
Equation
1
mg/
L/
day
x
A
x
RV
x
D
x
AF
=
mg/
kg/
day
BW
where:

A
=
Absorption.
The
ratio
of
deposition
and
absorption
in
the
respiratory
tract
compared
to
absorption
by
the
oral
route.
100%
absorption
is
assumed
for
inhalation.
RV
=
Respiratory
Volume
(
RV)
is
10.26
L/
hr/
kg
for
male
and
female
Sprague­
Dawley
rats.
D
=
Duration
(
D)
of
daily
animal
or
human
body
weight
in
kg.
Duration
of
the
rat
study
was
6
hr/
day.
AF
=
Activity
Factor
(
AF)
for
animals
is
1.
BW
=
Mean
animal
weight
for
Sprague­
Dawley
rats
is
0.236
kg.

Table
2.
Toxicological
Endpoints
for
Assessing
Occupational
and
Residential
Exposures/
Risks
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Acute
Dietary
Exposure
(
females
13+)
Developmental
NOAEL
=
0.5
Increased
post
implantation
loss
and
decreased
viable
fetuses
were
observed
at
LOAEL
=
1.5
mg/
kg/
day
Developmental
Toxicity
Study
in
Rabbits
for
gestation
days
6­
18
UF
=
100
FQPA=
1X
DB=
3X
Acute
Dietary
Exposure
(
general
population
&
infants/
children)
Maternal
NOAEL
=
0.75
Maternal
toxicity
characterized
as
increased
salivation
observed
at
LOAEL
=
3.0
mg/
kg/
day
Developmental
Toxicity
Study
in
Rats
for
gestation
days
6­
15
UF
=
100
FQPA=
1X
DB=
3X
Chronic
Dietary
Exposure
­
Reference
Dose
(
all
populations)
Developmental
NOAEL
=
0.5
Increased
post
implantation
loss
and
decreased
viable
fetuses
were
observed
at
LOAEL
=
1.5
mg/
kg/
day
Development
Toxicity
Study
in
Rabbits
for
gestation
days
6­
18
UF
=
100
FQPA=
1X
DB=
3X
Short­,
Intermediate­
Term
Oral
Exposure
NOAEL
=
0.75
Target
MOE=
300
Residential
Maternal
toxicity
characterized
as
increased
salivation
at
were
observed
at
LOAEL
=
3.0
mg/
kg/
day
Developmental
Toxicity
Study
in
Rats
for
gestation
days
6­
15
Short­,
Intermediate­,
and
Long­
Term
Dermal
Exposure
Dermal
NOAEL=
100
Target
MOEs=
100
Occupational;
300
Residential
Decreased
body
weight
gain
and
food
consumption/
food
efficiency
at
LOAEL
=
1000
mg/
kg/
day
90­
day
Subchronic
Dermal
Toxicity
Study
in
Rats
Short­,
Intermediate­,
and
Long­
Term
Inhalation
Exposure
Inhalation
NOAEL=
0.0005
mg/
L
(
i.
e.,
0.13
mg/
kg/
day)
Target
MOEs=
100
Occupational;
300
Residential
Clinical
signs
of
toxicity,
decreased
activity,
and
increased
lung
weights
at
LOAEL
=
0.0025
mg/
L
90­
day
Subchronic
Inhalation
Toxicity
Study
in
Rats
Oral
Cancer
Slope
Factor
No
chronic
or
carcinogenicity
studies
are
available
to
assess
the
carcinogenic
potential
of
zinc
pyrithione
N/
A
N/
A
11
UF
=
Uncertainty
Factor
NA
=
Not
applicable
Recommended
MOEs
of
100
for
the
occupational
assessment
are
based
on
applied
uncertainty
factors
of
10x
to
account
for
interspecies
extrapolation,
and
10x
for
intra­
species
variability.
FQPA
SF
=
An
additional
1x
is
applied
as
an
FQPA
safety
factor
for
the
non­
dietary
oral
(
incidental
ingestion)
residential
MOEs
calculated
in
this
assessment.
DB
UF
=
An
additional
3x
is
applied
as
a
database
uncertainty
factor
for
all
residential
MOEs
calculated
in
this
assessment.

For
the
residential
postapplication
assessment,
it
was
necessary
to
address
potential
exposures
through
both
the
dermal
route
(
adults
and
children)
and
oral
route
(
child
incidental
ingestion
via
hand­
to­
mouth
and
direct
mouthing
of
treated
articles).
The
NOAEL
of
0.75
mg/
kg/
day
was
selected
by
the
ADTC/
HIARC
for
the
general
population
and
infants
based
on
evidence
of
increased
salivation
in
dams
at
a
LOAEL
of
3.0
mg/
kg/
day
(
MRID
428279­
05).
For
the
female
population,
a
NOAEL
of
0.5
mg/
kg/
day
was
selected
based
on
increased
post­
implantation
loss
and
decreased
number
of
viable
fetuses
at
a
LOAEL
of
1.5
mg/
kg/
day
(
U.
S.
EPA,
1999a).

The
1999
HIARC
report
also
addressed
the
potential
increased
susceptibility
of
infants
and
children
from
exposure
to
zinc
pyrithione
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
However,

a
subsequent
evaluation
of
the
hazard
and
exposure
data
for
zinc
pyrithione
was
conducted
by
the
Health
Effects
Division's
FQPA
Safety
Factor
Committee
on
August
7,
2001
for
the
purpose
of
determining
the
appropriate
safety
factor
under
FQPA.
They
initially
recommended
that
an
additional
safety
factor
of
10x
be
retained
for
zinc
pyrithione
and
that
this
factor
be
applied
to
all
population
subgroups
for
assessing
residential
risks.
Since
that
time,
changes
to
the
application
of
the
FQPA
safety
factor
have
been
published
by
the
Agency.
For
zinc
pyrithione,
while
the
rat
and
rabbit
developmental
toxicity
studies
show
qualitative
evidence
of
increased
susceptibility,
there
is
an
adequately
characterized
endpoint
in
both
studies.
Thus,
the
effects
observed
in
offspring
in
the
developmental
toxicity
studies
can
be
used
to
select
dietary
endpoints
for
assessing
incidental
oral
ingestion
exposure,
and
are
thus
protective
of
infants
and
children.
Therefore,
the
special
FQPA
safety
factor
is
reduced
to
1x.
However,
a
database
uncertainty
factor
of
3x
is
applied
to
all
assessed
residential
exposure
scenarios
(
i.
e.,
oral,
dermal
and
inhalation
routes)
due
to
a
lack
of
characterization
of
neurotoxic
dose­
response
relationships
for
zinc
pyrithione
(
U.
S.
EPA,
ADTC
2004).

For
assessing
all
potential
occupational
exposures,
a
margin
of
exposure
(
MOE)
of
100
was
selected.

For
the
residential
exposure
assessment
an
FQPA
safety
factor
(
1x)
and
a
database
uncertainty
factor
(
3x)
were
applied
resulting
in
the
selection
of
an
MOE
of
300
for
the
non­
dietary
oral
exposure
scenarios.
The
database
uncertainty
factor
(
3x)
was
also
applied
to
all
assessed
residential
dermal
and
inhalation
exposure
scenarios
for
a
selected
MOE
of
300.

Studies
with
zinc
pyrithione
were
not
available
to
address
chronic
toxicity
and
carcinogenicity
for
this
chemical.
[
Data
on
the
carcinogenic
potential
of
a
related
compound,
sodium
pyrithione,
showed
no
evidence
of
carcinogenicity,
and
was
classified
as
a
Group
D
(
not
classifiable
as
to
carcinogenicity)
carcinogen
by
the
Health
Effects
Division
Carcinogenicity
Peer
Review
Committee.]
Therefore,
a
cancer
risk
assessment
was
12
not
conducted
since
carcinogenic
endpoints
related
to
lifetime
average
absorbed
doses
of
zinc
pyrithione
from
occupational
and
residential
exposures
have
not
been
identified.

(
c)
Dermal
Absorption
A
dermal
absorption
factor
is
not
required
because
a
dermal
NOAEL
was
selected
for
the
dermal
risk
assessments.
However,
it
should
be
noted
that
the
3%
dermal
absorption
factor
demonstrated
in
the
swine
study
is
supported
by
a
literature
study
in
mice
which
also
showed
a
dermal
absorption
of
3%
(
U.
S.
EPA,

1999a).

B.
Occupational
and
Residential
Exposures
(
1)
Handler
Exposures
EPA
has
determined
that
there
is
a
potential
for
exposures
to
mixers,
loaders,
applicators,
or
other
handlers
associated
with
the
registered
use
patterns
of
zinc
pyrithione
pesticide
products.
There
are
potential
exposures
from
use
in
commercial,
industrial,
and
residential
settings
via
the
dermal
and
inhalation
routes.

EPA
has
identified
the
following
levels
of
handler
exposures:

°
Primary
Handlers
­­
Defined
as
persons
having
direct
exposure
to
the
pesticide
formulations
during
mixing/
loading/
applying
operations.
For
this
RED,
primary
handlers
are
"
occupational
handlers"
of
EPA­
registered
zinc
pyrithione
pesticide
product
concentrates
used
for
industrial
manufacturing
purposes
as
dry
film,
in
can,
and
general
materials
preservatives
for
incorporation
into
various
substrates
prone
to
fungal
and
bacterial
degradation
(
e.
g.,
water­
based
emulsions,
coatings,
slurries,
thermoplastic
resins,
rubber,
textiles,
and
polymeric
systems).
In
addition,
do­
it­
yourself
(
D­
I­
Y)
painters
are
considered
primary
handlers
for
antifoulant
paints
(
i.
e.
boat
owner's
painting
hulls
of
recreational
boats
in
residential
settings).

°
Secondary
Handlers
­­
Defined
as
persons
having
direct
exposure
to
the
pesticide
active
ingredient
as
a
result
of
its
incorporation
into
manufactured
end
products.
Exposure
occurs
during
normal
use
patterns
of
the
end
products.
For
this
RED,
secondary
handlers
are
both
"
occupational
handlers"
and
"
residential
handlers"
of
caulks,
sealants,
paints,
and
other
end
products
to
which
zinc
pyrithione
has
been
added
as
a
preservative.

EPA
has
identified
the
following
exposure
scenarios
for
primary
occupational
handlers,
secondary
occupational
handlers,
and
primary
and
secondary
residential
handlers.
These
exposure
scenarios
are
further
developed
in
Table
4
for
each
of
the
major
registered
materials
preservation
use
patterns.
A
separate
section
details
the
scenarios
for
residential
handlers
of
antifoulant
paints.

Primary
Occupational
Handlers
13
°
mixing/
loading/
applying
liquid
zinc
pyrithione
pesticide
product
concentrates
using
open
pour
methods.

°
mixing/
loading/
applying
liquid
zinc
pyrithione
pesticide
product
concentrates
using
metering
equipment
(
pump
liquid).

°
mixing/
loading/
applying
powder
zinc
pyrithione
pesticide
product
concentrates
using
open
pour
methods.

°
mixing/
loading/
applying
powder
zinc
pyrithione
pesticide
product
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques).

Secondary
Occupational
Handlers
°
handling
zinc
pyrithione­
containing
paint
end
products
using
paint
brush,
airless
sprayer,
and
aerosol
spray
can
application
methods.

Primary
Residential
Handlers
(
Antifoulants)

°
handling
zinc
pyrithione­
containing
antifoulant
paints
using
a
paint
brush.

°
handling
zinc
pyrithione­
containing
antifoulant
paints
using
an
airless
sprayer.

Secondary
Residential
Handlers
(
Materials
Preservatives)

°
handling
zinc
pyrithione­
containing
paint
end­
products
using
paint
brush,
airless
sprayer,
and
aerosol
spray
can
application
methods.

(
a)
Antifoulant
Use
Pattern
Zinc
Pyrithione
is
an
antifouling
agent
used
to
control
slime
and
algae
growth
below
the
water
line
of
recreational
and
commercial
boat
hulls
in
fresh,
salt,
or
brackish
water.
Zinc
pyrithione
is
incorporated
into
various
antifoulant
paint
formulations.
The
registered
antifoulant
paint
end
products
bear
labeling
with
specified
use
patterns,
application
methods
and
personal
protective
equipment
(
PPE).
Labeling
for
the
following
products
(
EPA
Reg.
Nos.)
shown
in
Table
3
have
been
reviewed
and
representative
products
selected
for
the
residential
handler
assessment:

Table
3.
Zinc
Pyrithione
Antifoulant
Paint
Use
Pattern
EPA
Reg.
No.
Percent
(%)
Zinc
Pyrithione
in
Formulation
Use
Pattern
Table
3.
Zinc
Pyrithione
Antifoulant
Paint
Use
Pattern
14
2693­
187
3.8
%
Limited
to
commercial
use
only.
No
restrictions
on
application
methods.
Requires
eyewear,
long
pants,
long­
sleeved
shirt,
hat,
gloves,
and
respirator.
(
Accepted
label
12/
6/
2001)

2693­
188
3.18
%
Limited
to
commercial
use
only.
No
restrictions
on
application
methods.
Requires
eyewear,
long
pants,
long­
sleeved
shirt,
hat,
gloves,
and
respirator.
(
Accepted
label
9/
7/
2000)

2693­
194
47.04
%
No
restrictions
on
use
but
does
not
specifically
mention
recreational
boats.
No
restrictions
on
application
methods.
This
is
the
Activator
product
portion
of
a
twopart
mixture.
Requires
eyewear
only.
(
Accepted
label
5/
2/
2002)

2693­
200
3.04
%
No
restrictions
on
use
but
does
not
specifically
mention
recreational
boats.
Application
methods
listed
as
brush
or
roller
and
that
"
spraying
is
not
recommended".
Requires
eyewear,
long
pants,
long­
sleeved
shirt,
hat,
gloves,
and
respirator.
Product
can
be
thinned
up
to
10%
and
covers
320
ft2/
gallon
at
a
2
mil
dry
film
thickness.
(
Accepted
label
10/
3/
2002)

2693­
203
3.39
%
Label
specifically
mentions
small
craft
and
car
top
boats.
Application
methods
listed
as
brush
or
roller
and
that
"
spraying
is
not
recommended".
Requires
eyewear,
long
pants,
long­
sleeved
shirt,
hat,
gloves,
and
respirator.
Product
can
be
thinned
up
to
10
to
25%
and
covers
400
ft2/
gallon
and
recommends
a
minimum
of
3
coats.
(
Accepted
label
10/
3/
2002)

64684­
4
4.8
%
Label
specifies
commercial
and
recreational
use.
Application
methods
listed
as
brush
or
roller
but
does
not
prohibit
spraying.
Requires
eye
wear,
long
pants,
longsleeved
shirt,
hat,
and
gloves
while
"
spraying,
sanding
or
blasting
the
paint"
and
respirator.
Unclear
if
PPE
is
for
the
preparation
of
the
hull
or
for
the
painting.
Thinning
is
not
recommended
and
recommends
a
minimum
of
3
coats.
(
Accepted
label
3/
17/
2000)

64684­
6
4.7
%
No
restrictions
on
use
but
does
not
specifically
mention
recreational
boats.
Application
methods
listed
as
brush,
roller,
and
spraying.
Requires
eyewear,
long
pants,
long­
sleeved
shirt,
hat,
and
gloves
while
"
spraying,
sanding
or
blasting
the
paint"
and
respirator.
Unclear
if
the
PPE
is
for
the
preparation
of
the
hull
or
for
the
painting.
Thinning
is
not
recommended
for
brush
and
roller
and
up
to
10
percent
for
spraying.
A
minimum
of
3
coats
is
recommended
and
covers
300
ft2/
gallon.
(
Accepted
label
3/
17/
2000)

Note:
Bold
denotes
products
used
for
the
residential
handler
assessment
which
were
selected
as
representative
of
the
range
of
registered
antifoulant
end
products.

