Document ID: EPA-HQ-OPP-2006-0177-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-29T05:00Z

Glyphosate
NOF
Aug2005
Page
1
of
15
Monsanto
Company
authorizes
the
EPA
to
publish
the
following
summary
of
the
petition
to
comply
with
the
Food
Quality
Protection
Act
of
1996.
An
electronic
copy
on
computer
disc
is
provided
with
the
cover
letter
for
this
submission.

Summary
of
Petition
Petitioner
summaries
of
the
pesticide
petitions
are
printed
below
as
required
by
section
408
(
d)
(
3)
of
the
FFDCA.
The
summaries
of
the
petitions
were
prepared
by
the
petitioners
and
represent
the
views
of
the
petitioner.
EPA
is
publishing
the
petitions
summaries
verbatim
without
editing
them
in
any
way.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
method
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
4
(
IR­
4)

PP
[
]

EPA
has
received
a
pesticide
petition
(
PP
)
from
Interregional
Research
Project
Number
4
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902­
3390,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104­
170),
to
amend
40
CFR
part
180.364
by
revising
the
existing
tolerance
regulation
for
glyphosate
[(
N­
phosphonomethyl)
glycine].

This
petition
requests
that
40
CFR
180.364
be
amended
by
establishing
a
tolerance
for
residues
of
glyphosate
(
N­
(
phosphonomethyl)
glycine)
resulting
from
the
application
of
glyphosate,
the
isopropylamine
salt
of
glyphosate,
the
ethanolamine
salt
of
glyphosate,
the
potassium
salt
of
glyphosate,
and
the
ammonium
salt
of
glyphosate
in
or
on
Mulberry,
Indian
at
0.2
ppm.
In
addition,
PP
[
]
requests
to
revise
the
present
tolerance
for
Vegetable,
legume,
group
6,
except
soybean
to
8.0
ppm
from
the
present
value
of
6.0
ppm.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''

EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
and
a
complete
description
of
the
risk
Glyphosate
NOF
Aug2005
Page
2
of
15
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL 
5754 
7).

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residue
in
plants
is
adequately
understood
and
consists
of
the
parent,
glyphosate
and
its
metabolite
AMPA
(
aminomethyl­
phosphonic
acid).
Only
glyphosate
parent
is
to
be
regulated
in
plant
and
animal
commodities
since
the
metabolite
AMPA
is
not
of
toxicological
concern
in
food.
The
qualitative
nature
of
the
glyphosate
residue
will
not
be
changed
as
a
result
of
the
proposed
tolerance
changes.

The
qualitative
nature
of
the
residue
in
animals
is
adequately
understood,
and
will
not
be
affected
by
the
proposed
tolerance
change.
Glyphosate
herbicides
are
not
applied
directly
to
livestock,
so
their
only
exposure
is
via
plant
residues
their
diet.
The
terminal
residue
to
be
regulated
in
livestock
is
glyphosate
per
se.

2.
Analytical
method.
Adequate
enforcement
methods
are
available
for
analysis
of
residues
of
glyphosate
in
or
on
plant
commodities.
These
methods
include
gas
liquid
chromatography
(
GLC)
(
Method
I
in
Pesticides
Analytical
Manual
(
PAM)
II;
the
limit
of
detection
is
0.05
ppm)
and
High
Performance
Liquid
Chromatography
(
HPLC)
with
fluorometric
detection.
The
HPLC
procedure
has
undergone
successful
Agency
validation
and
was
recommended
for
inclusion
in
PAM
II.
A
gas
chromatography/
mass
spectrometry
(
GC/
MS)
method
for
glyphosate
crops
has
also
been
validated
by
EPA's
Analytical
Chemistry
Laboratory
(
ACL).
The
proposed
revisions
in
the
tolerance
regulation
does
not
change
the
residue
to
be
analyzed,
which
remains
as
glyphosate
per
se.

The
unpublished
methods
may
be
requested
from:
Calvin
Furlow,
PRRIB,
IRSD
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(
703)
305­
5229;
e­
mail
address:
furlow.
calvin@
epa.
gov.

3.
Magnitude
of
residues.
Adequate
data
concerning
glyphosate
residues
on
raw
agricultural
commodities
(
RACs)
and
relevant
processed
commodities
has
been
submitted
to
the
Agency.
Accordingly,
the
available
residue
data
for
glyphosate
support
the
proposed
revisions
of
the
tolerance
regulation
for
glyphosate.
In
addition,
any
secondary
residues
occurring
in
liver,
or
kidney
of
cattle,
goats,
horses,
and
sheep,
and
meat­
by­
products
of
poultry,
and
eggs,
will
be
covered
by
existing
tolerances.
Any
residues
occurring
in
harvestable
aquatic
species
will
be
covered
by
existing
glyphosate
tolerances
for
fish
and
shellfish.

