Page
1
of
15
Interregional
Research
Project
4
and
Monsanto
Company
authorize
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.

ENVIRONMENTAL
PROTECTION
AGENCY
(
EPA)

40
CFR
Part
180
Glyphosate;
Pesticide
Tolerances
DATE:

ACTION:
Notice
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
glyphosate
in
or
on
sunflower
seed
and
safflower
seed.
The
Interregional
Research
Project
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.

DATES:
This
regulation
is
effective
.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP­
,
must
be
received
on
or
before
.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPPin
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Tompkins
(
PM
25),
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305­
5697;
e­
mail
address:
Tompkins.
Jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

________________________________________________________________________________

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
________________________________________________________________________________

This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
Page
2
of
15
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
"
Laws
and
Regulations,"
"
Regulations
and
Proposed
Rules,"
and
then
look
up
the
entry
for
this
document
under
the
"
Federal
Register­
Environmental
Documents."
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml­
00/
Title­
40/
40cfr180­
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.

2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP­
.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

II.
Summary
1.
IR­
4
PP
________

EPA
has
received
a
pesticide
petition
(_______)
from
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,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.364
by
establishing
a
regulation
to
permit
residues
of
the
herbicide
glyphosate
[(
Nphosphonomethyl
glycine]
in
or
on
the
following
raw
agricultural
commodities,
sunflower,
seed
at
25.0
parts
per
million
(
ppm);
and
safflower,
seed
at
25.0
ppm.
IR­
4
further
proposes
to
delete
the
present
entire
entries
for
sunflower,
seed
at
0.1
ppm
and
for
safflower,
seed
at
0.1
ppm,
as
these
tolerances
are
no
longer
needed.
EPA
has
determined
that
the
petitions
contain
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
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
these
petitions.

IV.
Statutory
Findings
The
petitions
request
that
40
CFR
180.364
be
amended
by
establishing
tolerances
for
residues
of
the
herbicide
glyphosate
in
or
on
sunflower,
seed
at
25.0
ppm
and
safflower,
seed
at
25.0
ppm.

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...."
Page
3
of
15
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
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL­
5754­
7).

A.
Toxicological
Profile
EPA
has
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
are
discussed
in
the
following
Table
1
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed
in
the
following
Table
2.

________________________________________________________________________________

Table
1.­­
Acute
Toxicity
of
Glyphosate
Technical
Guideline
Study
Type
Results
No.
870.1100
Acute
oral
LD[
50]
>
5,000
mg/
kg
Toxicity
Category
IV
870.1200
Acute
dermal
LD[
50]
>
5,000
mg/
kg
Toxicity
Category
IV
870.1300
Acute
inhalation
The
requirement
for
an
acute
inhalation
LC[
50]
study
was
waived
870.2400
Primary
eye
Corneal
opacity
or
irritation
irritation
clearing
in
7
days
or
less
Toxicity
Category
III
870.2500
Primary
skin
Mild
or
slight
irritant
irritation
Toxicity
Category
IV
870.2600
Dermal
Not
a
dermal
sensitizer
sensitization
________________________________________________________________________________

