Document ID: EPA-HQ-OPP-2003-0360-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-29T20:28:37Z

Page
1
of
20
Reassessment
of
Commodity
Tolerances
that
are
Insignificant
Contributors
to
the
N­
methyl
Carbamate
Cumulative
Risk
June
29,
2006
I.
Background
and
Introduction
The
Food
Quality
Protection
Act
(
FQPA)
of
1996
requires
EPA
to
consider
available
information
concerning
the
cumulative
effects
on
human
health
resulting
from
exposure
to
multiple
chemicals
that
have
a
common
mechanism
of
toxicity.
In
2001,
EPA
concluded
that
the
N­
methyl
carbamate
(
NMC)
pesticides
share
a
common
mechanism
of
toxicity
and
therefore
require
a
cumulative
assessment
under
FQPA.
The
ten
pesticides
in
the
NMC
common
mechanism
group
are
aldicarb,
carbaryl,
carbofuran,
formetanate
hydrochloride,
methiocarb,
methomyl,
oxamyl,
pirimicarb,
propoxur,
and
thiodicarb.
The
Agency's
tolerance
reassessment
decisions
for
these
ten
NMC
pesticides
must
be
based
on
the
interim
tolerance
reassessment
decisions
for
each
individual
compound,
as
well
as
the
NMC
cumulative
assessment.
EPA
released
the
Preliminary
Assessment
of
Cumulative
Risk
from
N­
Methyl
Carbamate
Pesticides
in
August
2005.

As
part
of
its
ongoing
work
to
complete
the
NMC
cumulative
assessment,
EPA
has
determined
that
144
of
the
NMC
tolerances
are
insignificant
contributors
to
the
overall
dietary
exposure
to
the
NMCs.
These
commodity/
chemical
combinations,
when
considered
together,
make
such
a
minor
or
negligible
contribution
to
the
cumulative
risk
of
the
NMCs
that
the
addition
or
subtraction
of
those
uses
from
the
risk
cup
would
have
no
quantified
significance
and
would
therefore
have
no
impact
on
whether
the
NMCs
as
a
group
meet
the
FQPA
safety
standard
in
section
408(
b)(
2)
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA).
Because
these
uses,
by
themselves,
add
no
meaningful
risk,
and
because,
as
a
result,
they
will
have
no
effect
on
the
retention
or
revocation
of
other
NMC
tolerances,
EPA
intends
to
count
these
negligible
uses
as
reassessed
before
the
final
NMC
cumulative
assessment
is
issued.
As
described
in
detail
below,
the
Agency
has
taken
a
conservative,
health­
protective
approach
in
determining
the
criteria
for
this
analysis
and
is
thus
confident
that
these
tolerances
can
be
considered
to
be
reassessed
as
required
under
section
408(
q).

For
each
of
the
144
tolerances
being
reassessed
at
this
time,
the
Agency
has
issued
an
Interim
Reregistration
Eligibility
Decision
(
IRED)
which
found
that,
apart
from
consideration
of
the
potential
cumulative
risks
from
all
of
the
NMCs,
each
tolerance
would
meet
the
section
408(
b)(
2)
safety
standard.
EPA
has
also
considered
the
impact
of
these
tolerances
on
the
NMC
cumulative
risks
and
has
determined
that
they
make
an
insignificant
contribution
to
the
overall
risks
from
the
NMCs.
Therefore,
these
tolerances
will
be
maintained
regardless
of
the
outcome
of
the
NMC
cumulative
assessment
and
any
potential
regulatory
action
taken
as
a
result
of
that
assessment.
Accordingly,
EPA
believes
it
is
appropriate
to
consider
these
144
tolerances
reassessed
for
the
purposes
of
FQPA
section
408(
q)
as
of
today's
date,
June
29,
2006.
Draft,
Internal,
Deliberative.

Page
2
of
20
II.
NMC
Tolerances
Requiring
Reassessment
under
FQPA
FQPA
required
EPA
to
reassess
all
tolerances
in
existence
when
FQPA
became
law
on
August
3,
1996.
For
the
ten
pesticides
in
the
NMC
common
mechanism
group,
there
were
a
total
of
320
tolerances
that
required
reassessment
because
they
were
in
existence
on
the
day
that
FQPA
was
enacted.

To
date,
ninety­
two
of
the
320
NMC
tolerances
requiring
reassessment
under
FQPA
have
already
been
reassessed.
The
ninety­
two
tolerances
include
seven
methiocarb
tolerances,
eighty
methomyl
tolerances,
and
five
thiodicarb
tolerances.
The
methiocarb
tolerances
are
considered
reassessed
because
all
methiocarb
tolerances
were
revoked
in
1998.1
The
methomyl
and
thiodicarb
tolerances
are
considered
reassessed
because
EPA
issued
REDs
and
associated
tolerance
reassessment
decisions
for
methomyl
and
thiodicarb
in
1998,
prior
to
the
Agency's
determination
that
these
compounds
would
be
part
of
the
NMC
common
mechanism
group.
Please
see
Table
A.
6
in
the
Appendix
for
a
listing
of
the
reassessed
tolerances
for
methiocarb,
methomyl,
and
thiodicarb.

III.
Determination
of
Insignificant
Contributors
This
section
describes
the
procedures
EPA
followed
to
determine
the
number
of
NMC
tolerances
that
could
be
reassessed
based
on
an
insignificant
contribution
to
the
total
NMC
risk
in
food.
These
NMC
tolerances,
termed
Insignificant
Contributors,
are
the
subset
of
NMC
crop/
chemical
combinations
that,
when
expressed
in
terms
of
index­
chemical
equivalents
and
considered
together
as
part
of
a
cumulative
risk
assessment,
contribute
to
only
a
small
fraction
of
the
NMC
cumulative
risk
from
food.
Such
a
designation
to
specific
crop/
chemical
combinations2
permits
the
Agency
to
conclude
that
the
contribution
to
dietary
risk
of
the
NMC
tolerances
associated
with
these
crop/
chemical
combinations
is
relatively
small
and
that
these
tolerances
can
thus
be
reassessed
prior
to
EPA's
issuance
of
the
revised
NMC
cumulative
risk
assessment.
Only
tolerances
for
NMCs
with
completed
IREDs
were
eligible
for
designation
as
Insignificant
Contributors.