(
b)
Materials
Preservation
Use
Pattern
Zinc
Pyrithione
is
used
as
an
industrial
preservative
to
prevent
decay
and
maintain
the
integrity
of
manufacturing
precursor
materials
and
manufactured
articles.
Zinc
pyrithione
is
a
bacteriostat,
fungicide,
microbiocide/
microbiostat
registered
for
use
in
food
packaging
adhesives
(
indoor
food),
paint
preservation
(
indoor/
outdoor
nonfood),
control
of
bacterial
growth
on
laundered
products
(
indoor
nonfood),
and
preservation
of
adhesives,
caulks,
patching
compounds,
sealants,
grouts,
latex
paints,
coatings,
dry
wall,
gypsum,
pearlite,
and
plaster
(
indoor
nonfood).
Zinc
pyrithione
is
used
for
the
control
of
mildew
in
nonfood
contact
polymers
and
control
of
mildew
and
bacteria
in
styrene
butadiene
rubber
and
thermoplastic
resins.
Materials
preservation
extends
to
in­
can
preservation
of
clay,
mineral,
pigment
and
guar
gum
slurries,
latex
emulsions,
and
similar
high
solids
aqueous
media.
15
There
are
five
registered
industrial
end­
use
products
containing
zinc
pyrithione
that
are
eligible
for
reregistration
under
Case
2480
as
materials
preservatives.
They
range
in
active
ingredient
concentration
from
5%
a.
i.
to
95%
a.
i.
and
are
sold
as
powder,
liquid,
and
aqueous
dispersion
(
solids
in
liquid)
formulations.
The
end­
use
products
are
applied
during
the
manufacturing
process
of
the
incorporated
treated
articles
and
treated
article
precursor
materials.
Zinc
Pyrithione
formulations
are
added
at
rates
typically
up
to
5000
ppm
using
both
open
pouring
and
closed
delivery
systems.
They
are
added
at
a
point
where
thorough
mixing
takes
place.
Variations
in
formulations,
conditions
of
use,
and
desired
degree
of
protection
for
the
manufactured
articles/
substrates
determines
the
pesticide
use
rates.
Representative
scenarios
developed
for
the
materials
preservation
use
pattern
are
detailed
in
Table
4.

The
resulting
manufactured
zinc
pyrithione­
treated
end
products
which
are
sold
or
distributed
are
exempt
from
pesticide
registration
requirements
under
FIFRA
if
they
qualify
as
treated
articles
under
the
"
treated
articles
exemption"
[
40
CFR,
Part
152.25(
a)].
The
"
treated
articles
exemption"
provides
an
exemption
from
FIFRA
requirements
for
qualifying
articles
or
substances
treated
with,
or
containing
a
registered
pesticide
if
(
1)
the
incorporated
pesticide
is
registered
for
use
in
or
on
the
article
or
substance
itself,
and
(
2)
the
sole
purpose
of
the
treatment
is
to
protect
the
article
or
substance
itself,
not
to
provide
additional
pesticidal
(
antimicrobial)
benefits.

Table
4.
Exposure
Scenarios
for
Occupational/
Residential
Handlers
Exposure
Scenario
Scenario
Description
Primary
Occupational
Handler
General
Preservative
Uses:
Dry
Film,
In
Can,
and
Materials
Preservation
(
1a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Scenario
encompasses
a
variety
of
general
preservatives
use
patterns
(
i.
e.,
dry
film,
in
can,
and
materials
preservation)
where
the
pesticide
is
incorporated
into
various
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
water­
based
emulsions,
coatings,
slurries,
thermoplastic
resins
(
e.
g.
air
ducts),
rubber,
textiles,
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
manufactured
food
processing
equipment
and
conveyor
belts).
The
biocide
is
added
using
open
pour
methods.
Potential
exposures
may
occur
during
the
open
loading/
applying
of
the
concentrate
into
bulk
tanks/
mixing
vats
or
other
containers
during
manufacturing
of
the
various
substrates.
The
manufacturing
of
caulks/
sealants
from
slurries
treated
for
dry
film
or
in
can
preservation
was
selected
as
the
representative
scenario.
Unit
exposures
from
CMA
database
for
pouring
liquid
preservatives
are
used
to
calculate
exposure
(
CMA,
1992).

(
1b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Scenario
encompasses
a
variety
of
general
preservatives
use
patterns
(
i.
e.,
dry
film,
in
can,
and
materials
preservation)
where
the
pesticide
is
incorporated
into
various
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
water­
based
emulsions,
coatings,
slurries,
thermoplastic
resins
(
e.
g.
air
ducts),
rubber,
textiles,
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
manufactured
food
processing
equipment
and
conveyor
belts).
The
biocide
is
added
using
an
automated
metering
system.
Potential
exposures
may
occur
during
the
loading
and
setup/
maintenance
of
the
automated
metering
system
during
manufacturing
of
the
various
substrates.
Liquid
concentrates
are
pumped
into
tanks
or
bins
and
diluted
into
a
slurry.
The
manufacturing
of
caulks/
sealants
from
slurries
treated
for
dry
film
or
in
can
preservation
was
selected
as
the
representative
scenario.
Unit
exposures
from
CMA
database
for
pumping
liquid
preservatives
are
used
to
calculate
exposure
(
CMA,
1992).
Table
4.
Exposure
Scenarios
for
Occupational/
Residential
Handlers
Exposure
Scenario
Scenario
Description
16
(
1c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Scenario
encompasses
a
variety
of
general
preservatives
use
patterns
(
i.
e.,
dry
film,
in
can,
and
materials
preservation)
where
the
pesticide
is
incorporated
into
various
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
water­
based
emulsions,
coatings,
slurries,
thermoplastic
resins
(
e.
g.
air
ducts),
rubber,
textiles,
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
manufactured
food
processing
equipment
and
conveyor
belts).
The
powder
biocide
is
added
using
open
pour
methods
into
liquid
slurries.
Potential
exposures
may
occur
during
the
open
loading/
applying
of
the
concentrate
into
bulk
tanks/
mixing
vats
or
other
containers
during
manufacturing
of
the
various
substrates.
The
manufacturing
of
caulks/
sealants
from
slurries
treated
for
dry
film
or
in
can
preservation
was
selected
as
the
representative
scenario.
Unit
exposures
from
CMA
database
for
solid
pour
are
used
to
calculate
exposure
(
CMA,
1992).

(
1d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Scenario
encompasses
a
variety
of
general
preservatives
use
patterns
(
i.
e.,
dry
film,
in
can,
and
materials
preservation)
where
the
pesticide
is
incorporated
into
various
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
water­
based
emulsions,
coatings,
slurries,
thermoplastic
resins
(
e.
g.
air
ducts),
rubber,
textiles,
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
manufactured
food
processing
equipment
and
conveyor
belts).
The
powder
biocide
is
added
using
an
automated
metering
system
into
liquid
slurries.
Potential
exposures
may
occur
during
the
loading
and
setup/
maintenance
of
the
automated
metering
system
during
manufacturing
of
the
various
substrates.
The
manufacturing
of
caulks/
sealants
from
slurries
treated
for
dry
film
or
in
can
preservation
was
selected
as
the
representative
scenario.
No
unit
exposure
data
were
available
to
represent
mixing/
loading/
applying
of
powder
formulations
in
closed
delivery
systems.
Therefore,
CMA
unit
exposure
data
for
general
preservatives
for
pump
liquid
(
a
closed
delivery
system)
are
used
as
a
surrogate
to
calculate
exposure
(
CMA,
1992).

Paints:
Dry
Film
Preservation
(
2a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Scenario
occurs
when
the
pesticide
is
added
at
anytime
during
the
paint
manufacturing
process
for
dry
film
preservation.
The
biocide
is
added
using
open
pour
methods.
Potential
exposures
may
occur
during
the
loading/
applying
of
the
concentrate
into
bulk
tanks/
mixing
vats
for
incorporation
into
paint
formulations.
CMA
unit
exposure
data
for
general
preservatives
for
pour
liquid
are
used
to
calculate
exposure
(
CMA,
1992).

(
2b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Scenario
occurs
when
the
pesticide
is
added
at
anytime
during
the
paint
manufacturing
process
for
dry
film
preservation.
The
biocide
is
added
using
an
automated
metering
system.
Potential
exposures
may
occur
during
loading
and
setup/
maintenance
of
the
automated
metering
system.
CMA
unit
exposure
data
for
general
preservatives
for
pump
liquid
are
used
to
calculate
exposure
(
CMA,
1992).

(
2c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Scenario
occurs
when
the
pesticide
is
added
at
anytime
during
the
paint
manufacturing
process
for
dry
film
preservation.
The
powder
biocide
is
added
using
open
pour
methods.
Potential
exposures
may
occur
during
the
loading/
applying
of
the
concentrate
into
bulk
tanks/
mixing
vats
for
incorporation
into
paint
formulations.
CMA
unit
exposure
data
for
general
preservative
for
solid
pour
data
are
used
to
calculate
exposure
(
CMA,
1992).

(
2d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Scenario
occurs
when
the
pesticide
is
added
at
anytime
during
the
paint
manufacturing
process
for
dry
film
preservation.
The
powder
biocide
is
added
using
an
automated
metering
system.
Potential
exposures
may
occur
during
loading
and
setup/
maintenance
of
the
automated
metering
system.
No
unit
exposure
data
were
available
to
represent
mixing/
loading/
applying
of
powder
formulations
in
closed
delivery
systems.
Therefore,
CMA
unit
exposure
data
for
general
preservatives
for
pump
liquid
(
a
closed
delivery
system)
are
used
as
a
surrogate
to
calculate
exposure
(
CMA,
1992).

Fabrics/
Textiles:
Laundering
Treatment
for
Materials
Preservation
Table
4.
Exposure
Scenarios
for
Occupational/
Residential
Handlers
Exposure
Scenario
Scenario
Description
17
(
3a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Scenario
occurs
when
the
pesticide
concentrate
is
added
to
the
"
acid
sour"
operation
during
industrial
laundering
treatments
of
manufactured
fabrics/
textiles.
The
biocide
is
added
in
a
recirculating
water
system
using
open
pour
methods.
Potential
exposures
may
occur
via
loading
and
filling
bulk
tanks,
contact
with
wet
laundered
fabrics/
textiles
or
exposure
to
mists
or
vapors
from
the
laundry
machines.
Unit
exposures
from
CMA
database
for
pouring
liquid
preservatives
are
used
to
calculate
exposure
(
CMA,
1992).

(
3b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Scenario
occurs
when
the
pesticide
concentrate
is
added
to
the
"
acid
sour"
operation
during
industrial
laundering
treatments
of
manufactured
fabrics/
textiles.
The
biocide
is
added
in
a
recirculating
water
system
using
an
automated
metering
system.
Potential
exposures
may
occur
via
loading
and
setup/
maintenance
of
the
automated
metering
system.
Unit
exposures
from
CMA
database
for
pumping
liquid
preservatives
are
used
to
calculate
exposure(
CMA,
1992).

(
3c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Scenario
occurs
when
the
pesticide
concentrate
is
added
to
the
"
acid
sour"
operation
during
industrial
laundering
treatments
of
manufactured
fabrics/
textiles.
The
powder
biocide
is
added
in
a
recirculating
water
system
using
open
pour
methods.
Potential
exposures
may
occur
via
loading
and
filling
bulk
tanks,
contact
with
wet
laundered
fabrics/
textiles
or
exposure
to
mists
or
vapors
from
the
laundry
machines.
Unit
exposures
from
CMA
database
for
general
preservatives
for
solid
pour
are
used
to
calculate
exposure
(
CMA,
1992).

(
3d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Scenario
occurs
when
the
pesticide
concentrate
is
added
to
the
"
acid
sour"
operation
during
industrial
laundering
treatments
of
manufactured
fabrics/
textiles.
The
powder
biocide
is
added
in
a
recirculating
water
system
using
an
automated
metering
system.
Potential
exposures
may
occur
via
loading
and
setup/
maintenance
of
the
automated
metering
system.
No
unit
exposure
data
were
available
to
represent
mixing/
loading/
applying
of
powder
formulations
in
closed
delivery
systems.
Therefore,
CMA
unit
exposure
data
for
general
preservatives
for
pump
liquid
(
a
closed
delivery
system)
are
used
as
a
surrogate
to
calculate
exposure
(
CMA,
1992).

Secondary
Occupational
Handler
(
4a
Handling
zinc
pyrithione­
containing
paint
end
products
using
a
paint
brush
application
method
Scenario
occurs
when
an
occupational
handler
applies
biocide­
treated
paint
using
a
paint
brush.
PHED
unit
exposure
data
for
paint
brush
are
used
(
PHED,
1997).

(
4b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
Scenario
occurs
when
an
occupational
handler
applies
biocide­
treated
paint
using
an
airless
sprayer.
PHED
unit
exposure
data
for
airless
sprayer
are
used
(
PHED,
1997).

(
4c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method
Scenario
occurs
when
an
occupational
handler
applies
biocide­
treated
paint
using
an
aerosol
spray
can.
PHED
unit
exposure
data
for
aerosol
spray
are
used
(
PHED,
1997).

Secondary
Residential
Handler
(
5a)
Handling
zinc
pyrithione­
containing
paint
end
products
using
a
paint
brush
application
method
Scenario
occurs
when
a
residential
handler
applies
biocide­
treated
paint
using
a
paint
brush.
PHED
unit
exposures
from
the
Residential
SOPs
are
used
for
paint
brushing
by
a
residential
handler
(
EPA
1997).
Garrod
et
al
(
2000)
is
also
used
for
determining
inhalation
exposure.

(
5b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
Scenario
occurs
when
a
residential
handler
applies
biocide­
treated
paint
using
an
airless
sprayer.
PHED
unit
exposures
from
the
Residential
SOPs
are
used
for
airless
spraying
by
a
residential
handler
(
EPA
1997).
Table
4.
Exposure
Scenarios
for
Occupational/
Residential
Handlers
Exposure
Scenario
Scenario
Description
18
(
5c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method
Scenario
occurs
when
a
residential
handler
applies
biocide­
treated
paint
using
an
aerosol
spray
can.
PHED
unit
exposures
from
the
Residential
SOPs
are
used
for
aerosol
spraying
by
a
residential
handler
(
EPA
1997).

