Document ID: EPA-HQ-OPP-2005-0479-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-14T04:00Z

Reregistration
Eligibility
Decision
for
Dicamba
and
Associated
Salts
List
[
B]

Case
No.
0065
Reregistration
Eligibility
Decision
(
RED)
Document
for
Dicamba
and
Associated
Salts
Approved
by:
__________________
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
__________________
Glossary
of
Terms
and
Abbreviations
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
BCF
Bioconcentration
Factor
CFR
Code
of
Federal
Regulations
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EUP
End­
Use
Product
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLN
Guideline
Number
HAFT
Highest
Average
Field
Trial
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
µ
g/
g
Micrograms
Per
Gram
µ
g/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEL
No
Observed
Adverse
Effect
Level
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SAP
Science
Advisory
Panel
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
TRR
Total
Radioactive
Residue
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UF
Uncertainty
Factor
UV
Ultraviolet
WPS
Worker
Protection
Standard
1
Table
of
Contents
Dicamba
Reregistration
Eligibility
Decision
Team
.................................................................
2
I.
Introduction.......................................................................................................................
3
II.
Chemical
Overview
.......................................................................................................
3
III.
Summary
of
Dicamba
Risk
Assessment
.......................................................................
5
A.
Human
Health
Risk
Assessment
...................................................................................
5
1.
Toxicology....................................................................................................................
6
2.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
..................................
8
3.
Residential
Exposure
and
Risk
.............................................................................
9
4.
Aggregate
Exposure
and
Risk.................................................................................
11
5.
Occupational
Exposure
and
Risk............................................................................
11
6.
Incidents
reports.....................................................................................................
14
B.
Environmental
Risk
Assessment
....................................................................................
14
1.
Environmental
Fate
and
Transport............................................................................
14
2.
Environmental
Effects.................................................................................................
15
3.
Ecological
Incidents....................................................................................................
19
4.
Risk
to
Endangered
Species
.......................................................................................
20
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
..............
20
A.
Determination
of
Reregistration
Eligibility................................................................
20
B.
Public
Comments
and
Responses...............................................................................
21
C.
Regulatory
Position
.....................................................................................................
21
1.
Food
Quality
Protection
Act
Findings
....................................................................
21
2.
Endocrine
Disruptor
Effects
...................................................................................
21
3.
Cumulative
Risks.....................................................................................................
22
4.
Tolerance
Reassessment
Summary.........................................................................
22
D.
Regulatory
Rationale...................................................................................................
22
1.
Human
Health
Risk
Assessment
.............................................................................
22
2.
Environmental
Risk
Mitigation
..............................................................................
23
V.
What
Registrants
Need
to
Do
.........................................................................................
24
A.
Manufacturing
Use
Products
......................................................................................
25
1.
Additional
Generic
Data
Requirements
.................................................................
25
2.
Labeling
for
Manufacturing­
Use
Products.........................................................
25
B.
End­
Use
Products
....................................................................................................
25
1.
Additional
Product­
Specific
Data
Requirements
...............................................
25
2.
Labeling
for
End­
Use
Products...........................................................................
26
VI.
Conclusions..................................................................................................................
26
2
Dicamba
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Environmental
Fate
and
Effects
Risk
Assessment
Bill
Erickson
Ibrahim
Abdel­
Saheb
Shannon
Borges
Health
Effects
Risk
Assessment
Christine
Olinger
Tim
Dole
Biological
and
Economic
Analysis
Assessment
Nicole
Zinn
Elisa
Rim
Registration
Support
Joanne
Miller
Risk
Management
Kendra
Tyler
Laura
Parsons
3
I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
data
submitted
to
the
Environmental
Protection
Agency.
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
risks
arising
from
the
currently
registered
uses
of
dicamba,
to
determine
the
need
for
additional
data
on
health
and
environmental
effects,
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.
As
a
result
of
this
review,
the
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
determined
that
all
products
containing
the
active
ingredient
dicamba
are
eligible
for
reregistration
provided
that
the
risk
mitigation
measures
indicated
in
this
document
are
adopted.
The
completion
of
the
dicamba
RED
does
not
result
in
any
additional
tolerances
being
reassessed
since
all
60
existing
tolerances
were
reassessed
in
2000,
when
a
new
food
use
was
established
for
dicamba
[
65
FR
33709,
(
May
24,
2000)].

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
dicamba.
The
Food
Quality
Protection
Act
(
FQPA)
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."
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
dicamba,
and
dicamba
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
Therefore,
for
the
purposes
of
reregistration,
EPA
has
not
assumed
that
dicamba
shares
a
common
mechanism
of
toxicity
with
other
compounds.
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

II.
Chemical
Overview
 
Common
Name:
Dicamba
is
an
acid
which
forms
salts
in
aqueous
solutions.
Various
dicamba
salts
are
formulated
for
herbicidal
use
and
the
following
compounds
are
considered
in
this
decision
document:
dimethylamine
(
DMA)
salt,
sodium
(
NA)
salt,
isopropylamine
(
IPA)
salt,
diglycolamine
(
DGA)
salt,
and
potassium
(
K)
salt.

 
Chemical
Name:
3,6­
dichloro­
2­
methoxybenzoic
acid
or
2­
methoxy­
3,6­
dichlorobenzoic
acid
4
 
CAS
Registry
Numbers:

Dicamba
Acid:
1918­
00­
9
Dicamba
DMA:
2300­
66­
5
Dicamba
NA:
1982­
69­
0
Dicamba
IPA:
555871­
02­
8
Dicamba
DGA:
1040440­
79­
1
Dicamba
K:
10007­
85­
9
 
OPP
Chemical
Numbers:

Dicamba
Acid:
029801
Dicamba
DMA:
029802
Dicamba
NA:
029806
Dicamba
IPA:
128944
Dicamba
DGA:
128931
Dicamba
K:
129043
 
Common
Trade
Names:
Banvel;
Trimec
 
Basic
Manufacturer:
BASF
Dicamba
(
2­
methoxy­
3,6­
dichlorobenzoic
acid)
is
a
selective
benzoic
acid
herbicide
registered
for
the
post
emergent
control
of
certain
broadleaf
weeds
and
woody
plants.
It
was
first
registered
in
the
United
States
in
1967
and
is
widely
used
in
agricultural,
industrial,
and
residential
settings.
According
to
the
EPA
Pesticide
Sales
and
Usage
Report
for
2000/
2001,
dicamba
is
the
seventh
most
commonly
used
conventional
pesticide
in
the
home
and
garden
market
sector.
The
residential
products
are
typically
formulated
as
dry
weed­
and­
feed
products
or
as
liquids
in
concentrates
or
ready­
to­
use
sprays.
Many
of
these
formulations
include
other
herbicides
to
provide
a
broader
spectrum
of
weed
control.

Use
Sites:

 
Dicamba
salts
have
registered
uses
on
right­
of­
way
areas,
asparagus,
barley,
corn,
grasses
grown
in
pasture
and
rangeland,
oats,
proso
millet,
rye,
sorghum,
soybeans,
sugarcane,
and
wheat.
Golf
courses
and
residential
lawns
are
also
registered.

Mode
of
Action:

 
Dicamba
is
an
auxin
agonist
and
causes
rapid
and
uncontrolled
growth
of
the
stems,
petioles,
and
leaves
of
sensitive
plants.
This
uncontrolled
cell
division
and
growth
in
turn
results
in
the
destruction
of
vascular
tissue,
leading
to
plant
death.
Weed
control
is
generally
achieved
in
5
to
7
days.
5
Formulations:

 
There
are
434
dicamba
products
formulated
as
liquids,
wettable
powders,
standard
granules,
and
water
dispersible
granules.
Residential
products
are
typically
formulated
as
granular
weed­
and­
feed
formulations
or
as
liquids
in
concentrates
or
ready­
to­
use
sprays.

Methods
and
Timing
of
Application:

 
Application
methods
include
groundboom,
rights­
of­
way
sprayer,
turfgun,
backpack
sprayer,
tractor­
drawn
broadcast
spreader,
push­
type
broadcast
spreader,
and
by
fixedwing
aircraft.
Typically
one
application
is
made
per
growing
season.

Use
Rates:

 
Rates
for
all
salts
and
formulations
are
normalized
to
dicamba
acid
equivalents
per
acre
(
ae/
A).
Application
rates
range
from
0.5
to
2.8
lb
ae/
A.

III.
Summary
of
Dicamba
Risk
Assessment
The
following
is
a
summary
of
EPA's
human
health
and
ecological
risk
findings
and
conclusions
for
dicamba,
as
presented
fully
in
the
documents:
"
Dicamba:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document,"
written
by
C.
Olinger,
Y.
Yang,
T.
Dole,
and
M.
Hawkins
(
9/
13/
2005),
and
"
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Dicamba
and
Dicamba
Sodium,
Potassium,
Diglycoamine,
Dimethylamine,
and
Isopropylamine
Salts,"
written
by
W.
Erickson,
I.
Abdel­
Saheb,
and
S.
Borges
(
11/
15/
05).
There
were
no
public
comments
which
required
revisions
to
the
risk
assessments.