B.
Toxicological
Profile
EPA
has
previously
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
acute
toxic
effects
caused
by
glyphosate
have
been
evaluated
by
the
Agency,
but
an
acute
dietary
endpoint
has
not
been
selected
for
the
general
population
or
for
females
13
 
50,
since
an
appropriate
endpoint
attributable
to
a
single
exposure
was
not
demonstrated.
The
nature
of
the
subchronic,
chronic
and
other
toxic
effects
caused
by
glyphosate
are
summarized
in
the
following
Table
1
in
addition
to
the
relevant
no
observed
Glyphosate
NOF
Aug2005
Page
3
of
15
adverse
effect
levels
(
NOAELs)
and
the
lowest
observed
adverse
effect
levels
(
LOAELs)
from
the
toxicity
studies
reviewed.

Table
1.
Subchronic,
Chronic
and
Other
Toxicity
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
in
rats
NOAEL
less
than
50
milligrams
(
mg)/
kilogram
(
kg)/
day
for
both
sexes
LOAEL
=
50
mg/
kg/
day
based
on
increased
phosphorus
and
potassium
in
both
sexes
870.3100
90­
Day
oral
toxicity
in
mice
NOAEL
=
1,500
mg/
kg/
day
in
both
sexes
LOAEL
=
7,500
mg/
kg/
day
in
both
sexes
based
on
decreased
body
weight
gain
in
both
sexes.
870.3485
28­
Day
inhalation
toxicity
 
rat
exposure;
6
hours/
day,
5
days/
week
for
4
weeks)
NOAEL
=
0.36
mg/
L,
LOAEL
=
>
0.36
high
dose
tested
(
HDT)
mg/
L,
not
established
870.3200
21
dermal
toxicity
in
rabbits
NOAEL
=
1,000
mg/
kg/
day
for
males
and
5,000
mg/
kg/
day
for
females
LOAEL
=
5,000
mg/
kg/
day
in
males
based
on
decreased
food
consumption
870.3700
Prenatal
developmental
toxicity
in
rats
Maternal
NOAEL
=
1,000
mg/
kg/
day
day
based
on
mortality,
LOAEL
=
3,500
mg/
kg/
day
based
on
mortality,
increased
clinical
signs,
and
reduced
body
weight
gain
Developmental
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
3,500
mg/
kg/
day
based
on
decreases
in
total
implantations/
dam
and
nonviable
fetuses/
dam,
increased
number
of
litters
and
fetuses
with
unossified
sternebrae,
and
decreased
fetal
body
weight.

870.3700
Prenatal
developmental
toxicity
in
rabbits
Maternal
NOAEL
=
175
mg/
kg/
day
LOAEL
=
350
mg
/
kg/
day
based
on
mortality,
and
clinical
signs
Developmental
NOAEL
=
175
mg/
kg/
day
LOAEL
=
350
mg/
kg/
day
(
insufficient
litters
available
to
assess
developmental
toxicity)

870.3800
Reproduction
and
fertility
effects
in
rats
(
2­
generation)
Parental/
Systemic
NOAEL
=
500
mg/
kg/
day
for
males
and
females
LOAEL
=
1,500
mg/
kg/
day
for
males
and
females
based
on
clinical
signs,
decreased
body
weights,
decreased
weight
gain,
and
decreased
food
consumption
in
both
sexes
Reproductive
NOAEL
=
>
1500
HDT
mg/
kg/
day
in
males
and
females
LOAEL
=
>
1500
HDT
mg/
kg/
day
for
males
and
females,
not
established
Offspring
NOAEL
=
500
kg/
day
for
males
and
females
LOAEL
=
1500
mg/
kg/
day
for
males
and
females
based
on
reduced
pup
weights
in
both
sexes
during
second
and
third
weeks
of
lactation
870.4100
Chronic
toxicity
in
dogs
NOAEL
=
500
HDT
mg/
kg/
day
in
Glyphosate
NOF
Aug2005
Page
4
of
15
males
and
females
LOAEL
=
>
500
mg/
kg/
day
in
males
and
females,
not
established
870.4300
Combined
Chronic
Toxicity/

Carcinogenicity
in
rats
NOAEL
=
362
mg/
kg/
day
in
males
and
457
mg/
kg/
day
in
females
LOAEL
=
940
mg/
kg/
day
in
males
and
1,183
kg/
kg/
day
in
females
based
on
decreased
weight
gain
in
females,
and
increased
incidence
of
cataracts
and
lens
abnormalities,
decreased
urinary
pH,
increased
absolute
liver
weight,
and
increased
relative
liver
weight/
brain
weight
in
males.
No
evidence
of
carcinogenicity.

870.4300
Carcinogenicity
in
mice
NOAEL
=
750
mg/
kg/
day
in
males
and
females
LOAEL
=
4,500
mg/
kg/
day
in
both
sexes
based
on
decreased
body
weight
gains
in
both
sexes,
increased
incidence
of
renal
proximal
tubule
epithelial
basophilia
and
hypertrophy
in
females
and
increased
incidence
of
interstitial
nephritis,
hepatocellular
hypertrophy
and
hepatocellular
necrosis
in
males.
No
evidence
of
carcinogenicity.