(
2)
Handler
Exposure
Data
and
Assumptions
In
the
development
of
this
Reregistration
Eligibility
Decision
(
RED)
Document,
limited
handler
exposure
data
were
available
for
use
by
the
Agency.
In
the
absence
of
chemical­
specific
data
for
zinc
pyrithione,
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1,
the
Chemical
Manufacturers
Association
(
CMA),
and
Garrod
et
al.
(
2000)
were
used
to
estimate
unit
exposures.
Zinc
pyrithione
product
labeling
information
along
with
EPA
use
estimates
were
relied
on
to
calculate
the
approximate
amount
handled
per
day.
These
data
were
used
to
predict
handler
exposures
for
the
various
scenarios
(
PHED,
1997;
CMA,
1992;
and
U.
S.
EPA,
1997a).

(
a)
Handler
Exposure
Data
Chemical­
specific
handler
exposure
data
were
not
submitted
by
the
registrant
for
Zinc
Pyrithione;

therefore,
surrogate
data
from
CMA,
PHED,
the
residential
SOPs,
and
Garrod
et
al.
(
2000)
were
used
to
estimate
exposure.

(
i)
Chemical
Manufacturers
Association
(
CMA)
Data
The
CMA
study
data
were
used
to
estimate
primary
exposures
for
the
following
occupational
handler
scenarios
(
Table
4).

Primary
Occupational
Handlers
General
Preservative
Uses:
Dry
Film,
In
Can,
and
Materials
Preservative
(
1a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods;
(
1b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
pump
equipment
(
pump
liquid);
(
1c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods;
and
(
1d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment.

Paints:
Dry
Film
Preservation
(
2a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods;
1
These
guideline
have
been
superceded
by
Series
875.1000­
875.1600
of
the
Pesticide
Assessment
Guidelines.

19
(
2b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
pump
equipment
(
pump
liquid);
(
2c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods;
and
(
2d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment.

Fabrics/
Textiles:
Laundering
Treatment
for
Materials
Preservation
(
3a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods;
(
3b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
pump
equipment
(
pump
liquid);
(
3c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods;
and
(
3d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment.

The
CMA
(
1992)
"
Antimicrobial
Exposure
Assessment
Study"
was
conducted
in
order
to
meet
the
requirements
of
Subdivision
U
of
the
Pesticide
Assessment
Guidelines
for
"
Applicator
Exposure
Monitoring"
1
and
the
"
Occupational
and
Residential
Exposure
Test
Guidelines"
in
Series
875
to
support
the
registration
of
antimicrobial
pesticide
active
ingredients.
The
purpose
of
this
CMA
study
was
to
characterize
exposure
to
antimicrobial
chemicals
in
order
to
support
certain
antimicrobial
pesticide
reregistrations
(
CMA,
1992).
The
unit
exposures
presented
in
the
most
recent
EPA
evaluation
of
the
CMA
database
(
EPA,
1999b)
were
used
in
this
assessment.

The
Agency
determined
that
the
CMA
study
had
fulfilled
the
basic
requirements
of
Subdivision
U
­

Applicator
Exposure
Monitoring.
The
advantages
of
CMA
data
over
other
"
surrogate
data
sets"
are
that
the
chemicals
and
the
job
functions
of
mixer/
loader/
applicator
were
defined
based
on
common
application
methods
used
for
antimicrobial
pesticides.
Note
that
there
were,
however,
a
few
deficiencies
in
this
study
particularly
with
respect
to
quality.
[
Refer
within
to
Section
(
9)
Data
Gaps,
Uncertainties
and
Limitations.]

Exposure
results
from
the
CMA
study
seem
to
indicate
that
dermal
exposure
is
the
primary
exposure
route
for
the
seven
antimicrobial
chemicals
analyzed.
Inhalation
exposures
in
the
CMA
data
were
very
low,

usually
below
the
chemical
limit
of
detection.
Therefore,
the
data
in
the
CMA
study
might
not
be
a
valid
estimation
of
inhalation
exposure
for
zinc
pyrithione.

(
ii)
Pesticide
Handlers
Exposure
Database
(
PHED)
Data
20
The
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1
was
used
to
estimate
exposures
for
the
following
primary
residential
handlers
using
antifoulant
paints
(
Tables
3
and
5),
and
secondary
occupational/
secondary
residential
handler
scenarios
(
Table
4)
for
materials
preservatives:

Primary
Residential
Handlers
(
Table
5)
Handling
zinc
pyrithione­
containing
antifoulant
paints
using
a
paint
brush;
and
(
Table
5)
Handling
zinc
pyrithione­
containing
antifoulant
paints
using
an
airless
sprayer.

Secondary
Occupational/
Residential
Handlers
(
4a,
6a)
Handling
zinc
pyrithione­
containing
paint
end
products
using
a
paint
brush
application
method;

(
4b,
6b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method;
and
(
4c,
6c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method.

PHED
Data
PHED
was
designed
by
a
task
force
consisting
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,
1997).
PHED
is
a
generic
database
containing
measured
exposure
data
for
workers
involved
in
the
handling
or
application
of
pesticides
under
actual
field
conditions,
in
primarily
agricultural
settings.
Currently,
the
database
contains
values
for
over
1,700
monitored
exposure
events
(
i.
e.,
replicates).

The
basic
assumption
underlying
the
system
is
that
exposure
to
pesticide
handlers
can
be
calculated
using
the
monitored
data
because
exposure
is
primarily
a
function
of
the
physical
parameters
of
the
handling
and
application
process
(
i.
e.,
the
pesticide
use
scenario
based
on
the
packaging
type,
application
method,
and
any
protective
clothing
worn).
PHED
also
contains
algorithms
that
allow
the
user
to
complete
surrogate,

taskbased
exposure
assessments
beginning
with
one
of
the
four
main
data
files
contained
in
the
system
(
i.
e.,

mixer/
loader,
applicator,
flagger,
and
mixer/
loader/
applicator).

Users
can
select
data
from
each
major
PHED
file
and
construct
exposure
scenarios
that
are
representative
of
the
use
of
the
chemical.
The
subsetting
algorithms
in
PHED
are
based
on
the
central
assumption
that
one
magnitude
of
handler
exposures
to
pesticides
are
primarily
a
function
of
activity,

formulation
type,
application
method,
and
clothing
scenario.
However,
to
add
consistency
to
the
risk
assessment
process,
the
EPA,
in
conjunction
with
the
PHED
Task
Force,
has
evaluated
all
data
within
the
system
and
developed
surrogate
exposure
tables
that
contain
a
series
of
standard
unit
exposure
values
for
21
various
exposure
scenarios.
These
standard
unit
exposure
values
are
based
on
the
"
best
fit"
values
calculated
by
PHED.
PHED
calculates
"
best
fit"
exposure
values
by
assessing
the
distributions
of
exposures
for
each
body
part
included
in
data
sets
selected
for
the
assessment
(
i.
e.,
chest
or
forearm)
and
then
calculating
a
composite
exposure
value
representing
the
entire
body.
PHED
categorizes
distributions
as
normal,
lognormal,

or
in
any
"
other"
category.
Generally,
most
data
contained
in
PHED
are
lognormally
distributed
or
fall
into
the
PHED
"
other"
distribution
category.
If
the
distribution
is
lognormal,
the
geometric
mean
for
the
distribution
is
used
as
the
"
best
fit"
exposure
value.
If
the
data
are
an
"
other"
distribution,
the
median
value
of
the
data
set
is
used
in
the
calculation
of
the
"
best
fit"
exposure
value.
As
a
result,
the
surrogate
unit
exposure
values
that
serve
as
the
basis
for
this
assessment
generally
range
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
PHED
unit
exposure
data
used
in
this
assessment
represent
the
estimated
level
of
exposure
expected
per
unit
amount
of
pesticide
handled
and
are
reported
in
units
of
mg
exposure/
lbs
ai
handled
(
PHED,
1998).

PHED
has
long
been
used
as
a
surrogate
for
handler
exposure
assessment.
The
data
for
PHED
may
have
some
advantages
to
CMA
data
in
that
they
are
generally
rated
as
grades
A,
B,
C,
so
it
tends
to
have
better
quality
QA/
QC
(
i.
e.,
better
field,
lab
and
storage
stability
recoveries),
more
replicates
(
i.
e.,
over
15
replicates),

less
variability
(
i.
e.,
lower
CVs),
and
reportable
inhalation
unit
exposure
values.
Data
confidence
refers
to
both
the
"
quality"
and
the
"
amount"
of
data
for
each
PHED
run.
Each
study
in
PHED
has
been
graded
from
"
A"

to
"
E"
according
to
certain
Quality
Assurance/
Quality
Control
(
QA/
QC)
factors
(
PHED,
1998).

The
confidence
levels
for
the
unit
exposures
are
Grade
C
for
paintbrush,
Grades
B
and
C
for
airless
spraying,
and
Grades
A
and
B
for
aerosol
can.

(
iii)
Residential
Exposure
Assessment
Standard
Operating
Procedures
(
SOPs)

The
residential
exposure
assessment
SOPs
are
designed
for
use
in
assessing
exposure
to
pesticides
in
residential
settings.
The
objective
of
these
SOPs
is
to
provide
standard
default
methods
for
developing
residential
exposure
assessments
for
both
handler
and
postapplication
exposures
when
chemical­
and/
or
sitespecific
field
data
are
limited.
These
methods
may
be
used
in
the
absence
of,
or
as
a
supplement
to,

chemicaland
or
site­
specific
data.
The
SOPs
were
prepared
by
EPA's
Office
of
Pesticide
Programs,
Health
Effects
Division
and
Antimicrobials
Division
with
input
from
EPA's
Office
of
Pollution
Prevention
and
Toxics,
and
Office
of
Research
and
Development
(
U.
S.
EPA,
1997a).

For
the
residential
handler
exposure
assessment,
dermal
and
inhalation
exposure
data
are
from
the
residential
SOPs
developed
using
PHED
Version
1.1.
The
values
of
the
residential
PHED
data
versus
the
occupational
PHED
data
generally
differ
because
the
baseline
attire
is
different.
The
baseline
residential
clothing
attire
is
short
pants,
short­
sleeve
shirt,
socks,
shoes,
and
no
gloves.
The
occupational
baseline
scenario
generally
represents
a
handler
wearing
a
long­
sleeved
shirt,
long
pants,
socks,
and
shoes
with
no
respirator
or
chemical­
resistant
gloves.
The
grading
scheme
for
the
residential
PHED
data
is
described
in
the
22
occupational
section.
The
confidence
levels
of
paintbrush,
airless
sprayer,
and
aerosol
can
are
Grade
C
for
paintbrush,
Grades
B
and
C
for
airless
spraying,
and
Grades
A
and
B
for
aerosol
can.

(
iv)
Literature
Study
 
Garrod
et
al.
(
2000)

The
Garrod
et
al
(
2000)
study
was
identified
by
the
registrant
during
the
30­
day
error
comment
period
of
the
Reregistration
Eligibility
Decision
(
RED)
process
for
Zinc
Pyrithione
(
i.
e.,

zinc
omadine
®
)
.
The
Garrod
et
al
(
2000)
study
was
reviewed
by
the
Antimicrobials
Division
(
AD)

to
provide
dermal
and
inhalation
unit
exposures
(
UEs)
appropriate
for
use
in
developing
antifoulant
and
wood
preservative
outdoor
painting
exposure
scenarios
for
amateur
(
consumer)
applicators.
The
antifoulant
paint
in
this
study
was
applied
using
a
paint
brush
and
roller
to
boat
hulls
of
recreational
craft
stored
on
sling/
cradle/
trailers.
The
scenario
monitored
in
this
study
(
i.
e.,
antifoulant
applications
via
brush/
roller)
is
more
representative
for
Do­
It­
Yourself
(
DIY)
painters
than
the
surrogate
data
available
in
the
Pesticide
Handlers
Exposure
Database
(
PHED).
The
surrogate
data
in
PHED
are
based
on
an
indoor
painting
scenario
where
latex
paint
containing
a
fungicide
is
applied
to
interior
bathroom
walls
with
a
brush.
However,
only
the
air
concentration
data
are
available
from
Garrod
et
al
(
2000).
The
dermal
portion
of
the
study
monitored
mostly
exposure
on
the
outside
of
clothing
and
only
one
patch
was
used
underneath
clothing.
New
studies
measuring
both
dermal
and
inhalation
exposures
are
recommended.
QA/
QC
samples
consisted
of
laboratory
recoveries.
The
laboratory
recovery
results
were
mostly
in
the
90
percent
range.
No
replicates
were
corrected
for
recovery.
The
article
did
not
mention
field
fortifications
or
storage
stability
samples
(
nor
did
it
discuss
shipment
or
storage
of
field
samples).

(
b)
Estimated
Amount
Handled
(
i)
Antifoulants
The
estimated
amounts
handled
per
day
were
used
in
conjunction
with
data
from
PHED
to
calculate
exposure
dose
estimates
for
residential
handler
scenarios.
Based
on
review
of
the
existing
labels,
the
residential
assessment
for
antifoulants
is
based
on
two
products.
EPA
Reg.
No.
64684­
4
has
been
selected
because
it
specifically
lists
recreational
use,
is
formulated
at
4.8
percent,
and
does
not
prohibit
spraying.
EPA
Reg.
No.

2693­
194
is
also
included
because
of
the
high
concentration
(
47.04
percent
diluted
as
a
two
part
mixture)
and
there
are
no
label
restrictions.
Recreational
boat
owners
have
several
techniques
they
can
use
to
paint
their
hulls
including
paint
brush,
roller,
and
airless
sprayer.
There
are
no
chemical­
specific
exposure
data
to
assess
these
techniques.
However,
surrogate
data
are
available
for
painting
with
a
brush
and
an
airless
sprayer.
The
surrogate
data
are
based
on
PHED
data
for
painters
wearing
long
pants,
long
sleeve
shirts,
no
gloves,
and
no
respirator.
The
test
subjects
were
painting
a
bathroom
with
a
paint
brush
and
staining
the
outside
of
a
house
23
with
an
airless
sprayer.
The
dermal
and
inhalation
exposures
from
these
techniques
have
been
normalized
by
the
amount
of
active
ingredient
handled
and
reported
as
PHED
unit
exposures
(
UE)
expressed
as
mg/
lb
ai
handled.
Although
the
exposures
while
painting
a
boat
hull
may
differ
slightly,
the
data
are
judged
to
be
representative
of
painting
and
are
used
in
this
assessment.
The
data
from
Garrod
et
al.
(
2000)
were
also
used
as
a
comparison
to
PHED
because
the
Garrod
(
2000)
study
design
is
more
representative
of
the
use
(
i.
e.,

painting
boat
hulls
using
an
antifoulant
paint).
The
air
concentration
data
from
Garrod
(
2000)
are
used
to
present
the
inhalation
route­
specific
risks
in
normalized
units
of
mg/
m3.