________________________________________________________________________________

Table
2.­­
Toxicity
Profile
of
Glyphosate
Technical
Guideline
Study
Type
Results
No.
870.3100
90­
Day
oral
NOAEL
=
1,500
mg/
kg/
day
in
males
and
toxicity
rodents
­
females
mouse
LOAEL
=
4,500
mg/
kg/
day
in
males
and
females
based
on
decreased
body
weight
gain
870.3100
90­
Day
oral
NOAEL
=
<
50
mg/
kg/
day
in
males
and
toxicity
rodents
­
females
rat
(
range­
finding)
LOAEL
=
50
mg/
kg/
day
in
males
and
females
based
on
increased
phosphorus
and
potassium
values
870.3150
90­
Day
oral
NOAEL
=
400
mg/
kg/
day
in
males
and
toxicity
in
rodents
females
­
rat
(
aminomethyl
LOAEL
=
1,200
mg/
kg/
day
in
males
and
phosphoric
acid
­
females
based
on
body
weight
loss
and
Page
4
of
15
plant
metabolite
of
histopathological
lesions
of
the
glyphosate)
urinary
bladder.
870.3485
28­
Day
inhalation
NOAEL
=
0.36
mg/
L
toxicity
­
rat
LOAEL
=
>
0.36
(
HDT)
mg/
L,
not
(
exposure;
6
established
hours/
day,
5
days/
week
for
4
weeks)
870.3200
21­
Day
dermal
NOAEL
=
1,000
mg/
kg/
day
in
males
and
toxicity
­
rabbit
females
LOAEL
=
5,000
mg/
kg/
day
based
on
slight
erythema
and
edema
on
intact
and
abraded
skin
of
both
sexes,
and
decreased
food
consumption
in
females
870.3700
Prenatal
Maternal
developmental
in
NOAEL
=
1,000
mg/
kg/
day
rodents
­
rat
LOAEL
=
3,500
mg/
kg/
day
based
on
inactivity,
mortality,
stomach
hemorrhages
and
reduced
body
weight
gain
Developmental
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
3,500
mg/
kg/
day
based
on
increased
incidence
in
the
number
of
fetuses
and
litters
with
unossified
sternebrae
and
decreased
fetal
body
weight.
870.3700
Prenatal
Maternal
developmental
in
NOAEL
=
175
mg/
kg/
day
nonrodents
­
rabbit
LOAEL
=
350
mg/
kg/
day
based
on
mortality,
diarrhea,
soft
stools,
and
nasal
discharge.
Developmental
NOAEL
=
350
mg/
kg/
day
LOAEL
=
>
350
(
HDT)
mg/
kg/
day,
not
established
870.3800
Reproduction
and
Parental/
Systemic
fertility
effects
­
NOAEL
=
30
mg/
kg/
day
rat
(
3­
generation)
LOAEL
=
>
30
(
HDT)
mg/
kg/
day,
not
established
Reproductive
NOAEL
=
30
mg/
kg/
day
LOAEL
=
>
30
(
HDT)
mg/
kg/
day,
not
established
Offspring
NOAEL
=
10
mg/
kg/
day
LOAEL
=
30
mg/
kg/
day
based
on
focal
dilation
of
the
kidney
in
male
F3b
pups
870.3800
Reproduction
and
Parental/
Systemic
fertility
effects
­
NOAEL
=
500
mg/
kg/
day
in
males
and
rat
(
2­
generation)
females
LOAEL
=
1,500
mg/
kg/
day
in
males
and
females
based
on
soft
stools,
decreased
body
weight
gain
and
food
consumption.
Focal
dilation
of
the
kidney
observed
at
30
mg/
kg/
day
in
Page
5
of
15
the
3­
generation
study
was
not
observed
at
any
dose
level
in
this
study.
Reproductive
NOAEL
=
>
1,500
(
HDT)
mg/
kg/
day
in
males
and
females
LOAEL
=
>
1,500
(
HDT)
mg/
kg/
day
in
males
and
females,
not
established
Offspring
NOAEL
=
500
mg/
kg/
day
in
males
and
females
LOAEL
=
1,500
mg/
kg/
day
in
males