870.5100
Gene
mutation
assay
in
S.
typhimurium
strains
Negative
 
non­
mutagenic
when
tested
up
to
1000
[
mu]
g/
plate
in
the
presence
and
absence
of
activation
in
S.
typhimurium
TA98,
TA100,
TA1535,
and
TA1537
870.5100
Gene
mutation
assay
in
E.
coli
and
S.
typhimurium
strains
Negative
for
reverse
gene
mutation,
both
with
and
without
S­
9,
up
to
5000
[
mu]
g/
plate
(
or
cytotoxicity)
with
E.
coli
WP2hcrA
and
S.
typhimurium
TA98,
TA100,
TA1535,
TA1537,
and
TA1538
870.5300
In
vitro
gene
mutation
assay
in
Chinese
hamster
ovary
cells/
HGPRT
Negative
 
non­
mutagenic
at
the
HGPRT
locus
in
Chinese
hamster
ovary
cells
tested
up
to
cytotoxic
concentrations
or
limit
of
solubility,
in
presence
and
absence
of
activation
870.5385
Cytogenetics
 
In
vivo
bone
marrow
chromosome
aberrations
assay
Negative
 
non­
mutagenic
in
the
rat
bone
marrow
chromosome
assay
up
to
1,000
mg/
kg
in
both
sexes
of
Sprague­
Dawley
rats
870.5550
Other
mechanisms
 
in
vitro
rec­
assay
with
B.
subtilis
There
was
no
evidence
of
recombination
in
the
rec­
assay
up
to
2000
[
mu]
g/
plate
with
B.
subtilis
H17
(
rec+)
and
M45
H17
(
rec+)
and
M45
(
rec­)(
rec­)

870.6200
Acute
neurotoxicity
screening
battery
in
rats
Not
required
870.6200
Subchronic
neurotoxicity
screening
battery
Not
required
870.6300
Developmental
neurotoxicity
in
rats
Not
required
870.7485
Metabolism
in
rats
Following
a
single
oral
dose,
30­
36%
was
absorbed
and
less
than
0.27%
was
eliminated
asCO2.
Urine
and
feces
contained
97.5%
as
Glyphosate
NOF
Aug2005
Page
5
of
15
parent.
Aminomethylphosphonic
acid
(
AMPA)
was
only
metabolite
found
at
0.2­
0.3%
of
administered
dose.
Less
than
1.0%
of
the
absorbed
dose
remained
in
tissues
and
organs,
primarily
in
the
bone.

870.7600
Dermal
Penetration
Not
required
Endocrine
disruption
The
above
studies
measure
numerous
endpoints
with
sufficient
sensitivity
to
detect
potential
endocrine­
modulating
activity.
No
effects
have
been
identified
in
subchronic,
chronic
or
developmental
toxicity
or
multi­
generation
reproduction
studies
to
indicate
any
endocrine­
modulating
activity
by
glyphosate.
In
addition,
no
adverse
were
not
seen
when
glyphosate
was
tested
in
a
dominant­
lethal
mutation
assay.
While
this
assay
was
designed
as
a
genetic
toxicity
test,
agents
that
can
affect
male
reproduction
function
will
also
cause
effects
in
this
assay.

C.
Toxicological
Endpoints
The
dose
representing
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences.

For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
Safety
Factor.

For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.

The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10
­
6
or
one
in
a
million).
Glyphosate
NOF
Aug2005
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6
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15
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
  
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
glyphosate
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Glyphosate
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
females
13
 
50
years
old
and
general
population)
None
Not
applicable
There
were
no
effects
that
could
be
attributed
to
a
single
exposure
(
dose)
in
oral
toxicity
studies
including
the
developmental
toxicity
studies
in
rats
and
rabbits
Chronic
Dietary
(
all
populations)
NOAEL
=
175
mg/
kg/
day;
UF
=
100;
Chronic
RfD
=
1.75
mg/
kg/
day
FQPA
SF
=
1;
cPAD
=
cRfD
FQPA
SF
=
1.75
mg/
kg/
d
Developmental
toxicity
in
rabbits
Maternal
LOAEL
=
350
mg/
kg/
day
based
on
diarrhea,
nasal
discharge,
and
mortality
Developmental
toxicity
was
not
observed
at
any
dose
tested.
Short­
term,

Intermediateterm
incidental
oral
(
Residential)
NOAEL
=
175
mg/
kg/
day
LOC
for
MOE
=
100
Developmental
toxicity
in
rabbits
Maternal
LOAEL
=
350
mg/
kg/
day
based
on
diarrhea,
nasal
discharge,
and
mortality
Developmental
toxicity
was
not
observed
at
any
dose
tested.
Short­
term
and
long­
term
dermal
(
1
 
