UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Date:
March
7,
2002
Memorandum
SUBJECT:
Pronamide:
Residential
Risk
Assessment
and
Recommendations
for
the
Tolerance
Reassessment
Eligibility
Decision
(TRED)
Document.

FROM:
Barry
O'Keefe,
Biologist
Reregistration
Branch
3
Health
Effects
Division
(7509C)

THROUGH:
Catherine
Eiden,
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(7509C)

TO:
Gary
Bangs,
Risk
Assessor
Reregistration
Branch
3
Health
Effects
Division
(7509C)

PC
Code:
101701
DP
Barcode:
D275538
Pronamide
study
MRID:
44952501
This
is
a
preliminary
exposure
and
risk
assessment.
The
assessment
is
limited
to
registered
residential
uses
of
pronamide.
Pronamide
is
a
restricted
use
pesticide,
and
therefore
requires
professional
applicators.

HED
has
determined
that
there
is
a
potential
for
exposure
in
occupational
settings
from
handling
pronamide
products
during
the
application
process
(i.
e.,
mixer/
loader,
applicator
and
mixer/
loader/
applicator)
and
from
entering
previously
treated
areas.
As
a
result,
risk
assessments
would
normally
have
been
completed
for
occupational
handler
and
postapplication
scenarios.
The
occupational
handler
and
postapplication
risk
assessment
was
previously
performed
as
part
of
the
pronamide
reregistration
eligibility
decision
(RED)
document
completed
in
May,
1994.
However,
for
pronamide
the
occupational
handler
and
postapplication
scenarios
will
not
be
assessed
now,
since
this
assessment
is
only
for
a
tolerance
reassessment
eligibility
decision
(TRED)
document.
Additionally,
the
determination
of
the
status
of
the
Agency's
occupational
exposure
data
base
for
regulatory
purposes
was
not
performed.
When
an
occupational
risk
assessment
is
performed
data
gaps
may
be
identified,
and
additional
data
and/
or
studies
may
be
required.
No
residential
exposure
data
and/
or
specific
studies
are
required
at
this
time.
2
TABLE
OF
CONTENTS
EXECUTIVE
SUMMARY......................................................
3
1.
BACKGROUND
.......................................................
10
1.
1
Purpose.........................................................
10
1.2
Criteria
for
Conducting
Exposure
Assessments
.........................
10
1.3
Summary
of
Toxicity
Concerns
Relating
to
Residential
Exposures
..........
10
1.
4
Incident
Reports..................................................
12
1.
5
Summary
of
Use
Patterns
and
Formulations
............................
13
2.0
RESIDENTIAL
AND
OTHER
NON­
OCCUPATIONAL
EXPOSURES
AND
RISKS
.....................................................................
17
2.1
Methods
of
Estimating
Non
Cancer
Risks
And
Calculating
Exposures
.............
17
2.2
Residential
Handler
Exposures
and
Risks
....................................
19
2.2.1
Residential­
Handler
Exposure
Scenarios,
Data,
and
Assumptions
...........
19
2.3
Non­
Occupational
Postapplication
Exposure
and
Risk
Estimates
.................
19
2.3.1
Postapplication
Exposure
Scenarios,
Data,
and
Assumptions
...............
19
2.3.2
Postapplication
Exposure
and
Non­
Cancer
Risk
Estimates
................
25
2.3.3
Postapplication
Cancer
Risk
Estimates
................................
26
2.3.4
Summary
of
Postapplication
Risks,
Data
Gaps,
and
Confidence
in
Exposure
and
Risk
Estimates
...................................................
27
2.4
RESIDENTIAL
AND
NON­
OCCUPATIONAL
RISK
CHARACTERIZATION
....
28
2.4.1
Residential
Handler
Risk
Characterization
.............................
28
2.4.2
Non­
Occupational
Postapplication
Risk
Characterization
.................
28
References
..................................................................
29
Appendix
Pronamide
Exposure
and
Risk
Estimates
­
Tables
4
through
7
....................
30
Table
4.
Summary
of
Postapplication
Turf
Transferable
Residue
Study
..................
31
Table
5.
Pronamide
Residential
Postapplication
Activities
on
Treated
Turf:
Dermal
Exposure
and
Non­
Cancer
Risk
Estimates
...........................................
32
Table
6.
Pronamide
Postapplication
Dermal
Cancer
Risk
Estimates
for
Activities
on
Treated
Turf
.................................................................
33
Table
7.
Residential
Oral
Nondietary
Short­
Term
Postapplication
Risks
to
Children
from
"Hand­
to­
Mouth"
and
Ingestion
Exposure
When
Reentering
Treated
Lawns
........
34
3
EXECUTIVE
SUMMARY
Background:
Use
Pronamide
is
a
restricted
use,
selective
pre
and
postemergent
herbicide
used
to
control
grasses
and
broadleaf
weeds.
It
is
applied
as
a
liquid
spray,
which
is
packaged
in
water
soluble
pouches
and
then
mixed
in
water
before
application.
It
is
a
soil
active
systemic
herbicide
with
uptake
by
susceptible
weeds
occurring
through
the
roots.
Therefore,
to
be
effective,
pronamide
is
applied
to
the
soil
and
transported
by
water
into
the
root
zone
where
it
is
taken
up
by
plants.
Pronamide
is
applied
in
the
late
Fall
and/
or
late
Winter,
only
by
certified
pesticide
applicators
and
professional
lawn
care
operators
(LCOs).

Pronamide
is
registered
for
use
in
agricultural,
ornamental,
and
residential
settings.
There
are
two
manufacturers
of
pronamide
end­
use
products
with
only
two
active
section
3
registrations.
There
are
also
nine
active
24C
registrations.
Major
food/
feed
crops
include:
stone
fruits
(apricot,
cherry,
nectarine,
peach,
plum,
prune),
pome
fruits
(apple,
pear),
grapes,
artichokes,
berries
(blackberry,
blueberry,
boysenberry,
red
raspberry,
black
raspberry),
leafy
greens
(lettuce,
endive,
radicchio),
winter
peas,
chicory,
rhubarb,
sugarbeets,
and
forages
(alfalfa,
clover,
birdsfoot
trefoil,
crown
vetch,
sainfoin).
Non­
agricultural
uses
include
woody
ornamentals,
ornamental
warm
season
grasses
grown
for
turf
(i.
e.
bermudagrass,
Zoysiagrass,
St.
Augustine,
and
Centipedegrass)
or
seed
(bermudagrass),
residential/
recreational
turf
(bermudagrass
lawns,
playing
fields,
and
golf
courses),
Christmas
trees,
grasses
grown
for
seed,
rangeland,
and
fallow
land.
There
is
a
potential
for
exposure
from
commercial
applications
to
agricultural
and
residential/
recreational
areas.
Therefore,
normally
both
occupational
and
residential
exposure
assessments
would
be
conducted.
However,
since
this
is
a
Tolerance
Reassessment
Eligibility
Decision
(TRED)
document,
only
a
residential
postapplication
exposure
assessment
was
conducted;
i.
e.
for
residential/
recreational
turf
uses.

Hazard
Profile
As
reported
by
the
Hazard
Identification
Assessment
Review
Committee
(HIARC)
2
,
for
shortterm
(1­
30
days)
incidental
oral
exposures
an
adjusted
dose
of
8.46
mg/
kg/
day
was
established
for
use
in
this
risk
assessment.
This
dose
is
derived
from
the
no
observed
adverse
effect
level
(NOAEL)
from
a
chronic
toxicity/
carcinogenicity
study
in
rats,
where
the
effects
are
increased
liver
weight
and
non­
neoplastic
histologic
changes
in
liver,
thyroid,
and
ovaries
observed
at
the
lowest
observed
adverse
effect
level
(LOAEL)
of
42.6
mg/
kg/
day.
The
dose
selection
is
based
on
a
maternal
toxicity
NOAEL
of
5
mg/
kg/
day
and
clinical
signs
of
toxicity
(soiled
anal
area
and
anorexia)
and
liver
effects
(punctate
vacuolation
of
hepatocytes)
observed
at
the
LOAEL
of
20
mg/
kg/
day
in
the
developmental
toxicity
study
conducted
in
rabbits.
Although
this
study
is
of
the
appropriate
route
(oral)
and
duration
(13
days),
the
NOAEL
(5
mg/
kg/
day)
in
this
study
is
lower
than
the
NOAEL
(8.46
mg/
kg/
day)
established
in
the
chronic
toxicity/
carcinogenicity
study
in
the
rat.
The
apparent
disparity
between
these
NOAELs
is
driven
by
the
doses
of
pronamide
selected
for
testing
in
these
studies.
The
HIARC
concluded
that
using
a
more
realistic
NOAEL
of
8.46
mg/
kg/
day,
rather
than
5
mg/
kg/
day,
would
provide
a
sufficiently
4
protective
dose
for
risk
assessment.

The
NOAEL
of
3
mg/
kg/
day
established
in
the
special
thyroid
study
conducted
in
male
rats
was
also
considered.
However
this
dose
was
not
selected
because
the
wide
gap
between
the
NOAEL
(3
mg/
kg/
day)
and
the
LOAEL
(67
mg/
kg/
day)
in
this
study
resulted
in
the
3
mg/
kg/
day
dose
(NOAEL)
being
artificially
low.
In
addition,
the
LOAEL
of
67
mg/
kg/
day
is
comparable
to
the
LOAEL
(56
mg/
kg/
day)
established
in
the
chronic
toxicity/
carcinogenicity
study
conducted
in
rats.

For
short­
term
(1­
30
days)
dermal
exposures
the
same
oral
dose
and
endpoint
was
selected
for
risk
assessment,
i.
e.
8.46
mg/
kg/
day.
A
dermal
absorption
factor
is
needed,
since
the
endpoint
is
based
on
a
study
using
oral
dosing.
A
default
dermal
absorption
factor
of
100%
relative
to
oral
absorption
was
chosen
by
the
HIARC,
since
the
dermal
absorption
study
sent
to
the
Agency
was
classified
as
unacceptable
(i.
e.
unable
to
verify
amount
applied
and
poor
recovery
data)
and
no
dermal
toxicity
studies
were
submitted.

In
accordance
with
the
Agency's
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(September
30,
1992),
the
HED
Carcinogenicity
Peer
Review
Committee
(CPRC)
classified
pronamide
as
a
Group
B2
chemical)
probable
human
carcinogen
with
inadequate
evidence
in
humans).
This
decision
was
based
on
the
finding
of
two
types
of
tumors
in
the
rat
(benign
testicular
interstitial
cell
tumors
and
uncommon
thyroid
follicular
cell
adenomas),
and
one
type
of
tumor
in
the
mouse
(hepatocellular
adenomas
and
carcinomas).
A
linear,
low
dose
approach
(Q1
*
)
is
used
for
human
risk
characterization.
The
most
potent
unit
risk
Q1
*
,
based
on
male
mouse
liver
adenoma
and/
or
carcinoma
combined
tumor
rates,
is
2.59
x
10
­2
(mg/
kg/
day)
­1
in
human
equivalents
[converted
from
animal
to
humans
by
use
of
the
(mg/
kg
body
weight)
3/
4
interspecies
scaling
factor].
Therefore,
the
Hazard
Identification
Assessment
Review
Committee
(HIARC)
recommended
that
a
cancer
risk
assessment
be
conducted
for
pronamide
(November
6,
2001).

In
a
memo
dated
December
19,
2001,
the
FQPA
Safety
Factor
Committee
recommended
that
the
FQPA
safety
factor
be
reduced
to
3x.
The
FQPA
Committee
determined
that
the
safety
factor
is
necessary
when
assessing
the
risk
posed
by
pronamide
because
of
evidence
of
endocrine
effects.
The
FQPA
safety
factor
is
required
for
all
population
subgroups
when
assessing
residential
exposures
of
all
durations.

Residential
Exposure
Estimates
Background
When
the
pronamide
RED
document
was
completed
in
May,
1994,
the
Agency
did
not
have
the
data
to
make
a
reregistration
decision
on
pronamide
for
use
on
residential
lawns.
An
estimate
of
risk
was
not
feasible
because
of
numerous
uncertainties
in
potential
exposure
levels,
especially
for
children.
In
the
1994
RED
document,
regulatory
decisions
concerning
postapplication
reentry
to
residential
lawns
were
postponed
until
after
the
submittal
and
review
of
studies
5
required
to
support
the
residential
lawn
use;
i.
e.
foliar
dislodgeable
dissipation
(old
guideline
132­
1(
a)
or
new
guideline
875.2100)
and
dermal
passive
dosimetry
(old
guideline
133­
3
or
new
guideline
875.2400).
In
the
interim
since
1994,
a
turf
transferrable
residue
(TTR)
study
was
submitted,
reviewed,
and
found
acceptable
and
useful
for
some
aspects
of
risk
assessment.
The
study
provided
the
required
residue
dissipation
data.
The
methodology
used
to
determine
turf
transferability
(i.
e.
the
modified
California
roller
method)
does
not
match
the
Agency's
current
methodology
(i.
e.
Jazzercise
and
the
California
roller
method)
used
to
determine
the
dermal
transfer
coefficient
on
turf.
Note,
that
the
Outdoor
Residential
Exposure
Task
Force
(ORETF)
is
currently
funding
a
study
which
is
intended
to
provide
concurrent
TTR
and
transfer
coefficient
data
for
a
surrogate
chemical.
The
requirement
for
a
dermal
passive
dosimetry
study
remains
outstanding.
However,
the
Agency
can
perform
an
adequate
risk
assessment
to
estimate
risk
on
residential
lawns
by
using
dissipation
data
from
the
TTR
study
in
conjunction
with
the
transferability
assumptions
and
equations
found
in
the
Agency's
residential
SOPs.