The
amount
of
antifouling
paint
handled
by
a
do­
it­
yourself
(
DIY)
boat
hull
painter
is
determined
by
the
size
of
the
hull
painted.
Based
on
label
directions,
one
gallon
of
the
antifouling
paint
covers
roughly
300
ft2
with
a
minimum
of
3
coats
applied.
The
antifouling
paint
in
label
64684­
4
contains
4.8
percent
ai
and
assuming
one
gallon
of
paint
weighs
~
10
lbs/
gallon
this
corresponds
to
0.48
lb
ai/
gallon.
Label
2693­
194
is
a
two
part
mixture
with
the
Activator
portion
consisting
of
47.04
percent
ai.
One
pint
of
Activator
is
mixed
with
7
pints
of
paint.
Thus,
the
final
paint
mixture
consists
of
0.588
lb
ai/
gallon
(
1.25
lb
per
pint/
gallon
paint
x
0.4704
ai
=
0.588
lb
ai/
gallon).
Various
size
boats
can
be
potentially
painted
and
this
assessment
presents
a
range
of
boats.
There
are
no
label
restrictions
on
the
drying
time
between
coats
of
paint,
and
therefore,
it
is
assumed
that
the
recommended
number
of
coats
of
paint
can
be
applied
in
one
day.
Refinements
to
the
amount
handled
on
a
daily
basis
can
be
made
if
drying
times
are
in
the
range
of
24­
hours.
The
range
of
boats
and
amounts
of
ai
handled
are
listed
below:

$
14
ft
Boat
­
The
surface
area
of
the
hull
of
a
14
ft
boat
with
a
5
ft
beam
is
~
70
ft2
which
corresponds
to
0.336
lb
ai
handled
for
label
64684­
4
(
i.
e.,
((
70
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.48
lb
ai/
gallon)

and
0.4116
lb
ai
for
label
2693­
194
(
i.
e.,
((
70
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.588
lb
ai/
gallon).

It
is
also
estimated
that
it
would
require
~
2
hours
to
paint
3
coats.

$
20
ft
Boat
­
The
surface
area
of
the
hull
of
a
20
ft
boat
with
a
8
ft
beam
is
~
160
ft2
which
corresponds
to
0.768
lb
ai
handled
for
label
64684­
4
(
i.
e.,
((
160
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.48
lb
ai/
gallon)
and
0.9408
lb
ai
for
label
2693­
194
(
i.
e.,
((
160
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.588
lb
ai/
gallon).
It
is
also
estimated
that
it
would
require
~
4
hours
to
paint
3
coats.

$
30
ft
Boat
­
The
surface
area
of
the
hull
of
a
30
ft
boat
with
a
10
ft
beam
is
~
300
ft2
which
corresponds
to
1.44
lb
ai
handled
for
label
64684­
4
(
i.
e.,
((
300
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.48
lb
ai/
gallon)
and
1.764
lb
ai
for
label
2693­
194
(
i.
e.,
((
300
ft2
x
3
coats)/
300
ft2
per
gallon)
x
0.588
lb
ai/
gallon).
It
is
also
estimated
that
it
would
require
~
6
hours
to
paint
3
coats.

(
ii)
Materials
Preservatives
24
The
estimated
amounts
handled
per
day
were
used
in
conjunction
with
data
from
PHED,
the
residential
SOPs,
or
CMA
to
calculate
exposure
dose
estimates
for
handlers
in
various
scenarios.
The
estimates
of
amount
handled
during
manufacturing
are
10,000
pounds
of
slurry,
1,000
gallons
of
paint,
and
1,000
gallons
of
water
for
laundry
treatments.
These
estimates
are
based
on
Agency
standard
values
for
industrial
practices
and
were
used
for
all
preservatives
and
paints
(
density
of
10
lb/
gal).
An
estimate
of
1,000
gallons
of
"
acid
sour"
was
used
for
laundry
treatments.
According
to
the
registrant,
the
"
acid
sour"
is
made
in
1,000
gallon
batches.
This
may,
however,
be
an
overestimate
because
the
batch
may
last
a
few
days
or
weeks
depending
on
the
volume
of
fabrics/
textiles
treated.

Assumptions
for
secondary
occupational
handlers
use
of
paint
for
brushing
(
5
gallons)
and
airless
spraying
(
50
gallons)
are
also
consistent
with
Agency
standard
values
used
in
previous
assessments.
Assumed
amounts
for
the
secondary
residential
handlers
use
of
paint
for
brushing
(
2
gallons),
airless
spraying
(
15
gallons),
and
aerosol
can
(
three
12­
oz
cans)
are
consistent
with
the
Residential
SOPs
(
EPA,
1997a,
2001).

Table
5
provides
the
estimates
used
to
calculate
the
amount
of
zinc
pyrithione
handled
for
each
exposure
scenario.

Note
that
the
exposure
scenarios
developed
for
the
secondary
occupational
handlers
differ
from
the
secondary
residential
handlers
in
terms
of
the
amount
of
product
handled
per
day
and
in
the
data
used.
The
PHED
data
from
the
residential
SOPs
assumes
that
handlers
may
wear
short
pants,
short­
sleeved
shirt,
socks,

and
shoes.
The
occupational
PHED
data
generally
represents
a
handler
wearing
a
long­
sleeved
shirt,
long
pants,
socks,
and
shoes.

Table
5.
Exposure
Estimates/
Assumptions
for
Amount
of
Zinc
Pyrithione
Handled
Per
Day
Exposure
Scenario
Scenario
Description
Primary
Occupational
Handler
General
Preservative
Uses:
Dry
Film,
In
Can,
and
Materials
Preservation
(
1a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Assumes
treatment
per
day
of
10,000
pounds
of
slurry
used
for
various
manufactured
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
caulks/
sealants,
grouts/
patching
compounds,
processed
rubber,
textiles,
thermoplastic
resin­
based
articles
(
e.
g.
air
ducts),
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
food
processing
equipment
and
conveyor
belts).
EPA
Reg.
1258­
841
(
48
percent
active
ingredient
(
a.
i.))
indicates
that
the
maximum
application
rate
is
1000
ppm
(
10.4
lb/
1000
lbs)
to
caulk/
sealants
or
5
lb
ai/
1000
lbs.

(
1b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Assumes
treatment
per
day
of
10,000
pounds
of
slurry
used
for
various
manufactured
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
caulks/
sealants,
grouts/
patching
compounds,
processed
rubber,
textiles,
thermoplastic
resin­
based
articles
(
e.
g.
air
ducts),
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
food
processing
equipment
and
conveyor
belts).
EPA
Reg.
1258­
841
(
48
percent
active
ingredient
(
a.
i.))
indicates
that
the
maximum
application
rate
is
1000
ppm
(
10.4
lb/
1000
lbs)
to
caulk/
sealants
or
5
lb
ai/
1000
lbs.
Table
5.
Exposure
Estimates/
Assumptions
for
Amount
of
Zinc
Pyrithione
Handled
Per
Day
Exposure
Scenario
Scenario
Description
25
(
1c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Assumes
treatment
per
day
of
10,000
pounds
of
slurry
used
for
various
manufactured
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
caulks/
sealants,
grouts/
patching
compounds,
processed
rubber,
textiles,
thermoplastic
resin­
based
articles
(
e.
g.
air
ducts),
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
food
processing
equipment
and
conveyor
belts).
EPA
Reg.
1258­
840
(
95
percent
active
ingredient
(
a.
i.))
indicates
that
the
maximum
application
rate
is
5000
ppm
(
5
lb/
1000
lbs)
to
caulk/
sealants
or
4.75
lb
ai/
1000
lbs.
Maximum
application
rate
of
5
lb
ai/
1000
lbs
will
be
used
for
this
assessment
with
an
assumption
of
10,000
pounds
of
slurry.

(
1d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Assumes
treatment
per
day
of
10,000
pounds
of
slurry
used
for
various
manufactured
substrates
(
e.
g.,
food/
non­
food
contact
adhesives,
caulks/
sealants,
grouts/
patching
compounds,
processed
rubber,
textiles,
thermoplastic
resin­
based
articles
(
e.
g.
air
ducts),
and
food/
non­
food
contact
polymeric
systems;
including
repeat­
use
polymeric
food
contact
materials
such
as
food
processing
equipment
and
conveyor
belts).
EPA
Reg.
1258­
840
(
95
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
5000
ppm
(
5
lb/
1000
lbs)
to
caulk/
sealants
or
4.75
lb
ai/
1000
lbs.
Maximum
application
rate
of
5
lb
ai/
1000
lbs
will
be
used
for
this
assessment
with
an
assumption
of
10,000
pounds
of
slurry.

Paints:
Dry
Film
Preservation
(
2a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Assumes
1,000
gallons
of
paint
are
manufactured
per
day.
EPA
Reg.
1258­
841
(
48
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
10000
ppm
(
10.83
lb/
1000
lbs)
to
paints
or
5.2
lb
ai/
1000
lbs
(~
5
lb
ai/
1000
lbs).

(
2b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Assumes
1,000
gallons
of
paint
are
manufactured
per
day..
EPA
Reg.
1258­
841
(
48
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
10000
ppm
(
10.83
lb/
1000
lbs)
to
paints
or
5.2
lb
ai/
1000
lbs
(~
5
lb
ai/
1000
lbs).

(
2c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Assumes
1,000
gallons
of
paint
are
manufactured
per
day.
EPA
Reg.
1258­
840
(
95
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
5000
ppm
(
5
lb/
1000
lbs)
to
paints
or
4.75
lb
ai/
1000
lbs
(~
5
lb
ai/
1000
lbs).

(
2d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Assumes
1,000
gallons
of
paint
are
manufactured
per
day.
EPA
Reg.
1258­
840
(
95
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
5000
ppm
(
5
lb/
1000
lbs)
to
paints
or
4.75
lb
ai/
1000
lbs
(~
5
lb
ai/
1000
lbs).

Fabrics/
Textiles:
Laundering
Treatment
for
Materials
Preservation
(
3a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
Assumes
1,000
gallons
water
handled
per
day.
EPA
1258­
841
(
48
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
9
ounces
of
48%
per
1,000
gallons.
EPA
Reg
1258­
841,
the
amount
handled
can
be
converted
to
0.27
lb
ai/
1,000
gallons
(~
0.25
lb
ai/
1,000
gallons)
as
follows:
9
ounces
x
1
lb
/
16
oz
ounces
x
0.48
(
48%)

(
3b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
Assumes
1,000
gallons
water
handled
per
day.
EPA
1258­
841
(
48
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
9
ounces
of
48%
per
1,000
gallons.
EPA
Reg
1258­
841,
the
amount
handled
can
be
converted
to
0.27
lb
ai/
1,000
gallons
(~
0.25
lb
ai/
1000
gallons)
as
follows:
9
ounces
x
1
lb
/
16
oz
ounces
x
0.48
(
48%)
Table
5.
Exposure
Estimates/
Assumptions
for
Amount
of
Zinc
Pyrithione
Handled
Per
Day
Exposure
Scenario
Scenario
Description
26
(
3c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
Assumes
1,000
gallons
water
handled
per
day.
EPA
1258­
840
(
95
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
18
ounces
of
95%
per
1,000
gallons.
EPA
Reg
1258­
840
indicates
an
acid
sour
density
of
8.3
lb/
gallon,
the
amount
handled
can
be
converted
to
1.1
lb
ai/
1,000
gallons
(~
1lb
ai/
1000
gallons)
as
follows:
18
ounces
x
1
gallon/
128
ounces
x
8.3
lb/
gallon
x
0.95
(
95%)

(
3d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
Assumes
1,000
gallons
water
handled
per
day.
EPA
1258­
840
(
95
percent
active
ingredient
(
a.
i.)
indicates
that
the
maximum
application
rate
is
18
ounces
of
95%
per
1,000
gallons.
EPA
Reg
1258­
840
indicates
an
acid
sour
density
of
8.3
lb/
gallon,
the
amount
handled
can
be
converted
to
1.1
lb
ai/
1,000
gallons
(~
1lb
ai/
1000
gallons)
as
follows:
18
ounces
x
1
gallon/
128
ounces
x
8.3
lb/
gallon
x
0.95
(
95%)

Secondary
Occupational
Handler
(
4a)
Handling
zinc
pyrithione­
containing
paint
end
products
using
a
paint
brush
application
method
Assumes
5
gallons
or
50
pounds
of
paint
are
used
per
day
for
occupational
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.

(
4b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
Assumes
50
gallons
or
500
pounds
of
paint
are
used
per
day
for
occupational
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.

(
4c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method
Assumes
0.28
gal/
day
(
three
12­
oz
cans)
are
used
per
day
for
occupational
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.

Secondary
Residential
Handler
(
5a)
Handling
zinc
pyrithione­
containing
paint
end
products
using
a
paint
brush
application
method
Assumes
2
gallons
of
paint
are
used
per
day
for
residential
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.

(
5b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
Assumes
15
gallons
of
paint
are
used
per
day
for
residential
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.
(
SOEs
2001)

(
5c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method
Assumes
0.28
gal/
day
(
three
12­
oz
cans)
are
used
per
day
for
residential
scenario.
Approximately
5
lb
ai
are
added
per
1000
lbs
(
100
gallons)
of
paint.

(
3)
Handler
Risk
Assessment
and
Characterization
(
a)
Handler
Exposure
and
Non­
Cancer
Risk
Calculations
Handler
exposure
assessments
are
completed
by
EPA
using
a
baseline
exposure
scenario
and,

if
required,
increasing
levels
of
risk
mitigation
[
personal
protective
equipment
(
PPE)
and
engineering
controls]
to
achieve
an
appropriate
margin
of
exposure
(
MOE)
or
non­
cancer
risk
for
occupationally
exposed
workers
only.
The
baseline
scenario
generally
represents
a
handler
wearing
a
long­
sleeved
shirt,
long
pants,
socks,
and
shoes
with
no
respirator
or
chemical­
resistant
gloves.
PPE
scenarios
generally
represent
handlers
wearing
one
or
more
of
the
following
PPE:
double
layer
clothing,

chemical­
resistant
gloves,
and/
or
a
respirator.
Engineering
controls
generally
represent
the
use
of
closed
systems
for
mixing/
loading/
applying.
27
(
i)
Antifoulants
Table
6
presents
the
estimated
dermal
and
inhalation
exposures
and
MOEs.
The
clothing
scenarios
presented
are
based
on
DIY
wearing
long
pants,
long
sleeved
shirts,
no
gloves,
and
no
respirator.

Table
6.
Exposure
and
MOEs
for
Do­
it­
yourself
Boat
Hull
Painters
Scenario
Boat
Size
a
Amount
(
Lb
ai)
b
Unit
Exposure
(
mg/
lbai)
c
Dermal
Dosed
(
mg/
kg/
day)
Inhalation
Dosee
(
mg/
kg/
day)
Dermal
MOE
f
Target
MOE

300
Inhalation
MOE
g
Target
MOE

300
Dermal
Inhalation
EPA
Reg.
No.
64684­
4
(
4.8
percent
ai)
All
Estimates
Based
on
3
Coats
of
Paint
in
One
Day
Brush
(
PHED)
14ft
x
5
ft
0.336
180
0.28
0.86
0.0013
120
97
20ft
x
8
ft
0.768
2.0
0.0031
51
42
30ft
x
10ft
1.44
3.7
0.0058
27
23
Brush
&

roller
(
Garrod
et
al.