The
Agency
notes
that
this
is
a
screening­
level
assessment
designed
to
ensure
that
risk
will
not
be
underestimated.
EPA
fully
expects
that
additional
NMC
tolerances
will
be
eligible
for
reassessment
in
the
near
future
when
the
Agency
issues
the
revised
NMC
cumulative
assessment,
which
will
use
more
refined
information.

1
63
Federal
Register
57067,
October
26,
1998.
2
In
some
cases,
a
crop/
pesticide
combination
is
really
a
crop
group/
pesticide
combination
if
the
tolerance
is
applicable
to
a
crop
group.
For
example,
if
a
tolerance
were
established
for
a
given
pesticide
on
citrus
fruits,
this
would
be
considered
a
single
crop
(
group)/
pesticide
combination
despite
the
fact
that
the
tolerance
applies
to
all
crops
in
that
crop
group
(
e.
g.,
oranges,
grapefruits,
lemons,
limes,
etc.)
Draft,
Internal,
Deliberative.

Page
3
of
20
Hazard/
Relative
Potency
Factors
In
the
current
analysis,
EPA
used
the
relative
potency
factors
(
RPFs)
and
points
of
departure
established
in
the
preliminary
cumulative
risk
assessment
(
August
2005)
for
brain
cholinesterase
inhibition.
For
details
about
the
data
and
methods
used
to
derive
these
values,
please
refer
to
Chapter
I.
B
and
associated
appendices
and
data
sets
in
the
preliminary
cumulative
risk
assessment
(
August
2005)
(
available
at
http://
www.
epa.
gov/
pesticides/
cumulative).
The
Agency
used
benchmark
dose
(
BMD)
methods
to
estimate
the
dose
expected
to
result
in
10%
brain
cholinesterase
inhibition
(
BMD10)
in
adult
rats
following
acute
exposures.
EPA
calculated
RPFs
by
dividing
BMDs
for
specific
pesticides
by
the
BMD
for
the
index
chemical,
oxamyl.

The
Agency
anticipates
that
most
of
the
RPFs
and
points
of
departure
used
in
this
Insignificant
Contributors
analysis
(
and
also
in
the
August
2005
preliminary
NMC
cumulative
assessment)
will
be
substantially
similar
to
those
that
will
be
used
in
the
forthcoming
revised
NMC
cumulative
assessment.
If
some
values
do
differ,
it
will
be
because
the
revised
cumulative
assessment
uses
values
that
have
been
further
refined
based
on
recently­
submitted
data.

Dietary
Exposure
EPA
began
the
process
of
identifying
Insignificant
Contributors
by
performing
a
baseline
dietary
exposure
analysis.
The
baseline
assessment
for
the
Insignificant
Contributors
analysis
used
the
same
residue
and
consumption
data
from
the
August
2005
preliminary
NMC
cumulative
risk
assessment
(
except
that
2004
PDP
data
were
also
included),
and
it
also
included
similar
assumptions
about
processing
factors,
zero
residues,
and
crop
translations.
3
EPA
used
pesticide
residues
reported
in
PDP
from
1994­
2004
(
registered
or
not)
from
all
ten
NMC
pesticides
for
this
Insignificant
Contributors
analysis.
The
PDP
residue
data
were
further
extended
(
translated)
to
other
commodities
identified
as
reasonable
for
translation
of
pesticide
residue
data
per
Agency
policy.
4
Residues
from
fish
and
eggs
were
not
included
in
this
assessment
and,
based
on
examination
of
FDA
monitoring
results,
are
not
anticipated
to
contribute
significantly
to
risk
associated
with
the
NMC
pesticides.
However,
recent
PDP
data
on
beef,
pork,
and
poultry
were
included
in
the
assessment.
Together,
the
food
commodities
in
the
PDP
program
and
those
commodities
to
which
the
residues
are
translated
account
for
greater
than
90%­
95%
of
children's
diets.
Exposure
for
children
1­
2
years
of
age
was
earlier
identified
as
of
specific
interest
since
this
was
the
subgroup
with
the
highest
exposure
in
the
preliminary
NMC
cumulative
risk
assessment.
Dietary
(
food
only)
exposure
was
estimated
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
software
which
incorporates
the
1994­
96/
1998
USDA
continuing
Surveys
for
Food
Intake
by
Individuals
(
CSFII)
data
and
EPA's
Revised
Food
3
The
key
differences
between
the
food
files
used
in
the
August
2005
preliminary
NMC
cumulative
risk
assessment
and
those
used
in
the
Insignificant
Contributors
analysis
are:
(
1)
PDP
residues
were
updated
to
include
the
most
recent
PDP
data
(
through
2004)
including
additional
data
on
methomyl
on
strawberries;
(
2)
processing
factors
were
updated
to
account
for
new
food
forms
that
appeared
in
the
new
PDP
data;
and
(
3)
aldicarb
data
on
potatoes
was
modified
by
deleting
the
pre­
1996
aldicarb
data
on
potatoes.
The
deletion
of
pre­
1996
aldicarb
data
is
appropriate
because
the
use
of
aldicarb
on
potatoes
was
voluntarily
suspended
in
1990.
The
use
was
reinstated
in
1995.
Accordingly,
PDP
data
beginning
in
1996
is
most
appropriate
to
reflect
current
aldicarb
use
on
potatoes.
4
OPP/
HED
SOP
99.3.
Memorandum
from
Margaret
Stasikowski,
Health
Effects
Division
to
Staff.
"
Translation
of
Monitoring
Data."
HED
Standard
Operating
Procedure
99.3
(
3/
26/
99),
USEPA.
Draft,
Internal,
Deliberative.

Page
4
of
20
Commodity
Intake
Database
(
Revised
FCID).
For
more
information,
please
refer
to
Chapter
I.
C
and
the
associated
appendices
and
datasets
in
the
preliminary
NMC
cumulative
risk
assessment.