Short­
Term
Exposure
Scenarios
A
review
of
incident
data
sources
found
that
relatively
few
incidents
of
pronamide
poisonings
were
reported.
1
There
are
only
two
Poison
Center
reports,
no
incident
reports
in
OPPs
Incident
Data
System
and
only
two
reports
from
the
California
Pesticide
Illness
Surveillance
Program.
In
sum,
recommendations
based
on
the
few
incidents
reported
are
unlikely.

All
pronamide
end
use
products
are
labeled
as
restricted
use
pesticides.
Therefore,
residents
are
restricted
from
handling
or
applying
pronamide
products.
Consequently,
only
residential/
recreational
postapplication
exposures
to
the
general
population
are
anticipated
and
are
evaluated
in
this
assessment.
Adults
and
children
are
potentially
exposed
to
pronamide
residues
after
application
of
pronamide
products
by
professional
lawn
care
operators
(LCOs)
in
residential/
recreational
settings.
Applications
are
made
to
lawns,
playing
fields,
and
golf
courses.
After
application
to
turf,
short­
term
dermal
exposures
are
anticipated
for
adults
and
children.
Incidental
oral
exposure
is
also
expected
to
occur
for
small
children
and
is
combined
with
their
dermal
exposures,
where
applicable
(i.
e.,
playing
on
turf).
Residential
exposures
have
been
estimated
based
on
label
application
frequency
and
timing,
and
the
persistence
of
pronamide.
Most
assumptions
for
risk
estimation
were
based
on
the
Residential
SOPs
(see
section
2.0).

Residents
are
assumed
to
play
or
work
on
treated
lawns,
or
play
golf
within
the
first
24
hours
of
spraying.
Restrictions
on
early
re­
entry
are
impractical
and
unenforceable
for
residents.
Therefore,
short­
term
risks
from
residential
postapplication
dermal
and
incidental
oral
exposures
are
anticipated
and
were
estimated
for
pronamide.
No
intermediate­
or
long­
term
exposure
scenarios
(i.
e.
>
30
days)
are
anticipated,
since
turf
residues
dissipate
rapidly
to
below
the
limit
of
quantification
by
day
14
following
application
(pronamide
TTR
study).
The
short­,
intermediate­,
and
long­
term
endpoints
are
the
same.
Postapplication
exposures
via
the
inhalation
route
are
not
anticipated,
since
pronamide
is
applied
as
a
liquid,
and
is
a
mobile
systemic
herbicide,
which
when
watered
in
(as
directed
on
the
label)
quickly
moves
into
soil,
where
it
is
rapidly
absorbed
into
vegetation.
Additionally,
the
uses
and
primary
exposures
are
6
outdoors,
allowing
for
significant
dilution.

The
scenarios
assessed
for
the
purpose
of
determining
risk
estimates
included
adults
and
children
(toddlers)
performing
high­
contact
play
or
work
activities
on
treated
lawns,
and
adults
mowing
lawns
or
golfing.
Small
children
(toddlers)
were
also
assessed
for
incidental
oral
exposure
from
ingestion
of
soil,
object­
to­
mouth
activity
(turfgrass
mouthing),
and
hand­
to­
mouth
activity
while
playing
on
treated
lawns.
Some
of
these
exposures
were
combined,
where
it
was
deemed
reasonably
likely
that
activities
would
co­
occur.
Residential
risk
estimates
utilized
data
from
a
submitted
turf
transferable
residue
(TTR)
study,
as
well
as
the
EPA's
original
and
revised
Draft
SOPs
for
Residential
Exposure
Assessment.
3,
5
For
pronamide
short­
term
non­
occupational
risks,
HED
has
established
a
level
of
concern
for
MOEs
<
300.

Wherever
available,
reported
usage
data
are
used
in
this
process
to
define
values
such
as
application
rates
and
application
frequency.
Only
one
end
use
product
label
can
be
used
in
a
residential
setting.
This
residential
label
(EPA
Reg.
No.
8660­
85)
indicates
a
maximum
application
rate
of
1.5
lb
ai/
acre
for
pre­
emergence
applications
by
lawn
care
operators
(LCOs)
to
lawns,
playing
fields,
and
golf
courses
as
a
single
application.
The
maximum
application
rate
for
post­
emergence
applications
is
1.0
lb
ai/
acre.
The
label
indicates
that
typical
application
rates
for
pre­
and
post­
emergence
applications
are
at
0.5
to
1.0
lb
ai/
acre,
with
the
maximum
rate
being
used
in
areas
of
heavy
growth
weeds.
This
residential
label
does
not
specify
or
restrict
the
number
of
applications
allowed
per
year
to
turf.
However,
the
agricultural
label
(EPA
Reg.
No.
707­
159)
allows
only
one
application
per
year
to
grasses
grown
for
turf
or
seed.
For
both
labels,
applications
to
turf
are
only
made
in
the
late
Fall
or
late
Winter.
For
residential
turf,
it
is
reasonable
to
assume
that
typically
only
one
application
is
made,
and
potentially
only
two
applications
would
be
made
in
any
year.
If
two
applications
were
made,
one
would
probably
be
made
in
late
Fall,
followed
by
another
application
in
late
Winter.
Therefore,
HED
assumed
one
application
per
year
to
estimate
short­
term
exposures.

Results
from
environmental
fate
studies
indicate
that
pronamide
is
very
persistent
in
soil
and
water
with
half­
lifes
of
many
months.
Additionally,
rotational
crop
studies
show
accumulation
in
several
crop
types
at
one,
six
and
twelve
months
after
application.
Results
from
a
recent
turf
transferable
residue
study
on
turf
using
pronamide
(i.
e.
MRID
44952501)
indicate
that
the
halflife
of
turf
transferrable
(TTR)
residues
was
slightly
less
than
two
days.
The
residential
label
(EPA
Reg.
No.
8660­
85)
instructs
applicators
to
lightly
irrigate
within
a
day
of
application
if
no
rain
occurs.
Such
irrigation
occurred
at
24
hours
after
application
in
the
TTR
study.
Since
the
compound
is
soluble
in
water,
and
therefore
mobile,
it
is
likely
the
irrigation
dissolves
the
compound
and
transports
it
from
the
turf
into
the
soil.
Study
data
showed
that
residues
dissipate
to
below
the
level
of
quantification
by
day
14
following
application.
Therefore,
only
short­
term
(i.
e.,
one
day
to
one
month)
exposures
would
be
anticipated,
since
most
of
the
pesticide
should
move
into
the
soil,
and
any
remaining
foliar
residues
should
dissipate
within
a
month.
While
residues
in
soil
could
persist
for
greater
than
30
days,
it
is
unlikely
that
children
will
play
on
or
contact
soil
for
greater
than
30
consecutive
days
during
the
late
Fall
or
late
Winter
months.

The
HED
always
completes
short­
term
risk
assessments
using
maximum
application
rates
for
7
each
scenario
because
what
is
possible
under
the
label
(the
legal
means
of
controlling
pesticide
use)
must
be
evaluated
for
complete
stewardship
in
order
to
ensure
the
HED
has
no
risk
concern
for
the
specific
use.

Cancer
Exposure
Scenario
The
low­
dose
extrapolation
model
used
to
estimate
the
Q1
*
assumes
that
any
exposure
at
any
time
may
increase
the
risk
of
cancer.
Therefore,
HED
conducted
an
exposure
assessment
for
cancer
based
on
residential
exposures
to
pronamide.
The
same
residential
exposure
scenarios
assumed
under
the
short­
term
exposure
assessment
were
used
as
the
basis
of
the
exposure
scenario
for
cancer.

Based
on
the
pesticide
label,
a
typical
residential/
recreational
lawn
application
rate
of
1.0
lb/
acre,
with
an
application
frequency
of
once
per
year,
was
assumed
for
the
residential
cancer
risk
assessment.
Pronamide
is
applied
in
the
dormant
season,
which
reduces
the
number
of
contact
days
expected.
A
single
exposure
is
deemed
more
likely,
but
up
to
14
days
exposure
could
occur
based
on
the
residue
dissipation
pattern.
The
14­
day
average
turf
residues
from
the
TTR
study
(MRID
44952501)
were
used
(i.
e.
0.07913
F
g/
cm
2
,
when
adjusted
to
a
typical
application
rate
of
1.0
lb
ai/
acre);
since
residues
in
the
TTR
study
dissipated
to
the
level
of
quantitation
by
14
days
after
application.
The
average
residue,
and
an
exposure
frequency
of
one
day
per
year,
or
50
days
in
a
lifetime,
was
assumed
for
high
contact
activities
(e.
g.
playing
and
working
on
lawns
and
turf)
and
low
contact
activities
(e.
g.
mowing
or
golfing).

Residential
Postapplication
Short­
Term
Risk
Estimates
The
level
of
concern
(LOC)
for
residential
risks
for
short­
term
dermal
and
incidental
oral
exposures
is
set
by
the
HED
at
a
margin
of
exposure
(MOE)
<
300.

Turf
transferrable
residue
(TTR)
data
from
the
pronamide
TTR
study
provided
by
the
registrant
were
used
quantitatively
in
this
risk
assessment.
Risk
estimates
based
on
residue
data
from
the
TTR
study
for
short­
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
on
day
zero
following
application
(DAT
0)
exceed
HED's
level
of
concern,
i.
e.
result
in
MOEs
<
300
for
adults
(MOE
=
71)
and
children
(MOE
=
42).
However,
using
DAT
2
residue
data
from
the
TTR
study
yielded
MOEs
that
do
not
exceed
the
level
of
concern
(MOEs
$
300)
for
adults
(MOE
=
890)
and
children
(MOE
=
530)
during
high
contact
lawn
activities.
Note
that
the
test
plots
were
irrigated
immediately
after
the
DAT
1
samples
were
taken,
i.
e.
24
hours
after
application
of
pronamide,
as
specified
on
the
label.
The
data
show
that
watering­
in
the
pronamide
product
clearly
alleviates
these
risk
concerns.
Risk
estimates
for
short­
term
dermal
contact
with
residues
on
treated
turf
during
the
low
contact
activities
of
grass
mowing
or
golfing
on
the
day
of
treatment
(DAT
0)
do
not
exceed
the
level
of
concern
(MOEs
$
300)
for
adults
(MOEs
2100
and
1000,
respectively)
(See
Table
5.)

HED
also
assessed
short­
term
risks
to
small
children
from
incidental
oral
ingestion
of
pronamide
residues
following
application
to
residential
lawns
(see
Table
7).
The
risk
calculations
for
small
8
children's
non­
dietary
ingestion
of
pronamide
on
treated
turf
indicate
that
risks
do
not
exceed
the
level
of
concern
(i.
e.
MOEs
$
300)
for
incidental
hand­
to­
mouth
activity
(MOE
=
380),
incidental
ingestion
of
soil
(MOE
=
113,000),
and
incidental
object
to
mouth
activity
(MOE
=
1500).
The
small
children's
combined
oral
hand­
to­
mouth
scenarios
(MOE
=
300)
also
do
not
exceed
the
level
of
concern.
When
risks
from
dermal
exposures
from
pronamide
to
small
children
are
combined
with
risks
from
incidental
oral
exposures,
the
combined
short­
term
risk
estimates
exceed
the
level
of
concern
(MOEs
<
300),
with
an
MOE
at
37.
However,
the
likelihood
of
all
incidental
oral
exposures
co­
occurring
with
dermal
exposures
is
low.

Residential
Postapplication
Cancer
Risk
Estimates
The
HED
endeavors
to
reduce
estimated
cancer
risks
for
the
general
population
to
less
than
one
in
one
million
(10
­6
).
Estimated
adult
cancer
risks
were
calculated
using
the
same
residential
exposure
scenarios
as
described
above;
i.
e.
performing
high­
contact
play
or
work
activities
on
treated
lawns,
mowing
lawns
or
golfing.
An
adult
mowing
a
treated
lawn
has
a
cancer
risk
of
5.73
x
10
­8
.
The
adult
golfer
cancer
risk
is
estimated
at
1.15
x
10
­7
.
An
adult
performing
dermal
high
contact
activities
on
turf
has
a
cancer
risk
of
8.36
x
10
­7
.
In
order
to
exceed
the
cancer
risk
(1.0
x
10
­6
),
exposure
frequencies
of
17.5,
8.7
and
1.2
days
per
year
would
be
needed
for
the
activities
of
mowing,
golfing
and
high
contact
work,
respectively.

