Document ID: EPA-HQ-OPP-2002-0159-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-07-12T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
February
7,
2002
SUBJECT:
Chronic
and
Cancer
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Decision
Document
(TRED)
for
Pronamide;
PC
code
[101701];
DP
Barcode
[D280422].

FROM:
Dave
Soderberg,
Chemist
Jose
Morales,
Chemist
Steve
Knizner,
Branch
Chief
RRB3,
Health
Effects
Division
(HED)
(7509C)

THROUGH:
Catherine
Eiden,
Branch
Senior
Scientist
RRB3,
Health
Effects
Division
(7509C)

And
Christina
Swartz,
Chemist
David
Hrdy,
Biologist
Dietary
Exposure
Science
Advisory
Council
(DESAC)
Health
Effects
Division
(7509C)

And
Chemistry
Science
Advisory
Council
(Chem
SAC)
Health
Effects
Division
(7509C)

TO:
Gary
Bangs,
Industrial
Hygienist
RRB3
Health
Effects
Division
(7509C)

And
Cecelia
R.
Watson,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(7508C)
1
cPAD
=
chronic
Population
Adjusted
Dose
=
Chronic
RfD
FQPA
Safety
Factor
1
EPA
Reviewers:
Dave
Soderberg,
Jose
Morales,
Steve
Knizner;
Date:
17
Jan,
2002
STUDY
TYPE:
Chronic
and
Cancer
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Decision
Document
(TRED)
for
Pronamide
SYNONYMS:
Propyzamide
[3,
5
dichloro­
N­(
1,1­
dimethyl­
2­
propynyl)
benzamide]

RESIDUE
OF
CONCERN:
The
nature
of
the
residue
in
plants
and
animals
is
adequately
understood.
The
residues
of
concern
are
pronamide
and
its
metabolites
containing
the
3,5­
dichlorobenzoyl
moiety.

Executive
Summary
A
chronic
and
cancer
dietary
exposure
assessment
was
requested
to
support
the
Tolerance
Reassessment
Eligibility
Document
(TRED)
for
Pronamide.
In
response,
a
refined
tier
3
chronic/
cancer
dietary
exposure
assessment
was
conducted
for
all
supported
food
uses
(i.
e,
all
currently
registered
and
proposed
uses).
Although
tolerance
level
residues
were
used
for
some
newly
registered
crops,
the
assessment
was
based
primarily
upon
residue
monitoring
data
for
fruits
and
vegetables
and
upon
calculation
of
anticipated
residues
for
meat,
milk,
poultry
and
eggs,
and
is
the
most
refined
to
date
for
pronamide.
We
note
that
these
data
consisted
almost
entirely
of
non­
detectable
residues.
Estimates
of
percent
crop
treated
(%
CT)
generated
by
the
Biological
and
Economic
Assessment
Division
(BEAD)
were
used
to
further
refine
this
assessment.
This
assessment
showed
that
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
cPAD
1
)
for
the
general
U.
S.
population
and
for
all
population
subgroups.
The
chronic
dietary
exposure
estimates
for
the
two
most
highly
exposed
population
subgroups,
children
1­
6
and
seniors,
are
both
estimated
at
0.000005
mg/
kg/
day
(<
1%
cPAD).
The
cancer
dietary
risk
estimate
is
1.06
x
10
­7
for
the
U.
S.
population,
and
is
below
the
level
that
HED
generally
considers
to
be
of
concern
(1.0
x
10
­6
).

I.
Introduction
This
memorandum
provides
the
results
of
the
dietary
exposure
assessment
for
the
general
U.
S.
population
and
various
population
subgroups
to
residues
of
pronamide
and
its
metabolites
containing
the
3,5­
dichlorobenzoyl
moiety.
Risk
estimates
were
generated
for
chronic
longterm
and
cancer
dietary
exposure
using
the
most
recent
version
of
the
Dietary
Exposure
Evaluation
Model
(DEEM™,
Version
7.75),
and
using
toxicological
doses
and
endpoints
2
selected
by
the
HED
Hazard
Identification
Assessment
Review
Committee
(HIARC).
The
committee
concluded
that
toxicological
effects
were
not
expected
after
a
single
dietary
dose
and
so
did
not
select
an
acute
dietary
endpoint
for
pronamide.
This
assessment
is
the
first
dietary
exposure
analysis
that
has
been
conducted
for
pronamide
under
the
Food
Quality
Protection
Act
(FQPA).
A
previous
dietary
assessment
was
a
Dietary
Risk
Evaluation
System
(DRES)
analysis
reported
by
M.
Metzger,
Feb
19,
1994.

For
a
general
introduction
to
dietary
exposure
assessments
references
are
available
on
the
EPA/
pesticides
web
site.
See,
for
instance:
"Available
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide",
6/
21/
2000,
web
link:
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf
;
or
see
HED
SOP
99.6,
8/
20/
99.

II.
Toxicological
Information
On
November
6,
2001,
the
Health
Effects
Division
(HED)
Hazard
Identification
Assessment
Review
Committee
(HIARC)
evaluated
the
recommendations
of
the
HED
toxicologist
for
pronamide
with
regard
to
the
acute
and
chronic
Reference
Doses
(RfDs),
and
with
regard
to
the
toxicological
endpoint
selection
for
occupational/
residential
exposure
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
pronamide
was
also
evaluated
as
required
by
the
Food
Quality
Protection
Act
(FQPA)
of
1996.

On
December
3,
2001,
the
FQPA
Safety
Factor
Committee
met
to
evaluate
both
the
hazard
and
exposure
databases
for
pronamide.
The
Safety
Factor
Committee
recommended
that
the
10x
FQPA
Safety
Factor
for
pronamide
be
reduced
to
3x.
A
summary
of
the
doses
and
endpoints
relevant
to
dietary
exposure
assessment
is
presented
in
Table
1.

Table
1.
Summary
of
Toxicological
Doses
and
Endpoints
for
Pronamide
for
Use
in
Dietary
Exposure
Assessment
EXPOSURE
SCENARIO
DOSE
(MG/
KG/
DAY)
ENDPOINT
STUDY
Acute
Dietary
females
(13­
50)
and
general
population
including
infants
and
children
No
appropriate
endpoint
was
available
to
quantitate
risk
to
the
general
population
from
a
singledose
administration
of
pronamide.
The
developmental
effect,
abortion,
was
not
considered
to
occur
after
a
single
dose
in
this
instance
because
they
were
observed
in
rabbits
during
the
post­
dosing
phase
of
the
study
(days
22­
24).
Therefore,
no
endpoint
was
chosen
to
quantitate
risk
to
females
13­
50
from
a
single­
dose
administration
of
pronamide.