The
purpose
of
this
section
is
to
summarize
the
key
features
and
findings
of
the
risk
assessments
in
order
to
help
the
reader
better
understand
the
risk
management
decision
reached
by
the
Agency.
While
the
full
risk
assessments
and
related
supporting
documents
are
not
included
in
this
document,
they
are
available
in
the
public
docket
at
www.
regulations.
gov
(
docket
#
EPA­
HQ­
OPP­
2005­
0479)
and
on
the
Agency's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

A.
Human
Health
Risk
Assessment
The
Agency
has
conducted
a
human
health
risk
assessment
for
dicamba
for
the
purpose
of
making
a
reregistration
eligibility
decision.
The
Agency
evaluated
the
toxicology,
product
and
residue
chemistry,
and
occupational
and
residential
exposure
studies
submitted
for
dicamba
and
determined
that
the
data
are
adequate
to
support
a
reregistration
decision.
A
summary
of
the
human
health
risk
assessment
findings
and
conclusions
are
below.
6
1.
Toxicology
The
available
toxicity
data
on
dicamba
are
adequate
to
assess
dicamba's
hazard
potential.
Table
1
below
presents
the
acute
toxicity
profile
for
dicamba:

Table
1.
Acute
Toxicity
Profile
on
Dicamba
Acid
Guideline
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
oral
toxicity
/
rat
00078444
LD50
=>
2740
mg/
kg
III
870.1200
Acute
dermal
toxicity
/
rat
00241584
LD50
=>
2000
mg/
kg
III
870.1300
Acute
inhalation
toxicity
/
rat
00263861
LC50
=>
5.3
mg/
L
IV
870.2400
Primary
eye
irritation
/
rabbit
00241584
Irritant
II
870.2500
Primary
dermal
irritation
/
rabbit
00237955
Irritant
II
870.2600
Dermal
sensitization
/
guinea
pig
00263861
Non­
Sensitizer
­­

See
Table
2
for
a
summary
of
the
toxicological
endpoints
used
in
the
human
health
risk
assessment
for
dicamba.

FQPA
Considerations
Developmental
studies
were
conducted
on
both
rats
and
rabbits,
following
in
utero
and/
or
pre­/
post­
natal
exposure
to
dicamba.
No
evidence
of
increased
susceptibility
was
observed.
In
addition,
no
evidence
of
developmental
anomalies
of
the
fetal
nervous
system
were
observed
in
the
prenatal
developmental
toxicity
studies
in
either
rats
or
rabbits
at
maternally
toxic
doses
of
up
to
300
or
400
mg/
kg/
day.
Also,
no
evidence
of
behavioral
or
neurological
effects
on
the
offspring
was
observed
in
the
two­
generation
reproduction
study
in
rats.
Based
on
the
weight
of
evidence,
a
developmental
neurotoxicity
study
(
DNT)
is
not
required.
Additionally,
because
the
dicamba
dietary
and
residential
risk
assessments
are
not
expected
to
underestimate
exposure,
the
special
FQPA
safety
factor
has
been
removed
(
reduced
to
1X)
for
the
dicamba
risk
assessment.
7
Table
2.
Summary
of
Toxicological
Endpoints
Dicamba
Exposure
Scenario
Factor
Used
in
Risk
Assessment
Study
and
Endpoint
of
Risk
Assessment
Dietary
Risk
Assessment
Dietary
(
Acute)­
all
populations
UF=
300x
aRfD=
1.0
mg/
kg/
day
aPAD=
1.0
mg/
kg/
day
MRID
no:
42774104
Acute
Neurotoxicity
Study
in
Rats
The
aRfd
was
determined
based
on
a
LOAEL
of
300
mg/
kg/
day
in
the
rat
acute
neurotoxicity
study
and
an
UF
of
300x
(
10x
for
interspecies
extrapolation,
a
10x
for
intraspecies
variation,
and
a
3x
for
using
a
LOAEL,
instead
of
a
NOAEL)
LOAEL
=
300
mg/
kg/
day
Neurotoxicity
signs
such
as
impaired
gaits
and
righting
reflex
were
seen
in
both
male
and
females
at
the
lowest
dose
tested,
300
mg/
kg/
day
Dietary
(
Chronic)­
all
populations
UF=
100x
cRfD=
0.45
mg/
kg/
day
cPAD=
0.45
mg/
kg/
day
MRID
no:
43137101
Multi­
Generation
Reproduction
Study
in
Rats
The
cRfD
was
established
based
on
the
NOAEL
of
45
mg/
kg/
day
in
the
multi­
generation
reproduction
study
and
an
uncertainty
factor
of
100x
(
10x
for
interspecies
extrapolation,
10x
for
intraspecies
variation).
NOAEL
=
45
mg/
kg/
day
LOAEL
=
136
mg/
kg/
day
Decreased
pup
weight
was
seen
at
the
LOAEL
of
136
mg/
kg/
day
Residential
Risk
Assessment
(
Adults
and
Toddlers)

Acute
Oral
Exposure
(
Toddlers)
Level
of
Concern
MOE=
300
MRID
no:
42774104
Acute
Neurotoxicity
Study
in
Rats
LOAEL
=
300
mk/
kg
Dermal
and
Inhalation
Short,
Intermediate
&
Long­
term
Level
of
Concern
MOE=
100
15%
dermal
absorption
factor
100%
inhalation
absorption
MRID
no:
43137101
Multi­
Generation
Reproduction
Study
in
Rats
NOAEL
=
45
mg/
kg/
day
LOAEL
=
136
mg/
kg/
day
(
Occupational)
Non­
Dietary
Risk
Assessment
Dermal­
Short
&
Intermediate
Term
(
1­
30
days)
Level
of
Concern=
100
15%
dermal
absorption
factor
MRID
no:
43137101
NOAEL
=
45
mg/
kg/
day
LOAEL
=
136
mg/
kg/
day
Inhalation­

Short
&
Intermediate
Term
(
1­
30
days)
Level
of
Concern
MOE=
100
100%
inhalation
absorption
MRID
no:
43137101
NOAEL
=
45
mg/
kg/
day
LOAEL
=
136
mg/
kg/
day
Cancer
Not
likely
to
be
carcinogenic
to
humans
MRID
no:
00146150
MRID
no:
40872401
UF
=
uncertainty
factor
MOE
=
margin
of
exposure
aRfD
=
acute
reference
dose
cRfD
=
chronic
reference
dose
LOAEL=
lowest
observed
adverse
effect
level
NOAEL
=
no
observed
adverse
effect
level
8
2.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
Dietary
risk
assessment
incorporates
both
exposure
to
and
toxicity
of
a
given
pesticide.
Dietary
risk
is
expressed
as
a
percentage
of
a
level
of
concern.
The
level
of
concern
is
the
dose
predicted
to
result
in
no
unreasonable
adverse
health
effects
to
any
human
population
subgroup,
including
sensitive
members
of
such
population
subgroups.
This
level
of
concern
is
referred
to
as
the
population
adjusted
does
(
PAD),
which
reflects
the
reference
dose
(
RfD),
either
acute
or
chronic,
adjusted
to
account
for
the
FQPA
safety
factor.

Estimated
risks
that
are
less
than
100%
of
the
PAD
are
below
the
EPA's
level
of
concern.
The
acute
PAD
(
aPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
on
any
given
day
with
no
adverse
health
effect
expected.
The
chronic
PAD
(
cPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
over
the
course
of
a
lifetime
with
no
adverse
health
effects
expected.

a.
Acute
Dietary
(
Food
and
Drinking
Water)

Acute
dietary
risk
is
based
on
the
quantity
of
food
and
water
consumed
in
one
day
and
the
estimated
maximum
residue
values
in
food
and
water.
EPA
evaluated
the
acute
dietary
risks
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID
 
,
Version
2.03),
which
incorporates
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.

EPA
conducted
an
unrefined,
Tier
1
acute
dietary
food
exposure/
risk
analysis
for
dicamba
using
tolerance
level
residue
values,
default
processing
factors,
and
the
assumption
of
100%
crop
treated
for
all
commodities.
For
Tier
1
analysis,
which
are
based
on
upper­
bound
pesticide
residue
value
inputs
(
e.
g.,
assuming
100%
of
registered
crops
are
treated
with
the
pesticide,
or
that
residues
are
present
at
tolerance
level),
EPA
presents
acute
dietary
results
at
the
95th
percentile
of
exposure
which
provides
a
high­
end
estimate
of
risk
and
is
protective
of
the
general
U.
S.
population
and
all
population
subgroups.