Summary
of
Risk
Concerns,
Exposure
Assumptions,
and
Confidence
in
Estimates
The
exposure
estimates
generated
for
the
residential/
recreational
turf
uses
used
the
HED
SOPs
that
are
based
on
some
upper­
percentile
assumptions
(i.
e.,
duration
of
exposure
and
maximum
application
rate
for
short­
term
assessments)
and
are
considered
to
be
representative
of
high
end
exposures.
The
uncertainties
associated
with
this
assessment
stem
from
the
use
of
assumptions
regarding
the
transfer
of
pronamide
residues.
The
exposure
estimates
are
believed
to
be
reasonably
high­
end
estimates,
since
the
maximum
application
rate
is
used,
a
100%
dermal
absorption
factor
is
assumed,
and
exposures
are
assumed
to
occur
on
the
day
of
treatment.
The
translation
of
a
dose
based
on
a
chronic
effect
for
the
purpose
of
short­
term
risk
estimation
also
contributes
to
a
high­
end
exposure
estimate.
However,
dermal
exposure
estimates
are
not
considered
overly
conservative,
since
turf
transferrable
residue
(TTR)
data
from
a
pronamide
TTR
field
study
was
used;
specifically
0.289
µg/
cm
2
,
which
is
the
average
residue
observed
on
day
zero
after
application,
and
represents
1.65%
of
the
pronamide
applied
(i.
e.
the
transfer
efficiency).
The
study
was
acceptable
and
met
the
OPPTS
guidelines,
so
the
level
of
confidence
is
fairly
high.
There
is
less
confidence
in
the
oral
risk
estimates,
which
are
solely
based
on
the
HED
SOPs.

HED
assumes
that
the
general
public's
exposure
may
not
be
mitigated
by
use
of
personal
protective
gear.
Therefore,
only
administrative
controls
(e.
g.,
formulation
changes
or
use
rate
reductions)
are
feasible
methods
of
risk
reduction.
Mitigating
circumstances
for
residential
exposure
to
pronamide
residues
may
include
the
watering­
in
of
the
product
to
turf
immediately
after
application,
instead
of
within
24
hours
after
application,
as
the
label
currently
recommends.
Pronamide
product
was
watered­
in
for
the
TTR
study
(MRID
44952501).
This
instruction,
9
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering­
in.
HED
recommends
that
the
residential
turf
label
(EPA
Reg.
No.
8660­
85)
be
changed
to
specify
only
one
application
per
year
and
to
required
the
product
to
be
watered­
in
to
turf
immediately
after
application.
The
exposure
scenarios
and
risk
estimates
are
summarized
below.

Summary
of
Postapplication
Exposure
Scenarios
and
Risk
Estimates
Exposure
Scenario
Route
of
Exposure
Population
Short­
Term
MOE
using
DAT
0
TTR
Data
from
Turf
Study
a
Short­
Term
MOE
using
DAT
2
TTR
Data
from
Turf
Study
a
Short­
Term
MOE
using
HED
Residential
SOPs
a
Cancer
Risk
Estimate
b
High
Contact
Activities
­
Playing
or
Working
on
Lawns
or
Turf
Dermal
Adult
71
890
N/
A
8.
36E­
07
Toddler
42
530
N/
A
N/
A
Low
Contact
Activity
­
Mowing
Dermal
Adult
2100
26,000
N/
A
5.
73E­
08
Low
Contact
Activity
­
Golf
Course
Reentry
Dermal
Adult
1000
13,000
N/
A
1.
15E­
08
Incidental
Hand­
toMouth
Activity
(Finger
Licking)
Oral
Toddler
N/
A
N/
A
380
N/
A
Incidental
Object­
toMouth
Activity
(Turfgrass
Mouthing)
Oral
Toddler
N/
A
N/
A
1500
N/
A
Incidental
Ingestion
of
Soil
Oral
Toddler
N/
A
N/
A
113,000
N/
A
Combined
Postapplication
Exposures
Incidental
Oral
NonDietary
Oral
Toddler
N/
A
N/
A
300
N/
A
Dermal
&
Incidental
Oral
Oral
&
Dermal
Toddler
N/
A
N/
A
37
N/
A
a
Short­
term
Margin
of
Exposure.
MOEs
that
are
<
300
are
of
concern
for
short­
term
exposures
and
are
shown
in
bold.
N/
A
=
Not
Applicable.
b
The
HED
endeavors
to
reduce
estimated
cancer
risks
for
the
general
population
to
less
than
one
in
one
million
(10
­6
).
N/
A
=
Not
Applicable.
10
Pronamide:
Residential
Exposure/
Risk
Characterization
1.
BACKGROUND
1.1
Purpose
This
document
is
intended
to
support
the
development
of
the
Pronamide
Tolerance
Reassessment
Eligibility
Decision
(TRED)
document
and
includes
the
results
of
HED's
review
of
the
potential
human
health
effects
associated
with
non­
dietary
exposure
to
pronamide.
This
is
a
preliminary
exposure
and
risk
assessment.
HED
has
determined
that
there
is
a
potential
for
exposure
in
occupational
settings
from
handling
pronamide
products
during
the
application
process
(i.
e.,
mixer/
loader,
applicator
and
mixer/
loader/
applicator)
and
from
entering
previously
treated
areas.
As
a
result,
risk
assessments
would
normally
have
been
completed
for
occupational
handler
and
postapplication
scenarios.
However,
for
pronamide
the
occupational
handler
and
postapplication
scenarios
will
not
be
assessed,
since
the
assessment
is
only
for
a
TRED
document.
The
assessment
is
limited
to
registered
non­
occupational
postapplication
(residential
and
recreational)
uses
of
pronamide,
i.
e.
residential/
recreational
turf
only.
Pronamide
is
a
restricted
use
pesticide,
and
therefore
requires
professional
applicators.

1.2
Criteria
for
Conducting
Exposure
Assessments
A
residential
exposure
assessment
is
required
for
an
active
ingredient
(ai)
if
(1)
certain
toxicological
criteria
are
triggered
and
(2)
there
is
potential
exposure
to
handlers,
such
as
mixers,
loaders
and
applicators
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
Pronamide
meets
the
criteria,
because
of
the
potential
for
postapplication
residential
exposure
to
residues
on
turf.
Therefore,
a
residential
risk
assessment/
characterization
was
completed
for
this
chemical.
Non­
occupational
(residential/
public)
handler
exposures
are
not
expected,
since
all
pronamide
products
are
labeled
as
restricted
use
pesticides.
Postapplication
exposures
to
pronamide
residues
are
anticipated
to
be
short­
term
(one
to
30
days)
in
duration
for
residential
scenarios,
since
pronamide
specific
data
show
that
turf
transferrable
residues
decline
to
less
than
the
limit
of
quantification
by
day
14
after
application
(see
Table
4.).

1.3
Summary
of
Toxicity
Concerns
Relating
to
Residential
Exposures
Toxicological
Endpoints
The
toxicological
endpoints
(effects),
the
doses
and
the
uncertainty
factors
that
were
used
to
complete
this
assessment
are
summarized
in
Table
1
below
in
order
to
provide
a
quick
reference
to
the
residential
post­
application
exposure
assessments
(based
on
the
November
1,
2001,
HIARC
Report).
11
Table
1.
Toxicological
Endpoints
for
Assessing
Residential
Risks
for
Pronamide.

Exposure
Scenario
Study
Dose
Absorption
Endpoint
UF
&
FQPA/
Target
MOE
Short­
term
Dermal
&
Inhalation
Chronic
Toxicity/
Carcinogenicity
in
Rats
Oral
NOAEL
8.46
mg/
kg/
day
100%
of
oral
Increased
liver
weight
&
nonneoplastic
histologic
changes
in
liver,
thyroid
&
ovaries
300
Intermediateterm
Dermal
&
Inhalation
300
Long­
term
Dermal
&
Inhalation
300
Short­
term
Incidental
Oral
Ingestion
N/
A
300
Intermediateterm
Incidental
Oral
Ingestion
N/
A
300
Lifetime
Cancer
Risk
[All
Populations]
Chronic
Toxicity/
Carcinogenicity
in
Rats
&
Carcinogenicity
in
Mice
Q1
*
=
0.0259
(mg/
kg/
day)
­1
N/
A
Benign
testicular
interstitial
cell
tumors
&
uncommon
thyroid
follicular
cell
adenomas
in
rats;
Hepatocellular
carcinoma
in
mouse
N/
A
Acute,
Short­
term,
Intermediate­
term,
and
Long­
term
Endpoints:
Pronamide
is
classified
as
category
III
for
acute
dermal
and
inhalation
toxicity
and
primary
eye
irritation,
category
IV
for
acute
oral
toxicity
and
for
primary
skin
irritation.
Pronamide
is
not
a
skin
sensitizer.

For
short­
term
(1­
30
days)
incidental
oral
exposures
an
adjusted
dose
of
8.46
mg/
kg/
day
was
established
for
use
in
this
risk
assessment.
This
dose
is
derived
from
the
no
observed
adverse
effect
level
(NOAEL)
from
a
chronic
toxicity/
carcinogenicity
study
in
rats,
where
the
effects
are
increased
liver
weight
and
non­
neoplastic
histologic
changes
in
liver,
thyroid,
and
ovaries
observed
at
the
lowest
observed
adverse
effect
level
(LOAEL)
of
42.6
mg/
kg/
day.
The
dose
selection
is
based
on
a
maternal
toxicity
NOAEL
of
5
mg/
kg/
day
and
clinical
signs
of
toxicity
(soiled
anal
area
and
anorexia)
and
liver
effects
(punctate
vacuolation
of
hepatocytes)
observed
at
the
LOAEL
of
20
mg/
kg/
day
in
the
developmental
toxicity
study
conducted
in
rabbits.
Although
this
study
is
of
the
appropriate
route
(oral)
and
duration
(13
days),
the
NOAEL
(5
mg/
kg/
day)
in
this
study
is
lower
than
the
NOAEL
(8.46
mg/
kg/
day)
established
in
the
chronic
12
toxicity/
carcinogenicity
study
in
the
rat.
The
apparent
disparity
between
these
NOAELs
is
driven
by
the
doses
of
pronamide
selected
for
testing
in
these
studies.
The
HIARC
concluded
that
using
a
more
realistic
NOAEL
of
8.46
mg/
kg/
day,
rather
than
5
mg/
kg/
day,
would
provide
a
sufficiently
protective
dose
for
risk
assessment.

The
NOAEL
of
3
mg/
kg/
day
established
in
the
special
thyroid
study
conducted
in
male
rats
was
also
considered.
However
this
dose
was
not
selected
because
the
wide
gap
between
the
NOAEL
(3
mg/
kg/
day)
and
the
LOAEL
(67
mg/
kg/
day)
in
this
study
resulted
in
the
3
mg/
kg/
day
dose
(NOAEL)
being
artificially
low.
In
addition,
the
LOAEL
of
67
mg/
kg/
day
is
comparable
to
the
LOAEL
(56
mg/
kg/
day)
established
in
the
chronic
toxicity
/carcinogenicity
study
conducted
in
rats.

For
short­
term
(1­
30
days)
dermal
exposures
the
same
oral
dose
and
endpoint
was
selected
for
risk
assessment,
i.
e.
8.46
mg/
kg/
day.
A
dermal
absorption
factor
is
needed,
since
the
endpoint
is
based
on
a
study
using
oral
dosing.
A
default
dermal
absorption
factor
of
100%
relative
to
oral
absorption
was
chosen
by
the
HIARC,
since
the
dermal
absorption
study
sent
to
the
Agency
was
classified
as
unacceptable
and
no
dermal
toxicity
studies
were
submitted.

Uncertainty
Factor
(UF):
The
short­
term
dermal
and
oral
incidental
endpoints
have
a
10x
UF
for
intra­
species
variability
and
a
10x
UF
for
inter­
species
extrapolation.
In
a
memo
dated
December
19,
2001,
the
FQPA
Safety
Factor
Committee
recommended
that
the
FQPA
safety
factor
be
reduced
to
3x.
The
FQPA
Committee
determined
that
the
safety
factor
is
necessary
when
assessing
the
risk
posed
by
pronamide
because
of
evidence
of
endocrine
effects.
The
FQPA
safety
factor
is
required
for
all
population
subgroups
when
assessing
residential
exposures
of
all
durations.
Total
uncertainty
factor
applied
to
short­
term
residential
exposures
is
300x.