Chronic
Dietary
(all
populations)
NOAEL
=
8.46
Increased
relative
(to
body)
liver
weight
and
non­
neoplastic
histologic
changes
in
the
liver,
thyroid,
and
ovaries.
Combined
Chronic
Toxicity/
Carcinogenicity
Study
­
Rat
UF
=
100
FQPA
SF
=
3
Chronic
RfD
=
0.08
mg/
kg/
day
Chronic
PAD
=
0.03mg/
kg/
day
3
Cancer
Q1*
=
2.59
x
10
­
2
(mg/
kg/
day)
­1
Group
B2
chemical
­
"Probable
human
carcinogen"
based
on
thyroid
follicular
cell
adenomas
(males
and
females)
and
benign
interstitial
cell
tumors
(males)
in
rats
and
hepatocellular
carcinomas
in
male
mice.
Combined
Chronic
Toxicity/
Carcinogenicity
Study
­
Rat
III.
Residue
Information
Pronamide/
propyzamide
[3,
5
dichloro­
n­(
1,1­
dimethyl­
2­
propynyl)
benzamide]
tolerances
are
established
under
40
CFR
§180.317(
a),
(b),
and
(c).
The
tolerance
expression,
listed
in
(a)
and
(c),
is
in
terms
of
"the
combined
residues
of
the
herbicide
propyzamide
and
its
metabolites
(containing
the
3,5­
dichlorobenzoyl
moiety
and
calculated
as
3,5­
dichloro­
N­(
1,1­
dimethyl­
2­
propynyl)
benzamide)."
The
tolerance
expression,
listed
in
(b),
is
in
terms
of
the
parent
only.
Pronamide
tolerances
listed
in
40
CFR
§180.317(
a)
range
from
0.02
ppm
(for
certain
animal
commodities)
to
10.0
ppm
(for
a
non­
grass
animal
feeds
group).
The
time­
limited
tolerances
listed
in
40
CFR
§180.317(
b),
with
an
expiration
date
of
12/
31/
01,
are
for
Section
18
emergency
exemptions
for
pronamide
uses
on
cranberries
(0.05
ppm)
and
grasses
(forage
1.0
ppm
and
hay
0.5
ppm).
The
tolerances
listed
in
40
CFR
§180.317(
c)
are
for
regional
registrations
of
pronamide
on
dried
(winter)
peas
(0.05
ppm)
and
rhubarb
(0.1
ppm).
Adequate
enforcement
methods
are
available
for
the
determination
of
residues
in/
on
plant
and
animal
commodities.
Updates
to
the
tolerances
that
are
used
in
this
document
are
taken
from
proposed
reassessments
of
tolerances
reported
in
the
residue
chemistry
chapter
of
the
TRED
(J.
Morales,
in
process).

Pronamide
is
a
systemic
herbicide.
Residues
are
translocated
into
the
plant
through
the
roots.
Pronamide
and
its
metabolites
containing
the
3,5­
dichlorobenzoyl
moiety
are
the
residues
of
concern.
Although
pronamide
is
a
large
part
of
the
total
residue
of
interest,
significant
amounts
of
metabolites
containing
the
3,5­
dichlorobenzoyl
moiety
may
also
be
present.
The
residues
measured
in
field
trials
include
these
metabolites
by
incorporation
of
a
hydrolysis
step;
however,
results
of
monitoring
by
the
U.
S.
Department
of
Agriculture,
Agricultural
Marketing
Service's
Pesticide
Data
Program
(PDP)
analyses
are
also
used
in
this
assessment
for
some
crops,
and
analyses
performed
by
PDP
measured
only
the
parent
compound.
Therefore,
all
PDP
results
are
multiplied
by
a
factor
of
2
to
assure
that
residues
of
the
3,5­
dichlorobenzoyl
containing
metabolites
are
conservatively
accounted
for
in
this
assessment.
[The
factor
of
2
comes
from
a
report
on
a
confined
rotational
crop
study
(L.
Cheng,
D197436,
5
May,
1994)
that
showed
residues
of
the
3,5­
dichlorobenzoyl
containing
metabolites
to
be
present
in
roughly
equal
amounts
to
the
parent
up
to
97
days
after
treatment.]
Because
all
PDP
results,
but
one,
are
non­
detects,
which
are
ordinarily
valued
at
½
of
the
method
limit
of
detection
(LOD),
this
means
that
the
non­
detects
in
the
PDP
data
for
this
assessment
are
valued
at
the
LOD
to
account
for
the
metabolites.

Percent
Crop
Treated
and
Processing
Information:
4
The
percent
crop
treated
(%
CT)
dataset
from
OPP's
Biological
and
Economic
Assessment
Division
(BEAD)
is
provided
in
Attachment
1.
This
report
was
last
updated
on
September
26,
2001.

No
processing
information
was
used
in
this
assessment.
DEEM™
default
processing
factors
were
used
wherever
they
existed
for
processed
food
derived
from
the
relevant
crops.
However,
because
residue
data
were
available
in
the
PDP
database
for
grape
juice,
pear
juice
and
apple
juice,
these
PDP
data
were
used
directly,
i.
e,
without
DEEM
default
processing
factors,
for
grape
juice
and
grape
wine,
and
for
pear
juice
and
apple
juice.
Factors
for
the
juice
concentrates
were
estimated
from
the
ratio
of
the
DEEM
default
factors
for
juice/
juice
concentrate.

Residue
Estimates:

Crops
Apples
­
In
the
year
2000,
PDP
analyzed
184
samples
of
fresh
apples
and
detected
no
residues
of
pronamide
with
an
average
LOD
of
0.005
ppm.
This
result
is
also
supported
by
multi­
year
FDA
testing
for
pronamide
in
apples
with
no
detectable
residues.
The
anticipated
residue
estimate
(AR)
for
apples
is
0.005
ppm.
BEAD
reported
that
1%
of
the
apple
crop
is
treated
with
pronamide.
For
apples
and
all
other
crops,
except
lettuce,
the
percent
crop
treated
value
is
applied
as
adjustment
factor
2
in
the
DEEM
TM
program.

Apple
Juice
­
In
1998,
PDP
tested
619
samples
of
apple
juice
for
pronamide
and
detected
no
residues.
The
average
LOD
was
0.013
ppm.
The
absence
of
residues
in
apple
juice
is
supported
by
the
absence
of
residues
in
apples.
Therefore
0.013
ppm
was
used
as
the
AR
for
apple
juice.
Because
1%
of
the
apple
crop
was
reported
to
be
treated
with
pronamide,
this
was
applied
as
adjustment
factor
2.
Since
direct
monitoring
data
were
available,
no
processing
factor
was
used
for
apple
juice
and
the
ratio
of
DEEM
default
processing
factors
of
3.9/
1.3
=
3.0
was
used
for
apple
juice
concentrate.

Apricot
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.005
ppm
(½
LOD)
for
stone
fruits
based
upon
the
then
available
FDA
data.
Because
FDA
methods
are
capable
of
measuring
parent
only,
and
to
assure
that
residues
of
3,5­
dichlorobenzoyl
containing
metabolites
are
also
included,
an
AR
of
0.01
ppm,
rather
than
the
previously
proposed
0.005
ppm,
should
be
used.
FDA
has
since
tested
the
following
numbers
of
stone
fruit
samples
for
pronamide
between
1993
­
1999
with
the
same
lower
limit
of
reported
results.

Table
2.
Number
of
Stone
Fruit
samples
Tested
by
FDA
in
recent
Years.
No
Residues
of
Pronamide
were
detected
in
these
samples.
5
year/
crop
1993
1994
1995
1996
1997
1998
1999
apricots2828288
2
8
18
cherries
80
43
47
15
46
29
68
nectarines35454
2
6
6
4
peaches
116
189
117
75
105
114
77
plums
3
14
4
2
­
­

None
of
these
samples
contained
any
detectable
residues
of
pronamide.
As
noted
below,
under
the
specific
crops,
in
the
year
2000
PDP
tested
cherries,
nectarines
and
peaches
for
pronamide
and
all
were
non­
detects.
A
weighted
average
LOD
from
these
various
samples
is
0.009
ppm.
An
AR
of
0.01
ppm
will
therefore
be
translated
to
apricots.
As
noted
under
the
peaches
topic,
cherries
and
plums
were
reported
by
BEAD
to
be
treated
at
a
rate
of
less
than
1%
of
the
crop.
Thus,
a
value
of
1
%
crop
treated
was
translated
to
all
stone
fruits.