As
described
in
more
detail
in
the
preliminary
NMC
cumulative
assessment,
EPA
adjusted
the
amount
of
residue
of
each
chemical
by
multiplying
by
an
RPF
to
obtain
the
equivalent
residue
of
an
index
chemical
and
summed
these
within
each
sample.
The
new
calculated
residue
is
termed
the
Index
Equivalent
Residue
(
ResidueIE)
and
the
exposure
value
resulting
from
combining
ResidueIE
and
consumption
is
termed
the
Index
Equivalent
Exposure
(
ExposureIE).
EPA
calculated
Margins
of
Exposure
(
MOEs)
by
comparing
the
potency
adjusted
exposure
to
the
point
of
departure
for
the
index
chemical
(
ie,
oxamyl).

Figure
1
below
provides
a
graphical
description
of
the
major
contributors
to
the
baseline
cumulative
dietary
risk
when
all
10
NMCs
are
included.

Figure
1.
Plot
of
major
contributors
to
the
NMC
cumulative
risk
from
food5
Relative
Contribution
of
Crop/
Chemical
Pairs
to
Top
0.2
Percentile
of
Cumulative
Distribution
for
Children
1­
2
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%

Strawberry
Potato
Grape
Peach
Nectarine
Apple
Squash,
summer
Orange
Cucumber
Plum
Watermelon
Methiocarb
Carbofuran
Oxamyl
Formetanate
hydrochloride
Carbaryl
Aldicarb
Methomyl
5
Three
NMCs
are
not
included
in
the
legend
 
propoxur,
thiodicarb,
and
pirimicarb.
These
pesticides
were
either
not
detected
in
the
PDP
data
or
were
detected
at
such
low
concentrations
and
frequencies
that
they
are
not
sufficient
contributors
to
appear
on
the
graph.
Draft,
Internal,
Deliberative.

Page
5
of
20
Criteria
for
Designation
as
an
Insignificant
Contributor
EPA
established
several
criteria
for
designating
crop/
chemical
combinations
as
Insignificant
Contributors.

1.
Crop/
chemical
combinations
that
produce
an
MOE
greater
than
1000
when
considered
together
are
Insignificant
Contributor
tolerances.

 
The
Agency
selected
1000
as
a
highly­
conservative
point
of
comparison,
incorporating
a
10x
for
interspecies
extrapolation,
a
10x
for
intraspecies
extrapolation,
and
a
10x
FQPA
safety
factor
for
protection
of
infants
and
children.
The
assignment
of
a
value
of
10x
for
the
interspecies
extrapolation
factor
is
conservative
given
that
human
studies
are
available
to
inform
the
chemical­
specific
interspecies
factor
for
some
NMCs.
6
The
assignment
of
a
value
of
10x
for
the
FQPA
safety
factor
is
also
conservative
given
that
there
are
studies
available
for
some
NMCs
which
compare
the
relative
sensitivity
in
juvenile
and
adult
rats,
and
which
will
be
used
to
inform
the
chemical­
specific
FQPA
factors.
7
2.
Only
tolerances
for
chemicals
with
completed
IREDs
are
eligible
for
designation
as
Insignificant
Contributors.

3.
Any
pesticide/
crop
combination
with
NO
detects
in
all
years
of
PDP
monitoring
was
considered
an
Insignificant
Contributor.

4.
Meat,
Milk,
Poultry
and
Egg
tolerances
for
which
exposure
is
deemed
negligible
were
considered
Insignificant
Contributors.

5.
Livestock
feedstuffs
associated
with
the
meat,
milk,
poultry,
and
egg
samples
with
few,
small,
or
no
detectable
residues
were
considered
Insignificant
Contributors.

Procedure
for
Identifying
the
Insignificant
Contributors
As
described
in
section
II
of
this
document,
there
were
a
total
of
320
NMC
tolerances
that
required
reassessment
because
they
were
in
existence
on
the
day
that
FQPA
become
law.
Ninety­
two
of
the
NMC
tolerances
have
already
been
reassessed
(
7
methiocarb
tolerances,
80
methomyl
tolerances,
and
5
thiodicarb
tolerances).
So,
EPA
used
228
tolerances
as
the
starting
point
for
the
`
Insignificant
Contributors'
analysis.

6
Human
studies
for
aldicarb,
methomyl,
and
oxamyl
were
reviewed
by
the
Human
Studies
Review
Board
(
HSRB)
in
April,
2006
and
determined
to
be
appropriate
for
use
in
the
NMC
Cumulative
Risk
Assessment.
At
the
May,
2006
meeting
of
the
HSRB,
the
board
did
not
support
the
use
of
the
carbofuran
oral
human
study
for
informing
the
inter­
species
factor.
7
Comparative
cholinesterase
studies
in
adult
and
juvenile
rats
are
available
for
carbofuran,
formetanate
HCl,
methomyl,
and
oxamyl
which
evaluate
peak
and
time
course
brain
ChE
inhibition.
A
dose­
response
study
with
adult
and
juvenile
rats
exposed
at
peak
time
of
effect
is
available
for
aldicarb.
Draft,
Internal,
Deliberative.

Page
6
of
20
EPA
notes,
however,
that
some
methomyl
uses
appear
to
be
contributors
to
the
cumulative
food
exposure
assessment.
Thus,
the
previously­
reassessed
methomyl
tolerances
were
reintroduced
into
the
analysis
and
methomyl
is
included
in
the
cumulative
dietary
risk
analysis
described
below.
Methomyl
does
in
fact
contribute
to
the
MOEs
provided
in
Table
1,
and
the
tolerance
count
is
given
in
two
different
ways
in
Table
1,
to
reflect
the
status
of
the
methomyl
tolerances.

EPA
has
developed
the
list
of
Insignificant
Contributor
tolerances
using
the
stepwise
approach
described
below.

1.
EPA
performed
a
baseline
cumulative
dietary
analysis
using
all
10
NMCs.

2.
EPA
removed
all
tolerances
for
aldicarb
and
carbofuran.
The
IREDs
for
these
two
NMCs
have
not
yet
been
completed
as
of
June
29,
2006,
and
therefore
these
tolerances
are
ineligible
for
Insignificant
Contributor
designation.

3.
EPA
performed
a
cumulative
dietary
analysis
of
the
remaining
potential
Insignificant
Contributor
crop/
chemical
combinations.
The
results
are
displayed
in
Figure
2.
The
plot
provides
a
rank
order
of
the
chemical­
commodity
combinations
that
contribute
to
the
NMC
cumulative
food
exposure
assessment.