30
days,
1­
6
months,
6
months
 
lifetime
(
Occupational
/
Residential)
None
None
Based
on
the
intermediate
systemic
NOAEL
of
1,000
mg/
kg/
day
in
the
21­
day
dermal
toxicity
study
and
the
lack
of
concern
for
developmental
and
reproductive
effects,
the
Glyphosate
NOF
Aug2005
Page
7
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15
quantification
of
dermal
risks
is
not
required.
Short­
term,

intermediateterm
and
longterm
inhalation
(
1
 
30
days,
1­
6
months,
6
months
 
lifetime
(
Occupational
/
Residential)
None
None
Based
on
the
systemic
toxicity
NOEAL
of
0.36
mg/
L
HDT
in
the
28­
day
inhalation
toxicity
study
in
rats,
and
the
physical
characteristics
of
the
technical
(
wetcake),
the
quantification
of
inhalation
risks
is
not
required.
Cancer
(
oral,
dermal,
inhalation)
Group
E
Not
applicable
No
evidence
of
carcinogenicity
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.

D.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.364)
for
the
residues
of
(
N­
(
phosphonomethyl)
glycine
resulting
from
the
application
of
the
isopropylamine
salt
of
glyphosate,
the
ammonium
salt
of
glyphosate,
and/
or
the
ethanolamine
salt
of
glyphosate,
in
or
on
a
variety
of
food
and
feed
commodities.
The
petitioner
proposes
to
add
a
tolerance
for
Indian
mulberry
at
0.2
ppm
and
to
increase
the
tolerance
for
vegetable
legume,
group
6,
except
soybean
from
the
present
level
of
6.0
ppm
to
8.0
ppm.
These
changes
are
not
expected
to
increase
the
dietary
burden
for
livestock,
so
that
the
existing
tolerances
for
livestock
commodities
are
sufficient.

Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposure
from
glyphosate
in
food
as
follows:

i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
day
or
single
exposure.
An
acute
dietary
endpoint
and
dose
was
not
identified
for
glyphosate.
A
review
of
the
rat
and
rabbit
developmental
studies
did
not
provide
a
dose
or
endpoint
that
could
be
used
to
quantify
risk
to
the
general
population
or
to
females
13
 
50
years
old
from
a
single­
dose
exposure
to
glyphosate.
Therefore,
no
acute
dietary
analysis
was
conducted.

ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID
®
)
software
version
2.03,
which
incorporates
consumption
data
from
the
USDA
1994
­
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII).
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
Glyphosate
NOF
Aug2005
Page
8
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15
chronic
exposure
assessments:
The
chronic
dietary
exposure
analysis
was
conducted
using
the
chronic
polulation
adjusted
dose
(
cPAD)
of
1.75
mg/
kg/
day.
For
chronic
dietary
exposure
and
risk
assessments,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
(
i.
e.,
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
milligrams/
kilogram
body
weight
day
(
mg/
kg
bwt/
day)
and
as
a
percent
of
the
cPAD
for
chronic
exposure.
This
procedure
is
performed
for
each
population
subgroup.

The
Tier
1
chronic
dietary
exposure
analysis
for
glyphosate
is
an
upper
bound
estimate
of
chronic
dietary
exposure.
The
chronic
dietary
exposure
analysis
was
performed
for
the
general
U.
S.
population
and
all
population
subgroups
using
DEEM
assuming
tolerance
levels
residues
and
100%
crop
treated
data
for
the
proposed
commodities
and
all
registered
uses.
For
chronic
dietary
risk,
the
Agency's
LOC
is
less
than
100%
cPAD.
Dietary
exposure
estimates
for
representative
population
subgroups
are
presented
in
Table
4.
The
results
of
the
chronic
analysis
indicate
that
the
estimated
chronic
dietary
risk
as
represented
by
the
percent
cPAD
is
below
the
Agency's
LOC
(
100%
cPAD)
for
the
U.
S.
population
and
all
population
subgroups.

Table
3.
Summary
of
Results
from
Chronic
DEEM
Analysis
of
Glyphosate
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
population
(
total)
0.035851
2.0
All
infants
(<
1
year
old)
0.059645
3.4
Children
(
1­
6
years
old)
0.082542
4.7
Children
(
7­
12
years
old)
0.052334
3.0
Females
(
13­
50
years
old)
0.028191
1.6
Males
(
13­
19
years
old)
0.036725
2.1
Males
(
20+
years
old)
0.030525
1.7
Seniors
(
55+
years
old)
0.023902
1.4
iii.
Cancer.
The
HED
Cancer
Peer
Review
Committee
classified
glyphosate
as
a
Group
E
chemical,
negative
for
carcinogenicity
in
humans,
based
on
the
absence
of
evidence
of
carcinogenicity
in
male
and
female
rats
as
well
as
in
male
and
female
mice.
There
is
no
evidence
of
carcinogenic
potential.

iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
The
Agency
used
tolerance
levels
and
100%
PCT
data
for
the
proposed
commodities
and
all
registered
uses.