2000)
14ft
x
5
ft
0.336
NA
0.00087
(
mg/
m3/%

ai)
NA
2
hrs
painting
NA
140
20ft
x
8
ft
0.768
4
hrs
painting
72
30ft
x
10ft
1.44
6
hrs
painting
48
Airless
14ft
x
5
ft
0.336
38
0.83
0.18
0.0040
550
33
20ft
x
8
ft
0.768
0.42
0.0091
240
14
30ft
x
10ft
1.44
0.78
0.017
130
8
EPA
Reg.
No.
2693­
194
(
47
percent
ai)
All
Estimates
Based
on
3
Coats
of
Paint
in
One
Day
Brush
14ft
x
5
ft
0.4116
180
0.28
1.1
0.0017
94
79
20ft
x
8
ft
0.9408
2.4
0.0038
41
35
30ft
x
10ft
1.764
4.5
0.0071
22
18
Brush
&

roller
(
Garrod
et
al.

2000)
14ft
x
5
ft
0.4116
NA
0.00087
(
mg/
m3/%

ai)
NA
2
hrs
painting
NA
15
20ft
x
8
ft
0.9408
4
hrs
painting
7
30ft
x
10ft
1.764
6
hrs
painting
5
Airless
14ft
x
5
ft
0.4116
38
0.83
0.22
0.0049
450
27
20ft
x
8
ft
0.9408
0.51
0.011
200
12
30ft
x
10ft
1.764
0.96
0.021
100
6
Bold
indicates
MOE
exceeds
level
of
concern
(
i.
e.,
MOE
less
than
target
MOE
of
300).
28
a
Hull
area
for
various
size
boats
assumes
that
the
dimension
of
the
hull's
painted
surface
area
is
roughly
based
on
length
and
width.

b
Amount
handled
based
on
the
label
(
300ft2/
gallon,
3
coats,
%
ai,
10
lb/
gal
density
of
paint).

c
Unit
exposures
based
on
PHED
data
for
painters
wearing
long
pants,
long
sleeve
shirt,
no
gloves,
and
no
respirator.
The
inhalation
UE
from
Garrod
et
al
(
2000)
is
normalized
by
the
percent
of
ai
in
the
paint.

d
Dermal
Dose
(
mg/
kg/
day)
=
dermal
UE
(
mg/
lbai)
x
amount
handled
(
lb
ai)
x
1/
70
kg
BW.

e
Inhalation
Dose
(
mg/
kg/
day)
=
inhalation
UE
(
mg/
lbai)
x
amount
handled
(
lb
ai)
x
1/
70
kg
BW.

f
Dermal
MOE
=
dermal
NOAEL
of
100
mg/
kg/
day
/
Dermal
dose
(
mg/
kg/
day).

g
Inhalation
MOE
=
NOAEL
0.13
mg/
kg/
day
/
Inhalation
dose
(
mkd)
or
the
route­
specific
inhalation
MOE
=
(
0.5
mg/
m3
x
6
hrs/
day
animal)
/
[(
paint
air
conc
mg/
3/%
ai
x
%
ai
in
paint
x
hrs
painting)
x
(
1
m3
work
breathing
rate
/
0.4
m3
resting
breathing
rate)].

Note:
The
route­
specific
inhalation
MOEs
do
not
coincide
with
the
route­
extrapolation
inhalation
MOEs
because
of
the
differences
in
methodologies
(
e.
g.,
UE,
dose
vs
air
conc,
estimates
of
hours
painting
versus
amount
of
ai
handled].

The
estimated
dermal
and
inhalation
MOEs
are
of
concern
for
most
of
boat
sizes
when
using
a
paint
brush.
For
the
airless
sprayers
the
dermal
MOEs
are
not
of
concern
(
i.
e.
are
greater
than
300)
for
a
14ft
boat
but
are
of
concern
for
the
larger
boats.
For
all
boat
sizes,
all
of
the
inhalation
MOEs
are
below
the
target
MOE
of
300.
The
majority
of
the
painting
exposure
is
attributed
to
the
hands
and
all
of
the
dermal
MOEs
would
not
be
of
concern
if
painters
wore
chemical
resistant
gloves.

(
ii)
Materials
Preservatives
Exposure
estimates
for
primary
occupational
handlers
are
presented
in
Table
7.
The
CMA
study
data
were
considered
more
appropriate
than
PHED
data
for
best
characterizing
the
antimicrobial
uses
of
zinc
pyrithione
in
industrial
manufacturing
settings.
The
CMA
study
provides
two
risk
mitigation
methods
(
open
pouring
of
liquid/
solid
using
gloves
and
pump
metering
liquid
using
gloves).
These
two
risk
mitigation
methods
are
both
reported
in
Table
7.
It
should
be
noted
that
no
adjustments
were
made
to
the
baseline
CMA
exposure
values
to
reflect
use
of
additional
PPE
(
i.
e.,
respirators).
It
is
not
standard
Agency
practice
to
apply
protection
factors
to
baseline
CMA
exposure
values
to
estimate
doses
adjusted
for
use
of
additional
PPE
in
scenarios
where
the
actual
CMA
data
were
not
generated
using
such
PPE.

The
CMA
study
does
not
assess
paint
application
methods/
exposure
doses.
Therefore,
the
PHED
database
is
used
to
assess
dermal
and
inhalation
exposures
to
secondary
handlers
applying
paint
end
products
containing
zinc
pyrithione,
using
a
paint
brush,
airless
sprayer,
and
aerosol
can.
Table
7
presents
the
exposure/
risk
calculations
at
baseline
for
secondary
occupational
handlers.
In
addition
to
the
baseline
calculations
for
the
airless
spray
painting
scenario,
MOEs
are
calculated
for
PPE
protection
using
gloves
and
an
organic
vapor
respirator.
Table
9
presents
the
exposure/
risk
calculations
at
baseline
for
secondary
residential
handlers
using
PHED
data
reported
in
the
residential
SOPs
(
U.
S.
EPA,
1997)
for
the
painting
scenarios.
It
is
not
current
Agency
policy
to
evaluate
PPE
for
residential
uses.
For
the
painting
scenarios
in
Table
8
for
occupational
handlers,
the
PHED
database
allows
for
the
calculation
of
unit
exposures
at
both
baseline
and
with
the
addition
of
PPE
by
applying
a
protection
factor
of
90%
to
baseline
values
for
chemical­
29
resistant
gloves
and/
or
organic
respirator
in
scenarios
where
the
actual
PHED
data
were
not
generated
using
such
PPE.

Although
the
secondary
occupational
handler
assessments
include
PPE
considerations,
the
mandatory
use
of
PPE
by
handlers
for
non­
spray
applications
of
paint
(
i.
e.,
paint
brush)
is
not
considered
a
viable
protective
measure
due
to
probable
non­
compliance
among
paint
handlers
even
if
the
zinc
pyrithione­
treated
paint
end
products
have
labeling
requiring
the
use
of
PPE.
However,
the
Agency
assumes
that
PPE
use
compliance
would
be
viable
for
the
spray
painting
scenarios,
specifically
airless
sprayer
applications
that
would
result
in
the
greatest
potential
for
inhaled
particulate
without
the
use
of
a
dust/
mist
or
organic
vapor
respirator.
30
Table
7.
Estimates
of
Exposures
and
Risks
to
Primary
Occupational
Handlers
of
Zinc
Pyrithione
Application
Scenarioa
Unit
Exposureb
(
mg/
lb
ai)
Use
Rate
(
lb
ai/
1000
lb,
or
lb
ai/
100
gal)
c
Amount
Handled
(
lb/
day
or
gal/
day)
d
Body
Weight
(
kg)
Dermal
Dose
(
mg/
kg/
day)
e
Inhalation
Dose
(
mg/
kg/
day)
f
Dermal
MOEg
Target
MOE

100
Inhalation
MOEh
Target
MOE

100
Dermal
Inhalation
General
Preservatives
Uses:
Dry
Film,
In
Can,
and
Material
Preservation
(
1a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
0.135
0.00361
5
lb
ai/
1,000
lb
10,000
lb/
day
70
0.0964
2.58E­
3
1037
50
(
1b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
0.00629
0.000403
5
lb
ai/
1,000
lb
10,000
lb/
day
70
0.0045
2.88E­
4
2.23E+
4
452
(
1c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
0.466
0.0125
5
lb
ai/
1,000
lb
10,000
lb/
day
70
0.333
8.93E­
3
300
15
(
1d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
0.00629
0.000403
5
lb
ai/
1,000
lb
10,000
lb/
day
70
0.0045
2.88E­
4
2.23E+
4
452
Paints:
Dry
Film
Preservation
(
2a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
0.135
0.00361
5
lb
ai/
100
gal
1,000
gal
70
0.0964
2.58E­
3
1037
50
(
2b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
0.00629
0.000403
5
lb
ai/
100
gal
1,000
gal
70
0.0045
2.88E­
4
2.23E+
4
452
(
2c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
0.466
0.0125
5
lb
ai/
100
gal
1,000
gal
70
0.333
8.93E­
3
300
15
Table
7.
Estimates
of
Exposures
and
Risks
to
Primary
Occupational
Handlers
of
Zinc
Pyrithione
Application
Scenarioa
Unit
Exposureb
(
mg/
lb
ai)
Use
Rate
(
lb
ai/
1000
lb,
or
lb
ai/
100
gal)
c
Amount
Handled
(
lb/
day
or
gal/
day)
d
Body
Weight
(
kg)
Dermal
Dose
(
mg/
kg/
day)
e
Inhalation
Dose
(
mg/
kg/
day)
f
Dermal
MOEg
Target
MOE

100
Inhalation
MOEh
Target
MOE

100
Dermal
Inhalation
31
(
2d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
0.00629
0.000403
5
lb
ai/
100
gal
1,000
gal
70
0.0045
2.88E­
4
2.23E+
4
452
Fabrics/
Textiles:
Laundering
Treatment
for
Material
Preservation
(
3a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
0.135
0.00361
0.25
lb
ai/
1,000
gal
1,000
gal
70
5.0E­
4
1.29E­
5
2.07E+
5
1.01E+
4
(
3b)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
metering
equipment
(
pump
liquid)
0.00629
0.000403
0.25
lb
ai/
1,000
gal
1,000
gal
70
2.2E­
5
1.44E­
6
4.45E+
6
9.03E+
4
(
3c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
0.466
0.0125
1
lb
ai/
1,000
gal
1,000
gal
70
6.7E­
3
1.79E­
4
1.5E+
4
728
(
3d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques)
0.00629
0.000403
1
lb
ai/
1,000
gal
1,000
gal
70
9.0E­
5
5.76E­
6
1.11E+
6
2.26E+
4
Footnotes:

a
Scenarios
based
on
use
patterns
described
on
labels
and
LUIS
report.
Primary
occupational
handlers
include
people
who
add
zinc
pyrithione
as
a
general
preservative
to
products
such
as
food/
non­
food
contact
adhesives;
floor
tile
adhesives;
caulks
and
sealants;
grout
and
patching
compounds;
food/
non­
food
contact
polymeric
materials;
rubber
and
thermoplastic
resins;

preservatives
in
latex
paint;
architectural
coatings;
dry
film
preservative
in
products
such
as
dry
wall
and
building
materials;
and
laundered
fabrics.

b
Unit
exposures
based
on
CMA
data
for
inhalation
and
dermal
exposure.
Data
represent
single
layer
clothing
and
gloves.

c
Represents
the
maximum
use
rates
on
the
registered
zinc
pyrithione
product
labels;
EPA
Registration
Nos.:
1258­
840
and
1258­
841.
32
d
Standard
EPA
default
assumptions:
10,000
for
caulk;
1,000
for
paint;
and
1,000
for
laundered
fabric.

e
Dermal
Dose
(
mg/
kg/
day)
=
[
Unit
Dermal
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]/
Body
Weight
(
kg).

f
Inhalation
Dose
(
mg/
kg/
day)
=
[
Unit
Inhalation
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]
/
Body
Weight
(
kg).

g
Dermal
MOE
=
Dermal
NOAEL
(
mg/
kg/
day)
/
Dermal
Dose
(
mg/
kg/
day).
Where
the
dermal
NOAEL
is
100
mg/
kg/
day.

h
Inhalation
MOE
=
Inhalation
NOAEL
(
mg/
kg/
day)
/
Inhalation
Dose
(
mg/
kg/
day).
Where
the
inhalation
NOAEL
of
0.0005
mg/
L/
day
is
converted
to
0.13
mg/
kg/
day.

Table
8.
Estimates
of
Exposures
and
Risks
to
Secondary
Occupational
Handlers
of
Zinc
Pyrithione
Application
Scenarioa
Unit
Exposure
(
mg/
lb
ai)
b
Use
Rate
(
Lb
ai/
1,000
lb
or
lb
ai/
100
gal)
c
Amount
Handled
(
lb/
day
or
gal/
day)
d
Body
Weight
(
kg)
Dermal
Dose
(
mg/
kg/
day)
e
Inhalation
Dose
(
mg/
kg/
day)
f
Dermal
MOEg
Target
MOE

100
Inhalation
MOEh
Target
MOE

100
Dermal
Inhalation
Paints
Containing
Zinc
Pyrithione
(
4a)
Handling
zinc
pyrithionecontaining
paint
end
products
using
a
paint
brush
application
method
180
0.28
5
lb
ai/
100
gal
5
gal/
day
70
0.64
1.0E­
3
156
130
(
4b)
Handling
zinc
pyrithionecontaining
paint
end
products
using
an
airless
sprayer
application
method
38
0.83
5
lb
ai/
100
gal
50
gal/
day
70
1.36
0.030
74
4.4
14*

(
PPE)
0.083**

(
PPE)
0.5*

(
PPE)
0.003**

(
PPE)
200
(
PPE)
44
(
PPE)

(
4c)
Handling
zinc
pyrithionecontaining
paint
end
products
using
an
aerosol
spray
can
application
method
190
1.3
5
lb
ai/
100
gal
0.28
gal/
day
(
3
12­
oz
cans)
70
0.038
2.60E­
4
2,632
500
Footnotes:

a
Scenarios
based
on
use
patterns
described
on
labels
and
LUIS
report.
Secondary
occupational
handlers
include
persons
who
apply
products
containing
zinc
pyrithione
incorporated
as
a
general
preservative
(
e.
g.,
floor
tile
adhesives,
caulks/
sealants,
grout/
patching
materials,
and
rubber/
thermoplastic
resin/
polymeric­
based
products),
and
persons
who
apply
latex
paint,
architectural
paints
and
coatings,
or
dry
wall
and
building
materials
that
contain
zinc
pyrithione.

b
Dermal
unit
exposures
based
on
data
from
PHED,
Version
1.1
(
single
layer
clothing;
long­
sleeved
shirt,
long
pants;
no
gloves),
except
for
scenario
4
which
is
based
on
CMA
data.
CMA
data
represent
single
layer
clothing
and
no
gloves.
Unit
exposure
values
for
inhalation
based
on
data
from
PHED,
Version
1.1
and
assumes
no
respirator
worn.