Carcinogenicity:
In
accordance
with
the
Agency's
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(September
30,
1992),
the
HED
Carcinogenicity
Peer
Review
Committee
(CPRC)
classified
pronamide
as
a
Group
B2
chemical
(probable
human
carcinogen
with
inadequate
evidence
in
humans).
This
decision
was
based
on
the
finding
of
two
types
of
tumors
in
the
rat
(benign
testicular
interstitial
cell
tumors
and
uncommon
thyroid
follicular
cell
adenomas),
and
one
type
of
tumor
in
the
mouse
(hepatocellular
carcinomas).
A
linear,
low
dose
approach
(Q1
*
)
is
used
for
human
risk
characterization.
The
most
potent
unit
risk
Q1
*
,
based
on
male
mouse
liver
adenoma
and/
or
carcinoma
combined
tumor
rates,
is
2.59
x
10
­2
(mg/
kg/
day)
­1
in
human
equivalents
[converted
from
animal
to
humans
by
use
of
the
(mg/
kg
body
weight)
3/
4
interspecies
scaling
factor].
Therefore,
the
Hazard
Identification
Assessment
Review
Committee
(HIARC)
recommended
that
a
cancer
risk
assessment
be
conducted
for
pronamide
(November
6,
2001).

1.4
Incident
Reports
A
review
of
incident
data
sources
was
conducted
for
pronamide
on
August
10,
2001
by
J.
Blondell.
1
Only
one
exposure
incident
to
pronamide
was
reported
to
Poison
Control
Centers
from
1993
through
1998.
Cases
involving
exposures
to
multiple
products
were
excluded.
No
cases
were
reported
among
children
under
six
years
of
age
or
among
older
children
and
adults
13
exposed
at
their
workplace.
There
was
one
non­
occupationally
exposed
case
among
older
children
and
adults
which
was
not
reported
to
have
symptoms
related
to
their
exposure
and
was
not
seen
in
a
health
care
facility.

Detailed
descriptions
of
two
cases
submitted
to
the
California
Pesticide
Illness
Surveillance
Program
(1982­
1999)
were
reviewed.
In
the
first
case,
a
worker
applied
pronamide
product
on
the
ground
for
ten
days
and
reported
malaise,
anorexia,
fatigue,
dizziness,
nausea,
and
vomiting.
In
the
second
case,
one
of
two
workers
moved
an
irrigation
pipe
in
a
field
and
later
reported
dizziness,
vomiting,
and
weakness.
Both
cases
were
categorized
as
`possible',
meaning
the
pronamide
exposure
was
a
possible
cause
of
the
reported
symptoms.

On
the
list
of
the
top
200
chemicals
for
which
the
National
Pesticide
Telecommunications
Network
(NPTN)
received
calls
from
1984­
1991,
inclusively,
pronamide
was
not
reported
to
be
involved
in
human
incidents.

In
summation,
very
few
illness
cases
have
been
reported
due
to
pronamide
and
none
have
been
confirmed.
No
recommendations
can
be
made
on
the
very
limited
incident
data
available
for
this
pesticide.

1.5
Summary
of
Use
Patterns
and
Formulations
Pronamide
products
are
described
in
this
section.
Additionally,
available
information
that
describes
the
manner
in
which
pronamide
products
are
applied
is
provided
in
this
section
(e.
g.
use
categories/
sites,
application
methods
and
application
rates).

i.
End­
Use
Products
Pronamide
was
manufactured
by
Rohm
&
Haas,
but
has
been
recently
sold
to
Dow
AgroSciences.
One
additional
registrant,
Pursell
Incorporated,
maintains
a
registration
on
one
end
use
product.
Based
on
a
review
(7/
25/
01)
of
the
Office
of
Pesticide
Programs­
Reference
Files
System
(REFS)
these
two
registrants
supported
13
registrations
of
four
products
containing
the
active
ingredient
pronamide,
including
one
technical
product,
one
formulation
intermediate,
two
section
3
registration
end
use
products,
and
nine
section
24(
c)
state
registration
labels.
All
end­
use
products
are
wettable
powders
packaged
in
water
soluble
pouches.

Table
2:
Active
Labels
for
Pronamide.

Formulation
Percent
Active
Ingredient
EPA
Registration
Number
Technical
92%
707­
113
Formulation
Intermediate
51%
707­
98
Wettable
Powder
51%
707­
159;
CO99001000
14
Wettable
Powder
50%
8660­
85;
AZ79003600;
CA86006500;
FL91000700;
ID91001600;
OR90000400;
OR99000700;
OR99000800;
WA91004300
ii.
Mode
of
Action
and
Targets
Controlled
Pronamide
(3,5­
dichloro­
N­(
1,1­
dimethyl­
2­
propynyl)
benzamide)
is
a
selective
pre­
and
postemergent
herbicide
used
to
control
grasses
and
broadleaf
weeds.
It
is
a
systemic
herbicide
with
uptake
by
susceptible
weeds
occurring
through
the
roots.
Therefore,
to
be
effective,
pronamide
is
applied
to
the
soil
and
transported
by
water
into
the
root
zone.
Applications
are
made
in
the
late
Fall
and/
or
late
Winter.

iii.
Registered
Use
Categories
Based
on
available
pesticide
usage
information
for
1991
through
2000
supplied
from
the
Biological
and
Economic
Analysis
Division
(BEAD)
Quantitative
Usage
Analysis
(QUA)
for
Pronamide,
dated
September
26,
2001,
total
annual
domestic
usage
of
pronamide
is
approximately
225,000
pounds
active
ingredient
(a.
i.).
In
terms
of
pounds
a.
i.,
total
usage
is
allocated
mainly
to
head
lettuce
(29%),
other
lettuce
(19%),
seed
crops
(13%),
fallowland
(11%),
hay
other
than
alfalfa
(8%),
horticulture
(3%)
and
alfalfa
(3%).
Sites
with
5%
or
more
of
acreage
treated
include
lettuce
other
than
head
lettuce
(49%),
head
lettuce
(36%),
California
endive/
escarole
(31%),
artichokes
(21%),
blackberries
(6%)
and
raspberries
(5%).
Rates
per
application
and
rates
per
year
are
each
generally
less
than
2
pounds
a.
i.
per
acre
for
agricultural
sites.
States
with
significant
usage
in
terms
of
pounds
a.
i.
include
Arizona,
California,
Oregon
and
Washington.

There
is
one
label
used
exclusively
for
occupational
use
on
commercial
sites,
i.
e.
EPA
Reg.
No.
707­
159.
Use
sites
on
this
label
include
stone
fruits,
pome
fruits,
grapes,
artichokes,
berries,
forages,
leafy
greens,
winter
peas,
Christmas
trees,
ornamentals,
turf,
rangeland,
and
fallow
land.
Another
label
is
used
exclusively
by
commercial
applicators
on
residential/
recreational
bermudagrass
turf,
i.
e.
EPA
Reg.
No.
8660­
85.
Use
sites
on
this
label
include
bermudagrass
lawns,
playing
fields,
and
golf
courses.
There
are
several
active
24C
state
labels.
However,
for
risk
assessment
purposes
the
use
sites
and
use
patterns
on
these
24C
labels
are
covered
by
EPA
Reg.
No.
707­
159.

iv.
Application
Parameters
Application
parameters
are
generally
defined
by
the
physical
nature
of
the
use
site,
the
physical
nature
of
the
formulation
(e.
g.,
form
and
packaging),
by
the
equipment
required
to
deliver
the
chemical
to
the
use
site,
and
by
the
application
rate
required
to
achieve
an
efficacious
dose,
along
with
seasonal
limits
to
applications.
Table
3
contains
the
crops,
application
types
and
rates
for
pronamide.
15
Table
3:
Use
Parameters
for
Pronamide
EPA
Reg.

No.
Formulation
Restrictions/
Limitations,
etc.
Use
Sites
Max
App
Rate
in
lb
a.
i./
A
Max.
#

of
Apps
per
Crop
Cycle
or
Year
Min
Interval
(Days)
Reentry
Interval
(Hours)
App
Timing
App
Method
Type
App
Equipment
707­
159
51%
W
(3
x
1
lb
water
soluble
pouches)
Restricted
Use
Pesticide.
Do
not
apply
this
product
through
any
type
of
irrigation
system.

Hand­
spray
applications
may
be
made
only
to
ornamentals
&

nursery
stock
of
ornamentals.
Apple,
Apricot,
Artichoke
Globes
(CA
only),
Cherry,
Grape,
Nectarine,

Peach,
Pear,
Plum,
Prune.

Blackberry,
Boysenberry,
Raspberry
(Black
&
Red).

Alfalfa,
Blueberry,
Chicory,

Christmas
Trees,
Clover,
Birdsfoot
Treefoil,
Crown
Vetch,
Endive
(Escarole),
Lettuce,
Radicchio,

Rhubarb
(OR
&
WA
only),
Sainfoin,

Woody
Ornamentals,
Nursery
Stock
of
Ornamentals.
Grasses
(Ornamental)
Grown
for
Seed
or
Turf,
Winter
Peas
(ID,
OR
&

WA
only).
Conservation
Reserve
Program
(CRP)
Established
Grass
Stands,

CRP
Fallow
land,
Fallow
land.
4.08
3.06
2.04
1.53
0.51
1
(Fruits);
2
Arti
choke)
1
1
1
1
NS
NS
NS
NS
NS
24
24
24
24
24
Preemergence
&
early
post

emergence
control
of
winter
annual
&
perennial
grasses
&

chickweed
&

preemergence
control
only
of
certain
other
grasses.
Treatments
mainly
in
fall,

and
some
in
winter.
Fruits
by
band
treatment
&

directed
spray.

Berries
by
band
treatment
&

broadcast.
Forages
by
broadcast
&
soil
incorporation.
Leafy
greens
by
band
treatment,

low
volume
spray,

broadcast
&
soil
incorporation.
Turf
&
Grasses
by
broadcast,
band
treatments
&

directed
sprays.
Fruits,
berries,
forages,
chicory,
artichoke,
fallow
land
&

ornamentals
by
low
pressure
ground
sprayer.
Alfalfa,
chicory,
endive
&
lettuce
by
soil
incorporation.
Artichoke,
Christmas
trees,

endive,
fallow
land
&
lettuce
by
aircraft.
Ornamentals
by
hand
held
sprayer.

8660­
85
50%
W
(6
x
8
oz
water
soluble
pouches)
Restricted
Use
Pesticide.
Not
for
use
on
turf
being
grown
for
sale
or
other
commercial
use
as
sod,
or
for
commercial
seed
production
or
for
research
purposes.
Bermudagrass
Lawns,
Playing
Fields,

&
Golf
Courses
(Not
recommended
on
greens.).
1.
5NS
NS
NS
Preemergence
&
early
post

emergence
control
of
Poa
annua
in
the
fall
or
late
winter.
Broadcast
Sprayer
OR90000
400
50%
W
Same
as
EPA
Reg.
No.
707­
159
Sugarbeets
1.
02NS
NS
NS
Fall
&
E
arly
Winter
Broadcast
Sprayer
EPA
Reg.

No.
Formulation
Restrictions/
Limitations,
etc.
Use
Sites
Max
App
Rate
in
lb
a.
i./
A
Max.
#

of
Apps
per
Crop
Cycle
or
Year
Min
Interval
(Days)
Reentry
Interval
(Hours)
App
Timing
App
Method
Type
App
Equipment
16
CO99001
000
50%
W
Same
as
EPA
Reg.
No.
707­
159
Alfalfa
2.
04
NS
NS
24
Fall,
Winter,
Spring
Broadcast
&
soil
incorporated.
Ground,
low
pressure
ground
sprayer,
soil
incorporated.

ID910016
00
50%
W
Same
as
EPA
Reg.
No.
707­
159
Blackberries
&
Raspberries
3.06
1
NS
24
Fall
&
Winter
Band
treatment
&

broadcast
Low
pressure
ground
sprayer.

WA9100
4300
50%
W
Same
as
EPA
Reg.
No.
707­
159
Christmas
Tree
Plantations
2.04
NS
NS
24
Fall
Band
treatment
&

broadcast
Aircraft
&
low
pressure
ground
sprayer.

AZ79003
600
50%
W
Same
as
EPA
Reg.
No.
707­
159
Lettuce
&
Endive
(Escarole)
2.04
1
for
Lettuce
NS
for
Endive
NS
24
Fall
&
Winter
Band
treatment,

low
volume
spray,

broadcast
&
soil
incorporation.
Aircraft,
low
pressure
ground
sprayer,
&
soil
incorporation.

CA86006
500
50%
W
Same
as
EPA
Reg.
No.
707­
159
Lettuce
1.53
1
NS
24
Fall
&
Winter
Band
treatment,

low
volume
spray,

broadcast
&
soil
incorporation.
Aircraft,
low
pressure
ground
sprayer,
&
soil
incorporation.

OR99000
700
50%
W
Same
as
EPA
Reg.
No.
707­
159
Grasses
grown
for
Seed
0.3825
1
NS
24
Fall
&
Winter
Broadcast
Ground
&
low
pressure
ground
sprayer.

OR99000
800
50%
W
Same
as
EPA
Reg.
No.
707­
159
Grasses
grown
for
Seed
0.255
1
NS
24
Fall
&
Winter
Broadcast
Ground
&
low
pressure
ground
sprayer.

FL91000
700
50%
W
Same
as
EPA
Reg.
No.
707­
159
Gladiolus
2.
0
4
NS
24
Preemergence
Ground
spray
Low
pressure
ground
sprayer.