2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
glyphosate
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
glyphosate.
Glyphosate
NOF
Aug2005
Page
9
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15
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
Screening
Concentration
in
Groundwater
(
SCI­
GROW),
which
predicts
pesticide
concentrations
in
ground
water.
In
general,
EPA
will
use
GENEEC
(
a
Tier
1
model)
before
using
PRZM/
EXAMS
(
a
Tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
PC
area
factor
as
an
adjustment
to
account
for
the
maximum
PC
coverage
within
a
watershed
or
drainage
basin.

None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.

Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
percent
(%)
%
RfD
or
%
PAD.
Instead,
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
glyphosate,
they
are
further
discussed
in
section
E
below.

Based
on
the
GENEEC
and
SCI­
GROW
models,
the
EECs
of
glyphosate
for
acute
exposures
are
estimated
to
be
21
parts
per
billion
(
ppb)
for
surface
water
and
0.0038
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.83
ppb
for
surface
water
and
0.0038
ppb
for
ground
water,
based
on
glyphosate
treatment
crops.
To
estimate
the
possible
concentration
of
glyphosate
in
surface
water
resulting
from
direct
application
to
water,
the
Agency
assumed
application
to
a
water
body
6
feet
deep.
At
an
application
rate
of
3.75
lb
acid
equivalent
(
ae)/
A,
the
estimated
concentration
is
230
ppb.
Because
the
glyphosate
water­
application
estimate
is
greater
than
the
crop
application
estimate,
230
ppb
is
the
appropriate
value
to
use
in
the
chronic
risk
estimate.

3.
From
non­
dietary
exposure.
The
term
  
residential
exposure''
is
used
in
this
document
to
refer
to
non­
occupational,
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).

i.
Non­
occupational
(
recreational)
exposures.
Glyphosate
is
currently
registered
for
use
on
the
following
residential
non­
dietary
sites:
Recreational
areas,
including
parks
and
golf
courses
for
control
of
broadleaf
weeds
and
grasses,
and
lakes
and
ponds,
including
reservoirs
for
control
of
nuisance
aquatic
weeds.
Based
on
the
registered
uses,
adult
and
child
golfers
are
anticipated
to
have
short­
term
post­
application
dermal
exposure
at
golf
courses.
Swimmers
Glyphosate
NOF
Aug2005
Page
10
of
15
(
adults,
children
and
toddlers)
are
anticipated
to
have
short­
term
post­
application
dermal
and
incidental
ingestion
exposures.
However,
since
the
Agency
did
not
select
dermal
endpoints,
no
post­
application
dermal
assessment
is
included;
only
a
post­
application
incidental
ingestion
exposure
assessment
(
swimmers)
is
included.
Risk
estimates
for
incidental
ingestion
by
swimmers
(
adults,
children,
and
toddlers)
ranged
from
7,600
to
36,000.
It
should
be
noted
however,
that
glyphosate
is
used
for
non­
selective
weed
control
on
emerged
aquatic
weeds.
In
this
use
pattern,
it
is
unlikely
that
swimmers
would
be
present
in
water
bodies
infested
with
floating
weeds.
Thus,
the
inclusion
of
the
swimmer
incidental
ingestion
exposure
assessment
is
considered
by
the
Agency
to
be
conservative.
Table
4
presents
a
summary
of
assumptions
used
to
estimate
the
exposure
to
adult
and
toddler
child
swimmers
and
the
corresponding
risk
estimates.

Table
4.
Assumptions
and
Risk
Estimates
for
Post­
Application
Swimmer
Exposure
Assessments
for
Glyphosate,
Isopropylamine
salt
Exposure
Scenario
AR
1
(
lb
a.
e./
A)
Maximum
Concentratio
n
in
water
(
mg/
L)
2
Potential
Dose
Rate(
PDR;
oral
mg/
kg
bw/
day)
3
Shortterm
MOE
4
Incidental
oral
ingestion,

adultfemale
3.75
1.38
0.00493
36,000
Incidental
oral,
toddler
0.023
7,600
1
Application
rate
from
registered
labels
for
aquatic
weed
control
using
glyphosate
IPA
salt
(
ex.
label
=
EPA
Reg.
No.
524­
343;
max
rate
=
7.5
pints/
A
containing
4
lb
ae
glyphosate/
gal.
x
1
gal./
4
pints
=
3.75
lb
ae/
A.
2
Maximum
concentration
in
water
(
top
1
ft.)
=
3.75
lb
ae/
A
x
1A/
43,560
ft2
x
454,000
mg/
lb
x
1/
ft
x
ft3
/
28.32
L
=
1.38
mg/
L.
3
PDR,
incidental
oral
exposure
=
concentration,
Cw
(
mg/
L)
x
ingestion
rate,
IgR
(
L/
hr)
x
exposure
time,
ET
(
hrs/
d)
x
1/
BW
(
adultfemale
=
60
kg;
toddler
=
15
kg).
4
MOE
=
NOAEL/
PDR;
short­
term
incidental
oral
NOAEL
=
175
mg/
kg
bw/
d;
The
LOC
for
adult
females
and
toddlers
for
short­
term,
incidental
oral
exposures
is
MOEs
<
100.