and
females
based
on
reduced
pup
weights
during
the
second
and
third
weeks
of
lactation
870.4100
Chronic
toxicity
NOAEL
=
500
(
HDT)
mg/
kg/
day
in
males
dogs
and
females
LOAEL
=
>
500
mg/
kg/
day
in
males
and
females,
not
established
870.4300
Chronic/
carcinogenic
NOAEL
=
362
mg/
kg/
day
in
males
city
rats
LOAEL
=
940
mg/
kg/
day
in
males
based
on
decreased
urinary
pH,
increased
incidence
of
cataracts
and
lens
abnormalities,
and
increased
absolute
and
relative
(
to
brain)
liver
weights
NOAEL
=
457
mg/
kg/
day
in
females
LOAEL
=
1,183
mg/
kg/
day
in
females
based
on
decreased
body
weight
gain
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
NOAEL
=
750
mg/
kg/
day
in
males
mice
LOAEL
=
4,500
mg/
kg/
day
in
males
based
on
significant
decreased
body
weight
gain,
hepatocyte
necrosis,
and
interstitial
nephritis
NOAEL
=
750
mg/
kg/
day
in
females
LOAEL
=
4,500
mg/
kg/
day
in
females
based
on
significant
decreased
body
weight
gain,
increased
incidence
of
proximal
tubule
epithelial
basophilia,
and
hypertrophy
in
the
kidney
of
females
No
evidence
of
carcinogenicity
870.5100
Gene
mutation
assay
Negative.
Non­
mutagenic
when
tested
in
S.
typhimurium
up
to
1,000
[
mu]
g/
plate,
in
strains
presence
and
absence
of
activation,
in
S.
typhimurium
strains
TA98,
TA100,
TA1535
and
TA1537.
870.5100
Gene
mutation
assay
Negative
for
reverse
gene
mutation,
in
E.
coli
WP2hcrA
both
with
and
without
S­
9,
up
to
and
S.
typhimurium
5,000
[
mu]
g/
plate
(
or
cytotoxicity)
strains
with
E.
coli
WP2hcrA
and
S.
typhimurium
TA98,
TA100,
TA1535,
TA1537,
and
TA1538
870.5300
Gene
mutation
assay
Negative.
Non­
mutagenic
at
the
HGPRT
in
Chinese
hamster
locus
in
Chinese
hamster
ovary
cells
ovary
(
CHO)
tested
up
to
cytotoxic
concentrations
cells/
HGPRT
or
limit
of
solubility,
in
presence
Page
6
of
15
and
absence
of
activation.
870.5385
Cytogenetics
­
In
Negative.
Non­
mutagenic
in
rat
bone
vivo
bone
marrow
marrow
chromosome
assay
up
to
1,000
chromosomal
mg/
kg
in
both
sexes
of
Sprague
Dawley
aberration
assay
rats
870.5550
Other
mechanisms
­
There
was
no
evidence
of
In
vitro
Rec­
Assay
recombination
in
the
rec­
assay
up
to
with
B.
subtilis
2,000
[
mu]
g/
disk
with
B.
subtilis
H17
(
rec+)
and
M45
H17
(
rec+)
and
M45
(
rec­)
(
rec­)
870.6200
Acute
neurotoxicity
N/
A
screening
battery
in
rats
870.6200
Subchronic
N/
A
neurotoxicity
screening
battery
in
rats
870.6300
Developmental
N/
A
neurotoxicity
in
rats
870.7485
Metabolism
and
Absorption
was
30­
36%
in
males
and
pharmacokinetics
­
females.
Glyphosate
was
excreted
rat
unchanged
in
the
feces
and
urine
(
97.5%
minimum).
The
only
metabolite
present
in
the
excreta
was
AMPA.
Less
than
1%
of
the
absorbed
dose
remained
in
the
carcass,
primarily
bone.
Repeat
dosing
did
not
alter
metabolism,
distribution,
and
excretion.
870.7600
Dermal
penetration
N/
A
________________________________________________________________________________