ID910016
00
50%
W
Same
as
EPA
Reg.
No.
707­
159
Raspberry
(Red
&
Black)
3.
06
1
NS
24
Fall
&
Winter
Band
treatment
&

broadcast
Sprayer
ai
=
active
ingredient;
NS
=
Not
Specified
WP
=
Wettable
Powder
17
2.0
RESIDENTIAL
AND
OTHER
NON­
OCCUPATIONAL
EXPOSURES
AND
RISKS
This
assessment
for
pronamide
reflects
the
HED's
current
approaches
for
completing
residential
exposure
assessments
based
on
the
guidance
provided
in
the
Draft:
Series
875­
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
B­
Postapplication
Exposure
Monitoring
Test
Guidelines,
the
Draft:
Standard
Operating
Procedures
(SOPs)
for
Residential
Exposure
Assessment,
the
Overview
of
Issues
Related
to
the
Standard
Operating
Procedures
for
Residential
Exposure
Assessment
presented
at
the
September
1999
meeting
of
the
FIFRA
Scientific
Advisory
Panel
(SAP),
and
the
Revised
SOPs
(February
2001)
for
Residential
Exposure
Assessment
6,5,
3
.
The
HED
is,
however,
currently
in
the
process
of
revising
its
guidance
for
completing
these
types
of
assessments.
Modifications
to
this
assessment
shall
be
incorporated
as
updated
guidance
becomes
available.
This
will
include
expanding
the
scope
of
the
residential
exposure
assessments
by
developing
guidance
for
characterizing
exposures
from
other
sources
not
already
addressed,
such
as
from
spray
drift;
residential
residue
track­
in;
exposures
to
farm
worker
children;
and
exposures
to
children
in
schools.

2.1
Methods
of
Estimating
Non
Cancer
Risks
And
Calculating
Exposures
The
exposures
that
were
calculated
below
represent
the
amount
of
pronamide
that
can
be
deposited
on
the
surface
of
the
skin
after
application,
or
that
can
be
attributed
to
the
mouthing
behaviors
of
children
after
contact
with
treated
turf.
The
HED
calculates
dose
levels
using
the
following
formula:

Where:

Daily
Dose
=
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(mg
pesticide
active
ingredient/
kg
body
weight/
day);

Daily
Exposure
=
the
amount
of
dermal
(on
the
skin),
or
nondietary
ingestion
(from
mouthing
behaviors
of
children)
exposure
(mg
pesticide
active
ingredient/
day);

Absorption
Factor
=
a
measure
of
the
flux
or
amount
of
chemical
that
crosses
a
biological
boundary
(%
of
the
total
available);
and
Body
Weight
=
body
weight
determined
to
represent
the
population
of
interest
in
a
risk
assessment
(kg).

For
pronamide,
the
average
body
weight
for
adults
used
in
all
residential
exposure
assessments
is
70
kg,
which
represents
the
general
population.
Although
the
short­
term
dermal
endpoint
is
from
a
developmental
study,
the
effect
is
clinical
signs
and
liver
toxicity,
not
developmental
18
toxicity.
The
average
body
weight
used
in
all
assessments
for
1­
6
year
old
children
is
15
kg,
based
on
the
SOPs
for
Residential
Exposure
Assessment.
A
100%
dermal
absorption
factor
is
applied
to
the
oral
NOAEL
used
for
dermal
risk
estimates
(i.
e.
dermal
and
oral
absorption
are
equivalent),
since
the
dermal
absorption
study
sent
to
the
Agency
was
classified
as
unacceptable
and
no
dermal
toxicity
studies
were
submitted.
For
oral
exposures
for
children,
the
oral
NOAEL
of
8.46
mg/
kg/
day
for
general
population
is
used.

HED
expresses
non
cancer
risk
estimates
for
residential
exposures
to
pesticides
as
a
Margin
of
Exposure
(MOE).
The
NOAEL
and
the
combined
uncertainty
factors
that
apply
to
all
pronamide
risk
estimates
are
listed
in
Section
1.3,
Table
1.
The
non­
occupational
short­
term
target
MOE
is
300.
MOEs
were
calculated
using
the
following
formula:

Where:

MOE
=
margin
of
exposure
or
ratio
of
endpoint
of
concern
to
the
chemical
exposure;

Absorbed
Daily
Dose
=
the
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(mg
pesticide
active
ingredient/
kg
body
weight/
day);
and
NOAEL
=
the
highest
dose
level
in
a
toxicity
study
where
no
observed
adverse
effects
occur
(mg
pesticide
active
ingredient/
kg
body
weight/
day).

In
order
for
the
Agency
to
make
more
informed
risk
management
decisions,
MOEs
can
be
added
together
in
order
to
look
at
the
combined
exposures
that
occur
for
an
individual
if
the
toxic
effect
for
each
route
of
exposure
(e.
g.,
to
the
skin
and
being
ingested)
is
the
same.
For
example,
combining
dermal
and
oral
non­
dietary
ingestion
MOEs
for
children
is
of
interest
because
these
exposures
can
occur
at
the
same
time.
The
equation
the
HED
uses
to
add
MOEs
together
is
presented
below:

MOE
total
=
1/((
1/
MOE
a)
+
(1/
MOE
b)
+....
(1/
MOE
n))

Where:
MOE
a,
MOE
b,
and
MOE
n
represent
MOEs
for
each
exposure
route
of
concern
Children's
dermal
high­
contact
exposures
to
pronamide
on
treated
lawns
were
combined
with
hand
to
mouth
exposure,
as
these
events
are
likely
to
coincide.
19
2.2
Residential
Handler
Exposures
and
Risks
2.2.1
Residential­
Handler
Exposure
Scenarios,
Data,
and
Assumptions
All
pronamide
end
use
products
are
labeled
as
restricted
use
pesticides.
Therefore,
residents
are
restricted
from
handling
pronamide
products.

2.3
Non­
Occupational
Postapplication
Exposure
and
Risk
Estimates
When
the
pronamide
RED
document
was
completed
in
May,
1994,
the
Agency
did
not
have
the
data
to
make
a
reregistration
decision
on
pronamide
for
use
on
residential
lawns.
An
estimate
of
risk
was
not
feasible
because
of
numerous
uncertainties
in
potential
exposure
levels,
especially
for
children.
In
the
1994
RED
document,
regulatory
decisions
concerning
postapplication
reentry
to
residential
lawns
were
postponed
until
after
the
submittal
and
review
of
studies
required
to
support
the
residential
lawn
use;
i.
e.
foliar
dislodgeable
dissipation
(old
guideline
132­
1(
a)
or
new
guideline
875.2100)
and
dermal
passive
dosimetry
(old
guideline
133­
3
or
new
guideline
875.2400).
In
the
interim
since
1994,
a
turf
transferrable
residue
(TTR)
study
was
submitted,
reviewed,
and
found
acceptable
and
useful
for
some
aspects
of
risk
assessment.
The
study
provided
the
required
residue
dissipation
data.
The
methodology
used
to
determine
turf
transferability
(i.
e.
the
modified
California
roller
method)
does
not
match
the
Agency's
current
methodology
(i.
e.
Jazzercise
and
the
California
roller
method)
used
to
determine
the
dermal
transfer
coefficient
on
turf.
Note,
that
the
Outdoor
Residential
Exposure
Task
Force
(ORETF)
is
currently
funding
a
study
which
is
intended
to
provide
con
current
TTR
and
transfer
coefficient
data
for
a
surrogate
chemical.
The
requirement
for
a
dermal
passive
dosimetry
study
remains
outstanding.
However,
the
Agency
can
perform
an
adequate
risk
assessment
to
estimate
risk
on
residential
lawns
by
using
dissipation
data
from
the
TTR
study
in
conjunction
with
the
transferability
assumptions
and
equations
found
in
the
Agency's
residential
SOPs.

2.3.1
Postapplication
Exposure
Scenarios,
Data,
and
Assumptions
Adults
and
children,
are
potentially
exposed
to
pronamide
residues
after
application
of
pronamide
products
in
residential
settings.
After
application
to
turf,
short­
term
dermal
exposures
are
anticipated
for
adults
and
children.
Incidental
oral
exposure
is
also
expected
to
occur
for
small
children
and
is
combined
with
their
dermal
exposures,
where
applicable
(i.
e.,
playing
on
turf).

Representative,
range­
finding
activities
include
working
and
playing
on
turf,
mowing,
golfing,
and
incidental
ingestion
by
children.
Therefore,
the
pronamide
post­
application
exposure/
risk
assessment
contains
exposure
scenarios
in
each
category.
The
physical,
behavioral,
and
physiological
differences
between
adults
and
children
are
continuously
being
studied
by
the
Agency
and
many
others,
and
the
current
standard
assumptions
set
forth
by
the
HED
and
the
Science
Advisory
Panel
(SAP)
are
contained
in
the
aforementioned
Residential
SOPs.
The
SOPs
were
updated,
in
February,
2001,
to
reflect
the
latest
research
findings
and
refined
assessment
strategies
since
the
presentation
to
the
SAP
in
September
1999.
20
Wherever
available,
reported
usage
data
are
used
in
this
process
to
define
values
such
as
application
rates
and
application
frequency.
Only
one
end
use
product
label
can
be
used
in
a
residential
setting.
This
residential
label
(EPA
Reg.
No.
8660­
85)
indicates
a
maximum
application
rate
of
1.5
lb
ai/
acre
for
pre­
emergence
applications
by
lawn
care
operators
(LCOs)
to
lawns,
playing
fields,
and
golf
courses
as
a
single
application.
The
maximum
application
rate
for
post­
emergence
applications
is
1.0
lb
ai/
acre.
The
label
indicates
that
typical
application
rates
for
pre­
and
post­
emergence
applications
are
at
0.5
to
1.0
lb
ai/
acre,
with
the
maximum
rate
being
used
in
areas
of
heavy
growth
weeds.
This
residential
label
does
not
specify
or
restrict
the
number
of
applications
allowed
per
year
to
turf.
However,
the
agricultural
label
(EPA
Reg.
No.
707­
159)
allows
only
one
application
per
year
to
grasses
grown
for
turf
or
seed.
For
both
labels,
applications
to
turf
are
only
made
in
the
late
Fall
or
late
Winter.
Therefore,
for
residential
turf,
it
is
reasonable
to
assume
that
typically
only
one
application
is
made,
and
potentially
only
two
applications
would
be
made
in
any
year.
If
two
applications
were
made,
one
would
probably
be
made
in
late
Fall,
followed
by
another
application
in
late
Winter.

Results
from
environmental
fate
studies
indicate
that
pronamide
is
very
persistent
in
soil
and
water
with
half­
lifes
of
many
months.
Additionally,
rotational
crop
studies
show
accumulation
in
several
crop
types
at
one,
six
and
twelve
months
after
application.
However,
results
from
a
recent
turf
transferable
residue
(TTR)
study
on
turf
using
pronamide
(i.
e.
MRID
44952501)
indicate
that
the
half­
life
of
turf
transferrable
residues
was
slightly
less
than
two
days.
Also,
the
residential
label
(EPA
Reg.
No.
8660­
85)
instructs
applicators
to
lightly
irrigate
within
a
day
of
application
if
no
rain
occurs.
Such
irrigation
occurred
at
24
hours
after
application
in
the
TTR
study.
Study
data
showed
that
residues
dissipate
to
below
the
level
of
quantification
by
day
14
following
application.
Therefore,
only
short­
term
(i.
e.,
one
day
to
one
month)
exposures
would
be
anticipated,
since
most
of
the
pesticide
should
move
into
the
soil,
and
any
remaining
foliar
residues
should
dissipate
within
a
month.
While
residues
in
soil
could
persist
for
greater
than
30
days,
it
is
unlikely
that
children
will
play
on
or
contact
soil
for
greater
than
30
consecutive
days
during
the
late
Fall
or
late
Winter
months.

MRID
44952501
(Determination
of
Turf
Transferrable
Residue
on
Turf
Treated
with
Kerb®
50W
Herbicide):
Turf
transferable
residues
(TTR)
were
monitored
using
the
Modified
California
Roller
sampling
methodology
for
the
typical
end­
use
product
(EPA
Reg.
No.
707­
159),
a
wettable
powder
formulation
containing
50
%
active
ingredient
(ai).
The
product
was
applied
at
one
geographically
representative
site
in
North
Carolina
(NC)
with
three
replicated
subplots.
A
single
application
by
ground
sprayer
was
applied
prior
to
monitoring.
The
product
was
applied
once
at
the
label
specified
maximum
application
rate
of
1.5
lb
ai
per
acre
(lb
a.
i./
A).
The
application
was
made
on
September
23,
1998,
which
agrees
with
the
label
specified
application
time
period
of
Fall
or
late
Winter.
Also,
the
treated
plot
was
irrigated
24
hours
after
the
application
(DAT
1;
but
after
samples
were
taken)
with
0.9
inches
of
water
to
move
the
ai
into
the
root
zone.
The
product
label
specifies
that
if
a
rain
event
does
not
occur
within
one
day
after
application,
that
the
site
should
be
lightly
irrigated.
Rain
occurred
prior
to
the
application
of
the
pronamide
and
then
again
on
DAT
7
(0.25
inches)
and
DAT
11
(0.23
inches).
Control
samples
were
taken
prior
to
application
for
background
analyses
and
for
fortification
purposes.
After
application
triplicate
samples
were
collected
at
day
zero
(0)
as
soon
as
the
spray
dried;
at
21
6,
12
and
24
hours
(0.25,
0.5
and
1)
and
2,
4,
7,
10
and
14
days
after
application
treatment
(DAT)
of
the
test
substance.
Samples
were
stored
in
a
freezer
for
15
to
37
days
prior
to
analysis.
Six
replicate
field
fortification
samples
at
each
of
two
levels
(50
and
10,000
µg)
were
prepared
at
sampling
times
DAT
0
and
DAT
14.
Fortification
samples
were
handled
and
stored
the
same
as
treated
samples.