The
MOEs
presented
in
Table
4
for
post­
application
exposure
by
swimmers
to
glyphosate
in
aquatic
weed
control
applications
are
greater
than
100
and
do
not
exceed
the
Agency's
LOC
for
short­
term
non­
occupational
(
recreational)
exposures
(
MOEs
less
than
100).

ii.
Residential
exposures.
Glyphosate
is
also
registered
for
broadcast
and
spot
treatments
on
home
lawns
and
gardens
by
homeowners
and
by
lawn
care
operators
(
LCOs).
Based
on
the
registered
residential
use
patterns,
there
is
a
potential
for
short­
term
dermal
and
inhalation
exposures
to
homeowners
who
apply
products
containing
glyphosate
(
residential
handlers).
Additionally,
based
on
the
results
of
environmental
fate
studies,
there
is
also
a
potential
for
short
Glyphosate
NOF
Aug2005
Page
11
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15
and
intermediate­
term
post­
application
dermal
exposures
by
adults
and
toddlers
and
incidental
ingestion
exposures
by
toddlers.
However,
since
the
Agency
did
not
select
short­
term
or
intermediate­
term
dermal
or
inhalation
endpoints,
no
residential
handler
or
postapplication
dermal
assessment
is
included;
only
a
post­
application
toddler
assessment
for
incidental
ingestion
exposures
is
included.
Risk
estimates
for
toddler
post­
application
incidental
ingestion
exposures
ranged
from
7,200
to
greater
than
10
6
.
All
recreational
and
residential
exposures
assessed
do
not
exceed
the
Agency's
level
of
concern
(
MOEs
less
than
100).
Table
5
provides
a
summary
of
the
short­
term
and
intermediate­
term
risk
estimates
for
post­
application
incidental
ingestion
exposures
to
toddlers.

Table
5.
Summary
of
Toddler
Incidental
Ingestion
Exposures
and
Risk
Estimates
for
Residential
Use
of
Glyphosate,
Isopropylamine
salt
1
Activity
AR
(
lbs
a.
e./
A)
2
Residue
Estimate
3
PDR
(
mg/
kg
bw/
d)
4
Short­
term
/
Intermediateterm
MOE
5
Hand­
tomouth
1.62
DFR:
0.908
[
mu]
g/
cm2
0.0242
7,200
Objectto
mouth
DFR:
3.63
[
mu]
g/
cm2
0.00605
29,000
Soil
ingestion
Soil
residue:
12.2
[
mu]
g/
g
soil
8.13
x
10
­
5
10
­
6
1
Sources:
Standard
Operating
Procedures
for
Residential
Exposure
Assessments,
Draft,
December
17,
1997
and
Exposure
SAC
Policy
No.
11,
February
22,
2001:
Recommended
Revisions
to
the
SOPs
for
Residential
Exposure.
2
AR
=
maximum
application
rate
on
Roundup
ProDry
label
(
EPA
Reg.
No.
524­
505)
for
residential
lawn
treatment.
3
Residue
estimates
based
on
the
following
protocol
from
the
Residential
OPs:
Hand­
to­
mouth
DFR
=
1.62
lb
ae/
A
x
0.05
x
(
4.54
x
10­
8
[
mu]
g/
lb
ae)
x
(
2.47
x
10­
8
A/
cm2)
=
0.908
g/
cm2.
Object­
to­
mouth
DFR
=
1.62
lb
ae/
A
x
0.20
x
(
4.54
x
108
[
mu]
g/
lb
ae)
x
(
2.47
x
10­
8
A/
cm2
=
3.63
[
mu]
g/
cm2.
Soil
Residue
=
1.62
lb
ae/
A
x
fraction
of
residue
in
soil
(
100%)/
cm
x
(
4.54
x
108
[
mu]
g/
lb
ae)
x
(
2.47
x
10­
8
A/
cm2)
x
0.67
cm3/
g
=
12.2
mu]
g/
g
soil.
4
Potential
Dose
Rate
(
PDR;
already
normalized
to
body
weight
of
toddler).
Hand­
to­
mouth
PDR
=
(
0.908
g/
cm2
x
0.50
x
20
cm2/
event
x
20
events/
hr
x
10­
3
mg/[
mu]
g
x
2
hrs/
d)/
15
kg
=
0.0242
mg/
kg
bwt/
day.
Object­
to­
mouth
PDR
=
(
3.63
g/
cm2
x
25
cm2
/
d
x
10­
3
mg/[
mu]
g)/
15
kg
=
0.00605
mg/
kg
bwt/
day.
Soil
Ingestion
PDR
=
(
12.2
[
mu]
g/
g
soil
x
100
mg
soil/
d
x
10­
6
g/[
mu]
g)/
15
kg
=
8.13
x
10­
5
mg/
kg
bwt/
day.
5
MOE
=
NOAEL/
PDR,
where
the
short­
term
incidental
oral
NOAEL
=
175
mg/
kg/
day
the
Agency's
LOC
is
for
MOEs
<
100
(
short­
term
residential).