*
Use
of
gloves
as
PPE
assumes
a
90%
protection
factor.
**
Use
of
organic
vapor
respirator
as
PPE
assumes
a
90%
protection
factor.

c
Represents
the
maximum
use
rates
on
the
registered
zinc
pyrithione
product
labels;
EPA
Registration
Nos.:
1258­
840,
1258­
841,
and
1258­
1183.

d
Standard
EPA
default
assumptions.

e
Dermal
Dose
(
mg/
kg/
day)
=
[
Unit
Dermal
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]
/
Body
Weight
(
kg).

f
Inhalation
Dose
(
mg/
kg/
day)
=
[
Unit
Inhalation
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]
/
Body
Weight
(
kg).
33
g
Dermal
MOE
=
Dermal
NOAEL
(
mg/
kg/
day)
/
Dermal
Dose
(
mg/
kg/
day).
Where
the
dermal
NOAEL
is
100
mg/
kg/
day.

h
Inhalation
MOE
=
Inhalation
NOAEL
(
mg/
kg/
day)
/
Inhalation
Dose
(
mg/
kg/
day).
Where
the
inhalation
NOAEL
of
0.0005
mg/
L/
day
is
converted
to
0.13
mg/
kg/
day.
34
Table
9.
Estimates
of
Exposures
and
Risks
to
Secondary
Residential
Handlers
of
Zinc
Pyrithione
Scenarioa
Unit
Exposure
(
mg/
lb
ai)
b
Use
Rate
(
Lb
ai/
1,000
lb
or
lb
ai/
100
gal)
c
Amount
Handled
(
lb/
day
or
gal/
day)
d
Body
Weight
(
kg)
Dermal
Dose
(
mg/
kg/
day)
e
Inhalation
Dose
(
mg/
kg/
day)
f
Dermal
MOEg
Acceptable
MOE

300
Inhalation
MOEh
Acceptable
MOE

300
Dermal
Inhalation
Paints
Containing
Zinc
Pyrithione
(
5a)
Handling
zinc
pyrithionecontaining
paint
end
products
using
a
paint
brush
application
method
230
0.28
5
lb
ai/
100
gal
2
gal/
day
70
0.328
4.0E­
4
304
325
(
5b)
Handling
zinc
pyrithionecontaining
paint
end
products
using
an
airless
sprayer
application
method
79
0.83
5
lb
ai/
100
gal
15
gal/
day
70
0.846
8.89E­
3
118
15
(
5c)
Handling
zinc
pyrithionecontaining
paint
end
products
using
an
aerosol
spray
can
application
method
220
2.4
5
lb
ai/
100
gal
0.28
gal/
day
(
3
12­
oz
cans)
70
0.044
4.80E­
4
2,273
271
Footnotes:

a
Scenarios
based
on
use
patterns
described
on
labels
and
LUIS
report.
Secondary
residential
handlers
include
homeowners
who
apply
products
containing
zinc
pyrithione
incorporated
as
a
general
preservative
(
e.
g.,
floor
tile
adhesives,
caulks/
sealants,
grout/
patching
materials,
and
rubber/
thermoplastic
resin/
polymeric­
based
products),
and
homeowners
who
apply
latex
paint,
architectural
coating,
and
dry
wall
and
building
materials
that
contain
zinc
pyrithione.

b
Dermal
unit
exposures
based
on
data
from
PHED,
Version
1.1
(
single
layer
clothing;
short­
sleeved
shirt,
short
pants;
no
gloves),
except
for
scenario
6
which
is
based
on
CMA
data.
CMA
data
represent
single
layer
clothing
and
no
gloves.
Unit
exposure
values
for
inhalation
based
on
data
from
PHED,
Version
1.1
and
assumes
no
respirator
worn.

*
Use
of
gloves
as
PPE
assumes
a
90%
protection
factor.
**
Use
of
organic
vapor
respirator
as
PPE
assumes
a
90%
protection
factor.

c
Represents
the
range
of
use
rates
in
the
zinc
pyrithione
labels;
EPA
registration
Numbers
1258­
840
and
1258­
841.

d
Standard
EPA
default
assumptions.

e
Dermal
Dose
(
mg/
kg/
day)
=
[
Unit
Dermal
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]
/
Body
Weight
(
kg).

f
Inhalation
Dose
(
mg/
kg/
day)
=
[
Unit
Inhalation
Exposure
(
mg/
lb
ai)
*
Use
Rate
(
lb
ai/
lb
product
or
lb
ai/
gal
product)
*
Amount
Handled
per
Day
(
lb
product/
day)]
/
Body
Weight
(
kg).

g
Dermal
MOE
=
Dermal
NOAEL
(
mg/
kg/
day)
/
Dermal
Dose
(
mg/
kg/
day).
Where
the
dermal
NOAEL
is
100
mg/
kg/
day.

h
Inhalation
MOE
=
Inhalation
NOAEL
(
mg/
kg/
day)
/
Inhalation
Dose
(
mg/
kg/
day).
Where
the
inhalation
NOAEL
of
0.0005
mg/
L/
day
is
converted
to
0.13
mg/
kg/
day.
35
Daily
Dermal
Dose

Unit
Exposure
x
Use
Rate
x
Amount
Handled
x
1
Body
Weight
Daily
Inhalation
Dose

Unit
Exposure
x
Use
Rate
x
Amount
Handled
x
1
Body
Weight
(
i)
Daily
Dermal
Dose
The
potential
daily
dermal
doses
in
Tables
7,
8,
and
9
were
calculated
using
the
following
equation:

Equation
2:

where:

Unit
Exposure
(
mg
ai/
lb
ai)
=
Values
obtained
from
CMA
(
CMA,
1992),
PHED
(
PHED,
1997),
or
Residential
SOPs
(
U.
S.
EPA,
1997a)

Use
Rate
(
lb
ai/
1000
lb
or
1
lb
ai/
100
gallons)
=
Values
from
Table
6
Amount
Handled
(
lb/
day
or
gal/
day)
=
Values
from
Table
6
Body
weight
(
kg)
=
70
kg
(
ii)
Daily
Inhalation
Dose
The
potential
daily
inhalation
doses
shown
in
Tables
7,
8,
and
9
were
calculated
using
the
following
equation:

Equation
3:

where:

Unit
Exposure
(
mg
ai/
lb
ai)
=
Values
obtained
from
CMA
(
CMA,
1992),
PHED
(
PHED,

1997),
or
Residential
SOPs
(
U.
S.
EPA,
1997a).

Use
Rate
(
lb
ai/
1000
lb
or
1
lb
ai/
100
gallons)
=
Values
from
Table
6
Amount
Handled
(
lb/
day
or
gal/
day)
=
Values
from
Table
6
Body
weight
(
kg)
=
70
kg
The
calculations
of
both
the
daily
dermal
and
inhalation
doses
of
zinc
pyrithione
received
by
handlers
were
used
to
assess
the
potential
dermal
and
inhalation
risks
to
handlers.
The
MOEs
were
calculated
using
a
dermal
NOAEL
of
100
mg/
kg/
day
and
an
inhalation
NOAEL
of
0.13
mg/
kg/
day,
respectively.
The
following
formula
describes
the
calculation
of
an
MOE:
36
MOE

NOAEL
(
mg/
m3)
x
D
A
Inhalation
Exposure
Concentration
(
mg/
m3)
x
D
H
x
Human
MV
ACTUAL
Human
MV
REST
Equation
4:

MOE
=
NOAEL
mg
kg
/
day
Daily
Dose
(
mg
/
kg
/
day)






The
inhalation
route­
specific
MOEs
for
the
antifoulant
paint
use
were
calculated
using
equation
4a.
This
equation
was
only
used
for
the
antifoulant
paints
because
the
inhalation
exposure
data
were
available
as
air
concentrations
(
mg/
m3)
for
this
scenario.

Equation
4a:

Where:

NOAEL
=
Inhalation
endpoint
of
concern
for
zinc
pyrithione
in
(
mg/
m3)

DA
=
Duration
of
daily
animal
exposure
in
study
(
hrs/
day)

Inhal
Exp
Con
=
Inhalation
exposure
concentration
from
Garrod
et
al
(
2000)
(
mg/
m3)

DH
=
Duration
of
daily
human
exposure
(
hrs/
day)

MVACTUAL
=
Minute
Volume
for
exposure
scenario
(
L/
min)

MVREST
=
Minute
Volume
at
rest
(
L/
min)

This
equation
accounts
for
the
differences
in
the
duration
of
daily
exposure
for
animals
(
D
A)
and
humans
(
D
H),
and
the
increased
respiration
and
exposure
that
results
from
the
increased
activity
(
USEPA
1998).

(
b)
Handler
Non­
Cancer
Risks
from
Exposure
to
Zinc
Pyrithione
The
target
MOE
is

100
for
occupational
handlers
and
the
target
MOE
is

300
for
residential
handlers
for
short­
term,
intermediate­
term,
and
long­
term
exposures.
The
results
presented
in
Tables
7,
8,
and
9
are
summarized
as
follows.
37
(
i)
Primary
Occupational
Handler
Scenarios
with
Non­
Cancer
Dermal
and
Inhalation
Risk
Concerns
(
Short­
Term,
Intermediate­
Term,
and
Long­
Term
Risks)

The
calculations
for
dermal
risk
indicate
that
MOEs
are
greater
than
100
for
the
all
the
primary
occupational
handler
scenarios
assessed.
(
See
Table
7.)
However,
a
few
scenarios
have
inhalation
risks
of
concern
(
MOEs
<
100)
at
baseline
(
no
respirator).
These
scenarios
are:

°
(
1a)
and
(
2a)
Mixing/
loading/
applying
liquid
pesticide
concentrates
using
open
pour
methods
(
MOEs
=
50);
and
°
(
1c)
and
(
2c)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
open
pour
methods
(
MOEs
=
15);

The
MOEs
for
inhalation
risks
are
not
of
concern
(
MOE

100)
for
the
remaining
primary
occupational
handler
scenarios.
It
should
be
noted
that
no
adjustments
were
made
to
the
baseline
CMA
exposure
values
to
reflect
use
of
additional
PPE
(
i.
e.,
respirators).
It
is
not
standard
Agency
practice
to
apply
protection
factors
to
baseline
CMA
exposure
values
to
estimate
adjusted
doses
representing
use
of
additional
PPE
in
scenarios
where
the
actual
CMA
data
were
not
generated
using
such
PPE.
In
addition,
there
are
a
number
of
data
gaps
for
many
of
the
scenarios
identified.

Data
Gaps
Since
CMA
data
are
not
available
for
closed
loading
of
powders
(
i.
e.,
metering
systems)
CMA
data
for
closed
liquid
delivery
systems
(
i.
e.,
metered
pump
liquid)
were
used
as
"
surrogate"
data.
There
is
some
uncertainty
regarding
whether
this
approach
may
underestimate
potential
exposures/
risks.
Therefore,
data
gaps
exist
for
the
following
scenarios:

°
(
1d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(

automaticdispensing
techniques);

°
(
2d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques);
and
°
(
3d)
Mixing/
loading/
applying
powder
pesticide
concentrates
using
metering
equipment
(
automatic­
dispensing
techniques).

(
ii)
Secondary
Occupational
Handler
Scenarios
with
Non­
Cancer
Dermal
and
Inhalation
Risk
Concerns
(
Short­
Term,
Intermediate­
Term,
and
Long­
Term
Risks)

The
calculations
of
dermal
risks
indicate
that
MOEs
are
less
than
100
at
baseline
for
the
following
scenarios
(
See
Table
8):
38
°
(
4b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
(
MOE
=
74
without
the
use
of
gloves
as
PPE).

The
use
of
adjusted
PHED
values
to
represent
use
of
chemical­
resistant
gloves
in
scenario
(
4b)
yielded
dermal
risk
MOE
greater
than
100
(
MOE
=
200),
which
is
not
of
concern.

The
calculations
of
inhalation
risks
indicate
that
MOEs
are
less
than
100
at
baseline
(
i.
e.,
no
respirator)
for
the
following
scenarios
(
See
Table
8):

°
(
4b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
(
MOE
=
4).

The
calculations
of
inhalation
risks
indicate
that
the
MOE
is
less
than
100
even
with
applied
protection
factors
for
organic
vapor
respirator
PPE
in
the
following
scenario:

°
(
4b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
(
MOE
=
44).

The
MOEs
for
inhalation
risks
are
not
of
concern
(
MOE

100)
for
the
remaining
secondary
occupational
handler
scenarios
(
i.
e.,
paint
brush
and
aerosol
spray
can).

(
iii)
Secondary
Residential
Handler
Scenarios
with
Non­
Cancer
Dermal
and
Inhalation
Risk
Concerns
(
Short­
Term,
Intermediate­
Term,
and
Long­
Term
Risks)

The
calculations
of
dermal
and
inhalation
risks
indicate
that
MOEs
are
less
than
300
at
baseline
for
the
following
scenarios
(
See
Table
9):

°
(
5b)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
airless
sprayer
application
method
(
dermal
MOE
=
118;
and
inhalation
MOE=
15),
and
°
(
5c)
Handling
zinc
pyrithione­
containing
paint
end
products
using
an
aerosol
spray
can
application
method
(
MOE
=
271).

It
is
not
current
Agency
policy
to
assume
PPE
for
residential
handlers.

(
4)
Postapplication
Exposures
and
Risks
EPA
has
determined
that
there
are
potential
exposure
concerns
relating
to
postapplication
exposures
to
zinc
pyrithione.
There
are
potential
exposures
following
applications
of
zinc
pyrithione
concentrates
in
industrial
settings
and
zinc
pyrithione­
treated
end­
products
manufactured
for
commercial,
industrial,
and
residential
use
sites.
EPA
has
identified
two
levels
of
postapplication
exposures:
primary
and
secondary
39
occupational,
and
secondary
residential
postapplication
exposures.
Zinc
pyrithione
has
a
low
vapor
pressure
(
i.
e.,<
1.87x10­
9
torr
@
25

C)
and
is,
therefore,
not
likely
to
generate
sufficient
vapor
to
cause
an
inhalation
concern
to
occupational
and
residential
populations
performing
postapplication
tasks,
or
occupying
recently
treated
areas,
or
from
bystander
contact
with
treated
articles.
Therefore,
postapplication
inhalation
exposures
were
not
assessed.

(
a)
Primary
Occupational
Postapplication
Exposures
EPA
has
identified
zinc
pyrithione
exposure
scenarios
for
primary
occupational
postapplication
exposures
in
commercial
and
industrial
settings
as
follows:

°
Dermal
and
inhalation
exposures
to
occupational
workers
in
areas
where
polymeric
materials
have
been
treated
with
zinc
pyrithione
during
the
manufacturing
process.

°
Dermal
and
inhalation
exposures
to
occupational
workers
in
areas
where
paints
have
been
treated
with
zinc
pyrithione
during
the
manufacturing
process.

°
Dermal
and
inhalation
exposures
to
occupational
workers
in
areas
where
adhesives,
coatings,
emulsions
have
been
treated
with
zinc
pyrithione
during
the
manufacturing
process.