Artichoke
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.005
ppm
based
upon
½
of
the
lower
limit
reported
in
field
trials
(which
also
include
testing
for
metabolites).
BEAD
reported
that
21%
of
artichokes
are
treated
with
pronamide.

Blackberries
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.01
ppm
for
blackberries,
blueberries,
boysenberries
and
raspberries
based
upon
field
trials.
BEAD
reported
that
6%
of
blackberries
are
treated
with
pronamide.

Blueberries
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.01
ppm
for
blackberries,
blueberries,
boysenberries
and
raspberries
based
upon
field
trials.
BEAD
reported
that
<1%
of
blackberries
are
treated
with
pronamide.
HED
practice
is
to
default
to
1%
crop
treated
when
BEAD
reports
less
than
1%
of
the
crop
is
treated.

Boysenberries
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.01
ppm
for
blackberries,
blueberries,
boysenberries
and
raspberries
based
upon
field
trials.
BEAD
reported
that
6%
of
blackberries
are
treated
with
pronamide,
and
this
value
was
translated
to
boysenberries.

Cherries
­
In
the
year
2000,
PDP
tested
275
samples
of
cherries
for
pronamide
and
detected
no
residues
with
an
average
LOD
of
0.0106
ppm.
This
result
is
supported
by
multi­
year
testing
by
FDA
for
pronamide
in
cherries
and
other
stone
fruits,
as
described
above.
Thus,
the
AR
for
cherries
is
0.011
ppm.
BEAD
has
reported
that
less
than
1%
of
cherries
are
treated
with
pronamide,
which
is
rounded
up
to
1%
by
HED.
6
Cranberries
­
The
tolerance
of
0.05
ppm
was
used
for
cranberries.
No
information
was
available
on
the
percentage
of
the
crop
treated
so
it
was
assumed
that
100%
of
cranberries
are
treated
with
pronamide.

Endive
­
The
tolerance
of
1
ppm
was
used
for
endive.
BEAD
reported
that
31%
of
the
endive
crop
is
treated
with
pronamide.

Grapes:
In
the
year
2000,
PDP
tested
741
grape
samples
for
pronamide
and
detected
no
residues
with
an
average
LOD
of
0.013.
This
result
is
supported
by
multi­
year
testing
by
FDA
for
pronamide
in
grapes
with
no
detections
of
pronamide.
This
value
is
the
AR.
BEAD
has
reported
that
<1%
of
grapes
are
treated
with
pronamide.

Grape
Juice
­
In
1998­
1999,
PDP
analyzed
1007
samples
of
grape
juice
and
found
no
residues
of
pronamide.
This
result
is
supported
by
the
findings
of
no
detectable
residues
in
grapes.
The
average
LOD
of
these
analyses
is
0.013
ppm.
Therefore
an
AR
of
0.013
was
used
for
grape
juice,
grape
juice
concentrate
and
wine.
BEAD
reported
that
1%
of
the
grape
crop
is
treated
with
pronamide.
Since
direct
analyses
were
used,
the
DEEM
processing
factor
was
removed
for
grape
juice,
and
was
replaced
by
the
ratio
of
the
DEEM
factors
for
grape
juice
concentrate/
grape
juice
(3.6/
1.2
=
3.0)
for
grape
juice
concentrate.

Lettuce:
In
1999
­
2000,
PDP
analyzed
925
samples
of
fresh
lettuce
for
pronamide
(parent
only).
One
sample
contained
a
detectable
residue
at
0.012
ppm
(evaluated
here
as
0.024
ppm
to
include
metabolites).
The
average
LOD
for
this
data
set
is
0.0148
ppm.
The
average
LOD,
rather
than
½
LOD,
is
used
as
a
conservative
estimate
of
the
non­
detect
level
for
all
pronamide
residues
containing
the
dichlorobenzene
ring
because
PDP
analyzed
only
for
parent
pronamide.
Lettuce
is
36%
crop
treated
in
the
assessment.
The
AR,
including
%
crop
treated,
is
0.0053
ppm.
(%
CT
cannot
be
applied
separately
for
lettuce,
because
that
would
incorrectly
change
the
one
detectable
residue.

Nectarines
­
In
the
year
2000,
PDP
analyzed
345
nectarines
for
pronamide
and
detected
no
residues
with
an
average
LOD
of
0.003
ppm.
This
finding
is
supported
by
multi­
year
testing
of
various
stone
fruits
by
FDA
with
no
detectable
residues,
as
described
above.
As
explained
for
peaches,
the
estimate
of
1%
crop
treated
is
translated
to
nectarines.

Peaches
­
In
the
year
2000,
PDP
tested
536
five­
pound
composite
samples
of
peaches
for
pronamide
and
detected
no
residues
with
an
average
LOD
of
0.012
ppm.
In
the
same
year
PDP
tested
532
individual
peaches
for
pronamide
and
detected
no
residues
with
an
average
LOD
of
0.012
ppm.
This
finding
is
also
supported
by
multi­
year
testing
of
various
stone
fruits
by
FDA
with
no
detectable
residues,
as
described
above.
BEAD
reported
less
than
1%
crop
treated
for
cherries
and
plums,
but
did
not
report
usage
for
other
stone
fruits.
Therefore,
1%
crop
treated
is
used
for
all
stone
fruits.

Pears
­
In
1998
­
1999,
PDP
analyzed
1007
fresh
pears
for
pronamide
(parent
only).
None
of
the
samples
contained
detectable
residues.
This
finding
is
supported
by
the
absence
of
residues
in
7
PDP
testing
of
apples
and
also
by
multi­
year
testing
by
FDA
with
no
detectable
residues.
The
average
LOD
for
this
data
set
is
0.011
ppm.
This
value
is
used
as
the
AR.
This
same
value
is
used
for
pear
juice
and
other
processed
pear
commodities.
PDP
also
analyzed
canned
pears
in
this
time
period,
and
also
found
no
detects
in
these
products.
The
value
of
1%
crop
treated
was
translated
from
apples.

Dried
Peas
­
The
tolerance
of
0.05
ppm
was
used
for
dried
peas.
BEAD
reported
that
considerably
less
than
1%
of
peas
are
treated
with
pronamide.
Dried
peas
were
presumed
to
be
subsumed
within
this
value,
and
since
the
reported
value
was
below
0.1%
crop
treated
for
all
peas,
it
was
reasonable
to
use
1%
crop
treated
for
dried
peas.

Plums
­
As
discussed
under
apricots,
an
AR
of
0.01
ppm
and
1%
crop
treated
is
also
used
for
plums.

Radicchio
­
The
tolerance
of
2
ppm
was
used
for
radicchio.
No
information
was
available
on
the
percent
of
radicchio
treated
with
pronamide,
therefore,
100%
of
the
crop
was
assumed
to
be
treated.

Raspberries
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.01
ppm
for
blackberries,
blueberries,
boysenberries
and
raspberries
based
upon
field
trials.
BEAD
reported
that
5%
of
raspberries
are
treated
with
pronamide.

Rhubarb
­
A
previous
AR
memo
(L.
Cheng,
12/
15/
93,
No
DP
Barcode)
recommended
an
AR
of
0.039
ppm
for
rhubarb
based
upon
field
trials.
BEAD
did
not
report
what
percent
of
rhubarb
is
treated
with
pronamide.
In
such
cases
HED
practice
is
to
default
to
100%
crop
treated.