All
MOEs
calculated
for
post­
application
toddler
exposures
do
not
exceed
the
Agency's
level
of
concern
for
residential
exposures
(
MOEs
less
than
100).
Glyphosate
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Aug2005
Page
12
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4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
  
other
substances
that
have
a
common
mechanism
of
toxicity.''

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
glyphosate
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
glyphosate
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
glyphosate
has
a
common
mechanism
of
toxicitywith
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

E.
Safety
Factor
for
Infants
and
Children
1.
In
general,
FFCDA
Section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
database
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
UFs
(
safety
factors)
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.

2.
Prenatal
and
postnatal
sensitivity.
The
toxicology
database
for
glyphosate
is
adequate
according
to
the
Subdivision
F
Guideline
requirements
for
a
food­
use
chemical.
Acceptable
developmental
toxicity
studies
in
the
rat
and
rabbit
are
available,
as
is
an
acceptable
2­
generation
reproduction
study
in
the
rat.
Based
on
the
available
data,
the
Agency
determined
that
there
is
no
evidence
of
either
a
quantitative
or
qualitative
increased
susceptibility
following
in
utero
glyphosate
exposure
to
rats
and
rabbits,
or
following
prenatal/
postnatal
exposure
in
the
2­
generation
reproduction
study
in
rats.

3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
glyphosate
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
Agency
determined
that
the
FQPA
safety
factor
to
protect
infants
and
children
can
be
removed
(
reduced
from
10X
to
1X)
for
all
population
subgroups
and
exposure
scenarios
because:
a.
The
toxicology
data
base
is
complete.
b.
A
developmental
neurotoxicity
study
is
not
required.
c.
The
dietary
(
food
and
drinking
water)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
2
There
is
no
evidence
of
increased
susceptibility
in
rats
and
rabbits
to
in
utero
and/
or
postnatal
exposure
to
glyphosate.

F.
Aggregate
Risks
and
Determination
of
Safety
Glyphosate
NOF
Aug2005
Page
13
of
15
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
 (
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.

A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.

When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.

1.
Acute
aggregate
risk
(
food
+
drinking
water).
The
Agency
did
not
identify
an
appropriate
acute
dietary
endpoint
that
is
the
result
of
a
single­
dose
administration
of
glyphosate.
Accordingly,
glyphosate
is
not
expected
to
pose
an
acute
risk.

2.
Chronic
aggregate
risk
(
food
+
drinking
water).
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure
(
tolerance
level
residues
and
100%
crop
treated
data
for
all
proposed
commodities
and
registered
uses),
EPA
has
concluded
that
exposure
to
glyphosate
from
food
will
utilize
2.0%
of
the
cPAD
for
the
U.
S.
population,
3.4%
of
the
cPAD
for
all
infants
(
less
than
1­
year
old)
and
4.7%
of
the
cPAD
for
children
1­
6
years
old.
The
results
of
the
chronic
analysis
(
Table
3
in
this
unit)
indicate
that
the
chronic
dietary
risk
estimates
for
the
general
U.
S.
population
and
all
population
subgroups
associated
with
the
existing
and
proposed
uses
of
glyphosate
do
not
exceed
the
Agency's
LOC
(
less
than
100%
of
the
cPAD).
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
glyphosate
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
glyphosate
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
6
below:
Glyphosate
NOF
Aug2005
Page
14
of
15
Table
6.
Aggregate
Risk
Assessment
for
Chronic
(
Non­
Cancer)
Exposure
to
Glyphosate
Subgroup
cPAD
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Maximum
Chronic
Water
Exposure
1
Ground
Water
EEC,
ppb
Surface
Water
EEC,
ppb
Chronic
DWLOC
2
U.
S.
population
(
total)
1.75
0.035851
1.714149
0.0038
230
60000
All
infants
(<
1
year
old)
1.75
0.059645
1.690355
0.0038
230
17000
Children
(
1­
6
years
old)
1.75
0.082542
1.667458
0.0038
230
17000
Children
(
7­
12
years
old)
1.75
0.052334
1.697666
0.0038
230
17000
Females
(
13­
50
years
old)
1.75
0.028191
1.721809
0.0038
230
60000
Males
(
13­
19
years
old)
1.75
0.036725
1.713275
0.0038
230
60000
Males
(
20+
years
old)
1.75
0.030525
1.719475
0.0038
230
60000
Seniors
(
55+
years
old)
1.75
0.023902
1.726098
0.0038
230
60000
1
Maximum
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
(
mg/
kg/
day)
 
chronic
food
exposure
from
DEEMTM
(
mg/
kg/
day).
2
The
chronic
DWLOCs
were
calculated
as
follows:
DWLOC
([
mu]
g/
L)
=
Maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)/
consumption
L/
day)
x
0.001
mg/[
mu]
g.