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
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.
Page
7
of
15
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).
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
(
MOE[
cancer]
=
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
3.

________________________________________________________________________________

Table
3.­­
Summary
of
Toxicological
Dose
and
Endpoints
for
glyphosate
for
Use
in
Human
Risk
Assessment
Exposure
Dose
Used
in
FQPA
SF
*
and
Assessment
Study
Scenario
Risk
Level
of
and
Toxicological
Assessment,
UF
Concern
for
Effects
Risk
Acute
dietary
None
None
An
acute
dietary
(
females
13­
50
endpoint
was
not
years
old
and
selected
for
the
general
general
population
population)
or
females
13­
50,
since
an
appropriate
endpoint
attributable
to
a
single
exposure
was
not
identified
in
the
toxicology
data
base
Chronic
dietary
NOAEL
=
175
FQPA
SF
=
1
Developmental
(
all
mg/
kg/
day
cPAD
=
cRfD
/
toxicity
study
­
populations)
UF
=
100
FQPA
SF
rabbit
Chronic
RfD
=
=
1.75
LOAEL
=
350
1.75
mg/
kg/
day
mg/
kg/
day
mg/
kg/
day
based
on
diarrhea,
nasal
discharge
and
death
in
maternal
animals
Short­,
and
NOAEL
=
175
LOC
for
MOE
=
Developmental
intermediate­
mg/
kg/
day
100
toxicity
study
­
term
incidental,
rabbit
oral
LOAEL
=
350
(
Residential)
mg/
kg/
day
based
on
diarrhea,
nasal
discharge
and
death
in
maternal
animals
Short­,
None
None
Based
on
the
intermediate­
systemic
NOAEL
of
and
long­
term
1,000
mg/
kg/
day
in
dermal
(
1­
30
the
21­
day
dermal
days,
1­
6
toxicity
study
in
months,
6
rabbits,
and
the
Page
8
of
15
months­
lifetime)
lack
of
concern
(
Occupational/
for
developmental
Residential)
and
reproductive
effects,
the
quantification
of
dermal
risks
is
not
required
Short­,
None
None
Based
on
the
intermediate­
systemic
toxicity
and
long­
term
NOAEL
of
0.36
mg/
L
inhalation
(
1­
30
(
HDT)
in
the
28­
days,
1­
6
day
inhalation
months,
6
toxicity
study
in
months­
lifetime)
rats,
and
the
(
Occupational/
physical
Residential)
characteristics
of
the
technical
(
wetcake),
the
quantification
of
inhalation
risks
is
not
required
Cancer
(
oral,
Cancer
Risk
Assessment
No
evidence
of
dermal,
classification
not
required
carcinogenicity
inhalation)
(
Group
E)
________________________________________________________________________________

*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.364)
for
the
residues
of
glyphosate,
in
or
on
a
variety
of
raw
agricultural
commodities.
The
current
proposal
to
establish
tolerances
for
sunflower,
seed
at
25.0
ppm
and
safflower,
seed
at
25.0
ppm,
is
not
expected
to
result
in
an
increase
in
the
dietary
burden
for
cattle,
poultry,
and
hogs.
Commodities
from
sunflower
and
safflower
are
only
small
contributors
to
livestock
diets
compared
to
corn,
sorghum,
pasture
grasses,
alfalfa,
etc.
which
already
have
higher
established
tolerances.
Respective
dietary
burdens
of
210
ppm
and
220
ppm
were
recently
estimated
by
the
Agency
for
dairy
and
beef
cattle,
based
on
existing
tolerances,
and
the
present
proposal
is
not
expected
to
change
these
estimates.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
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.
A
review
of
the
toxicity
data
base,
including
the
developmental
toxicity
studies
in
rats
and
rabbits,
did
not
provide
an
endpoint
that
could
be
used
to
quantitate
risk
to
the
general
population
and
to
females
13­
50
years
old
from
a
single­
dose
administration
of
glyphosate.
Therefore,
no
acute
dietary
analysis
was
conducted
for
glyphosate.

ii.
Chronic
exposure.
The
glyphosate
chronic
dietary
exposure
analysis
was
conducted
using
the
DEEM
 
software
Version
7.87,
which
incorporates
consumption
data
from
USDA's
CSFII,
1989­
1992.
The
1989­
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
3
consecutive
days,
and
therefore
represent
more
than
30,000
unique
person
days
of
data.
Foods
as
consumed
(
i.
e.,
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(
i.
e.,
apples­
cooked/
canned
or
wheat­
flour)
by
recipe
translation
files
internal
to
the
DEEM
 
software.
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.

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
Page
9
of
15
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
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
or
pending
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
4.­­
Summary
of
Results
from
Chronic
DEEM
 
Analysis
of
Glyphosate
Subgroup
Exposure
%
cPAD
(
mg/
kg/
day)
U.
S.
population
(
total)
0.033662
1.9
All
Infants
(<
1
year
old)
0.075573
4.3
Children
(
1­
6
years
old)
0.072233
4.1
Children
(
7­
12
years
old)
0.047962
2.7
Females
(
13­
50
years
old)
0.025215
1.4
Males
(
13­
19
years
old)
0.032879
1.9
Males
(
20+
years
old)
0.028631
1.6
Seniors
(
55+
years
old)
0.023870
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.

iv.
Anticipated
residue
and
percent
crop
treated
information.
The
Agency
used
tolerance
levels
and
100%
percent
crop
treated
(
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.