The
residues
of
concern
for
tolerance
enforcement
and
risk
assessment
are
dicamba,
the
3,6­
dichloro­
5­
hydroxybenzoic
acid
(
5­
OH
dicamba)
metabolite,
and
the
3,6­
dichlorosalicylic
acid
(
DCSA)
metabolite.
The
Agency
assessed
dietary
risk
from
drinking
water
using
the
full
distribution
of
estimated
residues
in
surface
water,
generated
by
PRZM­
EXAMS
models
from
use
of
dicamba
on
sugarcane,
which
is
the
worst­
case
risk
scenario.
Residues
of
dicamba
acid
and
it's
degradate,
DCSA,
were
combined
for
the
risk
assessment.
The
acute
dietary
estimates
are
below
the
Agency's
level
of
concern
at
the
95th
exposure
percentile
for
all
population
subgroups
When
considering
food
alone,
the
most
highly
exposed
subgroup
for
acute
exposure
is
children,
aged
1­
2,
with
5.4%
of
the
aPAD
consumed.
When
considering
both
food
and
water,
the
most
highly
exposed
subgroup
was
infants
with
11%
of
the
aPAD
consumed
at
the
95th
percentile.
See
Table
3
for
a
summary
of
dietary
exposure
and
risk
for
dicamba.
9
b.
Chronic
Dietary
(
Food
and
Drinking
Water)

EPA
conducted
an
unrefined
Tier
1
chronic
dietary
food
risk
analysis
using
the
average
consumption
values
for
food
and
the
average
tolerance
levels
of
those
foods.
Estimated
exposure
to
dicamba
and
its
residues
of
concern
for
all
population
subgroups
is
well
below
the
level
of
concern.
When
considering
food
alone,
or
food
and
water,
the
most
highly
exposed
subgroup
is
children,
aged
1­
2,
at
6.5%
and
6.6%
of
the
cPAD,
respectively.

Actual
exposures
to
dicamba
are
likely
to
be
considerably
lower
than
these
estimates.
These
assessments
assume
all
commodities
have
tolerance
level
residues;
however,
residues
sampled
in
most
field
trials
were
lower.
The
assessments
also
assume
100%
of
all
crops
are
treated,
but
a
screening
level
usage
analysis
indicates
that
the
percent
crop
treated
for
most
commodities
is
less
than
20%.
Only
drinking
water
from
surface
water
sources
are
considered,
but
the
model
estimates
for
ground
water
are
much
lower
than
surface
water
estimates;
therefore
the
use
of
surface
water
is
protective.
A
summary
of
the
dietary
exposure
and
risk
for
dicamba
is
presented
in
Table
3
below.

Table
3.
Summary
of
Dietary
Exposure
and
Risk
for
Dicamba:
Food
and
Water
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Population
Subgroup
Dietary
exposure
mg/
kg/
day)
%
aPAD
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.0435
4.4
0.0118
2.6
All
Infants
(<
1
year
old)
0.108
11
0.0199
4.4
Children
1­
2
years
old
0.0756
7.6
0.0297
6.6
For
additional
information,
please
see
Section
5.2
of
the
HED
risk
assessment.

3.
Residential
Exposure
and
Risk
Both
spot
and
broadcast
treatments
are
permitted
by
product
labels.
Exposures
from
lawn
treatment
are
expected
to
be
short­
term
in
duration
because
the
label
allows
only
two
broadcast
treatments
per
year
and
use
directions
for
spot
treatments
recommend
repeat
applications
after
two
to
three
weeks
for
hard­
to­
kill
weeds.

Non­
cancer
risk
estimates
(
such
as
residential
estimates)
are
expressed
as
a
margin
of
exposure
(
MOE)
which
is
a
ratio
of
the
dose
from
a
toxicological
study
selected
for
risk
assessment,
typically
a
NOAEL,
to
the
predicted
exposure.
Estimated
MOEs
are
compared
to
a
level
of
concern
which
reflects
the
dose
selected
for
risk
assessment
and
uncertainty
factors
(
UFs)
applied
to
that
dose.
The
standard
UF
is
100x,
which
includes
10x
for
interspecies
extrapolation
(
to
account
for
differences
between
laboratory
animals
and
humans)
and
10x
for
intraspecies
variation
(
to
account
for
differences
within
a
species
of
laboratory
animal).
Additional
uncertainty
or
safety
factors
may
also
be
applied.
In
the
case
of
dicamba,
EPA's
level
of
concern
for
residential
exposure
is
an
MOE
of
100
for
short­,
intermediate­,
and
long­
term
residential
risk
assessments
for
both
dermal
and
inhalation
routes
of
exposure.
EPA's
level
of
concern
for
acute
exposures
is
an
MOE
of
300,
which
incorporates
the
standard
uncertainty
10
factors
and
a
3X
for
using
a
LOAEL
rather
than
a
NOAEL
as
the
endpoint.
EPA
determined
that
the
available
data
support
the
removal
of
the
default
10X
FQPA
safety
factor.
Thus,
scenarios
that
yield
MOEs
that
are
less
than
300
for
acute
exposure
and
less
than
100
for
all
other
exposures
may
trigger
concern.
No
scenarios
resulted
in
exceedances
of
the
levels
of
concern.

a.
Residential
Handler
Exposure
and
Risk
The
handler
exposure
data
were
taken
from
the
Pesticide
Handler
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
data.
The
residential
handler
risks
were
calculated
using
standard
assumptions,
the
highest
quality
unit
exposure
data
available,
and
the
maximum
label
application
rates.
All
the
MOEs
for
residential
handler
exposure
are
greater
than
the
level
of
concern
MOEs
of
300
for
acute
exposures
and
100
for
short­
term
exposures,
and
therefore
the
risks
are
below
the
EPA's
level
of
concern.
Seven
scenarios
for
residential
handling
and
application
of
dicamba
were
assessed
resulting
in
MOEs
ranging
from
3,800
to
62,000.

b.
Residential
Postapplication
Exposure
and
Risk
Residential
postapplication
exposure
data
were
taken
from
four
turf
transferable
residue
studies.
All
of
the
studies
were
reviewed
by
the
Agency
and
were
found
to
meet
the
guidelines
for
postapplication
exposure
monitoring.
Acute
MOEs
for
toddlers
ingesting
granules
resulted
in
acute
MOEs
>
1500.
Please
see
the
HED
risk
assessment
for
more
details
on
granular
ingestion.
The
acute
MOEs
for
toddlers
playing
on
turf
are
greater
than
the
MOE
of
300
for
dermal
and
incidental
ingestion
risk,
and
are
below
EPA's
level
of
concern.
Typically,
the
Agency
does
not
assess
inhalation
risk
for
postapplication
exposures
since
inhalation
is
not
considered
to
be
an
important
postapplication
route
of
exposure
for
most
active
ingredients.
All
short­
term
MOEs
for
both
adults
and
toddlers
are
greater
than
100
and
are
below
the
EPA's
level
of
concern.
A
summary
of
the
MOE
estimates
is
included
in
Tables
5
and
6.

Table
5.
Acute
Dicamba
MOEs
for
Turf
Exposures
(
Application
Rate
=
1.0
lb
ae/
acre)

Scenario
TTR
(
ug/
cm2)
TC
(
cm2/
hr)
Dermal
MOE
Hand­
to­
Mouth
MOE
Object­
to­
Mouth
MOE
Soil
Ingestion
MOE
Total
MOE
Toddlers
Playing
0.29
5,200
9,900
20,000
80,000
5,900,000
6,100
Target
MOE
is
300
Table
6.
Short
Term
Dicamba
MOEs
for
Turf
Exposures
(
Application
Rate
=
1.0
lb
ae/
acre)

Scenario
TTR
(
ug/
cm2)
TC
(
cm2/
hr)
Dermal
MOE
Hand­
to­
Mouth
MOE
Object
to
Mouth
MOE
Soil
Ingestion
MOE
Total
MOE
Toddlers
Playing
0.060
5,200
7,200
7,200
29,000
2,100,000
3,200
Adult
Yard
work
Golf
0.060
0.060
14,500
500
12,000
170,000
N/
A
Target
MOE
is
100
TTR
=
turf
transferable
residues
TC
=
transfer
coefficient
For
more
residential
exposure
information,
please
see
the
HED
risk
assessment.
11
4.
Aggregate
Exposure
and
Risk
The
FQPA
amendments
to
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA,
Section
408(
b)(
2)(
A)(
ii))
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposure
and
other
exposures
for
which
there
is
reliable
information."

An
aggregate
risk
assessment
looks
at
the
combined
risk
from
dietary
exposure
(
food
and
drinking
water
pathways)
as
well
as
exposure
from
non­
occupational
sources
(
e.
g.,
residential
uses).
Acute
aggregate
exposures
(
less
than
one
day)
may
result
from
consuming
treated
food
or
drinking
water.
Acute
aggregate
exposures
may
also
result
from
residential
exposures
such
as
adults
doing
yard
work
or
playing
golf
on
treated
turf,
or
from
children
playing
on
treated
turf.
Typically
the
Agency
does
not
aggregate
acute
dietary
exposures
with
acute
residential
exposures,
because
it
is
very
unlikely
that
high­
end
food
and
water
exposures
will
occur
on
the
same
day
as
the
maximum
residential
exposures.
Therefore,
acute
aggregate
risks
for
dicamba
are
equal
to
the
acute
dietary
risks.
As
noted
above,
the
acute
dietary
risk
estimates
for
the
U.
S.
population
and
all
subgroups
are
well
below
the
Agency's
level
of
concern.
The
most
highly
exposed
subgroup
is
infants
at
11%
of
the
aPAD.