Animal
Products
Chronic
Anticipated
Residues
­
Meat/
Milk/
Poultry/
Eggs
Feedstuffs
Anticipated
residues
for
meat
and
milk
were
calculated
using
a
dairy
cattle
feeding
study
and
field
trial
data
for
residues
of
pronamide
in/
on
alfalfa,
plus
percent
of
crop
treated
information
(A.
Halverson,
9/
26/
01).
The
field
trial
data
used
to
calculate
the
AR
for
alfalfa
hay
and
meal
were
presented
in
a
previous
memo
(L.
Cheng,
12/
17/
93).
Briefly,
alfalfa
seed,
hay
and
meal
were
the
major
feed
items
for
cattle
and
poultry.
An
anticipated
residue
(4.8
ppm)
in
alfalfa
hay
was
calculated
based
on
field
data
obtained
from
trials
conducted
in
CA,
ID,
MN,
WA
(West
of
the
Mississippi
River),
MS,
NJ,
NY,
and
PA
(East
of
the
Mississippi
River).
Alfalfa
seed
and
meal
were
assumed
to
contain
similar
levels
of
pronamide
residues.

Because
chronic
ARs
were
being
calculated,
the
alfalfa
anticipated
residue
level
for
dietary
burden
calculations
was
adjusted
by
the
percent
of
crop
treated
data.
The
estimated
maximum
percent
crop
treated
from
BEAD
for
alfalfa
is
0.2%
and
the
average
is
0.1%.
These
estimates
are
far
below
the
usual
HED
default
of
1%,
so
HED
considered
using
these
actual
estimates
to
avoid
overestimating
pronamide
residues
in
the
large
consumption
items:
meat,
milk,
poultry
and
eggs.
To
assure
this
would
be
correct,
HED
consulted
BEAD
about
the
expected
reliability
of
these
8
estimated
values.
For
safety,
BEAD
recommended
using
a
more
conservative
estimate
of
0.5%
(electronic
communication,
A.
Halverson
to
D.
Soderberg,
6
February
2002),
and
the
ARs
were
calculated
using
this
value
of
0.5%.

Meat
and
Fat
Two
groups
of
cattle
were
fed
alfalfa
hay
containing
20
or
40
ppm
field­
aged
pronamide
residues
for
three
weeks.
Residues
in
tissues
are
listed
in
Table
3.

Table
3.
Pronamide
Residues
in
Meat
and
Fat.

Sample
Dose
Level
(ppm)
Residues
(ppm)
Number
of
Samples
Average
Residue
(ppm)
after
feeding
at
20
ppm
Kidney
20
40
0.05­
0.31
0.66­
1.18
2
2
0.18
Liver
20
40
0.23­
0.55
0.92­
1.48
2
2
0.39
Diaphragm
muscle
20
40
<0.01­
0.02
0.05­
0.06
2
2
0.015
Front
leg
muscle
20
40
<0.01­
0.02
0.03­
0.05
2
2
0.015
Hind
leg
muscle
20
40
<0.01­
0.02
0.03­
0.06
2
2
0.015
Mesentery
fat
20
40
0.02­
0.08
0.21­
0.48
2
2
0.05
Thoracic
fat
20
40
<0.01­
0.09
0.18­
0.34
2
2
0.05
Kidney
fat
20
40
0.02­
0.10
0.25­
0.47
2
2
0.06
Assuming
40%
alfalfa
hay
(89%
dry
matter)
and
10%
alfalfa
meal
(89%
dry
matter)
in
the
cattle
diet,
with
an
AR
in
both
of
4.8
ppm
and
0.5%
crop
treated,
the
anticipated
dietary
burden
is
4.8
x
0.50/
0.89
x
0.005
=
0.013
ppm.
Using
the
results
obtained
from
the
20
ppm
feeding
level,
the
following
ARs
are
estimated:
muscle,
0.015/
20
x
.013
=
1
x
10
­5
ppm;
fat,
4
x
10
­5
ppm;
liver,
2.5
x
10
­4
ppm;
and
kidney,
1.2
x
10
­4
ppm.

Milk
Rohm
and
Haas
has
submitted
a
feeding
study
in
which
12
lactating
Holstein
and
Guernsey
cows
were
fed
alfalfa
hay
containing
pronamide
residues
at
3
dosage
levels
for
varying
9
periods
of
time.
The
dosage
levels
were
1.8
ppm
for
16­
30
days;
7.5
ppm
for
16­
30
days;
or
0.7
ppm
for
21
days
followed
by
3.5
ppm
for
16­
30
days.
Milk
was
collected
twice
daily
and
pooled
for
residue
analysis.
Results
are
summarized
in
Table
4.

Table
4.
Pronamide
Residues
in
Milk.

Sample
Feeding
Level,
ppm
Residues,
ppm
Number
of
Samples
Range
Average
Milk
0.7
<0.005
<0.005
33
1.8
<0.005­
0.007
<0.005
37
3.5
<0.005­
0.01
0.005
38
7.5
0.
005­
0.015
0.011
37
A
dairy
cattle
diet
of
50
percent
alfalfa
hay
(89%
dry
matter)
for
which
an
anticipated
residue
of
4.8
ppm
had
been
calculated,
in
conjunction
with
0.2%
crop
treated,
gives
an
anticipated
dietary
burden
of
0.013
ppm.
Based
on
the
average
residue
in
the
feeding
trial
being
non­
detectable
at
the
1.8
ppm
feeding
level
and
extrapolating
from
one­
half
the
limit
of
detection
(½
LOD
=
0.0025
ppm),
anticipated
residues
in
milk
are
1.8
x
10
­5
ppm.

Poultry
and
eggs
Hens
in
three
groups
of
15
animals
were
fed
diets
containing
0.22,
0.51,
or
1.82
ppm
pronamide
residues
for
a
period
of
up
to
seven
weeks.

Combined
residues
of
pronamide
and
its
metabolites
were
<0.01
ppm
in
all
eggs
from
the
0.22
and
0.51
ppm
feeding
groups
(94
eggs/
group).
Eggs
(7
samples)
in
the
1.82
ppm
feeding
group
contained
<0.01
ppm
residues
for
the
first
five
days
of
dosing,
after
which
residues
in
68
subsequent
samples
contained
<0.01­
0.022
ppm.
Most
samples
contained
residues
at
0.01­
0.016
ppm,
and
residues
remained
fairly
stable
over
the
duration
of
the
experiment.

Combined
residues
in
gizzard,
heart,
muscle,
skin,
fat,
and
liver
were
<0.01
ppm
in
hens
dosed
at
0.22
ppm.
At
the
0.51
ppm
dose
level,
0.01
ppm
residues
were
found
in
samples
of
fat
and
gizzard
(6
samples),
and
liver.
In
hens
dosed
at
1.82
ppm,
combined
residues
were
0.01­
0.03
ppm
in
gizzard,
<0.01
ppm
in
heart,
<0.01
ppm
(0.007,
0.008
ppm)
in
light
meat,
<0.01
ppm
(0.007
ppm)
in
dark
meat,
<0.01­
0.03
ppm
in
fat,
and
0.02­
0.04
ppm
in
liver.