°
Dermal
and
inhalation
exposures
to
occupational
workers
in
areas
where
fabrics
have
been
treated
with
zinc
pyrithione
in
the
manufacturing
process.

Postapplication
exposures
are
limited
to
mists
and
steams
resulting
from
manufacturing
process
operations.
However,
occupational
postapplication
dermal
and
inhalation
exposures
to
zinc
pyrithione
are
likely
to
be
minimal
compared
to
handler
situations
because
of
dilution
of
the
zinc
pyrithione
concentrates
into
manufactured
end­
use
product
matrices.
Since
primary
occupational
postapplication
dermal
exposures
are
likely
to
be
brief
and
concentrations
are
expected
to
be
more
diluted
compared
to
handler
exposures,
a
risk
assessment
is
not
required.

(
b)
Secondary
Occupational
Postapplication
Exposures
EPA
has
identified
one
secondary
occupational
postapplication
exposures
scenario
in
commercial
and
industrial
settings,
including
both
dermal
and
inhalation
exposures.
Workers
could
have
dermal
and
inhalation
exposures
to
zinc
pyrithione­
treated
adhesives,
caulks,
sealants,
and
paints.
However,
this
exposure
is
expected
to
be
minimal,
since
the
paint,
and
caulks
and
sealants
are
likely
to
dry
within
one
day.
Therefore,
these
scenarios
were
not
quantitatively
evaluated.
Exposures
resulting
from
contact
with
treated
fabrics/
textiles,

polymeric
materials
and
related
treated
substrates
are
expected
to
be
negligible
because
of
limited
transfer
of
product
residues
and
product
dilution.
40
(
c)
Residential
Postapplication
Exposures
and
Risks
Although
EPA­
registered
zinc
pyrithione
pesticide
product
concentrates
are
not
used
in
residential
areas,
the
manufactured
consumer
end­
products
containing
zinc
pyrithione
are
used
extensively
in
and
around
the
home.
Based
on
the
use
patterns,
EPA
has
identified
exposure
scenarios
for
assessing
residential
postapplication
exposures
including:

°
Dermal
exposures
to
consumers
from
products
made
of
polymeric
materials
containing
zinc
pyrithione,
such
as
shoe
sole
liners;

°
Non­
dietary
ingestion
exposures
to
children
associated
with
object­
to­
mouth
contact
with
zinc
pyrithione­
treated
polymeric
products
(
i.
e.,
toys);
and
°
Non­
dietary
ingestion
exposures
to
children
associated
with
hand­
to­
mouth
contact
with
zinc
pyrithione­
treated
polymeric
products
(
i.
e.,
toys).

Zinc
pyrithione
is
used
as
a
microbiostat
and
mildewcide
to
control
bacterial
and
mildew
growth
in
articles
used
as
components
of
heating
ventilation
and
air
conditioning
(
HVAC)
systems.
Zinc
pyrithione
(
EPA
Reg.
No.
1258­
840
at
95
percent
ai,
1258­
841
at
48
percent
ai,
and
1258­
1235
at
37.6
percent
ai)
is
impregnated
into
thermoplastic
resins
at
concentrations
up
to
4000
ppm.
These
thermoplastic
resins
can
be
incorporated
into
air
filters,
air
filtration
components,
air
filtration
media,
and
duct
work.
These
end
use
products
are
intended
for
industrial,
hospital,
residential
and
commercial
HVAC
systems.

Postapplication
residential
dermal
exposures
are
expected
to
be
of
minimal
concern
for
treated
articles
used
in
HVAC
systems
since
these
components
are
not
readily
available
for
dermal
contact.
Dermal
contact
with
wet
paint
was
not
assessed
because
the
paint
is
expected
to
dry
within
a
day,
so
any
potential
exposure
is
expected
to
be
negligible.
The
potential
postapplication
inhalation
exposure
from
zinc
pyrithione
treated
articles,
such
as
air
duct
surfaces
in
HVAC
systems,
is
expected
to
be
minimal
based
on
bounding
estimates
of
saturation
concentrations
and/
or
dry
aerosols
from
particles
degraded
from
air
duct
surfaces.
Thus,
there
are
no
risk
concerns
and
inhalation
postapplication
exposures
were
not
quantitatively
evaluated.

The
Food
Quality
Protection
Act
(
1996)
sets
an
explicit
standard
for
assessing
potential
exposures
and
risks
to
children/
infants
and
other
sensitive
sub­
populations
from
contact
with
pesticide
residues.

Specifically,
FQPA
requires
EPA
to
give
special
consideration
to
exposure
to
"
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue..."
Because
of
the
potential
increased
susceptibility
of
infants
and
children,

FQPA
requires
that
EPA
evaluate
and
characterize
potential
exposure/
risk
scenarios
specific
to
children/

infants
and
other
sensitive
sub­
populations
in
residential
settings.
41
(
i)
Dermal
Exposure
to
Rubber/
Plastic
Products
Incorporated
with
Preservative
To
calculate
dermal
exposures
to
preservatives
incorporated
into
polymeric
materials,
an
exposure
assessment
entitled
"
Health
Assessment
of
the
Use
of
Zinc
Pyrithione
Incorporated
Into
Polyurethane
Sole
Liners
of
Shoes"
MRID
441086­
01
was
used
for
"
surrogate"
exposure
information
(
Olin
Corporation,

1996).
In
general,
the
study
was
not
designed
to
satisfy
any
of
the
requirements
(
i.
e.,
laboratory,
method,

and
field
recoveries,
storage
stability
issues,
field
fortifications,
sufficient
replications)
of
EPA's
Series
875.2400
Occupational
and
Residential
Exposure
Test
Guidelines;
therefore,
the
study
does
not
comply
with
these
guidelines.
Review
of
this
study
was
based
solely
on
issues
of
technical
merit
and
a
discussion
of
uncertainties
and
limitations.
Leach
rate
information
provided
in
the
FDA
Migration
Study
(
MRID
441086­
02)
was
used
in
conjunction
with
information
in
the
Exposure
Factors
Handbook
(
U.
S.
EPA,

1997a)
to
estimate
dermal
exposure
to
preservative
incorporated
in
sole
liners
(
U.
S.
EPA,
2003).

The
dermal
assessment
assumes
that
0.4
percent
(
4,000
ppm)
of
zinc
pyrithione
is
incorporated
into
polyurethane.
The
FDA
Migration
Study
(
MRID
441086­
02)
indicates
that
1.5
ppm
(
0.00015%)
of
zinc
pyrithione
leaches
out
of
polyethylene
after
10
days
using
corn
oil
as
a
solvent.
For
this
assessment,
it
is
assumed
that
1.5
ppm
of
preservative
will
leach
out
from
the
sole
liner
and
be
available
for
contact.
This
assessment
conservatively
assumes
that
100
percent
of
the
residues
available
on
the
surface
of
the
soles
are
transferred
to
the
skin.
Both
feet
will
be
assumed
to
be
exposed.

The
Exposure
Factors
Handbook
indicates
that
the
50th
percentile
surface
area
of
feet
is
1,310
cm2
for
adult
males
and
1,140
cm2
for
adult
females
(
U.
S.
EPA,
1997b).
Since
only
the
soles
of
the
feet
are
expected
to
contact
the
liners,
one
half
of
the
surface
area
of
the
feet
is
assumed.
The
sole
liners
are
expected
to
be
1
cm
thick.
The
density
of
polyurethane
is
close
to
1
g/
cm3.
Thus,
the
mass
of
the
sole
liners
(
SL)
are
expected
to
be
655
gm
for
male
feet
and
570
gm
for
female
feet.
A
body
weight
of
70
kg
was
assumed.

For
children,
the
surface
area
of
the
feet
is
7.1
percent
of
the
total
surface
area
(
U.
S.
EPA,
1997b).

The
total
mean
surface
area
for
male
and
female
children
ages
3
to
4
is
6,565
cm2
(
U.
S.
EPA,
1997a).

Therefore,
the
surface
area
of
the
feet
is
466
cm2.
Since
only
the
soles
of
the
feet
are
expected
to
contact
the
sole
liner,
one
half
of
the
surface
area
of
the
feet
is
assumed
to
contact
the
sole
liner.
The
sole
liners
are
expected
to
be
1
cm
thick.
The
density
of
polyurethane
is
close
to
1
gm/
cm3.
Thus,
the
mass
of
the
sole
liners
(
SL)
is
expected
to
be
233
gm.
The
body
weight
used
for
children
(
ages
1
to
6)
is
15
kg.
This
scenario
was
considered
to
be
short­,
intermediate
and
long­
term
in
duration.

The
calculation
of
PDR
is
as
follows:
42
Equation
5:
PDR
=
[
SL
x
AR
x
LR
x
CF]
/
[
BW]

where:
PDR
=
Potential
dose
rate
from
dermal
contact
(
mg/
kg­
day)
SL
=
Mass
of
sole
liner
(
gm)
LR
=
Leach
rate.
Fraction
of
preservative
leaching
out
(
i.
e.,
1.5
ppm/
4,000
ppm)
AR
=
Application
rate
is
4,000
ppm.
3.8
mg
ai/
1,000
mg
polymer
incorporated
into
sole
liners
CF
=
Conversion
factor
is
1,000
mg/
gm
BW
=
The
body
weight
is
70
kg
for
adults
and
15
kg
for
children.

­­­­­
EXPOSURES
PREDICTED
­­­­­

PDR
=
1.33E­
2
mg/
kg­
day
adults
2.2E­
2
mg/
kg­
day
children
The
dermal
NOAEL
of
100
mg/
kg/
day
is
divided
by
the
PDR
to
calculate
MOE.
The
results
of
this
assessment
are
presented
in
Table
10.

(
ii)
Impregnated
Toys
Incidental
ingestion
exposures
were
assessed
for
a
toddler
exposed
to
a
zinc
pyrithione­
treated
plastic
toy.
Incidental
ingestion
exposures
were
assessed
for
both
hand­
to
mouth
and
toy­
to­
mouth
scenarios.
These
exposure
scenarios
were
assumed
to
be
of
short­
and
intermediate­
term
duration
(
up
to
6
months),
since
many
of
the
other
toys
children
could
play
with
during
childhood
are
not
likely
to
contain
zinc
pyrithione.
A
detailed
analysis
of
the
exposures
is
presented
below.
The
calculations
of
the
exposure
estimates
for
each
scenario
are
based
on
a
risk
analysis
conducted
for
Microban
Additive
"
B"
(
Triclosan
or
Irgasan
DP
300)
(
Dang,
1997)
which
assessed
risks
to
a
12
month
old
children
playing
with
treated
toys,

and
updated
exposure
assumptions
from
the
Residential
SOPs
(
2001).
Data
from
chemical­
specific
studies
were
also
used
in
this
analysis.
The
analysis
was
conducted
using
registrant­
submitted
migration
studies
(
MRIDs
44108601
and
44108602)
and
research
on
child
behavior
(
holding
and
mouthing
toys).
For
this
assessment,
incidental
ingestion
exposures
were
assessed
for
a
12
month
old
child
playing
with
a
"
Create­

A­
Song"
toy
treated
with
the
antimicrobial.
Dermal
exposure
to
impregnated
toys
was
considered
to
be
negligible,
since
most
dermal
contact
will
occur
only
through
the
hands,
and
thus
was
not
quantitatively
evaluated.

Non­
Dietary
Incidental
Ingestion
of
Preservative
from
Hand­
to­
Mouth
Contact
(
1)
Exposure
Algorithims
Equations
6
and
7
were
used
to
calculate
the
daily
dose
for
hand­
to­
mouth
incidental
ingestion
exposure
to
children
playing
with
a
treated
toy.
An
MOE
was
calculated
using
Equation
4.
43
Equation
6
SR
=
%
A.
I.
x
W
x
CF
x
F
SA
where:

SR
=
Surface
residue
(
mg
a.
i./
cm2)
(
0.0075
mg
ai/
cm2)

%
A.
I.
=
Percent
a.
i.
in
toy
by
total
weight
(%)
(
0.4%)

W
=
Weight
of
toy
(
g)
(
50
g)

CF
=
Conversion
factor
(
1,000
mg/
g)

F
=
Percent
additive
available
at
the
surface
of
the
toy
(%)
(
0.00375%
based
on
MRID
44108602)

SA
=
Surface
area
of
toy
(
cm2)
(
500
cm2)

Equation
7
PDD
=
SR
x
F1
x
F2
x
SA
x
FQ
x
ED
BW
where:

PDD
=
Potential
daily
dose
(
mg/
kg/
day)
(
0.0036
mg/
kg/
day)

SR
=
Surface
residue
(
mg
a.
i./
cm2)
(
0.0075
mg
ai/
cm2)

F1
=
Fraction
residue
transferred
from
toy
to
hand
(%)
(
50%)

F2
=
Fraction
residue
transferred
from
hand
to
mouth
(%)
(
50%)

SA
=
Surface
area
of
hands
contacting
the
toy
(
cm2)
(
20
cm2)

FQ
=
Frequency
of
mouthing
a
toy
(
events
per
hour)
(
20
times/
hr)

ED
=
Exposure
Duration
(
hr/
day)
(
2
hr)

BW
=
Body
weight
of
a
12
month
old
child
(
kg)
(
10
kg)

(
2)
Surrogate
Exposure
Data
and
Assumptions
The
non­
dietary
ingestion
of
preservative
from
Hand­
to­
Mouth
contact
uses
"
surrogate"
exposure
estimates
from
Dang,
1997
and
data
from
MRID
441086­
01.
Chemical­
specific
leaching
data
were
used
to
estimate
the
amount
of
active
ingredient
at
the
surface
of
the
toy
which
is
available
for
each
holding
event
using
Equation
7.
MRID
441086­
02
indicates
that
1.5
ppm
of
active
ingredient
out
of
4,000
ppm
of
zinc
pyrithione
incorporated
into
polyethylene,
leached
out
under
conditions
of
elevated
temperatures
and
10
days
of
extraction
(
i.
e.,
0.00375%
per
day).
This
exposure
estimate
is
based
on
the
assumption
that
for
each
holding
event,
diffusion
of
the
active
ingredient
available
at
the
surface
to
the
child's
hands
is
allowed
to
reach
equilibrium
(
Dang,
1997).
Other
inputs
used
in
the
calculation
are
as
follows:
44
°
The
percent
zinc
pyrithione
in
the
toy
by
total
weight
is
0.4%
(
based
on
same
assumptions
used
for
polyurethane
sole
liners);

°
The
total
surface
area
of
the
impregnated
material
was
assumed
to
be
500
cm2
(
i.
e.,
the
surface
area
of
an
impregnated
toy)
(
Dang,
1997);

°
The
weight
of
the
toy
is
50
grams,
based
on
data
that
show
a
polyethylene
highchair
sample
with
a
surface
area
of
12.7
cm2
weighs
1.3072
g
(
i.
e.,
0.1
g/
cm2,
or
0.1
g/
cm2
*
500
cm2
=
50
g)
(
Dang,

1997).

Using
the
above
data
and
assumptions,
the
residue
available
at
the
surface
at
any
one
time
is
0.000015
mg/
cm2.