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
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
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
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.
Page
10
of
15
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
%
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
the
aggregate
risk
section
E.
(
Aggregate
Risks
and
Determination
of
Safety)
of
this
Unit.

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
(
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
waterbodies
with
floating
weeds
present.
Thus,
the
inclusion
of
the
swimmer
incidental
ingestion
exposure
assessment
is
considered
by
the
Agency
to
be
conservative.
Table
5
presents
a
summary
of
assumptions
used
to
estimate
the
exposure
to
adult
and
toddler
child
swimmers
and
the
corresponding
risk
estimates.

________________________________________________________________________________

Table
5.­­
Assumptions
and
Risk
Estimates
for
Post­
Application
Swimmer
Exposure
Assessments
for
Glyphosate,
Isopropylamine
salt
Exposure
AR
1
(
lb
Maximum
Potential
Short­
term
Scenario
a.
e./
A)
Concentration
Dose
Rate
MOE
4
in
water
(
PDR;
oral
(
mg/
L)
2
mg/
kg
bw/
day)
3
Incidental
3.75
1.38
0.00493
36,000
oral
ingestion,
adult­
female
Incidental
0.023
7,600
oral,
toddler
________________________________________________________________________________

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.
Page
11
of
15
2
Maximum
concentration
in
water
(
top
1
ft.)
=
3.75
lb
ae/
A
x
1A/
43,560
ft<
2>
x
454,000
mg/
lb
x
1/
ft
x
ft<
3>/
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
(
adult­
female
=
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
5
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
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
or
intermediate­
term
dermal
or
inhalation
endpoints,
no
residential
handler
or
post­
application
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
6
provides
a
summary
of
the
short­
and
intermediate­
term
risk
estimates
for
post­
application
incidental
ingestion
exposures
to
toddlers.

________________________________________________________________________________

Table
6.­­
Summary
of
Toddler
Incidental
Ingestion
Exposures
and
Risk
Estimates
for
Residential
Use
of
Glyphosate,
Isopropylamine
salt
1
Activity
AR
(
lbs
Residue
PDR
(
mg/
kg
Short­/
a.
e./
A)
2
Estimate
3
bw/
d)
4
Intermediateterm
MOE
5
Hand­
to­
1.62
DFR:
0.908
0.0242
7,200
mouth
[
mu]
g/
cm
2
Object­
to­
DFR:
3.63
0.00605
29,000
mouth
[
mu]
g/
cm
2
Soil
Soil
residue:
8.13
x
10
­
5
10
6
ingestion
12.2
[
mu]
g/
g
soil
________________________________________________________________________________

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
SOPs:

a.
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/
cm
2
)
=
0.908
g/
cm
2
.

b.
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/
cm
2
)
=
3.63
[
mu]
g/
cm
2
.
Page
12
of
15
Soil
Residue
=
1.62
lb
ae/
A
x
fraction
of
residue
in
soil
(
100%)/
cm
x
(
4.54
x
10
8
[
mu]
g/
lb
ae)
x
(
2.47
x
10
­
8
A/
cm2)
x
0.67
cm
3
/
g
=
12.2
[
mu]
g/
g
soil.

4
Potential
Dose
Rate
(
PDR;
already
normalized
to
body
weight
of
toddler).

a.
Hand­
to­
mouth
PDR
=
(
0.908
g/
cm
2
x
0.50
x
20
cm
2
/
event
x
20
events/
hr
x
10
­
3
mg/[
mu]
g
x
2
hrs/
d)/
15
kg
=
0.0242
mg/
kg
bw/
d.

Object­
to­
mouth
PDR
=
(
3.63
g/
cm
2
x
25
cm
2
/
d
x
10
­
3
mg/[
mu]
g)/
15
kg
=
0.00605
mg/
kg
bw/
d.

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
bw/
d.

5
MOE
=
NOAEL/
PDR,
where
the
short­
term
incidental
oral
NOAEL
=
175
mg/
kg/
d
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).

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
toxicity
with
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).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
FFDCA
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
data
base
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
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.