3.
Short­
and
intermediate­
term
aggregate
risk
(
food
+
residential
+
water).
In
aggregating
short­
term­/
intermediate­
term
risk,
HED
considered
background
chronic
dietary
exposure
(
food
+
water)
and
shortterm
intermediate­
term
incidental
oral
exposures
(
see
Tables
6
and
7).
Because
the
incidental
oral
ingestion
exposure
estimates
for
toddlers
from
residential
turf
exposures
(
Table
7)
exceeded
the
incidental
oral
exposure
estimates
from
post­
application
swimmer
exposures
(
Table
6),
the
Agency
conducted
this
risk
assessment
using
exposure
estimates
from
just
the
worst­
case
situation.
No
attempt
was
made
to
combine
exposures
from
the
swimmer
and
residential
turf
scenarios
due
to
the
low
probability
of
both
occurring.

The
total
short­
term/
intermediate­
term
food
and
residential
aggregate
MOEs
are
1,800­
2,300.
As
these
MOEs
are
greater
than
100,
the
shortterm
intermediate­
term
aggregate
risk
does
not
exceed
the
Agency's
LOC.
For
surface
water
and
ground
water,
the
EECs
of
glyphosate
are
less
than
the
DWLOCs
for
glyphosate
in
drinking
water
as
a
contribution
to
shortterm
intermediate­
term
aggregate
exposure.
Therefore,
the
Agency
concludes
with
reasonable
certainty
that
residues
of
glyphosate
in
drinking
water
do
not
contribute
significantly
to
the
short
Glyphosate
NOF
Aug2005
Page
15
of
15
term/
intermediate­
term
aggregate
human
health
risk
at
the
present
time.
Table
8
summarizes
the
short­
term/
intermediate­
term
aggregate
exposure
to
glyphosate
residues.

Table
8.
Short­
Term/
Intermediate­
Term
Aggregate
Risk
and
DWLOC
Calculations
for
Exposure
to
Glyphosate
Residues
Short­
Term/
Intermediate­
Term
Exposure
Scenario
Population
Aggregate
MOE
(
food+
residential)
1
Aggregate
Level
of
Concern
(
LOC)
or
Target
MOE
2
Surface
Water
EEC
3
(
ppb)
Ground
Water
EEC
3
(
ppb)
Short­
Term/
Intermediate­
Term
DWLOC
4
(
ppb)

All
Infants
(<
1
year
old)
2300
100
230
0.0038
17,000
Children
(
1­
6
years
old)
1600
100
230
0.0038
17,000
Children
(
7­
12
years
old)
2200
100
230
0.0038
17,000
1
Aggregate
MOE
=
NOAEL/(
Average
food
exposure
+
Residential
exposure).
2
Basis
for
the
target
MOE:
interspecies
and
intraspecies
uncertainty
factors
totaling
100.
3
The
glyphosate
use
producing
the
highest
level
was
used.
4
DWLOC
([
mu]
g/
L
or
ppb)
=
maximum
water
exposure
(
mg/
kg/
day)
x
bwt
(
kg)
/
water
consumption
(
L)
x
10­
3
mg/[
mu]
g
(
10
kg
bwt
assumed).

4.
Aggregate
cancer
risk
for
U.
S.
population.
Glyphosate
has
been
classified
as
a
Group
E
chemical,
with
no
evidence
of
carcinogenicity
for
humans
in
two
acceptable
animal
studies.
Glyphosate
is
not
expected
to
pose
a
cancer
risk
to
humans.

5.
Determination
of
safety.
Based
on
these
risk
assessments,
Monsanto
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
to
glyphosate
residues.

G.
International
Residue
Limits
Several
maximum
residue
limits
(
MRLs)
for
glyphosate
have
been
established
by
CODEX
in
or
on
various
commodities.
These
limits
are
based
on
the
residue
definition
of
glyphosate
per
se.
Codex
has
not
established
an
MRL
for
glyphosate
residues
in
or
on
Indian
mustard,
but
has
established
MRLs
for
peas
(
dry)
at
5
ppm
and
for
beans
(
dry)
at
2
ppm.
Because
of
the
different
agronomic
practices
and
the
use
of
a
crop
group
tolerance
in
the
US,
the
present
proposal
for
"
vegetables,
legume
group
6
except
soybeans"
cannot
be
harmonized
with
Codex.