4.
EPA
removed
from
the
analysis,
in
groups
of
several
tolerances,
the
crop/
chemical
combinations
which
made
the
highest
contribution
to
the
cumulative
risk.
The
DEEMestimated
MOEs
that
resulted
from
the
sequential
removal
of
each
group
of
tolerances
are
provided
in
Table
1.
The
"
removed"
crop/
chemical
combinations
in
column
1
of
Table
1
are
not
deemed
Insignificant
Contributors
at
this
time
because
they
potentially
contribute
to
NMC
cumulative
risk
(
i.
e.,
they
are
responsible,
jointly,
for
MOEs
less
than
1000).

5.
EPA
repeated
the
removal
process
described
in
step
4
until
the
MOEs
at
the
99.9th
percentile
of
exposure
exceeded
1000
for
children
age
1­
2,
the
population
subgroup
determined
to
have
the
lowest
MOEs.
EPA's
analysis
of
risk
to
this
population
subgroup
is
therefore
protective
of
all
other
population
subgroups
groups.

6.
All
remaining
crop/
chemical
combinations
are
considered
Insignificant
Contributors
since,
when
considered
together,
they
contribute
only
minor
amounts
to
risk,
with
MOEs
of
greater
than
1000.
Draft,
Internal,
Deliberative.

Page
7
of
20
Figure
2.
Plot
of
major
contributors
to
the
NMC
cumulative
risk
from
food,
excluding
aldicarb
and
carbofuran
Exposure
at
the
99.8th
Percentile
and
Above
for
Children
1­
2
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
0.5
Strawberry
Grape
Peach
Nectarine
Apple
Plum
Watermelon
Squash,
summer
Spinach
Cucumber
Apricot
Lettuce
Pear
Cabbage
Cantaloupe
Asparagus
Squash,
winter
Brussels
sprouts
Orange
Cherry
Celery
Honeydew
melon
Pepper,
bell
Endive
Tomato
Methiocarb
Thiodicarb
Oxamyl
Formetanate
hydrochloride
Carbaryl
Methomyl
Sum
of
H
X
F
Food
PARENTPESTICIDE
IV.
Results
of
the
Insignificant
Contributors
Analysis
Table
1
presents
a
summary
of
the
results
of
the
Insignificant
Contributors
analysis.
The
table
shows,
sequentially,
the
crop/
chemical
combinations
that
were
removed
at
each
step
in
the
process.
The
table
also
provides
the
number
of
tolerances
removed
that
were
associated
with
the
these
crop/
chemical
combinations,
the
number
of
tolerances
that
remain,
the
associated
MOE,
as
well
as
a
reference
run
identification
number
for
the
DEEM
computer
files
used
to
produce
these
exposure
estimates
(
the
DEEM
files
are
provided
on
the
NMC
cumulative
web
page
at
www.
epa.
gov/
pesticides/
cumulative).
Page
8
of
20
Table
1.
Summary
of
Insignificant
Contributors
analysis
conducted
with
DEEM
Number
of
Tolerances
Scenario*
Number
of
Crop/
Chemical
Combinations
Removed
NMC
tolerances
(
excluding
those
previously
assessed)
All
NMC
tolerances
MOE
Ref.

Run
ID
Baseline
(
all
NMCs)
0
228
320
31
1
Remove
all
aldicarb
and
carbofuran
crop/
chemical
combinations
62
166
258
49
2
Remove
12
crop/
chemical
combinations
 
methomyl
on
strawberry,
cucurbits,
and
grape;
carbaryl
on
strawberry,
pome
fruit,
plum,
and
peach;
formetanate
hydrochloride
on
nectarine,
plum
(
no
tolerance),
and
peach;
and
oxamyl
on
summer
squash
and
cucumber.
12
158
247
154
3
Remove
7
crop/
chemical
combinations
 
carbaryl
on
grape;
formetanate
hydrochloride
on
apple;
methomyl
on
spinach,
lettuce,
cabbage,
and
peach;
oxamyl
on
apple
7
155
240
348
4
Remove
6
crop/
chemical
combinations
 
formetanate
hydrochloride
on
pear;
carbaryl
on
apricot
and
beans;

and
oxamyl
on
celery
and
watermelon;
methomyl
on
plum
(
no
tolerance)
6
150
235
519
5
Remove
6
crop/
chemical
combinations
 
formetanate
hydrochloride
on
apricot
(
no
tolerance);
carbaryl
on
citrus
fruit
and
peppers;
oxamyl
on
bell
pepper;

methomyl
on
apple
and
succulent
beans
6
147
230
783
6
Remove
5
crop/
chemical
combinations
 
carbaryl
on
nectarine
and
cherry;
oxamyl
on
pear;
methomyl
on
orange
and
tomato
5
144
225
1224
7
*
Italicized
crop/
chemical
combinations
are
ones
for
which
there
are
no
tolerances,
or
for
which
tolerances
were
previously
reassessed
(
i.
e.,
methomyl).
Page
9
of
20
A
total
of
144
of
the
228
NMC
tolerances
that
remain
to
be
reassessed
meet
EPA's
criteria
for
designation
as
Insignificant
Contributors
due
to
no
exposure
or
low
exposure.
A
total
of
84
tolerances
do
not
meet
the
Agency's
criteria
for
designation
as
Insignificant
Contributors,
either
because
they
are
aldicarb
or
carbofuran
tolerances,
or
because
their
inclusion
in
the
analysis
results
in
MOEs
of
less
than
1000.
Please
see
Table
2,
below,
for
a
summary
of
the
tolerance
breakdown.
(
A
listing
of
the
144
tolerances
being
reassessed
at
this
time
appears
in
Table
A.
1.
A
listing
of
the
84
tolerances
not
meeting
the
Insignificant
Contributors
criteria
appears
in
Tables
A.
4
and
A.
5.)
EPA
may
require
mitigation
for
some
of
the
uses
associated
with
the
84
tolerances
not
meeting
the
Insignificant
Contributors
criteria,
in
connection
with
its
completion
of
the
outstanding
IREDS
and
release
of
the
revised
NMC
cumulative
risk
assessment.