The
expected
dietary
intake
of
pronamide
by
poultry
is
based
on
a
diet
of
20%
alfalfa
seed
and
5%
alfalfa
meal,
correcting
for
0.5%
crop
treated,
resulting
in
an
anticipated
dietary
burden
of
0.006
ppm.
Based
on
the
results
from
the
0.22
ppm
feeding
group
(all
non­
detectable
residues)
and
using
one­
half
the
limit
of
detection
(½
LOD
=
0.005
ppm),
the
AR
for
all
poultry
commodities
is
1.4
x
10
­4
ppm.

Table
5.
Data
and
Residue
Estimates
Used
in
Dietary
Analyses
10
Crop
Food
Forms
Included
Source
of
Data
Processing
Factor
Percent
Crop
Treated
Anticipated
Residue
(ppm)

Apples
All
PDP
DEEM
Default
1%
0.
005
Apple
Juice
All
PDP
1%
0.
013
Apricots
All
translated
from
other
stone
fruits
DEEM
Default
1%
0.
01
Artichokes
All
previous
AR
memofield
trials
DEEM
Default
21%
0.005
Blackberries
All
previous
AR
memofield
trials
DEEM
Default
6%
0.
01
Blueberries
All
previous
AR
memofield
trials
DEEM
Default
1%
0.
01
Boysenberries
All
previous
AR
memofield
trials
DEEM
Default
6%
0.
01
Cherries
All
PDP
DEEM
Default
1%
0.
011
Cranberries
All
tolerance
DEEM
Default
100%
0.05
Endive
All
tolerance
DEEM
Default
31%
1.0
Grapes
Fresh
Grapes,
Raisins
and
Leaves
PDP
DEEM
Default
1%
0.
013
Grape
Juice
Juice,
Concentrate
and
Wine
PDP
1%
0.
013
Lettuce
All
PDP
DEEM
Default
0
0.0053
(includes
%
CT)

Nectarines
All
PDP
DEEM
Default
1%
0.
003
Peaches
All
PDP
DEEM
Default
1%
0.
012
Pears
All
PDP
DEEM
Default
1%
0.
011
Peas
(Dried)
All
tolerance
DEEM
Default
1%
0.
05
Plums
All
translated
from
other
stone
fruits
DEEM
Default
1%
0.
01
Prunes
All
translated
from
other
stone
fruits
DEEM
Default
1%
0.
01
Radicchio
All
tolerance
DEEM
Default
100%
2.0
Raspberries
All
previous
AR
memofield
trials
DEEM
Default
5%
0.
01
Rhubarb
All
previous
AR
memofield
trials
DEEM
Default
100%
0.039
Crop
Food
Forms
Included
Source
of
Data
Processing
Factor
Percent
Crop
Treated
Anticipated
Residue
(ppm)

11
Beef
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00025
Kidney
All
calculated
ARs
DEEM
default
N/
A
0.00012
Beef
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00004
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Chicken
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Eggs
All
calculated
ARs
DEEM
Default
N/
A
0.00014
Goat
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00025
Kidney
All
calculated
ARs
DEEM
default
N/
A
0.00012
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00004
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Hog
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00025
Kidney
All
calculated
ARs
DEEM
default
N/
A
0.00012
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00004
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Horse
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Milk
All
calculated
ARs
DEEM
Default
N/
A
0.000018
Poultry
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Crop
Food
Forms
Included
Source
of
Data
Processing
Factor
Percent
Crop
Treated
Anticipated
Residue
(ppm)

12
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Sheep
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00025
Kidney
All
calculated
ARs
DEEM
default
N/
A
0.00012
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00004
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Turkey
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.000055
Veal
Muscle
All
calculated
ARs
DEEM
Default
N/
A
0.00001
Byproducts
All
calculated
ARs
DEEM
Default
N/
A
0.00012
Liver
All
calculated
ARs
DEEM
Default
N/
A
0.00025
Kidney
All
calculated
ARs
DEEM
default
N/
A
0.00012
Fat
All
calculated
ARs
DEEM
Default
N/
A
0.00004
Other
Organ
Meat
All
calculated
ARs
DEEM
Default
N/
A
0.00012
*
Ordinarily,
in
this
assessment,
the
ARs
for
the
fruit
and
vegetable
crops
are
based
entirely
upon
LODs
and
the
percent
crop
treated
is
entered
into
the
DEEM
program
separately
from
the
AR,
as
adjustment
factor
2.
However,
this
was
not
possible
for
lettuce,
because
lettuce
has
one
sample
with
detected
residues
of
pronamide.
Therefore,
for
lettuce
the
AR
includes
the
36%
crop
treated
and
adjustment
factor
2
is
set
to
a
value
of
1.

IV.
DEEM™
Program
and
Consumption
Information
13
The
chronic
and
cancer
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(DEEM™)
software
Version
7.75,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(CSFII),
1989­
1992.
The
1989­
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"person
days"
of
data.
Foods
"as
consumed"
(e.
g.,
apple
pie)
are
linked
to
raw
agricultural
commodities,
and
their
food
forms
(e.
g.,
apples­
cooked/
canned
or
wheat­
flour),
by
proprietary
recipe
translation
files
internal
to
the
DEEM
software.

For
chronic
and
cancer
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
(e.
g.,
orange
or
orange­
juice)
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
Exposure
estimates
are
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.

HED
notes
that
there
is
a
degree
of
uncertainty
in
estimating
exposures
for
certain
population
subgroups
that
may
not
be
sufficiently
represented
in
the
consumption
surveys
(e.
g,
nursing
and
non­
nursing
infants
or
Hispanic
females).
Therefore,
risks
estimated
for
these
population
subgroups
are
not
reported
explicitly
but
are
included
within
larger
representative
populations
(e.
g.,
all
infants
or
females,
13­
50
years).

V.
Results
and
Discussion
A
refined,
tier
3,
chronic
and
cancer
dietary
exposure
assessment
for
pronamide
was
performed.
The
analysis
was
based
primarily
upon
residue
monitoring
data
for
fruits
and
vegetables
and
upon
calculated
ARs
for
meat,
milk,
poultry
and
eggs.
Field
trial
data
and
tolerance
level
residues
were
used
for
some
minor
crops.
This
assessment
is
the
most
refined
to
date
for
pronamide.
Results
for
chronic
exposure
are
shown
in
Table
6
and
in
Attachment
2.
Results
for
cancer
exposure
are
shown
in
Table
7
and
Attachment
3.
All
results
for
all
appropriate
population
subgroups
are
below
HED's
levels
of
concern.

Table
6.
Results
of
Chronic
Dietary
Exposure
Analysis
14
Population
Subgroup
cPAD
(mg/
kg/
day)
Exposure
(mg/
kg/
day)
%
cPAD
U.
S.
Population
(total)
0.
03
mg/
kg/
day
0.
000004
<1%

All
Infants
(<
1
year)
0.
03
mg/
kg/
day
0.
000002
<1%

Children
1­
6
years
0.
03
mg/
kg/
day
0.
000005
<1%

Children
7­
12
years
0.
03
mg/
kg/
day
0.
000004
<1%

Females
13­
50
0.03
mg/
kg/
day
0.
000004
<1%

Males
13­
19
0.03
mg/
kg/
day
0.
000003
<1%

Males
20+
years
0.
03
mg/
kg/
day
0.
000004
<1%

Seniors
55+
0.03
mg/
kg/
day
0.
000005
<1%

Table
7.
Results
of
Cancer
Dietary
Exposure
Analysis
Population
Subgroup
Exposure
(mg/
kg/
day)
Anticipated
Cancer
Risk
U.
S.
Population
(total)
0.
000004
1.06
X
10
­7
VI.
Uncertainties
Because
the
estimated
exposure
is
well
below
the
chronic
and
cancer
levels
of
concern,
any
uncertainties
are
unlikely
to
cause
the
exposure
to
exceed
a
level
of
concern.
However,
there
are
some
conservative
assumptions
that
may
have
introduced
some
uncertainties
into
this
assessment.
Tolerance
level
residues
and
100
%
CT
were
assumed
for
cranberries
and
radicchio.
The
LOD
was
used
instead
of
½LOD
for
the
non­
detects
in
the
PDP
data.
For
the
animal
product
ARs
the
maximum
percent
crop
treated
was
assumed
instead
of
the
average
percent
crop
treated.
Default
DEEM
processing
factors
were
used
for
most
processed
foods.