The
short­
term
aggregate
assessment
considered
exposures
from
food,
drinking
water,
residential
handler,
and
residential
postapplication
activities.
Average
food
and
water
exposure
estimates
were
used
in
the
assessment.
The
residential
handler
scenario
that
resulted
in
the
highest
exposures,
adults
who
mix/
load/
apply
with
a
(
mix­
your­
own)
hose­
end
sprayer,
was
used
in
the
adult
aggregate
assessment.
The
exposure
from
the
yard
work
postapplication
scenario
was
used
for
the
adult
assessment,
and
the
exposure
from
the
toddler
playing
on
turf
scenario
was
used
in
the
child
assessment.
The
MOEs
for
all
scenarios
for
the
short­
term
aggregate
assessment
range
from
1,030
to
2,720.
Since
the
MOEs
are
greater
than
100,
the
risks
are
below
the
EPA's
level
of
concern.

There
are
no
residential
scenarios
that
would
result
in
intermediate­
or
long­
term
residential
exposures.
Therefore
no
intermediate­
term
aggregate
assessment
was
necessary,
and
chronic
aggregate
risks
are
equal
to
chronic
dietary
risks.
As
discussed
above,
the
chronic
dietary
aggregate
risk
estimates
for
the
U.
S.
population
and
all
subgroups
are
well
below
the
Agency's
level
of
concern.
The
most
highly
exposed
population
subgroup
is
children,
aged
1­
2
years,
at
6.6%
of
the
cPAD.

5.
Occupational
Exposure
and
Risk
Workers
can
be
exposed
by
mixing,
loading,
or
applying
dicamba
or
by
entering
a
previously
treated
site.
Like
residential
risk,
worker
risk
is
also
measured
by
MOEs.
For
handlers,
the
Agency
initially
assesses
risk
at
"
baseline"
which
considers
an
individual's
normal
work
clothing
(
e.
g.,
long
sleeve
shirt
and
long
pants),
no
gloves,
and
no
respirator.
If
there
is
a
concern
at
baseline,
the
Agency
considers
the
use
of
protective
measures
(
e.
g.,
personal
protective
equipment
and
engineering
controls)
to
lower
the
risk.
Personal
protective
equipment
(
PPE)
can
include
an
additional
layer
of
clothing,
chemical­
resistant
gloves,
or
a
respirator.
12
Common
examples
of
engineering
controls
include
enclosed
tractor
cabs,
closed
loading
systems,
and
water­
soluble
packaging.

a.
Occupational
Handler
Risk
The
handler
exposure
data
were
taken
from
the
Pesticide
Handler
Exposure
Database
(
PHED),
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
and
the
California
Department
of
Pesticide
Regulations
(
CA
DPR).
The
PHED
data
were
used
primarily
to
assess
the
large
scale
agricultural
and
forestry
scenarios
and
the
ORETF
data
were
used
for
evaluating
lawn
care
scenarios.
The
CA
DPR
data
were
used
to
assess
the
backpack
applicator
scenario
for
the
forest
site
preparation
use,
which
includes
multiple
applicators
that
are
supplied
by
a
nurse
tank.

Several
handler
exposure
scenarios
were
assessed,
and
can
be
found
in
the
human
health
risk
assessment.
The
MOEs
for
the
baseline
exposure
scenarios
that
are
below
the
Agency's
level
of
concern
are
shown
in
Table
7
below.
With
the
addition
of
chemical
resistant
gloves,
all
of
the
occupational
handler
scenarios
listed
below
have
MOEs
above
100,
and
are
not
of
risk
concern.
All
other
mixer,
loader,
or
applicator
scenarios
had
an
MOE
greater
than
100
for
workers
at
wearing
single
layer
of
clothing
and
no
chemical
resistant
gloves
(
baseline).
13
Table
7.
Dicamba
Handler
Combined
MOEs
Margins
of
Exposure
Exposure
Scenario
Crop
or
Site
Application
Rate
(
lb
ae/
acre)
Acres/
Day
Baseline
Baseline
+
Gloves
Mixer/
Loader
(
M/
L)

M/
L
WP
for
turfgun
application
M/
L
Liquids
for
Aerial
M/
L
Liquids
for
Aerial
M/
L
Liquids
for
Aerial
M/
L
Liquids
for
Groundboom
M/
L
Liquids
for
Groundboom
M/
L
Liquids
for
Groundboom
M/
L
Liquids
for
Groundboom
M/
L
Liquids
for
ROW
Sprayer
M/
L
Liquids
for
Turf
Gun
M/
L
Liquids
for
Backpack
Application
Backpack
Application
Turfgun
Application
M/
L/
A
Wettable
Powder
with
Turfgun
M/
L/
A
WDG
with
Turfgun
M/
L/
A
Liquid
Flowables
with
Turfgun
M/
L/
A
Liquids
with
Backpack
Sprayer
Load/
Apply
Granules
with
a
Push
Cyclone
Turf
Sugar
Cane
Soybeans,
RPF
Small
Grains,
Sugar
Cane
Soybean,
RPF
Small
Grains,
Corn
Sod
Farms
ROW
Turf
Forest
Site
Prep
Forest
Site
Prep
Turf
Turf
Turf
Turf
ROW,
RPF
Turf
1
2.8
2
0.5
2.8
2
0.5
1
2
1
2
1
1
1
1
1
2
1
100
1200
1200
1200
200
200
200
80
50
100
40
4
5
5
5
5
4
5
53
2
3
12
13
18
72
90
72
72
90
ND
ND
ND
ND
ND
ND
ND
>
1000
200
280
>
1000
>
1000
>
1000
>
1000
>
1000
>
1000
>
1000
>
1000
410
>
1000
>
1000
>
1000
>
1000
970
>
1000
RPF=
Rangeland,
Pastures,
and
Fallow
Land
ND=
Not
Determined
ROW=
Right
of
Way
b.
Occupational
Postapplication
Risk
Postapplication
dicamba
exposures
can
occur
in
the
agricultural
environment
when
workers
enter
fields
recently
treated
with
dicamba
to
conduct
tasks
such
as
scouting
and
irrigation.
Because
dicamba
is
typically
applied
once
per
season
and
the
relevant
agricultural
scenarios
occur
for
only
a
few
weeks
per
year,
it
is
anticipated
that
dicamba
exposures
would
be
primarily
short­
term,
and,
more
rarely,
intermediate­
term.

Occupational
postapplication
exposure
data
were
taken
from
the
three
turf
transferable
residue
studies
submitted.
All
of
the
short­
and
intermediate­
term
MOEs
are
above
100
on
day
of
treatment,
and
therefore
risks
are
not
of
concern.
The
current
Worker
Protection
Standard
(
WPS)
Restricted
Entry
Interval
(
REI)
for
dicamba
is
24
hours.
14
6.
Incidents
reports
The
incident
analysis
was
prepared
under
a
separate
memo
by
Monica
Spann,
M.
P.
H.,
and
Jerome
Blondell,
PhD.,
of
the
Office
of
Pesticide
Programs.
Only
those
incidents
involving
products
with
dicamba
as
the
sole
active
ingredient
in
a
product
were
considered.
There
was
only
a
single
report
in
the
Incident
Data
System
of
minor
eye
irritation
resulting
from
dicamba
flaked
dust
falling
into
a
person's
eye.

Poison
Control
Center
data
for
the
years
1993
through
2003
indicate
that
there
were
24
occupational
exposures
to
dicamba.
Of
these
24
cases,
three
had
a
moderate
medical
outcome
and
one
was
considered
a
major
medical
outcome.
The
major
outcome
case
was
a
15
year
old
who
was
exposed
in
the
eye
and
experienced
blurred
vision,
irritation,
non­
reactive
pupils,
and
a
visual
defect.

The
Poison
Control
Center
data
indicated
that
there
were
146
non­
occupational
(
i.
e.,
residential)
exposure
cases
and
13
of
these
cases
were
classified
as
a
moderate
medical
outcome
with
primary
symptoms
of
eye
irritation,
corneal
abrasion,
coughing,
and
difficulty
breathing.
One
case
with
major
medical
outcome
was
a
16
year­
old
with
chest
pain,
dysrhythmia,
tachycardia
(
fast
pulse),
multiple
seizures,
and
coma
after
inhalation.
However,
there
were
no
other
cases
with
such
serious
symptoms
among
the
146
exposures.

No
incidents
of
dicamba
poisoning
were
reported
in
California
from
1982
through
2003.

B.
Environmental
Risk
Assessment
The
Agency
has
conducted
an
environmental
assessment
for
dicamba
for
the
purpose
of
making
a
reregistration
decision.
The
Agency
evaluated
environmental
fate
and
ecological
studies
submitted
for
dicamba
and
determined
that
the
data
are
adequate
to
support
a
reregistration
decision.
More
in­
depth
details
of
the
studies
used
to
develop
the
risk
assessments
and
to
support
the
guideline
studies
are
provided
in
"
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Dicamba
and
Dicamba
Sodium,
Potassium,
Diglycoamine,
Dimethylamine,
and
Isopropylamine
Salts,"
written
by
W.
Erickson,
I.
Abdel
Saheb,
and
S.
Borges
(
11/
15/
05),
which
is
found
in
the
electronic
docket.
A
summary
of
the
environmental
risk
assessment
findings
and
conclusions
is
provided
below.