Sixty­
nine
of
the
80
previously­
reassessed
methomyl
tolerances
meet
EPA's
criteria
for
designation
as
`
Insignificant
Contributors'
due
to
no
exposure
or
low
exposure.
(
A
listing
of
these
69
tolerances
appears
in
Table
A.
2.)
However,
eleven
methomyl
tolerances
do
not
meet
the
`
Insignificant
Contributors'
criteria
because
the
Agency
needed
to
remove
them
from
the
analysis
in
order
to
reach
MOEs
of
greater
than
1000.
(
A
listing
of
these
11
tolerances
appears
in
Table
A.
3.)
Notwithstanding
the
fact
that
the
methomyl
tolerances
were
reassessed
in
connection
with
the
1998
methomyl
RED,
the
Agency
may
require
additional
mitigation
for
some
of
the
methomyl
uses
associated
with
the
eleven
methomyl
tolerances
that
do
not
meet
the
`
Insignificant
Contributors'
criteria.
The
Agency
will
make
its
decision
about
the
necessity
of
mitigation
in
conjunction
with
its
completion
of
the
final
NMC
cumulative
risk
assessment.

The
Agency
notes
that
this
is
a
screening­
level
assessment
designed
to
ensure
that
risk
is
not
underestimated.
By
selecting
a
point­
of­
comparison
value
of
1000,
the
Agency
has
produced
a
conservative
assessment
that
assumes
that
the
interspecies,
intraspecies,
and
FQPA
factors
will
be
assigned
values
of
10.
These
values
are
conservative
because
the
Agency
anticipates
that
the
interspecies
and/
or
FQPA
safety
factors
for
some
of
the
NMCs
will
be
assigned
lower
values
in
the
revised
NMC
cumulative
assessment,
based
on
recently­
submitted
data.

Following
the
completion
of
the
revised
NMC
cumulative
risk
assessment,
more
tolerances
are
expected
to
be
eligible
for
reassessment.
However,
for
purposes
of
this
screening­
level
analysis,
the
Agency
has
elected
to
assign
maximum
safety
factor
values
to
ensure
that
risk
is
not
underestimated.
Draft,
Internal,
Deliberative.

Page
10
of
20
Table
2.
Summary
of
tolerances
designated
as
`
Insignificant
Contributors'
compared
with
tolerances
excluded
from
the
assessment
Insignificant
Contributors
Tolerances
Excluded
from
the
Assessment
144
tolerances
 
11
tolerances:
Crop/
chemical
combinations
with
NO
detects
in
all
years
of
PDP
monitoring
[
listed
in
Table
A.
1
as
"
ND"]

 
27
tolerances:
Meat,
milk,
poultry
and
egg
tolerances
for
which
exposure
is
deemed
negligible
[
listed
in
Table
A.
1
as
"
M"]

 
32
tolerances:
Livestock
feed
stuffs
associated
with
the
meat,
milk,
poultry,
and
egg
samples
for
which
few,
small,
or
no
detectable
residues
were
found
[
listed
in
Table
A.
1
as
"
FS"]

 
74
tolerances:
Low
contributors
a
to
cumulative
risk
(
i.
e.,
MOEs
of
greater
than
1000
when
considered
together
)
[
listed
in
Table
A.
1
as
"
LC"]
84
Tolerances
 
62
tolerances
not
eligible
(
aldicarb
and
carbofuran)

52
low
contributorsa
10
high
contributors
62
TOTAL
23
aldicarb
39
carbofuran
62
TOTAL
[
Listed
in
Table
A.
5]

 
22
tolerances
not
eligible
(
high
contributors)

[
Listed
in
Table
A.
4]
11
carbaryl
4
formetanate
HCl
7
oxamyl
22
TOTAL
a
Low
contributors
are
those
tolerances
that
produce
MOEs
of
>
1000
when
the
high
contributors
are
not
included
in
the
analysis.

V.
Conclusions
EPA
has
concluded
that
the
144
tolerances
identified
in
this
document
as
Insignificant
Contributors
to
the
NMC
cumulative
risk
meet
the
safety
standard
of
section
408(
b)(
2)
of
the
FFDCA,
and
may
therefore
be
considered
reassessed,
pursuant
to
section
408(
q)
as
of
today's
date,
June
29,
2006.

As
a
result
of
this
decision,
there
are
84
NMC
tolerances
that
remain
to
be
reassessed.
These
remaining
84
tolerances
will
be
reassessed
when
EPA
completes
the
IREDs
for
aldicarb
and
carbofuran
and
issues
the
final
NMC
cumulative
risk
assessment.
Draft,
Internal,
Deliberative.

Page
11
of
20
APPENDIX
Table
A.
1
Insignificant
Contributor
Tolerances
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Reason
For
Insignificant
Contributor
Status1
Carbaryl
Alfalfa
FS
Carbaryl
Alfalfa,
Hay
FS
Carbaryl
Almonds
LC
Carbaryl
Almonds,
Hulls
FS
Carbaryl
Asparagus
LC
Carbaryl
Bananas
ND
Carbaryl
Beets,
Garden,
Roots
LC
Carbaryl
Beets,
Garden,
Tops
FS
Carbaryl
Beets,
Sugar
LC
Carbaryl
Blackberries
LC
Carbaryl
Blueberries
LC
Carbaryl
Boysenberries
LC
Carbaryl
Broccoli
LC
Carbaryl
Brussels
Sprouts
LC
Carbaryl
Cabbage
LC
Carbaryl
Cabbage,
Chinese
LC
Carbaryl
Carrots
LC
Carbaryl
Cattle,
Fat
M
Carbaryl
Cattle,
Kidney
M
Carbaryl
Cattle,
Liver
M
Carbaryl
Cattle,
Meat
By
Products
(
excluding
kidney
&
liver)
M
Carbaryl
Cattle,
Meat
M
Carbaryl
Cauliflower
ND
Carbaryl
Celery
LC
Carbaryl
Chestnuts
LC
Carbaryl
Clover
FS
Carbaryl
Clover,
Hay
FS
Carbaryl
Collards
LC
Carbaryl
Corn
(
including
sweet)
(
kernel
+
cobs
w/
husks
removed)
ND
Carbaryl
Corn,
Fodder
FS
Carbaryl
Corn,
Forage
FS
Carbaryl
Cotton,
Seed
FS
Carbaryl
Cranberries
LC
Carbaryl
Cucumbers
LC
Carbaryl
Dandelions
LC
Carbaryl
Dewberries
LC
Carbaryl
Dill
LC
Carbaryl
Eggplant
LC
Carbaryl
Endive
(
Escarole)
LC
Carbaryl
Filberts
(
Hazelnuts)
LC
Carbaryl
Flax,
Seed
LC
Carbaryl
Goats,
Fat
M
Draft,
Internal,
Deliberative.