VII.
Conclusions
A
tier
3
chronic
and
cancer
dietary
risk
assessment
was
conducted
for
all
supported
pronamide
food
uses.
Chronic
dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
appropriate
population
subgroups.
This
assessment
concludes
that
the
chronic
exposure
estimates
are
below
HED's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
chronic
dietary
exposure
estimate
for
both
of
the
two
highest
population
subgroups,
children
1­
6
years
and
seniors
55+
years,
is
0.000005
mg/
kg/
day
(<
1%
of
the
cPAD)
.
The
cancer
dietary
risk
estimate
associated
with
the
use
of
pronamide
for
the
U.
S.
population
is
1.06
x10
­7
,
and
is
therefore
below
the
level
(1.0
x
10
­6
)
that
generally
is
of
concern
to
HED.

VIII.
List
of
Attachments
15
Attachment
1:
Quantitative
Usage
Analysis
Attachment
2:
Results
of
Chronic
Dietary
Exposure
Analysis
Attachment
3:
Results
of
Cancer
Dietary
Exposure
Analysis
Attachment
4:
Residue
Input
File
cc:
RRB3RF;
D.
Soderberg;
S.
Knizner;
C.
Eiden;
C.
Swartz;
D.
Hrdy;
M.
Sahafeyen.
16
Attachment
1.
Quantitative
Usage
Analysis
for
Pronamide/
Propyzamide
Case
Number:
82
PC
Code:
101701
Date:
September
26,
2001
Analyst:
Alan
Halvorson
Based
on
available
pesticide
usage
information
for
1991
through
2000,
total
annual
domestic
usage
of
herbicide
pronamide
(propyzamide)
is
approximately
225
thousand
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.

Pronamide/
Propyzamide
Case
#:
0082
AI
#:
101701
EPA
QUANTITATIVE
USAGE
ANALYSIS
Analyst:
Alan
Halvorson
9­
26­
01
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Acres
Acres
Treated
(000)
%
Crop
Treated
Lb
AI
Appl'd
(000)
Avg
Applic
Rates/
Acre
States
of
Most
Usage
(000)
­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­
(%
of
total
lb
ai
Site
Grown
Est
Est
Est
lb
ai/
#
appl/
lb
ai/
used
by
these
states)

Avg
Max
Avg
Max
Avg
Max
year
year
appl
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Alfalfa
23,724
14.2
42.5
0.1%
0.2%
6.3
18.9
0.45
1.0
0.45
OR
KS
CA
WA
100%

Apples
513.9
2.9
8.8
1%
2%
4.1
12.3
1.41
1.0
1.41
OR
WA
NY
100%

Apricots
­
0*
0*
0*
0*
0*
0*
­
­
­

Artichokes
9.7
2.0
2.9
21%
30%
3.1
4.5
1.55
1.0
1.55
CA
100%

Berries
175.9
2.1
4.2
1%
2%
2.2
4.3
1.03
1.0
1.03
OR
WA
NY
100%

­
Blackberries
5.3
0.3
0.5
6%
9%
0.3
0.4
0.79
1.0
0.79
OR
100%

­
Blueberries
59.1
0.1
0.2
0.1%
0.4%
0.1
0.2
0.97
1.0
0.97
OR
NY
100%

­
Raspberries
13.9
0.7
1.1
5%
8%
0.9
1.5
1.38
1.0
1.38
OR
WA
100%

Cherries
117.6
0.2
0.6
0.2%
0.5%
0.2
0.6
1.00
1.0
1.00
MI
OR
100%

Clover,
CA
­
0.9
1.8
­
­
0.9
1.8
1.01
1.0
1.01

Cole
Crops
305.7
1.0
3.1
0.3%
1.0%
0.9
2.6
0.84
1.0
0.84
CA
100%

Cucumbers,
Process
71.5
0.3
1.0
0.4%
1.3%
0.3
0.9
0.94
1.2
0.78
NC
100%

Endive/
Escarole,
CA
3.3
1.0
1.3
31%
40%
0.9
1.1
0.87
1.0
0.87

Fallowland
19,334
96.1
192.2
0.5%
1.0%
24.0
48.0
0.25
1.0
0.25
WA
ID
100%

Grapes
942.7
0.2
0.7
0.02%
0.07%
0.4
1.2
1.87
1.0
1.87
PA
NC
100%

Hay,
Other(*)
34,597
17.9
53.6
0.1%
0.2%
17.0
50.9
0.95
1.0
0.95
OR
100%

Leafy
Veget,
Oth(**)
73.4
0.05
0.14
0.1%
0.2%
0.05
0.14
1.00
1.0
1.00
CA
100%

­
Celery
27.5
0.04
0.12
0.1%
0.4%
0.04
0.11
0.92
1.0
0.92
CA
100%

Lettuce,
Head
206.8
75.4
94.3
36%
46%
65.5
91.4
0.87
1.1
0.76
CA
AZ
99%

Lettuce,
Other
84.8
41.6
55.1
49%
65%
41.5
60.0
1.00
1.2
0.81
CA
76%

Nectarines
­
0*
0*
0*
0*
0*
0*
­
­
­

Peaches
171.0
0.3
0.9
0.2%
0.5%
0.3
0.9
1.00
1.0
1.00
WA
100%
17
Pears
70.9
2.3
5.4
3%
8%
4.1
10.0
1.76
1.0
1.76
OR
100%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Acres
Acres
Treated
(000)
%
Crop
Treated
Lb
AI
Appl'd
(000)
Avg
Applic
Rates/
Acre
States
of
Most
Usage
(000)
­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­
(%
of
total
lb
ai
Site
Grown
Est
Est
Est
lb
ai/
#
appl/
lb
ai/
used
by
these
states)

Avg
Max
Avg
Max
Avg
Max
year
year
appl
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Peas,
Green
270.6
0.4
1.2
0.1%
0.4%
0.4
1.3
1.09
1.0
1.09
MN
100%

Peppers
68.1
0.2
0.6
0.3%
0.8%
­
­
­
1.0
­

Plums/
Prunes
­
0*
0*
0*
0*
0*
0*
­
­
­

Rhubarb
­
­
­
­
­
­
­
­
­
­

Roots/
Tubers(#)
235.8
3.3
6.5
1%
3%
2.9
5.8
0.89
1.0
0.89
CA
100%

Seed
Crops
1,382.7
42.2
63.3
3%
5%
28.1
42.2
0.67
1.0
0.67
OR
98%

Sugar
Beets
1,454.4
4.5
13.5
0.3%
0.9%
3.6
10.8
0.80
1.0
0.80
OR
100%

Woodland
60,478
5.0
25.2
0.01%
0.04%
0.6
2.8
0.11
1.0
0.11
NC
100%

Golf
Courses
­
­
­
­
­
5.1
10.3
­
­
­
CA
FL
OK
SC
GA
AL
93%

Horticultural
­
­
­
­
­
5.9
11.9
­
­
­
FL
North­
Central
100%

Landscape
Maint,
CA
­
­
­
­
­
1.5
3.1
­
­
­

Lawn
Care
Operators
­
­
­
­
­
0.4
0.8
­
­
­

Ornamental
Turf,
CA
­
­
­
­
­
1.0
2.1
­
­
­

Rights­
of­
Way,
CA
­
­
­
­
­
0.1
0.2
­
­
­

Turf
Farms
­
­
­
­
­
1.9
3.8
­
­
­

Total
223.4
314.1
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(*)
Other
than
alfalfa
(**)
Other
than
lettuce
(#)
Beets,
carrots,
horseradish,
parsnips,
radish,
rutabagas,
sweet
potatoes,
turnips
and
yams.