1.
Environmental
Fate
and
Transport
The
Agency
bridged
the
environmental
fate
data
requirements
for
the
dicamba
sodium
and
potassium
salts,
dimethylamine
salt
(
DMA),
isopropylamine
salt,
and
diglycoamine
salt
(
DGA)
to
the
dicamba
acid
since
the
dicamba
salts
rapidly
convert
to
the
free
acid
of
dicamba.
Dicamba
acid
is
very
soluble
and
very
mobile
in
laboratory
soil
studies.

Aerobic
soil
metabolism
is
the
main
degradative
process
for
dicamba
acid.
The
observed
half­
life
for
dicamba
acid
was
six
days
with
formation
of
the
non­
persistent
degradate
DCSA.
DCSA
degraded
at
approximately
the
same
rate
as
dicamba
with
the
final
metabolites
being
15
carbon
dioxide
and
microbial
biomass.
Dicamba
is
stable
to
abiotic
hydrolysis
at
all
pH
levels
and
photodegrades
slowly
in
water
and
in
soil.

Under
anaerobic
soil
conditions,
dicamba
has
a
half­
life
of
141
days.
The
major
degradate
under
anaerobic
conditions
was
DCSA,
which
is
persistent
in
anaerobic
systems.
There
are
no
data
for
the
aerobic
aquatic
metabolism
in
dicamba;
however,
supplemental
information
indicates
that
dicamba
degrades
more
rapidly
in
aquatic
systems
when
sediment
is
present.

Based
on
fate
characteristics,
dicamba
and
DCSA
would
be
somewhat
persistent
in
aerobic
and
anaerobic
conditions
and
would
be
expected
to
be
persistent
in
groundwater.

2.
Environmental
Effects
a.
Ecological
Risk
Estimation
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
estimated
environmental
concentrations
(
EECs)
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
non­
target
organisms
from
the
use
of
dicamba
products,
the
Agency
calculates
a
Risk
Quotient
(
RQ),
which
is
the
ratio
of
the
EEC
to
the
most
sensitive
toxicity
endpoint
values,
such
as
the
median
lethal
dose
(
LD50)
or
the
median
lethal
concentration
(
LC50).
These
RQ
values
are
then
compared
to
the
Agency's
levels
of
concern
(
LOCs),
indicating
whether
a
pesticide,
when
used
as
labeled,
has
the
potential
to
cause
adverse
effects
on
non­
target
organisms
(
see
Table
8
below).
When
the
RQ
exceeds
the
LOC
for
a
particular
category,
the
Agency
presumes
a
risk
of
concern
to
that
category.
These
risks
of
concern
may
be
addressed
by
further
refinements
of
the
risk
assessment
or
mitigation.
Use,
toxicity,
fate,
and
exposure
are
considered
when
characterizing
the
risk,
as
well
as
the
levels
of
certainty
and
uncertainty
in
the
assessment.
EPA
further
characterizes
ecological
risk
based
on
any
reported
incidents
to
non­
target
terrestrial
or
aquatic
organisms
in
the
field
(
e.
g.,
fish
or
bird
kills).

Table
8.
EPA's
Levels
of
Concern
and
Associated
Risk
Presumptions
Risk
Presumption
LOC
terrestrial
animals
LOC
aquatic
animals
LOC
Plants
Acute
Risk
­
there
is
potential
for
acute
risk
0.5
0.5
1
Acute
Endangered
Listed
Species
­
endangered
species
may
be
adversely
affected
0.1
0.05
1
Chronic
Risk
­
there
is
potential
for
chronic
risk
1
1
Not
Assessed
b.
Aquatic
Organism
Risk
The
Agency
used
modeling
to
derive
estimated
environmental
concentrations
(
EECs)
for
dicamba
in
surface
water
to
represent
a
variety
of
aquatic
habitats,
such
as
ponds
adjacent
to
treated
fields,
which
are
relevant
to
risk
assessment
for
aquatic
animals.
16
Available
acute
toxicity
data
for
aquatic
species
indicate
that
dicamba
is
slightly
toxic
to
fish
and
invertebrates
with
LC50
and
the
median
effect
concentration
(
EC50)
values
for
fish
and
invertebrates
of
28
mg/
L
and
34.6
mg/
L
respectively.
There
were
no
exceedances
of
the
aquatic
acute
risk,
endangered
species,
and
chronic
risk
LOCs
for
fish
and
invertebrates
with
all
RQs
 

0.01,
indicating
that
freshwater
fish
and
invertebrates
inhabiting
surface
waters
adjacent
to
a
treated
field
would
not
be
at
risk
of
adverse
acute
effects
from
use
of
dicamba.
However,
since
there
are
no
chronic
studies
for
fish
and
invertebrates
which
measure
effects
such
as
survival,
growth,
and
reproduction
of
fish
and
invertebrates,
chronic
risk
to
aquatic
organisms
is
an
uncertainty.
Likewise,
due
to
insufficient
invertebrate
toxicity
data,
risk
to
sediment­
dwelling
benthic
organisms
remains
an
uncertainty.

Toxicity
studies
indicate
that
dicamba
is
not
toxic
to
aquatic
vascular
plants
with
the
EC50
for
the
freshwater
vascular
plant
of
3.25
mg/
L.
There
were
no
exceedances
of
the
acute
risk
LOC
for
freshwater
vascular
plants.
However,
the
LOCs
for
non­
vascular
plants
were
exceeded
for
the
application
rates
2.8
lbs
ae/
acre
and
2.0
lbs
ae/
acre.
Consequently,
aquatic
non­
vascular
plants
would
potentially
be
at
risk
for
adverse
effects
to
growth
and
development
from
use
of
dicamba
at
these
labeled
rates.

Table
9.
Summarized
Acute
Aquatic
Plant
Risk
Quotients
for
Dicamba
Acid
Non­
listed
Scenario
Listed
freshwater
vascular
Freshwater
vascular
Freshwater
non­
vascular
Michigan
asparagus
(
0.5
lbs
ae/
A)
Ground
app.
<
1
Aerial
app
.
<
1
<
1
<
1
<
1
<
1
Texas
pasture
(
2.0
lbs
ae/
A)
Ground
app.
<
1
Aerial
app.
<
1
<
1
<
1
1.39
1.38
Florida
sugarcane
(
2.8
lbs
ae/
A)
Ground
app.
<
1
Aerial
app.
<
1
<
1
<
1
2.79
2.72
All
aquatic
plant
RQs
from
other
dicamba
uses
at
rates
of
less
than
2
lb
ae/
A
were
less
than
1
and
are
below
EPA's
level
of
concern.

c.
Terrestrial
Organism
Risk
Birds
Dicamba
salts
are
categorized
as
practically
non­
toxic
to
avian
species
based
on
dietary
studies.
However,
oral
gavage
studies
indicate
dicamba
acid
was
moderately
toxic
to
bobwhite
quail
and
slightly
toxic
to
mallard
ducks.

The
acute
risk
LOC
was
exceeded
for
small
birds
consuming
mean
residues
of
dicamba
on
short
grass,
tall
grass,
broadleaf
forage,
and
small
insects,
and
for
large
birds
consuming
short
grass.
See
Table
10
for
a
listing
of
RQs
calculated
based
on
predicted
mean
residues
from
application
of
dicamba
at
various
rates.
Levels
of
concern
are
set
at
0.5
for
acute
risk
and
0.1
for
acute
endangered
species
risk.
17
Table
10.
Avian
Acute
Risk
Quotient
Summary
from
Predicted
Mean
Residues
RQs
Food
type
Weight
class
(
g)
2.8
lbs
ae/
acre
2.0
lbs
ae/
acre
1.0
lbs
ae/
acre
0.75
lb
ae/
acre
20
2.04
1.46
0.72
0.54
100
0.91
0.65
0.32
0.24
short
grass
1000
0.29
0.21
0.10
0.08
20
0.86
0.62
0.30
0.23
100
0.39
0.28
0.14
0.10
tall
grass
1000
0.12
0.09
0.04
0.03
20
1.08
0.77
0.38
0.28
100
0.48
0.35
0.17
0.13
broadleaf
forage,
small
insects
1000
0.15
0.11
0.05
0.04
20
0.17
0.12
0.06
0.04
100
0.08
0.05
0.03
0.02
fruit,
pods,
seeds,
large
insects
1000
0.02
0.02
0.01
0.01
The
Agency
assesses
acute
avian
risks
from
granular
formulations
differently
than
for
liquid
formulations
with
granular
RQ's
based
on
a
ratio
of
the
LD50
and
the
amount
of
active
ingredient
applied
to
one
square
foot
of
ground.
Dicamba
has
several
products
which
are
formulated
with
fertilizers
and
the
avian
and
mammalian
risks
from
these
products
were
assessed
after
the
risk
assessment
document
was
completed.
For
products
that
are
applied
at
0.29
lb
ae/
A
or
greater,
acute
risk
LOCs
are
exceeded
for
20
gram
birds
with
RQs
ranging
up
to
7.5
for
a
2.0
lb
ae/
A
application.
Please
see
the
EFED's
Response
to
Comments
document
for
the
complete
granular
assessment.