The
potential
daily
dose
(
Equation
7)
was
calculated
using
the
surface
residue
obtained
from
Equation
6.
The
daily
dose
equation
assumes
that
50%
of
the
available
residue
will
be
transferred
from
the
toy
to
the
child's
hands
and
then
50%
of
that
residue
will
then
be
transferred
to
the
child's
mouth
(
i.
e.,

saliva
extraction
factor).
The
surface
area
of
the
child's
hand
is
assumed
to
be
20
cm2,
which
represents
the
surface
area
of
three
fingers
for
a
young
child.
Other
inputs
from
Dang,
1997
which
were
used
in
the
calculation
are
as
follows:

°
An
exposure
duration
of
2
hours;

°
A
body
weight
of
10
kg
for
a
12
month
old;
and
°
A
mouthing
frequency
of
20
events
per
hour,
which
represents
the
90th
percentile
value
for
preschool
aged
children
(
ages
2­
5
yrs)
based
on
observations
of
video
tapes.

This
method
is
conservative
because
it
does
not
account
for
washing
of
the
toy
or
depletion
of
the
residue
after
each
toy­
to­
mouth
episode.

(
3)
Results
The
oral
potential
daily
dose
through
hand­
to­
mouth
contact
with
treated
plastic
toys
was
calculated
to
be
0.0003
mg/
kg/
day.
Using
0.75
mg/
kg/
day
for
children
as
the
NOAEL,
the
calculated
MOE
is
2500,
which
is
greater
than
the
target
MOE
of
300,
and
does
not
exceed
the
Agency's
level
of
concern.
These
results
are
shown
on
Table
10.

Non­
Dietary
Incidental
Ingestion
of
Preservative
from
Toy­
to­
Mouth
Contact
(
1)
Exposure
Algorithims
Equation
8
was
used
to
calculate
the
daily
dose
for
toy­
to­
mouth
exposure
to
children
playing
with
a
treated
toy.
An
MOE
was
calculated
using
Equation
4.
45
Equation
8
PDD
=
Total
SR
x
F
BW
where:

PDD
=
Potential
dermal
dose
(
mg/
kg/
day)

Total
SR
=
Total
surface
residue
(
mg)
(
0.0075
mg
for
a
500
cm2
toy)

F
=
Fraction
Ingested
(%)
(
50%,
saliva
extraction
factor)

BW
=
Body
weight
of
a
12
month
old
child
(
kg)
(
10
kg)

(
2)
Surrogate
Exposure
Data
and
Assumptions
The
potential
daily
dose
for
toy­
to­
mouth
exposure
is
based
on
similar
assumptions
as
the
potential
daily
dose
for
hand­
to­
mouth
exposures.
The
non­
dietary
ingestion
of
preservative
from
Toy­
to­
Mouth
contact
uses
"
surrogate"
exposure
estimates
from
Dang
(
1997)
and
data
from
MRID
441086­
02.
The
following
assumptions
were
used
in
this
assessment:

°
A
polyethylene
highchair
sample
with
a
surface
area
of
12.7
cm2
weighs
1.3072
grams
(
i.
e.,
0.1
gm/
cm2)
(
Dang,
1997).
°
The
total
surface
area
of
the
impregnated
material
was
assumed
to
be
500
cm2
(
i.
e.,
the
surface
area
of
an
impregnated
toy)
(
Dang,
1997).
°
MRID
441086­
02
estimates
that
out
of
4,000
ppm
of
zinc
pyrithione
incorporated
into
polyethylene,
only
1.5
ppm
leached
out
under
conditions
of
elevated
temperatures
and
10
days
of
extraction
(
0.00375%
per
day).
°
50%
of
the
surface
residue
from
the
toy
is
ingested
(
i.
e.,
saliva
extraction
factor);
°
The
body
weight
is
10
kg
(
12
month
old);
and
°
A
child
mouths
500
cm2
of
treated
toy
surface
per
day.

Using
these
assumptions,
a
polyethylene
sample
with
a
surface
area
of
500
cm2
weighs
50
grams
(
0.1
gm/
cm2
x
500
cm2)
and
contains
0.4%
ai
of
active
ingredient.
This
assessment
is
conservative
because
it
(
1)
does
not
account
for
washing
of
the
toy
or
depletion
of
the
residue
after
each
toy­
to­
mouth
episode,
(
2)
assumes
that
50%
of
the
available
residue
is
transferred
and
ingested
(
Dang,
1997),
and
(
3)

assumes
that
the
amount
accumulated
under
elevated
temperatures
is
the
amount
available
for
contact
for
the
each
event
per
day.

(
3)
Results
The
oral
potential
daily
dose
through
toy­
to­
mouth
contact
with
treated
plastic
toys
was
calculated
to
be
0.0004
mg/
kg/
day.
Using
0.75
mg/
kg/
day
as
the
NOAEL
for
children,
the
calculated
MOE
is
2000,

which
is
greater
than
the
target
MOE
of
300,
and
does
not
exceed
the
level
of
concern.
This
method
is
conservative
because
it
does
not
account
for
washing
of
the
toy
or
depletion
of
the
residue
after
each
toy­

tomouth
episode
and
it
assumes
that
50%
of
the
total
available
residue
on
the
toy
surface
is
transferred
and
ingested.
The
MOE
is
presented
in
Table
10.
46
(
5)
Aggregate
Postapplication
Residential
Risks
As
shown
in
Table
10,
the
combined
potential
dose
of
exposure
to
plastic
toys
(
incidental
ingestion)
is
0.0007
mg/
kg/
day.
Using
0.75
mg/
kg/
day
as
the
NOAEL,
the
MOE
for
total
exposure
is
1,100,
which
is
greater
than
the
target
MOE
of
300.
Therefore,
risk
resulting
from
contact
with
treated
plastic
toys
does
not
exceed
the
level
of
concern.
Dermal
exposures
were
not
aggregated
with
oral
exposures,
since
the
toxicological
effects
of
concern
are
different.
The
total
dermal
MOEs
are
also
greater
than
300,
and
do
not
exceed
the
Agency's
level
of
concern.

Table
10:
Summary
of
Short­,
and
Intermediate­
Term
Residential
Postapplication
Exposure
and
Risks
(
c)

Scenario
Receptor
Use
PDRa
(
mg/
kg/
day)
Dermal
MOEb
Target
MOE

300
Oral
MOEb
Target
MOE

300
Dermal
Contact
to
Rubber/
Plastic
Incorporated
with
Preservative
Adult
Rubber/
Plastic
1.3E­
2
7,700
NA
Toddlers
2.2E­
2
4,500
NA
Non­
Dietary
Ingestion
Toy­
to­
Mouth
Infants
Rubber/
Plastic
0.0004
NA
2,000
Non­
Dietary
Ingestion
Hand­
to­
Mouth
Infants
Rubber/
Plastic
0.0003
NA
2,500
Total
Exposure
and
Risk
Infant
Rubber/
Plastic
0.0007
(
total
oral)
NA
1,100
Toddler
2.2E­
2
(
dermal)
4,500
NA
Adult
1.3E­
2
(
dermal)
7,700
NA
NA
=
Not
applicable.
a
PDR
calculations
for
each
scenario
above
are
outlined
in
the
text..
b
MOE=
NOAEL
(
mg/
kg/
day)
/
PDR
(
mg/
kg/
day).
Dermal
NOAEL
is
100
mg/
kg/
day;
oral
NOAEL
general
population
and
children
is
0.75
mg/
kg/
day.
c
Dermal
risks
are
also
for
long­
term
exposures.

(
6)
Data
Gaps,
Uncertainties,
and
Limitations
Currently,
zinc
pyrithione
chemical­
specific
handler
or
postapplication
exposure
studies
that
meet
Agency
guidelines
have
not
been
identified
for
use
in
assessing
both
occupational
and
residential
exposures.

Surrogate
dermal
and
inhalation
data
primarily
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)

Version
1.1,
the
Chemical
Manufacturers
Association
(
CMA)
database,
and
draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
were
used
to
assess
handler
exposure.

Surrogate
data
were
not
available
for
the
following
scenario:
47
°
Mixing/
loading/
applying
"
powder"
pesticide
concentrates
using
metering
In
order
to
characterize
exposures
for
this
scenario
CMA
unit
exposure
data
for
metering
equipment
for
"
liquids"
was
used
as
a
surrogate
for
"
powders".
There
is
a
possibility
that
this
scenario
may
underestimate
actual
exposures.

In
addition,
note
that
CMA
surrogate
data
have
the
following
deficiencies:

°
The
inhalation
concentrations
were
typically
below
the
detection
limits,
so
the
unit
exposures
for
the
inhalation
exposure
route
could
not
be
accurately
calculated.
°
The
quality
of
the
CMA
data
were
assessed
using
the
same
grading
criteria
as
PHED
and
the
grades
were
all
at
C,
D,
E
lower
than
PHED
standards
(
i.
e.,
most
of
PHED
is
at
grades
A,
B,
C).
°
Grade
C,
D,
E
data
frequently
may
have
QA/
QC
problems
including
lack
of
either/
or
field
fortification,
laboratory
recoveries,
and
storage
stability
information.
°
Grade
C,
D,
E
data
has
an
insufficient
amount
of
replicates.
°
Grade
C,
D,
E
data
may
have
higher
variabilities
(
i.
e.,
high
CVs).

The
following
deficiencies
of
PHED
and
the
residential
SOPs
should
also
be
noted:

°
Data
includes
all
pesticides
not
just
antimicrobial
chemicals,
so
the
results
reported
in
PHED
may
be
misleading.
°
Pesticides
are
not
usually
volatile,
so
inhalation
unit
exposures
may
be
underestimated
for
antimicrobial
chemicals
that
are
volatile.
°
The
job
functions
that
commonly
use
pesticides
may
be
different
from
those
job
functions
using
antimicrobial
chemicals.
°
The
basic
assumption
underlying
the
database
is
that
exposure
to
pesticide
handlers
is
primarily
a
function
of
the
physical
parameters
associated
with
handling
and
applying
rather
than
the
chemical
properties
of
the
individual
active
ingredients.

To
assess
postapplication
dermal
and
incidental
oral
exposures,
several
sources
of
"
surrogate"
data
were
used
to
develop
the
residential
scenarios,
including
an
exposure
assessment
entitled
"
Health
Assessment
of
the
Use
of
Zinc
Pyrithione
Incorporated
Into
Polyurethane
Sole
Liners
of
Shoes"
MRID
441086­
01
(
Olin
Corporation,
1996)
used
in
conjunction
with
the
FDA
Migration
Study
(
MRID
441086­

02)
to
predict
the
leach
rate
(
U.
S.
EPA,
2003)
in
estimating
dermal
exposures
to
the
preservative
incorporated
into
polymeric
materials.
There
are
uncertainties
associated
with
use
of
these
data
since
the
FDA
leaching
data
generated
on
"
polyethylene"
might
not
best
represent
"
polyurethane­
treated"
articles
or
leaching
rates
for
other
treated
polymeric
materials.

Data
from
the
"
Risk
Analysis
For
Microban
Additive
"
B"
(
Triclosan
or
Irgasan
DP300)
Treated
Toys
For
Infants"(
Dang,
1997)
were
used
in
combination
with
leach
rate
data
from
MRID
441086­
02,
and
the
Residential
SOPs
(
1998,
2001)
to
develop
child
toy­
to­
mouth
and
hand­
to­
mouth
estimates
from
contact
with
treated
articles.
There
are
uncertainties
associated
with
this
approach
since
these
data
and
48
other
assumptions
used
might
not
best
represent
actual
leaching
dynamics
and
residue
loading,
transfer,

and
ingestion.

3.0
REFERENCES
CMA.
1992.
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study.

Popendorf,
W,
Selim,
M.,
Kross,
B.
The
University
of
Iowa.
MRID
425875­
01.
December
8,
1992.

Dang.
1997.
Risk
Analysis
for
Microban
Additive
"
B"
(
Triclosan
or
Irgasan
DP300)
Treated
Toys
for
Infants.
Memo
From
Winston
Dang
(
Antimicrobial
Division)
to
Frank
Sanders
and
William
Jordan
(
Antimicrobial
Division),
Dated
February
24,
1997.

Garrod
ANI,
Guiver
R,
Rimmer
DA.
2000.
Potential
Exposure
of
Amateurs
(
Consumers)

through
Painting
Wood
Preservative
and
Antifoulant
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Ann.
Occup.
Hyg.,
Vol.
44,

No.
6,
pp.
421­
426.

PHED
Surrogate
Exposure
Guide.
1997.
Estimates
of
Worker
Exposure
from
the
Pesticide
Handler
Exposure
Database
Version
1.1.
May
1997.

PHED
Surrogate
Exposure
Guide.
1998.
Estimates
of
Worker
Exposure
from
the
Pesticide
Handler
Exposure
Database
Version
1.1.
August
1998.

Olin
Corporation.
1996.
"
Health
Assessment
of
the
Use
of
Zinc
Pyrithione
Incorporated
Into
Polyurethane
Sole
Liners
of
Shoes."
Laboratory
Project
ID
ZPT­
896.
August
12,
1996.(
MRID
441086­
01).

U.
S.
EPA.
1995.
Dermal
Exposure
Model
Description
and
User's
Manual.
Draft
Report.
Prepared
for
Office
of
Pollution
Prevention
and
Toxics.
Exposure
Evaluation
Division.
Contract
No.
68­
D3­
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U.
S.
EPA.
1997a.
Standard
Operating
Procedures
(
SOPs)
for
Residential
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Assessments.

Prepared
for
the
Office
of
Pesticide
Programs,
Health
Effects
Division.
Contract
No.
68­
W6­
0030.

U.
S.
EPA.
1997b.
Exposure
Factors
Handbook.
Vol
I­
III.
Office
of
Research
and
Development.

Washington,
D.
C.
EPA/
600/
P­
95/
002Fa.

U.
S.
EPA.
1998.
Route­
to­
Route
Extrapolations.
Office
of
Pesticide
Programs.
Health
Effects
Division
(
HED).
Memo
From
John
E.
Whalen
(
HED)
to
Margaret
Stasikowski,
Director.
October
9,
1998.

U.
S.
EPA.
1999a.
Zinc
Pyrithione
­
Report
of
the
Hazard
Identification
Assessment
Review
Committee.

April
19,
1999.
49
U.
S.
EPA.
1999b.
Evaluation
of
the
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study
(
Amended
on
December
8,
1992).
Memorandum
from
Siroos
Mostaghimi,
Ph.
D.,

Environmental
Engineer
to
Julie
Fairfax,
PM
#
36.
November
4,
1999.

U.
S.
EPA
2001.
Residential
Standard
Operating
Procedures,
Science
Advisory
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for
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Policy
12.
February
22,
2001.

U.
S.
EPA.
2003.
Residue
Chemistry
Science
Chapter
for
Zinc
2­
pyridinethiol­
1­
oxide.
Memorandum
from
A.
Najm
Shamim,
Ph.
D.,
Chemist
to
Julie
Fairfax,
PM
#
36.

U.
S.
EPA.
2004
 
Zinc
Pyrithione:
Revised
Toxicology
Endpoint
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Revised
to
address
Registrant
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April
1,
2004.