Page
12
of
20
Table
A.
1
Insignificant
Contributor
Tolerances
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Reason
For
Insignificant
Contributor
Status1
Carbaryl
Goats,
Kidney
M
Carbaryl
Goats,
Liver
M
Carbaryl
Goats,
Meat
By
Products
(
excluding
kidney
&
liver)
M
Carbaryl
Goats,
Meat
M
Carbaryl
Grasses
FS
Carbaryl
Grasses,
Hay
FS
Carbaryl
Hogs,
Fat
M
Carbaryl
Hogs,
Kidney
M
Carbaryl
Hogs,
Liver
M
Carbaryl
Hogs,
Meat
By
Products
M
Carbaryl
Hogs,
Meat
M
Carbaryl
Horseradish
LC
Carbaryl
Horses,
Fat
M
Carbaryl
Horses,
Kidney
M
Carbaryl
Horses,
Liver
M
Carbaryl
Horses,
Meat
By
Products
(
excluding
kidney
&
liver)
M
Carbaryl
Horses,
Meat
M
Carbaryl
Kale
LC
Carbaryl
Kohlrabi
LC
Carbaryl
Lentils
ND
Carbaryl
Lettuce
LC
Carbaryl
Loganberries
LC
Carbary
Melons
LC
Carbaryl
Milk
M
Carbaryl
Millet,
Proso,
Grain
FS
Carbaryl
Millet,
Proso,
Straw
FS
Carbaryl
Mustard,
Greens
LC
Carbaryl
Okra
LC
Carbaryl
Olives
LC
Carbaryl
Oysters
M
Carbaryl
Parsley
LC
Carbaryl
Parsnips
LC
Carbaryl
Peanuts
LC
Carbaryl
Peanuts,
Hay
FS
Carbaryl
Peas,
Cowpeas
LC
Carbaryl
Peas,
Cowpeas,
Forage
FS
Carbaryl
Peas,
Cowpeas,
Hay
FS
Carbaryl
Peas,
Vines
FS
Carbaryl
Peas,
with
Pods
LC
Carbaryl
Pecans
LC
Carbaryl
Pineapples
LC
Carbaryl
Pistachios
LC
Carbaryl
Potatoes
ND
Carbaryl
Prickly
Pear
Cactus,
Fruit
LC
Carbaryl
Prickly
Pear
Cactus,
Pads
LC
Draft,
Internal,
Deliberative.

Page
13
of
20
Table
A.
1
Insignificant
Contributor
Tolerances
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Reason
For
Insignificant
Contributor
Status1
Carbaryl
Pumpkins
LC
Carbaryl
Radishes
LC
Carbaryl
Raspberries
LC
Carbaryl
Rice
LC
Carbaryl
Rice,
Straw
FS
Carbaryl
Rutabagas
LC
Carbaryl
Salsify,
Roots
LC
Carbaryl
Salsify,
Tops
LC
Carbaryl
Sheep,
Fat
M
Carbaryl
Sheep,
Kidney
M
Carbaryl
Sheep,
Liver
M
Carbaryl
Sheep,
Meat
By
Products
(
kidney
&
liver)
M
Carbaryl
Sheep,
Meat
M
Carbaryl
Sorghum,
Forage
FS
Carbaryl
Sorghum,
Grain
FS
Carbaryl
Soybeans
ND
Carbaryl
Soybeans,
Forage
FS
Carbaryl
Soybeans,
Hay
FS
Carbaryl
Spinach
LC
Carbaryl
Squash,
Summer
LC
Carbaryl
Squash,
Winter
LC
Carbaryl
Sunflower,
Seeds
LC
Carbaryl
Sweet
Potatoes
LC
Carbaryl
Swiss
Chard
LC
Carbaryl
Tomatoes
LC
Carbaryl
Trefoil,
Birdsfoot,
Forage
FS
Carbaryl
Trefoil,
Birdsfoot,
Hay
FS
Carbaryl
Turnips,
Roots
LC
Carbaryl
Turnips,
Tops
FS
Carbaryl
Walnuts
LC
Carbaryl
Wheat,
Fodder,
Green
FS
Carbaryl
Wheat,
Grain
FS
Carbaryl
Wheat,
Straw
FS
Formetanate
HCl
Grapefruit
LC
Formetanate
HCl
Lemons
LC
Formetanate
HCl
Limes
LC
Formetanate
HCl
Oranges
LC
Formetanate
HCl
Tangerines
LC
Oxamyl
Bananas
ND
Oxamyl
Cantaloupes
LC
Oxamyl
Citrus
Fruits
LC
Oxamyl
Cotton,
Seed
LC
Oxamyl
Eggplant
LC
Oxamyl
Honeydew
LC
Oxamyl
Peanuts
LC
Draft,
Internal,
Deliberative.

Page
14
of
20
Table
A.
1
Insignificant
Contributor
Tolerances
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Reason
For
Insignificant
Contributor
Status1
Oxamyl
Peanuts,
Hay
FS
Oxamyl
Peppermint,
Hay
FS
Oxamyl
Peppers,
Non­
Bell
LC
Oxamyl
Pineapples
ND
Oxamyl
Pineapples,
Bran
FS
Oxamyl
Potatoes
ND
Oxamyl
Pumpkins
LC
Oxamyl
Soybeans
ND
Oxamyl
Spearmint,
Hay
FS
Oxamyl
Squash,
Winter
LC
Oxamyl
Tomatoes
LC
Oxamyl
Vegetables,
Root
Crop
ND
1
FS
=
Feed
Stuff;
LC
=
Low
Contribution;
M
=
Meat,
Milk,
Poultry,
Eggs;
ND
=
No
detects
in
PDP.