The
Chronic
Risk
LOC
was
not
exceeded
for
any
use
with
the
maximum
RQ
of
1.0.
Consequently,
birds
are
not
expected
to
be
at
risk
from
chronic
developmental/
reproductive
effects
when
exposed
to
dicamba
as
a
result
of
the
labeled
uses
of
the
pesticide.

Mammals
Dicamba
acid
is
classified
as
practically
non­
toxic
to
small
mammals
on
an
acute
oral
basis.
There
were
no
exceedances
of
any
acute
LOC
from
predicted
mean
residues.

The
Agency
assesses
acute
mammalian
risks
from
use
of
granular
formulations
differently
than
the
use
of
liquid
formulations.
Granular
RQ's
are
based
on
the
ratio
of
the
LD50
and
the
amount
of
active
ingredient
applied
to
one
square
foot
of
ground.
Dicamba
has
several
products
which
are
formulated
with
fertilizers.
Avian
and
mammalian
risks
from
these
products
were
assessed
after
the
risk
assessment
document
was
posted
in
EPA's
public
docket.
For
products
that
are
applied
at
1.0
and
2.0
lb
ae/
A,
mammalian
endangered
species
LOCs
are
exceeded
for
15
gram
mammals
with
RQs
of
0.1
and
0.2,
respectively.
This
is
solely
based
on
EPA's
screening­
level
assessment.
The
assessment
for
larger
mammals
and
lower
application
rates
resulted
in
no
exceedances.
See
EFED's
Response
to
Comments
document
for
the
complete
granular
assessment.

The
Chronic
Risk
LOC
of
1.0
was
exceeded
for
mammals
consuming
maximum
and
mean
predicted
dicamba
residues
on
short
grass
for
application
rates
greater
than
or
equal
to
0.75
18
lb
ae/
A.
For
a
listing
of
RQs
for
mean
foliar
residues
on
different
food
items,
please
see
Table
11.
For
tall
grass,
broadleaf
forage,
and
small
insects,
the
chronic
risk
LOC
was
exceeded
as
well.
There
were
no
exceedances
of
the
chronic
risk
LOC
for
mammals
consuming
the
maximum
residues
on
fruit,
seeds,
and
large
insects.
As
a
result,
mammals
could
potentially
be
at
risk
for
developmental/
reproductive
effects
or
for
direct
effects
on
foraging
behavior
when
chronically
exposed
to
dicamba
as
a
result
of
the
labeled
uses
of
the
herbicide.

Table
11.
Mammalian
Chronic
Risk
Quotient
Summary
from
Predicted
Mean
Residues
RQs
Food
type
Weight
class
(
g)
2.8
lb
ae/
acre
2.0
lb
ae/
acre
1.0
lb
ae/
acre
0.75
lb
ae/
acre
15
2.29
1.63
0.82
0.61
35
1.96
1.40
0.70
0.53
short
grass
1000
1.03
0.74
0.37
0.28
15
0.97
0.69
0.35
0.26
35
0.83
0.59
0.30
0.22
tall
grass
1000
0.44
0.31
0.16
0.12
15
1.21
0.86
0.43
0.32
35
1.04
0.74
0.37
0.28
broadleaf
forage,
small
insects
1000
0.55
0.39
0.20
0.15
15
0.19
0.13
0.07
0.05
35
0.16
0.12
0.06
0.04
fruit,
pods,
seeds,
large
insects
1000
0.08
0.06
0.003
0.02
Dicamba
is
an
herbicide;
as
expected,
terrestrial
non­
target
plants
are
potentially
at
risk
from
its
use.
Seedling
emergence
and
vegetative
vigor
are
impacted
by
exposure
to
dicamba
acid;
adverse
effects
include
stunting,
chlorosis,
and
plant
death.
Plant
LOCs
are
1.0
for
both
non­
listed
and
listed
plants.
Dicots
are
much
more
sensitive
to
dicamba
than
monocots.
See
Table
12
for
a
listing
of
RQs.

Table
12.
Summarized
Terrestrial
Plant
Acute
Risk
Quotients
Acute
Non­
listed
RQs
Acute
Listed
RQs
Scenario
Adjacent
to
treated
sites
Semi­
aquatic
areas
Drift
Adjacent
to
treated
sites
Semi­
aquatic
areas
Drift
Sugarcane
(
2.8
lbs
ae/
A)
Ground
spray
application
Monocot
3.96
33.68
0.19
5.25
44.63
0.22
Dicot
62.22
528.89
4.12
76.36
649.09
7.00
Aerial
spray
application
Monocot
5.28
23.11
0.93
7.00
30.63
1.08
Dicot
82.96
362.96
20.59
101.82
445.45
35.00
Hay,
pasture/
rangeland,
soybean
and
agricultural
fallowland
(
2.0
lbs
ae/
A)

Ground
spray
application
Monocot
1.42
12.03
0.07
1.88
15.94
0.08
Dicot
22.22
188.89
1.40
27.27
231.82
2.50
Aerial
spray
application
Monocot
1.89
8.25
0.33
2.50
10.94
0.38
Dicot
29.63
129.63
7.35
36.36
159.09
12.50
19
Table
12.
Summarized
Terrestrial
Plant
Acute
Risk
Quotients
Acute
Non­
listed
RQs
Acute
Listed
RQs
Scenario
Adjacent
to
treated
sites
Semi­
aquatic
areas
Drift
Adjacent
to
treated
sites
Semi­
aquatic
areas
Drift
Corn
(
0.75lbs
as/
A)
Ground
spray
application
Monocot
1.06
9.02
0.05
1.41
11.95
0.06
Dicot
16.67
141.67
1.10
20.45
173.86
1.88
Aerial
spray
application
Monocot
1.42
6.19
0.25
1.88
8.20
0.29
Dicot
22.22
97.22
5.50
27.27
119.32
9.38
3.
Ecological
Incidents
Dicamba
acid:
Thirty­
five
ecological
incidents
attributed
to
dicamba
use
have
been
recorded
in
the
Ecological
Incident
Information
System
(
EIIS)
as
of
June
1,
2005.
Incidents
reported
include
terrestrial,
plant,
and
aquatic
impacts.
Although
the
database
lists
a
terrestrial
mammalian
incident
in
Utah
where
dicamba
was
applied,
the
database
states
that
dicamba
is
"
unlikely"
to
have
caused
the
incident.
Impacts
to
plants
included
a
wide
range
of
crops
(
soybeans,
corn,
wheat)
as
well
as
non­
agricultural
application.
The
specific
impacts
varied
from
browning
and
plant
damage
to
mortality
of
all
plants
within
the
treated
area.
Aquatic
impacts
consist
of
two
fish
kill
incidents
associated
with
agricultural
and
residential
turf
application.

Dicamba
Sodium
Salt:
Fifteen
incidents
attributed
to
dicamba
sodium
salt
use
have
been
recorded
in
the
EIIS
as
of
June
1,
2005.
All
reported
incidents
were
associated
with
plant
damage
to
crops
including
sorghum,
soybean,
corn,
and
sugar
beets.

Dicamba
Dimethylamine
Salt:
Forty­
six
incidents
attributed
to
dicamba
dimethylamine
salt
use
have
been
recorded
in
the
EIIS
as
of
June
1,
2005.
Incidents
reported
include
plant
and
aquatic
impacts.
The
majority
of
incidents
to
plants
(
40
of
45)
were
associated
with
residential
turf
application
and
ranged
from
browning
to
mortality.
Agricultural
application
resulted
in
plant
damage
to
cotton,
corn
and
soybeans.
The
single
reported
aquatic
incident
was
a
fish
kill
of
unknown
magnitude
resulting
from
turf
application.

Dicamba
Potassium
Salt:
Three
incidents
attributed
to
dicamba,
potassium
salt
use
have
been
recorded
in
the
EIIS
as
of
June
1,
2005.
There
were
2
incidents
reported
of
impacts
to
plants,
both
associated
with
application
on
corn
resulting
in
plant
damage.
The
sole
aquatic
impact
was
associated
with
agricultural
application
which
resulted
in
the
mortality
of
2,000
perch.

Dicamba
Diglycoamine
Salt:
Two
incidents
attributed
to
dicamba,
diglycoamine
salt
use
have
been
recorded
in
the
EIIS
as
of
June
1,
2005.
Both
incidents
were
associated
with
impacts
to
plants
(
soybeans)
which
resulted
in
plant
damage.
20
4.
Risk
to
Endangered
Species
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
dicamba
will
have
no
direct
acute
effects
on
threatened
and
endangered
freshwater
fish,
estuarine
fish,
and
aquatic
invertebrates.
However,
the
assessment
indicates
that
dicamba
has
the
potential
for
causing
risk
to
endangered
birds,
mammals,
and
non­
target
plants.
Further,
potential
indirect
effect
to
any
species
dependent
upon
a
species
that
experiences
effects
cannot
be
precluded
from
use
of
dicamba.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.
Chronic
RQs
exceeded
LOCs
for
endangered
mammals
at
all
application
rates
modeled.
Acute
LOCs
were
exceeded
for
endangered
birds
at
all
application
rates.
LOCs
were
exceeded
for
terrestrial
plants
adjacent
to
treated
areas
and
in
semi­
aquatic
areas
at
all
application
rates.

IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
A.
Determination
of
Reregistration
Eligibility
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submission
of
relevant
data
concerning
an
active
ingredient,
whether
or
not
products
containing
the
active
ingredient
are
eligible
for
reregistration.
The
Agency
has
previously
identified
and
required
the
submission
of
the
generic
(
i.
e.,
active
ingredient­
specific)
data
required
to
support
reregistration
of
products
containing
dicamba
as
an
active
ingredient.
The
Agency
has
reviewed
these
generic
data,
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
products
containing
dicamba.

The
Agency
has
completed
its
review
of
submitted
data
and
its
assessment
of
the
dietary,
residential,
occupational,
and
ecological
risks
associated
with
the
use
of
pesticide
products
containing
the
active
ingredient
dicamba.
Based
on
these
data,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
dicamba
to
make
its
decision
as
part
of
the
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
products
containing
dicamba
will
be
eligible
for
reregistration
provided
that
(
i)
required
product
specific
data
are
submitted,
(
ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
(
iii)
label
amendments
are
made
to
reflect
these
measures.
Needed
label
changes
and
language
are
listed
in
Section
V.
Appendix
A
is
a
detailed
table
listing
all
dicamba
uses
that
are
eligible
for
reregistration.
Appendix
B
identifies
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
determination
of
the
reregistration
eligibility
of
dicamba,
and
lists
the
submitted
studies
the
Agency
found
acceptable.
Data
gaps
are
identified
as
either
outstanding
generic
data
requirements
that
have
not
been
satisfied
with
acceptable
data
or
additional
data
necessary
to
confirm
the
decision
presented
here.

Based
on
its
evaluation
of
dicamba,
the
Agency
has
determined
that
dicamba
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA
and
FFDCA.
Accordingly,
should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
the
use
of
dicamba.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
dicamba
will
be
adequately
21
mitigated
for
the
purposes
of
this
interim
determination
under
FIFRA.
Additionally,
once
an
endangered
species
assessment
is
completed,
further
changes
to
these
registrations
may
be
necessary
as
explained
in
Section
IV.
D.
5.
a
of
this
document.

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
worked
extensively
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
dicamba.
During
the
public
comment
period
on
the
risk
assessments,
which
closed
on
February
27,
2006,
the
Agency
received
five
comments
from
five
sources:
BASF,
the
University
of
Hawaii
at
Manoa,
Department
of
the
Environment
San
Francisco,
The
Thurston
County,
Washington,
Public
Health
and
Social
Services
Department,
and
a
citizen.
BASF's
comments
pertained
to
ecological
and
water
risks
in
the
dicamba
science
chapters.
The
City
of
San
Francisco
and
Thurston
County
both
emphasized
the
importance
of
risk
reduction
measures
for
dicamba
through
alternative
pesticides.
The
University
of
Hawaii's
comment
was
in
support
of
benefits
of
use
of
dicamba
on
golf
courses,
seed
corn,
sugarcane,
and
asparagus.
The
citizen
comment
pertained
to
adverse
effects
from
using
dicamba.
The
comments
in
their
entirety
are
available
in
the
public
docket
(
EPA­
HQ­
OPP­
0479)
at
http://
www.
regulations.
gov.
A
detailed
Response
to
Comments
document
is
available
in
the
public
docket
as
well.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
Dicamba
tolerances
were
reassessed
in
2000
when
a
new
food
use
was
added.
However,
as
part
of
the
FIFRA
reregistration,
EPA
assessed
the
risks
associated
with
this
pesticide.
EPA
has
determined
that
aggregate
risk
from
food,
drinking
water,
and
residential
exposures
to
dicamba
is
within
is
own
"
risk
cup"
and
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
dicamba
meet
FQPA
safety
standards.
In
reaching
this
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
aggregate
exposure
from
food,
drinking
water,
and
residential
uses.
The
FQPA
Safety
Factor
has
not
been
retained
for
dicamba
because
acceptable
developmental
and
reproduction
studies
have
been
submitted
and
reviewed,
there
is
a
low
concern
and
no
residual
uncertainties
for
pre­
and
postnatal
toxicity,
and
the
dietary
and
the
residential
assessments
are
not
expected
to
underestimate
exposure.

2.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
22
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
EPA
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
for
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

In
the
available
toxicity
studies
on
dicamba,
there
was
no
evidence
of
endocrine
disruption
effects.
When
additional
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
dicamba
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption
3.
Cumulative
Risks
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
dicamba
and
any
other
substances.
For
the
purposes
of
this
reregistration
decision,
therefore,
EPA
has
not
assumed
that
dicamba
has
a
common
mechanism
of
toxicity
with
other
substances.

4.
Tolerance
Reassessment
Summary
The
completion
of
the
dicamba
RED
does
not
result
in
any
additional
tolerances
being
reassessed.
All
60
existing
tolerances
were
reassessed
at
the
time
a
new
food
use
was
established
for
dicamba.
Please
see
Federal
Register
Notice
65
FR
33709
(
May
24,
2000),
for
further
reference.

D.
Regulatory
Rationale
1.
Human
Health
Risk
Assessment
a.
Aggregate
Risk
As
discussed
in
Chapter
3,
aggregate
risk
refers
to
the
combined
risk
from
food,
drinking
water,
and
residential
exposures.
In
addition,
aggregate
risk
can
result
from
one­
time
(
acute),
short­
term
and/
or
chronic
exposures.
For
dicamba,
aggregate
risk
for
food,
drinking
water,
and
residential
exposures
are
below
the
Agency's
level
of
concern
for
acute,
short
term,
and
chronic
exposure.
No
mitigation
is
necessary
for
dietary,
drinking
water,
or
residential
exposure
to
dicamba.
b.
Occupational
Risk
(
i)
Handlers
Due
to
risk
exceedances
for
scenarios
such
as
mixing/
loading/
applying,
dicamba
labels
must
be
amended
to
add
chemical
resistant
gloves
to
all
mixers,
loaders,
applicators,
and
any
23
other
handlers.
The
addition
of
gloves
to
the
assessment
resulted
in
MOEs
>
280
for
all
exposure
scenarios.
(
ii)
Postapplication
There
are
no
short/
intermediate
re­
entry
risks
for
dicamba
on
the
day
of
application.
However,
due
to
a
toxicity
category
II
for
acute
eye
irritation,
the
current
REI
of
24
hours
will
remain
unchanged.

2.
Environmental
Risk
Mitigation
Because
of
the
potential
non­
target
animal
and
plant
risks,
the
Agency
is
requiring
that
the
maximum
application
rate
be
reduced
to
1.0
lb
ae/
acre
for
a
single
application
and
reduced
to
2.0
lb
ae/
acre
per
year
for
all
use
patterns.
This
will
result
in
lowering
the
potential
risks
of
concern
to
aquatic
plants.
This
rate
reduction
will
also
lower
acute
risks
to
all
animals
(
except
small
herbivorous
birds),
as
well
as
chronic
risk
to
mammals.
Assessed
risks
to
terrestrial
plants
will
be
lowered,
but
not
eliminated.

a.
Spray
Drift
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off­
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.

From
its
assessment
of
dicamba,
as
summarized
in
this
document,
the
Agency
concludes
that
no
specific
additional
drift
mitigation
measures
are
needed
at
this
time.
In
the
future,
dicamba
product
labels
may
need
to
be
revised
to
include
additional
or
different
drift
label
statements.
The
Agency
encourages
the
inclusion
of
best
management
practices
on
labels
to
reduce
spray
drift.

b.
Endangered
Species
Considerations
The
Agency's
screening
level
ecological
risk
assessment
for
endangered
species
results
in
the
determination
that
dicamba
will
have
no
direct
acute
effects
on
threatened
and
endangered
freshwater
fish,
estuarine
fish,
and
aquatic
invertebrates.
However,
the
Agency's
level
of
concern
was
exceeded
for
endangered
birds,
mammals,
and
non­
target
plants.
Further,
potential
indirect
effect
to
any
species
dependent
upon
a
species
that
experiences
effect
cannot
be
precluded
from
use
of
dicamba.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
effect"
findings
under
the
Endangered
Species
Act.
Chronic
RQs
exceeded
LOCs
for
endangered
mammals
at
all
application
rates
modeled.
Acute
24
LOCs
were
exceeded
for
endangered
birds
at
all
application
rates.
LOCs
were
exceeded
for
terrestrial
plants
adjacent
to
treated
areas
and
in
semi­
aquatic
areas
at
all
application
rates.