NOTES
ON
TABLE
DATA
­­­­­­­­­­­­­­­­­­

­
A
dash(­)
indicates
that
information
is
not
readily
available
or
is
not
applicable.

­
A
"0*"
indicates
that
available
EPA
sources
show
no
observed
usage
for
this
site,
which
implies
that
there
is
little
or
no
usage.

­
Allocation
of
usage
among
states
includes
only
states
covered
in
corresponding
data
sources.

­
Calculations
of
the
above
numbers
may
not
appear
to
agree
with
each
other
because
they
are
displayed
as
rounded.

­
Reported
usage
estimates
above
may
include
usage
due
to
Section
18s,
misuse,
errors,
etc.

­
Usage
data
cover
1992
­
2000
for
agriculture
and
1991
­
1999
for
non­
agriculture.

CROP/
SITE
GROUPS
AND
DEFINITIONS
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­
Sites
that
reference
California
give
usage
only
for
California,
not
for
the
total
U.
S.

­
Sub­
categories
under
a
crop
group
are
not
exhaustive.

DATA
SOURCES
­­­­­­­­­­­

­
CA
EPA,
Summary
of
Pesticide
Use
Report
Data,
1997,
1998
&
1999.

­
Garber
&
Hudson,
Pest
Management
in
the
United
States
Greenhouse
and
Nursery
Industry,
1993
data.

­
NCFAP,
National
Use
Pesticide
Database,
circa
1992
&
circa
1997.
18
­
US
EPA,
proprietary
data,
1991
­
1994
&
1996
­
2000.

­
USDA/
NASS,
Agricultural
Chemical
Usage

­
Fruits
Summary,
1993
&
1997.

­
Vegetables
Summary,
1996,
1998
&
2000
19
Attachment
2.
Results
of
Chronic
Dietary
Exposure
Analysis
U.
S.
Environmental
Protection
Agency
Ver.
7.73
DEEM
Chronic
analysis
for
PRONAMIDE
(1989­
92
data)

Residue
file
name:
D:\
pronamidefeb6b.
RS7
Adjustment
factor
#2
used.

Analysis
Date
02­
07­
2002/
08:
47:
49
Residue
file
dated:
02­
06­
2002/
17:
53:
38/
8
Reference
dose
(RfD,
Chronic)
=
.03
mg/
kg
bw/
day
COMMENT
1:
contains
PDP
data
from
2000
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­

U.
S.
Population
(total)
0.000004
0.0%

U.
S.
Population
(spring
season)
0.000005
0.0%

U.
S.
Population
(summer
season)
0.000003
0.0%

U.
S.
Population
(autumn
season)
0.000004
0.0%

U.
S.
Population
(winter
season)
0.000005
0.0%

Northeast
region
0.000005
0.0%

Midwest
region
0.000003
0.0%

Southern
region
0.000003
0.0%

Western
region
0.000006
0.0%

Hispanics
0.000005
0.0%

Non­
hispanic
whites
0.000004
0.0%

Non­
hispanic
blacks
0.000002
0.0%

Non­
hisp/
non­
white/
non­
black
0.000005
0.0%

All
infants
(<
1
year)
0.000002
0.0%
20
Nursing
infants
0.000001
0.0%

Non­
nursing
infants
0.000003
0.0%

Children
1­
6
yrs
0.000005
0.0%

Children
7­
12
yrs
0.000004
0.0%

Females
13­
19
(not
preg
or
nursing)
0.000002
0.0%

Females
20+
(not
preg
or
nursing)
0.000004
0.0%

Females
13­
50
yrs
0.000004
0.0%

Females
13+
(preg/
not
nursing)
0.000003
0.0%

Females
13+
(nursing)
0.000004
0.0%

Males
13­
19
yrs
0.000003
0.0%

Males
20+
yrs
0.000004
0.0%

Seniors
55+
0.000005
0.0%

Pacific
Region
0.000007
0.0%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
21
Attachment
3.
Results
of
Cancer
Dietary
Exposure
Analysis
U.
S.
Environmental
Protection
Agency
Ver.
7.73
DEEM
Chronic
analysis
for
PRONAMIDE
(1989­
92
data)

Residue
file
name:
D:\
pronamidefeb6b.
RS7
Adjustment
factor
#2
used.

Analysis
Date
02­
07­
2002/
08:
48:
48
Residue
file
dated:
02­
06­
2002/
17:
53:
38/
8
Q*
=
0.0259
COMMENT
1:
contains
PDP
data
from
2000
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Population
mg/
kg
Lifetime
risk
Subgroup
body
wt/
day
(Q*=
.0259)

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­

U.
S.
Population
(total)
0.000004
1.06E­
07
22
Attachment
4:
Residue
Input
File
U.
S.
Environmental
Protection
Agency
Ver.
7.73
DEEM
Chronic
analysis
for
PRONAMIDE
1989­
92
data
Residue
file:
D:\
pronamidefeb6b.
RS7
Adjust.
#2
used
Analysis
Date
02­
07­
2002
Residue
file
dated:
02­
06­
2002/
17:
53:
38/
8
Reference
dose
(RfD)
=
0.03
mg/
kg
bw/
day
Comment:
contains
PDP
data
from
2000
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Food
Crop
RESIDUE
Adj.
Factors
Comment
Code
Grp
Food
Name
(ppm)
#1
#2
­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­