Table
A.
2
Previously
reassessed
methomyl
tolerances
which
are
`
Insignificant
Contributors'
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Methomyl
Alfalfa
Methomyl
Asparagus
Methomyl
Avocados
Methomyl
Barley,
grain
Methomyl
Barley,
hay
Methomyl
Barley,
straw
Methomyl
Beans,
dry
Methomyl
Beets,
Tops
Methomyl
Blueberries
Methomyl
Broccoli
Methomyl
Brussels
Sprouts
Methomyl
Cabbage,
Chinese
Methomyl
Cauliflower
Methomyl
Celery
Methomyl
Collards
Methomyl
Corn,
Fodder
Methomyl
Corn,
Forage
Methomyl
Corn,
fresh
(
inc
sweet,
kernel
plus
cob
with
husks
removed)

Methomyl
Corn,
grain
(
inc
pop)

Methomyl
Cotton,
seed
Methomyl
Dandelions
Methomyl
Endive
(
Escarole)

Methomyl
Grapefruit
Methomyl
Grasses,
Bermuda
Methomyl
Grasses,
Bermuda,
hay
(
dry,
dehydrated)

Methomyl
Kale
Methomyl
Leeks
Methomyl
Lemons
Draft,
Internal,
Deliberative.

Page
15
of
20
Table
A.
2
Previously
reassessed
methomyl
tolerances
which
are
`
Insignificant
Contributors'
due
to
no
exposure
or
low
exposure
Pesticide
Name
Commodity
Name
Methomyl
Lentils
Methomyl
Mint,
hay
Methomyl
Mustard,
greens
Methomyl
Nectarines
Methomyl
Oats,
forage
Methomyl
Oats,
grain
Methomyl
Oats,
hay
Methomyl
Oats,
straw
Methomyl
Onions,
green
Methomyl
Parsley
Methomyl
Peanuts
Methomyl
Pears
Methomyl
Peas
Methomyl
Peas,
vines
Methomyl
Pecans
Methomyl
Peppers
Methomyl
Pomegranates
Methomyl
Rye,
forage
Methomyl
Rye,
grain
Methomyl
Rye,
straw
Methomyl
Sorghum,
forage
Methomyl
Sorghum,
grain
Methomyl
Soybeans
Methomyl
Soybeans,
forage
Methomyl
Swiss
chard
Methomyl
Tangerines
Methomyl
Turnips,
greens,
tops
Methomyl
Vegetables,
brassica,
leafy,
group
5
Methomyl
Vegetables,
fruiting
Methomyl
Vegetables,
leafy
Methomyl
Wheat,
forage
Methomyl
Wheat,
grain
Methomyl
Wheat,
hay
Methomyl
Wheat,
straw
Table
A.
3
Previously
reassessed
methomyl
tolerances
which
are
not
`
Insignificant
Contributors'
due
to
high
contribution
to
exposure
Pesticide
Name
Commodity
Name
Methomyl
Apple
Methomyl
Beans,
succulent
Methomyl
Cabbage
Methomyl
Cucurbits
Methomyl
Grapes
Methomyl
Lettuce
Draft,
Internal,
Deliberative.

Page
16
of
20
Table
A.
3
Previously
reassessed
methomyl
tolerances
which
are
not
`
Insignificant
Contributors'
due
to
high
contribution
to
exposure
Pesticide
Name
Commodity
Name
Methomyl
Oranges
Methomyl
Peaches
Methomyl
Spinach
Methomyl
Strawberries
Methomyl
Tomatoes
Table
A.
4
Tolerances
which
require
reassessment
that
are
not
`
Insignificant
Contributors'
due
to
high
contribution
to
exposure
Pesticide
Name
Commodity
Name
Carbaryl
Apricots
Carbaryl
Beans
Carbaryl
Cherries
Carbaryl
Citrus
Fruits
Carbaryl
Fruits,
Pome
Carbaryl
Grapes
Carbaryl
Nectarines
Carbaryl
Peaches
Carbaryl
Peppers
Carbaryl
Plums
(
fresh
prunes)

Carbaryl
Strawberries
Formetanate
HCl
Apples
Formetanate
HCl
Nectarines
Formetanate
HCl
Peaches
Formetanate
HCl
Pears
Oxamyl
Apples
Oxamyl
Celery
Oxamyl
Cucumbers
Oxamyl
Pears
Oxamyl
Peppers,
Bell
Oxamyl
Squash,
Summer
Oxamyl
Watermelons
Table
A.
5
Tolerances
which
require
reassessment
that
are
not
`
Insignificant
Contributors'
because
the
associated
IREDs
have
not
been
completed
Pesticide
Name
High
Contributor
versus
Low
Contributor
Commodity
Name
Aldicarb
High
Grapefruit
Aldicarb
High
Oranges
Aldicarb
High
Potatoes
Aldicarb
High
Sweet
Potatoes
Aldicarb
Low
Beans,
Dry
Aldicarb
Low
Beets,
Sugar
Aldicarb
Low
Beets,
Sugar,
Tops
Draft,
Internal,
Deliberative.

Page
17
of
20
Table
A.
5
Tolerances
which
require
reassessment
that
are
not
`
Insignificant
Contributors'
because
the
associated
IREDs
have
not
been
completed
Pesticide
Name
High
Contributor
versus
Low
Contributor
Commodity
Name
Aldicarb
Low
Citrus,
Dried
Pulp
Aldicarb
Low
Coffee
Beans
Aldicarb
Low
Cotton,
Seed
Aldicarb
Low
Cotton,
Seed,
Hulls
Aldicarb
Low
Lemons
Aldicarb
Low
Limes
Aldicarb
Low
Peanuts
Aldicarb
Low
Pecans
Aldicarb
Low
Sorghum,
Grain
Aldicarb
Low
Sorghum,
Bran
Aldicarb
Low
Sorghum,
Bran
Aldicarb
Low
Sorghum,
Grain,
Fodder
Aldicarb
Low
Soybeans
Aldicarb
Low
Sugarcane
Aldicarb
Low
Sugarcane,
Fodder
Aldicarb
Low
Sugarcane,
Forage
Carbofuran
High
Cucumbers
Carbofuran
High
Grapes
Carbofuran
High
Melons
Carbofuran
High
Potatoes
Carbofuran
High
Raisins
Carbofuran
High
Squash
Carbofuran
Low
Alfalfa,
Fresh
Carbofuran
Low
Alfalfa,
Hay
Carbofuran
Low
Artichokes
Carbofuran
Low
Bananas
Carbofuran
Low
Barley,
Grain
Carbofuran
Low
Barley,
Straw
Carbofuran
Low
Beets,
Sugar
Carbofuran
Low
Beets,
Sugar,
Tops
Carbofuran
Low
Coffee
Beans
Carbofuran
Low
Corn,
Fodder
Carbofuran
Low
Corn,
Forage
Carbofuran
Low
Corn,
Fresh
(
inc.
sweet)
(
kernel
+
cob
w/
husks
removed)