The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
(
ESA)
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
that
may
affect
any
particular
species,
EPA
uses
basic
toxicity
and
exposure
data
developed
for
the
REDs
and
considers
it
in
relation
to
individual
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species,
as
part
of
a
refined
species­
specific
analysis.
When
conducted,
this
species­
specific
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
that
are
being
implemented
at
that
time.

Following
this
future
species­
specific
analysis,
a
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
or
its
critical
habitat
may
result
in:
limitations
on
the
use
of
dicamba,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
or
the
National
Marine
Fisheries
Service
as
necessary.
If
the
Agency
determines
use
of
dicamba
"
may
affect"
listed
species
or
their
designated
critical
habitat,
EPA
will
employ
the
provisions
in
the
Services
regulations
(
50
CFR
Part
402).
Until
that
species­
specific
analysis
is
completed,
the
risk
mitigation
measures
being
implemented
through
this
RED
will
reduce
the
likelihood
that
endangered
and
threatened
species
may
be
exposed
to
dicamba
at
levels
of
concern.
EPA
is
not
requiring
specific
dicamba
label
language
at
the
present
time
relative
to
threatened
and
endangered
species.
If,
in
the
future,
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.

V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
dicamba
is
eligible
for
reregistration;
however,
additional
data
are
required
to
confirm
this
decision.
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
Notices
(
DCIs)
requiring
product
specific
data
and
generic
(
technical
grade)
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extension
and/
or
waiver
requests
with
a
full
written
justification.
For
product
specific
data,
the
registrant
will
have
8
months
to
submit
data
and
amended
labels.
For
generic
data,
due
dates
can
vary
depending
on
the
specific
studies
being
required.
Below
are
tables
of
additional
generic
data
that
the
Agency
intends
to
require
for
dicamba
to
be
eligible
for
reregistration.
25
A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
dicamba
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
data
listed
below
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.

Guideline
Study
Description
Residue
Chemistry
860.1340
Residue
Analytical
method
for
barley
grain
and
straw,
wheat
straw,
and
soybean
seeds.

860.1360
Multiresidue
methods
data
for
the
dicamba
metabolites
of
concern
(
5­
OH
dicamba
and
DCSA).

860.1380
Storage
stability
data
for
sugarcane
molasses
and
animal
commodities.

860.1500
Crop
Field
Trials
for
soybean
forage
and
hay
(
if
no
feeding
restrictions
appear
on
the
label).

860.1500
Crop
Field
Trials
for
sugarcane
Ecological
Exposure
850.4225
Seedling
emergence
for
end
use
products.

850.4250
Vegetative
vigor
studies
for
end
use
products
2.
Labeling
for
Manufacturing­
Use
Products
To
ensure
compliance
with
FIFRA,
manufacturing
use
product
(
MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices,
and
applicable
policies.

B.
End­
Use
Products
1.
Additional
Product­
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
product­
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
Registrant
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
26
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.
The
Agency
intends
to
issue
a
separate
product­
specific
data
call­
in
(
PDCI),
outlining
specific
data
requirements.

2.
Labeling
for
End­
Use
Products
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measures
outlined
in
the
Risk
Mitigation
Summary
section.
The
following
table
describes
how
language
on
the
labels
should
be
amended.

Conclusions
The
Agency
is
issuing
this
Reregistration
Eligibility
Decision
(
RED)
document
for
dicamba,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
This
RED
document
includes
guidance
and
time
frames
for
complying
with
any
required
label
changes
for
products
containing
dicamba.
The
Agency
has
determined
that
all
currently
registered
uses
of
dicamba
are
eligible
for
reregistration
provided
that
the
mitigation
measures
are
adopted
on
product
labels.

The
risk
assessments
for
dicamba
are
based
on
the
best
scientific
data
currently
available
to
the
Agency
and
are
adequate
for
regulatory
decision
making.

VI.
Appendices
27
Labeling
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.

The
following
table
describes
how
language
on
the
labels
should
be
amended.

Table
13:
Summary
of
Labeling
Changes
for
Dicamba
Description
Amended
Labeling
Language
Placement
on
Label
For
all
Manufacturing
Use
Products
"
Only
for
formulation
into
an
herbicide
for
the
following
use(
s)
[
small
grains,
corn,
sorghum,
sugar
cane,
golf
course
and
residential
lawns,
sod
farms,
pastures,
rangeland
and
rights
of
ways]."
Directions
for
Use
One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"
This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."

"
This
product
may
be
used
to
formulate
products
for
any
additional
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
"
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,

ponds,
estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollution
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."
Precautionary
Statements
End
Use
Products
Intended
for
Occupational
Use
(
WPS
and
Non
WPS
uses)
28
PPE
Requirements
Established
by
the
RED1
For
Liquid,
Wettable
Powder,
Granulars
and
Water
Dispersible
Granular
Formulations
"
Personal
Protective
Equipment
(
PPE)

Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemical­
resistant
material).
If
you
want
more
options,

follow
the
instructions
for
category"
[
registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical­
resistance
category
selection
chart."

All
mixers,
loaders,
and
applicators
and
other
handlers
must
wear
:

<
Long­
sleeved
shirt
and
long
pants
<
Shoes
plus
socks,
and
<
Chemical­
resistant
gloves
(
except
for
applicators
using
groundboom
equipment,
pilots
and
flaggers)

"
See
engineering
controls
for
additional
requirements
and
exceptions."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
User
Safety
Requirements
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry."
P
recautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
Engineering
Controls
for
Liquid,
Wettable
Powder,
Granulars
and
Water
Dispersible
Granular
Formulations
Pilots
must
use
cockpits
in
a
manner
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
(
40
CFR
170.240(
d)(
4­
6).
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
(
Immediately
following
PPE
and
User
Safety
Requirements.)

User
Safety
Recommendations
"
USER
SAFETY
RECOMMENDATIONS"

"
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet."

"
Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.
Precautionary
Statements
under:

Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)
29
Then
wash
thoroughly
and
put
on
clean
clothing."

"
Users
should
remove
PPE
immediately
after
handling
this
product.

Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."

Environmental
Hazards
"
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.
Do
not
contaminate
water
when
disposing
of
equipment
washwater
or
rinsate."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Restricted­
Entry
Interval
for
products
with
directions
for
use
within
scope
of
the
Worker
Protection
Standard
for
Agricultural
Pesticides
(
WPS)
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI)
of
24
hours."
Directions
for
Use,
Under
Agricultural
Use
Requirements
Box
30
Early
Entry
Personal
Protective
Equipment
for
products
with
directions
for
use
within
the
scope
of
the
WPS
F
or
minimum
early
entry
PPE
use
the
following:

"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil,
or
water,
is:

*
coveralls
worn
over
short­
sleeve
shirt
and
short
pants,

*
chemical
resistant
footwear
plus
socks
*
chemical­
resistant
gloves
made
of
any
waterproof
material
*
chemical­
resistant
headgear
for
overhead
exposure.

*
protective
eyewear
"
Notify
workers
of
the
application
by
warning
them
orally
and
by
posting
warning
signs
at
entrances
to
treated
area."
Direction
for
Use
Agricultural
Use
Requirements
box
Entry
Restrictions
for
products
having
occupational
uses
on
the
label
not
subject
to
the
WPS
For
products
applied
as
sprays
"
Do
not
enter
or
allow
others
to
enter
until
sprays
have
dried."

For
products
applied
dry
"
Do
not
enter
or
allow
others
to
enter
until
dusts
have
settled."
If
no
WPS
use
on
the
product
label,

place
the
appropriate
statement
in
the
Directions
for
Use
Under
General
Precautions
and
Restrictions.
If
the
product
also
contains
WPS
uses,
then
create
a
Non­
Agricultural
Use
Requirements
box
as
directed
in
PR
Notice
93­
7
and
place
the
appropriate
statement
inside
that
box.

General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application."
Place
in
the
Direction
for
Use
directly
above
the
Agricultural
Use
Box.

Other
Application
Restrictions
(
Risk
Labels
must
be
amended
to
reflect
the
following
maximum
application
Directions
for
Use
31
Mitigation)
rates
and
the
maximum
number
of
treatments
per
year:

Maximum
single
application
rate:
1.0
lb
ai/
acre
and
no
more
than
2
applications
per
year.

Spray
Drift
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift."
Directions
for
Use
End
Use
Products
Intended
for
Residential
Use
Environmental
Hazards
"
Do
not
apply
to
water.
Do
not
contaminate
water
when
disposing
of
equipment
washwaters
or
rinsate."
Precautionary
Statements
Immediately
Following
the
User
Safety
Recommendations
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
any
person,
pet,

either
directly
or
through
drift.
Keep
people
and
pets
out
of
the
area
during
application."
Directions
for
Use
under
General
Precautions
and
Restrictions
Entry
Restrictions
For
products
applied
as
sprays:

"
Do
not
allow
people
or
pets
to
enter
the
treated
area
until
sprays
have
dried."

For
products
applied
dried
"
Do
not
allow
people
or
pets
to
enter
the
treated
area
until
dusts
have
settled."
Directions
for
use
under
General
Precautions
and
Restrictions
32
1
PPE
that
is
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.

The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.