1
13A
Blackberries
0.010000
1.000
0.060
AR
mem
Full
comment:
AR
memo
­
field
trials
2
13A
Boysenberries
0.010000
1.000
0.060
AR
mem
Full
comment:
AR
memo
­
field
trials
5
13A
Raspberries
0.010000
1.000
0.050
AR
mem
Full
comment:
AR
memo
­
field
trials
7
13B
Blueberries
0.010000
1.000
0.010
AR
mem
Full
comment:
AR
memo
­
field
trials
8
O
Cranberries
0.050000
1.000
1.000
tolera
Full
comment:
tolerance
9
O
Cranberries­
juice
0.050000
1.100
1.000
tolera
Full
comment:
tolerance
13
O
Grapes
0.013000
1.000
0.010
PDP
14
O
Grapes­
raisins
0.013000
4.300
0.010
PDP
15
O
Grapes­
juice
0.013000
1.000
0.010
PDP
52
11
Apples
0.005000
1.000
0.010
PDP
53
11
Apples­
dried
0.005000
8.000
0.010
PDP
54
11
Apples­
juice/
cider
0.013000
1.000
0.010
PDP
56
11
Pears
0.011000
1.000
0.010
PDP
57
11
Pears­
dried
0.011000
6.250
0.010
PDP
59
12
Apricots
0.010000
1.000
0.010
other
23
Full
comment:
other
stone
fruits
60
12
Apricots­
dried
0.010000
6.000
0.010
other
Full
comment:
other
stone
fruits
61
12
Cherries
0.011000
1.000
0.010
PDP
62
12
Cherries­
dried
0.011000
4.000
0.010
PDP
63
12
Cherries­
juice
0.011000
1.500
0.010
PDP
64
12
Nectarines
0.003000
1.000
0.010
PDP
65
12
Peaches
0.012000
1.000
0.010
PDP
66
12
Peaches­
dried
0.012000
7.000
0.010
PDP
67
12
Plums
(damsons)
0.010000
1.000
0.010
other
Full
comment:
other
stone
fruits
68
12
Plums­
prunes
(dried)
0.010000
5.000
0.010
other
Full
comment:
other
stone
fruits
69
12
Plums/
prune­
juice
0.010000
1.400
0.010
other
Full
comment:
other
stone
fruits
176
4A
Lettuce­
leafy
varieties
0.005300
1.000
1.000
PDP
178
4A
Endive­
curley
and
escarole
1.000000
1.000
0.310
tolera
Full
comment:
tolerance
181
O
Artichokes­
globe
0.005000
1.000
0.210
AR
mem
Full
comment:
AR
memo
­
field
trials
­
1/
2
LOD
182
4A
Lettuce­
unspecified
0.005300
1.000
1.000
PDP
185
4B
Rhubarb
0.039000
1.000
1.000
AR
mem
Full
comment:
AR
memo
­
field
trial
average
192
4A
Lettuce­
head
varieties
0.005300
1.000
1.000
PDP
195
O
Grapes­
leaves
0.013000
1.000
0.010
PDP
203
1CD
Artichokes­
jerusalem
0.005000
1.000
0.210
AR
mem
Full
comment:
AR
memo
­
field
trials
­
1/
2
LOD
240
6C
Peas
(garden)­
dry
0.050000
1.000
0.010
tolera
Full
comment:
tolerance
315
O
Grapes­
wine
and
sherry
0.013000
1.000
0.010
PDP
318
D
Milk­
nonfat
solids
0.000018
1.000
1.000
AR
319
D
Milk­
fat
solids
0.000018
1.000
1.000
AR
320
D
Milk
sugar
(lactose)
0.000018
1.000
1.000
AR
24
321
M
Beef­
meat
byproducts
0.000120
1.000
1.000
AR
322
M
Beef­
other
organ
meats
0.000120
1.000
1.000
AR
323
M
Beef­
dried
0.000010
1.920
1.000
AR
324
M
Beef­
fat
w/
o
bones
0.000040
1.000
1.000
AR
325
M
Beef­
kidney
0.000120
1.000
1.000
AR
326
M
Beef­
liver
0.000250
1.000
1.000
AR
327
M
Beef­
lean
(fat/
free)
w/
o
bones
0.000010
1.000
1.000
AR
328
M
Goat­
meat
byproducts
0.000120
1.000
1.000
AR
329
M
Goat­
other
organ
meats
0.000120
1.000
1.000
AR
330
M
Goat­
fat
w/
o
bone
0.000040
1.000
1.000
AR
331
M
Goat­
kidney
0.000120
1.000
1.000
AR
332
M
Goat­
liver
0.000250
1.000
1.000
AR
333
M
Goat­
lean
(fat/
free)
w/
o
bone
0.000010
1.000
1.000
AR
334
M
Horsemeat
0.000010
1.000
1.000
AR
336
M
Sheep­
meat
byproducts
0.000120
1.000
1.000
AR
337
M
Sheep­
other
organ
meats
0.000120
1.000
1.000
AR
338
M
Sheep­
fat
w/
o
bone
0.000040
1.000
1.000
AR
339
M
Sheep­
kidney
0.000120
1.000
1.000
AR
340
M
Sheep­
liver
0.000250
1.000
1.000
AR
341
M
Sheep­
lean
(fat
free)
w/
o
bone
0.000010
1.000
1.000
AR
342
M
Pork­
meat
byproducts
0.000120
1.000
1.000
AR
343
M
Pork­
other
organ
meats
0.000120
1.000
1.000
AR
344
M
Pork­
fat
w/
o
bone
0.000040
1.000
1.000
AR
345
M
Pork­
kidney
0.000120
1.000
1.000
AR
346
M
Pork­
liver
0.000250
1.000
1.000
AR
347
M
Pork­
lean
(fat
free)
w/
o
bone
0.000010
1.000
1.000
AR
355
P
Turkey­
byproducts
0.000140
1.000
1.000
AR
356
P
Turkey­
giblets
(liver)
0.000140
1.000
1.000
AR
357
P
Turkey­­
fat
w/
o
bones
0.000140
1.000
1.000
AR
358
P
Turkey­
lean/
fat
free
w/
o
bones
0.000140
1.000
1.000
AR
360
P
Poultry­
other­
lean
(fat
free)
w/
0.000140
1.000
1.000
AR
361
P
Poultry­
other­
giblets(
liver)
0.000140
1.000
1.000
AR
362
P
Poultry­
other­
fat
w/
o
bones
0.000140
1.000
1.000
AR
25
363
P
Eggs­
whole
0.000140
1.000
1.000
AR
364
P
Eggs­
white
only
0.000140
1.000
1.000
AR
365
P
Eggs­
yolk
only
0.000140
1.000
1.000
AR
366
P
Chicken­
byproducts
0.000140
1.000
1.000
AR
367
P
Chicken­
giblets(
liver)
0.000140
1.000
1.000
AR
368
P
Chicken­
fat
w/
o
bones
0.000140
1.000
1.000
AR
369
P
Chicken­
lean/
fat
free
w/
o
bones
0.000140
1.000
1.000
AR
377
11
Apples­
juice­
concentrate
0.013000
3.000
0.010
PDP
380
13A
Blackberries­
juice
0.010000
1.000
0.060
AR
mem
Full
comment:
AR
memo
­
field
trials
385
P
Chicken­
giblets
(excl.
liver)
0.000140
1.000
1.000
AR
389
O
Cranberries­
juice­
concentrate
0.050000
3.300
1.000
tolera
Full
comment:
tolerance
392
O
Grapes­
juice­
concentrate
0.013000
3.000
0.010
PDP
398
D
Milk­
based
water
0.000018
1.000
1.000
AR
402
12
Peaches­
juice
0.012000
1.000
0.010
PDP
404
11
Pears­
juice
0.011000
1.000
0.010
PDP
410
12
Apricot
juice
0.010000
1.000
0.010
other
Full
comment:
other
stone
fruits
424
M
Veal­
fat
w/
o
bones
0.000040
1.000
1.000
AR
425
M
Veal­
lean
(fat
free)
w/
o
bones
0.000010
1.000
1.000
AR
426
M
Veal­
kidney
0.000120
1.000
1.000
AR
427
M
Veal­
liver
0.000250
1.000
1.000
AR
428
M
Veal­
other
organ
meats
0.000120
1.000
1.000
AR
429
M
Veal­
dried
0.000010
1.920
1.000
AR
430
M
Veal­
meat
byproducts
0.000120
1.000
1.000
AR
449
P
Turkey­
other
organ
meats
0.000140
1.000
1.000
AR
492
O
Radicchio
2.000000
1.000
1.000
tolera
Full
comment:
tolerance