The
results
of
the
TTR
data
(mean
and
coefficient
of
variation)
are
presented
in
Table
4.
Observed
residue
values
exhibited
a
wide
range
of
variability
(i.
e.
6
to137%).
Field
fortification
recoveries
averaged
85.8%
(standard
deviation
6.9%),
indicating
that
pronamide
was
relatively
stable
in
the
sampling
media
during
the
handling
and
storage
periods.
Versar
corrected
these
TTR
data
to
the
nearest
fortification
recovery.

These
data
had
only
minor
deficiencies;
such
as
a
limited
number
of
controls,
a
relatively
high
variance,
and
only
one
site
was
tested;
although
three
sites
are
required
in
the
guidelines.
Since
bermudagrass
is
a
regionally
selective
use
site,
the
employment
of
only
one
test
site
is
acceptable.
The
dissipation
rate
derived
from
these
data
was
relatively
rapid
with
an
estimated
pronamide
half­
life
of
1.8
days
in
turf.
Also,
the
data
show
that
the
average
pronamide
residues
found
immediately
after
application
(DAT
0)
was
approximately
one
percent
of
the
target
application.
The
maximum
average
pronamide
residue
found
shortly
after
application
(DAT
0.5)
was
approximately
2.6%
of
the
applied
pronamide
(i.
e.
the
transfer
efficiency),
and
the
overall
average
residue
observed
on
day
zero
after
application
(i.
e.
DAT
0,
DAT
0.25
&
DAT
0.5)
was
approximately
1.65%
of
the
applied
pronamide.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(percent
of
application
rate)
of
5%.
These
TTR
data
were
found
to
be
acceptable
for
use
quantitatively
in
the
postapplication
exposure
assessment.
The
HED
used
the
mean
observed
residue
data
from
DAT
0
through
DAT
0.5
from
this
study
to
estimate
short­
term
non­
occupational
exposures,
since
the
percent
transferred
was
greater
than
one
percent.
However,
the
predicted
TTR
data
are
most
suitable
for
longer
term
exposures.

The
HED
always
completes
short­
term
risk
assessments
using
maximum
application
rates
for
each
scenario,
because
what
is
possible
under
the
label
(the
legal
means
of
controlling
pesticide
use)
must
be
evaluated
for
complete
stewardship
in
order
to
ensure
the
HED
has
no
concern
for
the
specific
use.

As
a
result
of
home
lawn
uses,
the
HED
has
concerns
for
potential
postapplication
exposures
to
both
adults
and
children.
Anticipated
routes
of
postapplication
exposure
include
dermal
exposure
to
adults
and
children
(toddlers),
and
incidental
oral
exposure
to
children
(toddlers).
Postapplication
exposures
via
the
inhalation
route
are
not
anticipated,
since
pronamide
is
applied
as
a
liquid,
and
is
a
mobile
systemic
herbicide,
which
when
watered
in
(as
directed
on
the
label)
quickly
moves
into
soil,
where
it
is
rapidly
absorbed
into
vegetation.
Additionally,
the
uses
and
primary
exposures
are
outdoors,
allowing
for
significant
dilution.
Also,
the
vapor
pressure
of
pronamide
is
8.5E­
5
mm
Hg
at
25
0
C.

In
order
to
adequately
consider
the
risks
to
children,
the
guidance
from
the
HED's
updated
Residential
SOPs
(2/
01)
was
used
to
address
the
exposures
of
children
contacting
recently
22
treated
turf.
The
SOPs
for
turf
use
a
high
contact
activity
based
on
the
use
of
Jazzercise®
to
represent
the
exposures
of
an
actively
playing
child
or
active
adult.
Lower­
contact
activities,
such
as
walking,
mowing,
or
golfing,
for
example,
use
transfer
coefficients
based
on
mowing
and
golfing
studies.

The
HED
believes
that
pronamide
exposures
can
occur
over
a
single
day
or
up
to
a
few
weeks
at
a
time.
This
is
supported
by
the
length
of
time
that
residues
took
to
decline
in
the
pronamide
turf
TTR
study.
The
HED
classifies
these
as
short­
term
exposures
(one
day
to
one
month).
No
intermediate­
term
(one
to
six
months)
or
long­
term
(six
months
or
more)
residential
exposures
are
anticipated
with
the
use
of
pronamide,
due
to
the
product's
use
pattern,
and
since
turf
residues
dissipate
rapidly
to
below
the
limit
of
quantification
by
day
14
following
application
(pronamide
TTR
study),
and
the
short­,
intermediate­,
and
long­
term
endpoints
are
the
same.
These
classifications
are
the
basis
for
selecting
toxicological
endpoints
for
chemicals
and
are
generally
included
in
each
risk
assessment.
Route­
specific
(i.
e.,
dermal
and
incidental
oral)
pronamide
exposures
were
combined
where
appropriate
(i.
e.
small
children).

Restricted
entry
intervals
are
not
considered
a
practical
regulatory
tool
for
reducing
exposures
and
risks
in
the
residential
environment
(i.
e.,
for
the
general
population).
Although
LCOs
may
inform
residents
to
stay
off
treated
turf,
or
signs
may
be
posted,
there
is
no
practical
way
to
restrict
access
by
humans
or
pets.
Therefore,
for
chemicals
used
in
the
residential
environment
or
any
other
areas
where
the
general
population
can
be
exposed,
the
HED
currently
considers
the
risks
associated
with
a
chemical
on
the
day
they
are
applied.

Exposure
Scenarios
and
Assumptions:

The
activities
that
were
selected
as
the
basis
for
the
risk
assessment
are
represented
by
the
following
assumptions
and
transfer
coefficients
for
short­
term
endpoints:

°
Adults
involved
in
a
low
exposure
activity
on
turf
such
as
golfing
(4
hours
a
day),
mowing
(2
hours
per
day),
or
other
light
work
activities
(2
hours
per
day),
with
a
transfer
coefficient
=
500
cm
2
/hour;
°
Adults
involved
in
a
high
exposure
activity
on
turf
such
as
heavy
yard
work,
gardening
or
laying
sod
for
2
hours
per
day,
with
a
transfer
coefficient
=
14,500
cm
2
/hour;
°
Small
children
involved
in
a
high
exposure
activity
for
2
hours
per
day,
with
a
transfer
coefficient
=
5,200
cm
2
/hour
(based
on
the
recommended
revisions
to
the
SOPs
for
residential
exposure
assessments
(2/
2001));

Small
children's
exposure
levels
were
calculated
for
the
residential
exposure
assessment
and
for
the
purposes
of
completing
an
aggregate
risk
assessment
that
also
considers
exposure
from
dietary
intake
of
food
and
water
(for
all
age
groups).

Dermal
exposure
values
for
adults
and
children
on
the
day
of
treatment
were
calculated
based
on
the
following
equation
(see
Residential
SOP
2.2:
Postapplication
dermal
potential
dose
from
pesticide
residues
on
turf):
23
DE(
t)
(mg/
day)
=
(TTR(
t)
(µg/
cm
2
)
x
TC
(cm
2
/hr)
x
Hr/
Day)/
1000
(µg/
mg)

Where:

DE
=
Dermal
exposure
at
time
(t)
attributable
for
activity
in
a
previously
treated
area
(mg/
day);
TTR
=
Turf
Transferable
Residue
(TTR)
data
(from
MRID
#
44952501,
i.
e.
mean
observed
residue
value
of
0.289
µg/
cm
2
from
day
zero
after
application
(DAT
0)
through
DAT
0.5);
TC
=
Transfer
Coefficient
(cm
2
/hr);
and
Hr
=
Exposure
duration
in
hours.

The
HED's
Residential
SOP
contains
guidance
for
considering
children's
exposure
to
treated
turf.
The
dermal
calculations,
as
noted
above,
were
completed
based
on
the
guidance
provided
in
the
document.
All
nondietary
exposures
were
also
calculated
using
guidance
from
this
document.
Specifically,
the
kinds
of
nondietary
ingestion
exposures
that
were
considered
in
this
assessment
include
the
following:

°
Dose
from
hand­
to­
mouth
activity
calculated
using
SOP
2.3.2:
Postapplication
dose
among
small
children
from
incidental
nondietary
ingestion
of
pesticide
residues
on
residential
lawns
from
hand­
to­
mouth
transfer;
°
Dose
from
mouthing
treated
turf
calculated
using
SOP
2.3.3:
Postapplication
dose
among
small
children
from
the
ingestion
of
pesticide
treated
turfgrass;
and
°
Dose
from
incidental
ingestion
of
soil
calculated
using
SOP
2.3.4:
Postapplication
dose
among
small
children
from
the
ingestion
of
soil
in
pesticide
treated
areas.

Hand­
to­
Mouth
Transfer
(Mouthing)
The
following
demonstrates
the
method
used
to
calculate
exposures
that
are
attributable
to
a
child
touching
treated
turf
and
then
putting
their
hands
in
their
mouth
(SOP
2.3.2):

PDR
=
(AR
*
F­
DR
*
CF
*
SA
*
EXT
*
Freq
*
Hr
*
(1
mg/
1000
µg)

where:
PDR
=
potential
dose
rate
(mg/
day)
AR
=
application
rate
(lb
ai/
A)
F­
DR
=
fraction
of
dislodgeable
residue
from
turf
for
hand­
to­
mouth
behavior
with
wet
hands
(5%)
CF
=
conversion
factor
to
convert
lb
ai/
A
to
µg/
cm
2
(11.2)
SA
=
surface
area
of
1
to
3
fingers
(20
cm
2
);
EXT
=
extraction
rate
by
saliva
(50%)
Freq
=
frequency
of
hand­
to­
mouth
events
(20
events/
hour);
and
Hr
=
exposure
duration
(2
hours)
24
The
surface
area
for
1­
3
fingers
used
(20
cm
2
)
is
the
median
surface
area
for
a
small
child
(age
3
years)
as
updated
in
12/
99.
The
frequency
of
hand­
to­
mouth
events
is
20
events
per
hour
as
updated
in
12/
99.
The
fraction
of
residue
dislodgeable
from
wet
hands
is
five
percent
and
the
extraction
rate
by
saliva
is
fifty
percent
as
updated
in
12/
99.
The
time
spent
outdoors
(2
hours/
day)
is
also
a
recommended
value
from
the
U.
S.
EPA
Exposure
Factors
Handbook.
This
model
for
hand­
to­
mouth
dose
is
based
on
the
premise
that
a
child
puts
2­
3
fingers
in
their
mouth,
five
percent
of
the
residues
on
the
hands
are
transferred
from
the
hands
to
the
mouth,
fifty
percent
of
the
residues
is
extracted
by
saliva
and
that
all
of
the
residues
available
on
the
treated
turf
transfer
to
the
child's
hand
each
time
they
exhibit
this
behavior.

Object­
to­
Mouth
The
following
illustrates
the
approach
used
to
calculate
exposures
that
are
attributable
to
a
child
mouthing
treated
turf
(SOP
2.3.3):

PDR
=
(AR
*
F­
DR
*
CF
*
IgR
*
(1
mg/
1000µg)

where:
PDR
=
potential
dose
rate
(mg/
day);
AR
=
application
rate
F­
DR
=
fraction
of
residue
dislodgeable
from
turf
(20%)
CF
=
conversion
factor
to
convert
lb
ai/
A
to
µg/
cm
2
(11.2)
IgR
=
ingestion
rate
for
mouthing
of
grass
per
day
(25
cm
2
/day)

The
ingestion
rate
used
(25
cm
2
/day)
assumes
that
a
child
will
grab
a
handful
of
turf,
mouth
it
and
remove
twenty
percent
pronamide
residues,
and
then
remove
it
from
their
mouth
as
described
in
the
Residential
SOPs.
The
surface
area
of
25
cm
2
/day
is
thought
to
approximate
a
handful
of
turf
that
is
mouthed.