2.
Prenatal
and
postnatal
sensitivity.
The
toxicology
data
base
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:

1.
The
toxicology
data
base
is
complete.
Page
13
of
15
2.
A
developmental
neurotoxicity
study
is
not
required.

3.
The
dietary
(
food
and
drinking
water)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.

E.
Aggregate
Risks
and
Determination
of
Safety
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
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,
EPA
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
1.9%
of
the
cPAD
for
the
U.
S.
population,
4.3%
of
the
cPAD
for
[
All
Infants
(
less
than
1
year
old)
and
4.1%
of
the
cPAD
for
children
1­
6
years
old.
The
results
of
the
chronic
analysis
(
Table
4
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
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
7
below:

________________________________________________________________________________

Table
7.­­
Aggregate
Risk
Assessment
for
Chronic
(
Non­
Cancer)
Exposure
to
glyphosate
Scenario/
cPAD,
Chronic
Maximum
Ground
Surface
Chronic
Population
mg/
kg/
Food
Ex­
Chronic
Water
Water
DWLOC
2,
Subgroup
day
posure,
Water
EEC,
ppb
EEC,
ppb
ppb
mg/
kg/
Exposure
1,
day
mg/
kg/
Page
14
of
15
day
U.
S.
1.75
0.033662
1.716338
0.0038
230
60,100
population
All
infants
1.75
0.075573
1.674427
0.0038
230
16,700
(<
1
year
old)
Children
(
1­
6
1.75
0.072233
1.677767
0.0038
230
16,800
years
old)
Children
(
7­
1.75
0.047962
1.702038
0.0038
230
17,000
12
years
old)
Females
(
13­
1.75
0.025215
1.724785
0.0038
230
51,700
50
years
old)
Males
(
13­
19
1.75
0.032879
1.717121
0.0038
230
60,100
years
old)
Males
(
20+
1.75
0.028631
1.721369
0.0038
230
60,200
years
old)
Seniors
(
55+
1.75
0.023870
1.726130
0.0038
230
60,400
years
old)
________________________________________________________________________________

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
(
µ
g/
L)
=
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)
/
consumption
(
L/
day)
x
0.001
mg/
µ
g.

3.
Short­/
intermediate­
term
aggregate
risk
(
food
+
residential
+
water).
In
aggregating
short­/
intermediate­
term
risk,
HED
considered
background
chronic
dietary
exposure
(
food
+
water)
and
short/
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/
intermediate­
term
food
and
residential
aggregate
MOEs
are
1,800­
2,300.
As
these
MOEs
are
greater
than
100,
the
short­/
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
short­
/
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/
intermediate­
term
aggregate
human
health
risk
at
the
present
time.
Table
8
summarizes
the
short­/
intermediate­
term
aggregate
exposure
to
glyphosate
residues.

________________________________________________________________________________

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

All
Infants
1,900
100
230
0.0038
16,700
Page
15
of
15
(<
1
year
old)
Children
(
1­
6
1,800
100
230
0.0038
16,800
years
old)
Children
(
7­
12
2,300
100
230
0.0038
17,000
years
old)
________________________________________________________________________________

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
body
weight
(
kg)
/
water
consumption
(
L)
x
10
­
3
mg/[
mu]
g
(
10
kg
body
weight
assumed).

5.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
glyphosate
residues.

VI.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methods
are
available
for
analysis
of
residues
of
glyphosate
in
or
on
plant
and
livestock
commodities.
These
methods
include
GLC
(
Method
I
in
Pesticides
Analytical
Manual
(
PAM)
II;
the
limit
of
detection
is
0.05
ppm)
and
HPLC
with
fluorometric
detection.
Use
of
the
GLC
method
is
discouraged
due
to
the
lengthiness
of
the
experimental
procedure.
The
HPLC
procedure
has
undergone
successful
Agency
validation
and
was
recommended
for
inclusion
in
PAM
II.
A
GC/
MS
method
for
glyphosate
in
crops
has
also
been
validated
by
EPA's
Analytical
Chemistry
Laboratory
(
ACL).
Thus,
adequate
analytical
methods
are
available
for
residue
data
collection
and
enforcement
of
the
proposed
tolerance
changes
for
glyphosate.

B.
International
Residue
Limits
There
are
no
Codex
or
Canadian
MRLs
established
for
residues
of
glyphosate
in
or
on
sunflower,
seed
or
safflower,
seed.