Carbofuran
Low
Corn,
Grain
(
including
popcorn)

Carbofuran
Low
Cotton,
Seed
Carbofuran
Low
Cranberries
Carbofuran
Low
Milk
Carbofuran
Low
Oats,
Grain
Carbofuran
Low
Oats,
Straw
Carbofuran
Low
Peppers
Carbofuran
Low
Pumpkins
Carbofuran
Low
Rice
Carbofuran
Low
Rice,
Straw
Carbofuran
Low
Sorghum,
Fodder
Draft,
Internal,
Deliberative.

Page
18
of
20
Table
A.
5
Tolerances
which
require
reassessment
that
are
not
`
Insignificant
Contributors'
because
the
associated
IREDs
have
not
been
completed
Pesticide
Name
High
Contributor
versus
Low
Contributor
Commodity
Name
Carbofuran
Low
Sorghum,
Forage
Carbofuran
Low
Sorghum,
Grain
Carbofuran
Low
Soybeans
Carbofuran
Low
Soybeans,
Forage
Carbofuran
Low
Soybeans,
Hay
Carbofuran
Low
Strawberries
Carbofuran
Low
Sugarcane
Carbofuran
Low
Sunflower,
Seeds
Carbofuran
Low
Wheat,
Grain
Carbofuran
Low
Wheat,
Straw
Table
A.
6
Tolerances
that
have
already
been
reassessed
Pesticide
Name
Commodity
Name
Methiocarb
Citrus
Fruits
Methiocarb
Corn,
field,
grains
Methiocarb
Corn,
fodder
Methiocarb
Corn,
forage
Methiocarb
Corn
(
including
sweet)
(
kernel
+
cobs
w/
husks
removed)
Methiocarb
Corn,
grain
(
including
popcorn)
Methiocarb
Peaches
Methomyl
Alfalfa
Methomyl
Apples
Methomyl
Asparagus
Methomyl
Avocados
Methomyl
Barley,
grain
Methomyl
Barley,
hay
Methomyl
Barley,
straw
Methomyl
Beans,
dry
Methomyl
Beans,
succulent
Methomyl
Beets,
tops
Methomyl
Blueberries
Methomyl
Brassica
(
Cole)
Leafy
Vegetables
Methomyl
Broccoli
Methomyl
Brussels
sprouts
Methomyl
Cabbage
Methomyl
Cabbage,
Chinese
Methomyl
Cauliflower
Methomyl
Celery
Methomyl
Collards
Methomyl
Corn,
fodder
Methomyl
Corn,
forage
Methomyl
Corn
(
including
sweet)
(
kernel
+
cobs
w/
husks
removed)
Methomyl
Corn,
Grain
(
including
popcorn)
Methomyl
Cotton,
seed
Methomyl
Cucurbits
Methomyl
Dandelions
Methomyl
Endive
(
escarole)
Methomyl
Grapefruit
Methomyl
Grapes
Draft,
Internal,
Deliberative.

Page
19
of
20
Table
A.
6
Tolerances
that
have
already
been
reassessed
Pesticide
Name
Commodity
Name
Methomyl
Grasses,
bermuda
Methomyl
Grasses,
bermuda,
hay
(
dry,
dehydrated)
Methomyl
Kale
Methomyl
Leeks
Methomyl
Lemons
Methomyl
Lentils
Methomyl
Lettuce
Methomyl
Mint,
hay
Methomyl
Mustard,
greens
Methomyl
Nectarines
Methomyl
Oats,
forage
Methomyl
Oats,
grain
Methomyl
Oats,
hay
Methomyl
Oats,
straw
Methomyl
Onions,
green
Methomyl
Oranges
Methomyl
Parsley
Methomyl
Peaches
Methomyl
Peanuts
Methomyl
Pears
Methomyl
Peas
Methomyl
Peas,
vines
Methomyl
Pecans
Methomyl
Peppers
Methomyl
Pomegranates
Methomyl
Rye,
forage
Methomyl
Rye,
grain
Methomyl
Rye,
straw
Methomyl
Sorghum,
forage
Methomyl
Sorghum,
grain
Methomyl
Soybeans
Methomyl
Soybeans,
forage
Methomyl
Spinach
Methomyl
Strawberries
Methomyl
Swiss
Chard
Methomyl
Tangerines
Methomyl
Tomatoes
Methomyl
Turnips,
greens,
tops
Methomyl
Vegetables,
fruiting
Methomyl
Vegetables,
leafy
Methomyl
Wheat,
forage
Methomyl
Wheat,
grain
Methomyl
Wheat,
hay
Methomyl
Wheat,
straw
Methomyl
Barley,
Forage
Methomyl
Beans,
Forage
Methomyl
Hops,
Dried
Methomyl
Peanuts,
Hulls
Methomyl
Rye,
Hay
Methomyl
Vegetables,
Root
Crop
Methomyl
Watercress
Thiodicarb
Corn
(
including
sweet)
(
kernel
+
cobs
w/
husks
removed)
Thiodicarb
Cotton,
seed
Thiodicarb
Soybeans
Thiodicarb
Soybeans,
hulls
Draft,
Internal,
Deliberative.

Page
20
of
20
Table
A.
6
Tolerances
that
have
already
been
reassessed
Pesticide
Name
Commodity
Name
Thiodicarb
Cotton,
seed,
hulls