Incidental
Soil
Ingestion
The
following
is
the
formula
used
to
estimate
exposure
from
incidental
ingestion
of
soil
treated
with
pronamide
(SOP
2.3.4):

PDR
=
(AR
*
(1­
D)
t
*
IgR
*
CF1
*
CF2
*
CF3
*
CF4)

where:
PDR
=
potential
dose
rate
(mg/
kg/
day)
AR
=
application
rate
(lb
ai/
A)
(1­
D)
=
fraction
or
residue
retained
on
uppermost
1
cm
of
soil,
assumed
to
be
100
percent
based
on
soil
incorporation
into
top
1
cm
of
soil
after
application
(1.0/
cm)
t
=
postapplication
day
on
which
exposure
is
being
assessed,
assumed
to
be
day
0
IgR
=
ingestion
rate
of
soil
(100
mg/
day)
CF1
=
weight
unit
conversion
factor
to
convert
the
lbs
ai
in
the
25
application
rate
to
µg
for
the
soil
residue
value
(4.54
x
10
8
µg/
lb)
CF2
=
area
unit
conversion
factor
to
convert
the
surface
area
units
(ft
2
)
in
the
application
rate
to
cm
2
for
the
SR
value
(2.47
x
10
­8
acre/
cm
2
if
the
application
rate
is
per
acre)
CF3
=
volume
to
weight
unit
conversion
factor
to
convert
the
volume
units
(cm
3
)
to
weight
units
for
the
SR
value
(0.67
cm
3
/g
soil)
7
CF4
=
weight
unit
conversion
factor
to
convert
the
µg
of
residues
on
the
soil
to
grams
to
provide
units
of
mg/
day
(1E­
6
g/
µg)

The
estimated
exposure
from
ingestion
of
soil
from
an
area
treated
with
pesticide
is
a
minor
contributor
to
the
total
incidental
oral
dose.

The
following
specific
assumptions
and
factors
were
used
to
complete
the
exposure
assessment:

°
These
assessments
were
based
on
the
guidance
provided
in
the
Residential
SOPs
and
the
Recommended
Revisions
to
the
SOPs
for
Residential
Exposure
Assessments
(2/
22/
01).
°
To
assess
short­
term
dermal
exposures,
the
TTR
value
(0.289
µg/
cm
2
)
was
used
for
turf
on
the
day
of
application
(DAT
0
through
DAT
0.5)
from
the
turf
transferrable
residue
study
(MRID
44952501);
°
Calculations
for
short­
term
exposures
are
based
on
the
maximum
application
rate
(1.5
lb
ai/
acre)
for
residential
turf;
°
Due
to
a
lack
of
scenario­
specific
exposure
data,
HED
has
calculated
exposure
values
for
adults
using
surrogate
dermal
transfer
coefficients
that
represent
activities
such
as
mowing,
golfing,
and
yardwork.

2.3.2
Postapplication
Exposure
and
Non­
Cancer
Risk
Estimates
The
results
of
the
residential
post­
application
exposure
and
risk
estimates
are
presented
in
Tables
5­
7
in
Appendix
A.
The
dermal
non­
cancer
risk
estimates
for
adults
and
children
exposed
to
pronamide
while
doing
activities
on
turf
are
shown
in
Table
5.
The
dermal
cancer
risk
estimates
for
adults
exposed
to
pronamide
while
doing
activities
on
turf
are
shown
in
Table
6.
The
oral
nondietary
non­
cancer
risk
estimates
for
small
children
from
hand­
to­
mouth
and
ingestion
exposure
while
playing
on
pronamide­
treated
turf
are
contained
in
Table
7.
For
pronamide
short­
term
non­
occupational
risks,
the
HED
has
established
a
level
of
concern
for
MOEs
<
300.

Risk
estimates
for
short­
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
on
day
zero
following
application
(DAT
0)
exceed
HED's
estimated
level
of
concern,
using
residue
data
from
the
TTR
study,
i.
e.
result
in
MOEs
<
300
for
adults
(MOE
=
71)
and
children
(MOE
=
42).
However,
using
DAT
2
residue
data
from
the
TTR
study
yielded
MOEs
that
do
not
exceed
the
level
of
concern
(MOEs
$
300)
for
adults
(MOE
=
890)
and
children
(MOE
=
530)
during
high
contact
lawn
activities.
Note
that
the
test
plots
were
irrigated
immediately
after
the
DAT
1
samples
were
taken,
i.
e.
24
hours
after
application
of
pronamide,
as
specified
on
the
label.
The
data
show
that
watering­
in
the
pronamide
product
clearly
alleviates
these
risk
26
concerns.
Risk
estimates
for
adults
for
short­
term
dermal
contact
with
residues
on
treated
turf
during
the
low
contact
activities
of
grass
mowing
(MOE
=
2100)
or
golfing
(MOE
=
1000)
on
the
day
of
treatment
do
not
exceed
the
level
of
concern
(MOEs
$
300);
see
Table
5.

HED
also
assessed
short­
term
risks
to
small
children
from
incidental
oral
ingestion
of
pronamide
residues
following
application
to
residential
lawns
(see
Table
7).
The
level
of
concern
for
residential
risks
is
set
by
the
HED
at
a
MOE
<
300.
The
risk
calculations
for
small
children's
non­
dietary
ingestion
of
pronamide
on
treated
turf
indicate
that
risks
do
not
exceed
the
level
of
concern
(i.
e.
MOEs
$
300)
for
hand­
to­
mouth
finger
licking
(MOE
=
380),
incidental
ingestion
of
soil
(MOE
=
113,000),
and
incidental
object
to
mouth
(MOE
=
1500).
The
small
children's
combined
oral
hand­
to­
mouth
scenarios
(MOE
=
300)
also
do
not
exceed
the
level
of
concern.
When
risks
from
dermal
exposures
from
pronamide
to
small
children
are
combined
with
risks
from
incidental
oral
exposures,
the
combined
short­
term
risk
estimates
exceed
the
level
of
concern
(MOEs
<
300),
with
an
MOE
at
37.
However,
the
likelihood
of
all
incidental
oral
exposures
co­
occurring
with
dermal
exposures
is
low.

2.3.3
Postapplication
Cancer
Risk
Estimates
The
HED
endeavors
to
reduce
estimated
cancer
risks
for
the
general
population
to
less
than
one
in
one
million
(10
­6
).
Estimated
adult
cancer
risks
were
calculated
using
the
same
residential
exposure
scenarios
as
described
in
section
2.3.1.

The
lifetime
average
daily
dose
(LADD)
must
be
calculated
by
first
determining
the
dermal
exposure
(DE)
from
foliar
contact
(see
formula
above
in
Section
2.3.1);
i.
e.
DE(
t)
(mg/
day)
=
(TTR(
t)
(µg/
cm
2
)
x
TC
(cm
2
/hr)
x
hr/
day)/
1000
(µg/
mg).
Then,
the
dermal
exposure
is
converted
to
absorbed
daily
dose
multiplied
by
the
frequency
of
exposure
in
days
per
year,
as
follows:

LADD
(mg/
kg/
day)
=
DE/
70
kg
(mg/
kg/
day)
x
absorption
factor
(100%)
x
(exposure
frequency/
365
days
per
year)
x
(50
years
residential
duration/
70
year
lifetime)

and
the
cancer
risk
=
LADD
(mg/
kg/
day)
x
Q1
*
(mg/
kg/
day)
­1
Based
on
the
pesticide
label,
a
typical
residential/
recreational
lawn
application
rate
of
1.0
lb/
acre,
with
an
application
frequency
of
once
per
year,
was
assumed
for
the
residential
cancer
risk
assessment.
Pronamide
is
applied
in
the
dormant
season,
which
reduces
the
number
of
contact
days
expected.
A
single
exposure
is
deemed
more
likely,
but
up
to
14
days
exposure
could
occur
based
on
the
residue
dissipation
pattern.
The
14­
day
average
turf
residues
from
the
TTR
study
(MRID
44952501)
were
used
(i.
e.
0.07913
F
g/
cm
2
,
when
adjusted
to
a
typical
application
rate
of
1.0
lb
ai/
acre);
since
residues
in
the
TTR
study
dissipated
to
the
level
of
quantitation
by
14
days
after
application.
The
average
residue,
and
an
exposure
frequency
of
one
day
per
year,
or
50
days
in
a
lifetime,
was
assumed
for
high
contact
activities
(e.
g.
playing
and
working
on
lawns
and
turf)
and
low
contact
activities
(e.
g.
mowing
or
golfing).
An
adult
mowing
a
treated
lawn
one
day
each
year
has
a
cancer
risk
of
5.7
x
10
­8
.
The
average
golfer
plays
18
times
per
year,
so
one
day's
exposure
is
possible
if
pronamide
is
applied
once
per
year
27
on
average.
These
assumptions
are
not
meant
to
imply
that
exposures
will
occur
for
only
one
day.
The
adult
golfer
cancer
risk
is
estimated
at
1.2
x
10
­7
.
An
adult
performing
dermal
high
contact
activities
on
turf
during
the
2
week
period
of
residue
dissipation
has
a
cancer
risk
of
8.4
x
10
­7
.
The
HED
endeavors
to
reduce
estimated
cancer
risks
for
the
general
population
to
less
than
one
in
one
million
(10
­6
).
In
order
to
exceed
the
cancer
risk
(1.0
x
10
­6
),
exposure
frequencies
of
17.5,
8.7
and
1.2
days
per
year
would
be
needed
for
the
activities
of
mowing,
golfing
and
high
contact
work,
respectively.

2.3.4
Summary
of
Postapplication
Risks,
Data
Gaps,
and
Confidence
in
Exposure
and
Risk
Estimates
Residential
exposures
are
anticipated
as
a
result
of
professional
lawn
care
operator
application.
Risk
estimates
were
performed
for
potential
contact
with
lawn
or
soil
treated
with
pronamide,
using
data
from
a
turf
transferable
residue
study
submitted
for
pronamide,
and
using
HED's
Draft
SOPs
for
Residential
Exposure
Assessment.
These
estimates
are
considered
conservative,
but
appropriate,
since
the
study
data
and
risk
estimates
were
generated
at
the
maximum
application
rate.

The
Residential
SOPs
are
considered
to
be
upper
bound
scenarios
for
determining
risk
estimates.
The
adult
and
children's
transfer
coefficients
are
based
on
the
Jazzercise
protocol
and
an
upper
percentile
exposure
duration
value.
Where
study
data
were
used
with
the
SOP
formulae,
these
risk
estimates
were
better
refined,
and
hence,
less
conservative.
Therefore,
the
exposure
estimates
related
to
turf
skin
contact
(which
were
based
on
study
data)
are
more
refined
than
the
estimates
of
incidental
ingestion.

For
postapplication
residential
exposures,
the
scenarios
with
short­
term
risk
estimates
that
exceed
HED's
level
of
concern
(MOEs
<
300)
are
the
high
contact
dermal
exposure
activities
(adults
&
toddlers)
of
working
or
playing
on
lawns.
The
scenarios
with
risks
estimates
that
do
not
exceed
HED's
level
of
concern
(MOEs
$
300)
are
as
follows:
1)
the
low
contact
dermal
exposure
activities
of
mowing
lawns
(adults)
and
golfing
(adults)
on
treated
turf;
and
2)
the
incidental
oral
exposure
activities
by
toddlers
of
ingesting
soil,
hand­
to­
mouth
(finger
licking),
and
object
to
mouth
(turfgrass
mouthing)
while
playing
on
lawns.

Combining
risk
estimates
for
exposure
scenarios
that
are
likely
to
occur
together
resulted
in
risk
estimates
of
greater
concern.
For
example,
it
is
possible
that
the
same
child
could
receive
dermal
exposures
from
performing
high
contact
activities
on
a
lawn,
while
at
the
same
time
receive
incidental
oral
exposures
from
hand­
to­
mouth,
object­
to­
mouth
and/
or
soil
ingestion.
Combining
the
postapplication
turf
short­
term
risk
estimates
for
the
incidental
oral
nondietary
exposures
to
small
children
resulted
in
a
risk
estimate
(MOE
=
302)
that
does
not
exceed
HED's
level
of
concern
(MOE
<
300).
However,
combining
the
postapplication
turf
dermal
and
incidental
oral
risk
estimates
for
small
children
resulted
in
an
MOE
(MOE
=
37)
that
exceeds
HED's
level
of
concern
(MOEs
<
300);
primarily
due
to
the
dermal
exposure.
However,
the
likelihood
of
all
incidental
oral
exposures
co­
occurring
with
dermal
exposures
is
low.
28
2.4
RESIDENTIAL
AND
NON­
OCCUPATIONAL
RISK
CHARACTERIZATION
2.4.1
Residential
Handler
Risk
Characterization
All
pronamide
end
use
products
are
labeled
as
restricted
use
pesticides.
Therefore,
residents
are
restricted
from
handling
pronamide
products.

2.4.2
Non­
Occupational
Postapplication
Risk
Characterization
The
short­
term
residential
exposures
to
treated
lawns
were
based
upon
exposure
to
transferable
residues
at
the
earliest
possible
opportunity
(i.
e.
residues
at
day
zero
after
application),
the
maximum
application
rate,
and
a
100%
dermal
absorption.
While
these
are
high­
end
scenarios,
they
are
not
worst­
case,
because
the
time
of
exposure
is
short
(i.
e.
2
to
4
hours)
and
risk
estimates
are
based
on
behavioral
data,
actual
field
residue
data
supplied
by
the
registrant,
and
are
generated
using
HED
SOPs.
The
translation
of
a
dose
based
on
a
chronic
effect
for
the
purpose
of
short­
term
risk
estimation
also
contributes
to
a
high­
end
exposure
estimate.

Mitigating
circumstances
for
residential
exposure
to
pronamide
residues
may
include
the
watering­
in
of
the
product
to
turf
immediately
after
application,
instead
of
within
24
hours
after
application,
as
the
label
currently
recommends.
Pronamide
product
was
watered­
in
for
the
TTR
study
(MRID
44952501).
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering­
in.
HED
recommends
that
the
residential
turf
label
(EPA
Reg.
No.
8660­
85)
be
changed
to
specify
only
one
application
per
year,
and
require
the
product
to
be
watered
into
turf
immediately
after
application.
29
References
1.
Blondell,
J.
Review
of
Pronamide
Incident
Reports,
DP
Barcode
D276935.
EPA.
August
10,
2001.
2.
Hazard
Identification
Assessment
Review
Committee
(HIARC)
Meeting
on
Pronamide.
November
1,
2001.
3.
Recommended
Revisions
to
the
Standard
Operating
Procedures
(SOPs)
for
Residential
Exposure
Assessments.
EPA,
HED
Exposure
SAC,
February
22,
2001.
4.
Outdoor
Residential
Exposure
Task
Force.
Response
to
the
Outdoor
Residential
Exposure
Data
Call
in
Dated:
March
3,
1995.
ORETF.
November
12,
1999.
5.
Draft
SOPs
for
Residential
Exposure
Assessments.
EPA.
December
18,
1997.
6.
[Draft]
OPPTS
Series
875­
Occupational
and
Residential
Test
Guidelines:
Group
BPostapplication
Exposure
Monitoring
Test
Guidelines.
EPA.
February
1998
version.
7.
Martin,
D.;
Determination
of
Transferrable
Turf
Residues
on
Turf
Treated
with
Pronamide
(Kerb®
50W
Herbicide).
Rohm
and
Haas
Company;
06/
30/
99;
EPA
MRID
44952501.
30
Appendix
Pronamide
Exposure
and
Risk
Estimates
Tables
4
through
7
31
Table
4.
Summary
of
Postapplication
Turf
Transferable
Residue
Study
MRID
44952501
TTR
on
Turf
Treated
with
Pronamide
(50%
Wettable
Powder
in
Water
Soluble
Pouches)
Study
Application
Rate:
1.5
lb
ai/
acre
Slope
=
­0.387;
Intercept
=
­1.86;
R
2
=
0.79
DAT
(days)
Mean
Observed
TTR
(µg/
cm
2
)
(CV)
Predicted
TTR
(µg/
cm
2
)

0
0.161
(10.8)
0.155
0.25
0.252
(8.3)
­­


0.5
0.453
(18.0)
­­


Average
of
DAT
0­
0.5
0.289
­­


1
0.154
(7.24)
0.105
2
0.023
(48.0)
0.072
4
0.016
(12.8)
0.033
7
0.004
(6.2)
0.010
10
0.002
(38.2)
0.003
14
0.003
(137)
0.0007
Average
of
DAT
0­
14
0.1187
0.032
32
Table
5.
Pronamide
Residential
Postapplication
Activities
on
Treated
Turf:
Dermal
Exposure
and
Non­
Cancer
Risk
Estimates
Short­
term
Risk
Estimates
at
DAT
0
using
TTR
Data
from
Turf
Study
Short­
term
Risk
Estimates
at
DAT
2
using
TTR
Data
from
Turf
Study
Activity
Transfer
Coefficient
(cm
2
/hr)
(a)
TTR
µg/
cm
2
DAT
0
(b)
Dermal
Dose
(mg/
kg/
day)
(c)
MOE
(d)
TTR
µg/
cm
2
DAT
2
(b)
Dermal
Dose
(mg/
kg/
day)
(c)
MOE
(d)

high
contact
lawn
activities:
adults
14,500
0.2886
0.1196
71
0.023
0.00953
890
high
contact
lawn
activities:
toddler
5,200
0.2886
0.2001
42
0.023
0.0159
530
mowing
turf:
adults
500
0.2886
0.00413
2100
0.023
0.000329
26,000
golf
course
reentry:
adult
500
0.2886
0.00825
1000
0.023
0.000657
13,000
a
Transfer
coefficients
from
the
Residential
SOP's
(02/
01).

b
TTR
Source:
MRID
#
44952501
turf
transferable
residue
study
­
see
Table
4
for
raw
data
and
regression
statistics.
Mean
observed
residue
values
from
DAT
0
through
DAT
0.5
were
used
for
the
DAT
0
short­
term
assessments.
Mean
observed
residue
values
from
DAT
2
were
used
for
the
DAT
2
short­
term
assessments.

c
Dermal
Dose
=
TTR
(µg/
cm
2
)
x
TC
(cm
2
/hr)
x
conversion
factor
(1
mg/
1,000
µg)
x
exposure
time
(2
hrs/
day
playing
&
mowing;
4
hrs
golfing)
x
Dermal
Absorption
Factor
(100%/
100)/
body
weight
(70
kg
adult
or
15
kg
child
1­
6
yrs).
Short­
term
MOEs
were
calculated
using
DAT
0
or
DAT
2
values.

d
MOE
=
NOAEL
(8.
46
mg/
kg/
day;
based
on
an
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
300
or
greater;
numbers
are
rounded
to
two
significant
figures.

Note:
TTR
=
turf
transferable
residue
DAT
=
days
after
treatment
MOEs
in
bold
exceed
HEDs
level
of
concern
(i.
e.
MOEs
<
300).
33
Table
6.
Pronamide
Postapplication
Dermal
Cancer
Risk
Estimates
for
Activities
on
Treated
Turf
Activity
Typical
Application
Rate
(lb
ai/
acre)
(a)
Days
of
Exposure
per
Year
(b)
14­
day
avg
TTR,

adjusted
for
"typical"
rate
(µg/
cm
2
)
(c)
Transfer
Coefficient
(cm2/
hr)
(d)
Absorbed
Dermal
Daily
Dose
(mg/
kg/
day)
(e)
LADD
(mg/
kg/
day)
(f)
Cancer
Risk
(g)
Days
of
Exposure
per
Year
to
Exceed
1.0E­
06
High­
contact
activities
1.0
1
0.07913
7300
1.65E­
02
3.23E­
05
8.36E­
07
1.2
Mowing
1.0
1
0.07913
500
1.13E­
03
2.21E­
06
5.73E­
08
17.5
Golfing
1.0
1
0.07913
500
2.26E­
03
4.42E­
06
1.15E­
07
8.7
a
Typical
(not
maximum)
application
rates
were
used
to
adjust
TTR
study
residue
data;
rate
confirmed
per
label
and
registrants'
comments.

b
Average
or
typical
days
per
year
for
cancer
risk
estimates,
based
upon
a
single
annual
application
and
a
fairly
rapid
foliar
dissipation
rate
(half
life
of
1.8
days,
from
TTR
study,
i.
e.
MRID
#
44952501).

c
TTR
source:
MRID
#
44952501
turf
transferable
residue
study
­
see
Table
4
for
raw
data
and
regression
statistics.
Mean
observed
residue
values
for
DAT
0
through
DAT
14
were
used
for
the
assessment.
The
study
was
conducted
in
NC
using
a
maximum
application
rate
of
1.5
lb
ai/
acre.
When
assessing
activities
involving
a
different
application
rate
than
what
was
used
in
the
study,
the
TTR
values
are
adjusted
proportionately
to
reflect
the
different
application
rate.
For
example,
for
the
"typical"
application
rate
of
1.0
lb
ai/
acre
:
normalized
(adjusted)
TTR
=
Turf
study
TTR
x
1.0
lb
ai/
A
assessed
rate
/
1.5
lb
ai/
A
study
rate;
0.1187
µg/
cm
2
x
1.0
lb
ai/
A
assessed
rate
/
1.5
lb
ai/
A
study
rate
=
0.07913
µg/
cm
2
.

d
Transfer
coefficient
from
the
updated
Residential
SOP's
(02/
01).

e
Absorbed
daily
dose
=
Average
day
0­
14
TTR
(µg/
cm
2
)
x
intermediate­
term
transfer
coefficient
(cm
2
/hr)
x
mg/
1,000
µg
x
exposure
duration
(2
hrs/
day
for
playing/
gardening/
mowing;
4
hrs/
day
to
play
golf)
x
dermal
absorption
factor
(100%)
/
body
weight
(70
kg
adult).

f
LADD
=
absorbed
daily
dose
(mg/
kg/
day)
x
days
of
exposure/
year
x
50
years
of
expected
exposure/
(365
days/
year
x
70
year
lifetime);

g
Cancer
Risk
=
LADD
x
Q
1
*
,
where
Q
1
*
=
2.59
x
10
­2
(mg/
kg/
day)
­1
TTR
used
for
cancer
risk
estimate
=
0­
14
DAT
average
residue
normalized
for
typical
application
rate.

TTR
=
turf
transferable
residue
DAT
=
days
after
treatment
34
Table
7.
Residential
Oral
Nondietary
Short­
Term
Postapplication
Risks
to
Children
from
"Hand­
to­
Mouth"
and
Ingestion
Exposure
When
Reentering
Treated
Lawns
Type
of
Exposure
Short­
term
Oral
Dose
a
(mg/
kg/
day)
Short­
term
MOE
b
(1)
Hand
to
Mouth
Activity
(Finger
licking)
0.0224
380
(2)
Incidental
Object
to
Mouth
(Turfgrass
Mouthing)
0.0056
1500
(3)
Incidental
Ingestion
of
Soil
7.51E­
5
113,000
Combined
Oral
Nondietary
c
0.028
300
Combined
Oral
and
Dermal
d
­­­
37
a
Application
rate
for
the
short­
term
estimates
represents
maximum
label
rate
from
current
EPA
registered
label:
EPA
Reg.
No.
8660­
85
wettable
powder
product
formulation,
max
rate
is
1.5
lb
ai/
acre.
Incidental
oral
doses
were
calculated
using
formulas
presented
in
the
Residential
SOPs
(updated
1999­
2000).
Short­­
term
doses
were
calculated
using
the
following
formulas:
(1)
Hand­
to­
mouth
oral
dose
to
children
on
the
day
of
treatment
(mg/
kg/
day)
=
[application
rate
(lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(5%)
x
11.2
(conversion
factor
to
convert
lb
ai/
acre
to
µg/
cm
2
)]
x
median
surface
area
for
1­
3
fingers
(20
cm
2
/event)
x
hand­
to­
mouth
rate
(20
events/
hour)
x
exposure
time
(2
hr/
day)
x
0.001
mg/
:
g]
x
50%
extraction
by
saliva
/
bw
(15
kg
child
1­
6
yrs).
This
formula
is
based
on
proposed
changes
to
the
December
1999
Residential
SOPs.
(2)
Turf
mouthing
oral
dose
to
child
on
the
day
of
treatment
(mg/
kg/
day)
=
[application
rate
(lb
ai/
acre)
x
fraction
of
residue
dislodgeable
for
transfer
to
mouth
(20%)
x
11.2
(conversion
factor
to
convert
lb
ai/
acre
to
µg/
cm
2
)
x
ingestion
rate
of
grass
(25
cm
2
/day)
x
0.001
mg/
:
g]
/
bw
(15
kg
child
1­
6
yrs).
(3)
Soil
ingestion
oral
dose
to
child
on
the
day
of
treatment
(mg/
kg/
day)
=
[(
application
rate
(lb
ai/
acre)
x
fraction
of
residue
retained
on
uppermost
1
cm
of
soil
(100%
or
1.0/
cm)
x
4.54e+
08
µg/
lb
conversion
factor
x
2.47e­
08
acre/
cm
2
conversion
factor
x
0.67
cm
3
/g
soil
conversion
factor)
x
100
mg/
day
ingestion
rate
x
1.0e­
06
g/
µg
conversion
factor]
/
bw
(15
kg;
child
1­
6
yrs).
Short
term
dose
based
residue
on
the
soil
on
day
of
application.
b
Short­
term
MOE
=
NOAEL
(8.46
mg/
kg/
day)
/
Oral
Dose
(mg/
kg/
day).
NOAEL
from
a
non­
developmental
toxicity
study
in
rabbits;
target
MOE
of
100.
Numbers
are
rounded
to
two
significant
figures.
c
Combined
MOEs
=
NOAEL
/
[sum
of
incidental
oral
doses],
with
a
target
MOE
of
100.
d
Combined
Dermal
+
Incidental
Oral
MOEs
=
1/
[1/
MOEdermal
+
1/
MOEoral
];
see
Table
5
for
dermal
MOE
for
high­
contact
short­
term
activity
for
toddlers
on
turf
(MOE
=
42).
MOEs
in
bold
exceed
HEDs
level
of
concern
(i.
e.
MOEs
<
300).
