Document ID: EPA-HQ-OPP-2005-0263-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-21T04:00Z

United
States
Prevention,
Pesticides
EPA
738­
R­
06­
016
Environmental
Protection
and
Toxic
Substances
March
2006
Agency
(
7508C)

Reregistration
Eligibility
Decision
for
MCPB,
and
Salts
(
Case
2365)
2
Reregistration
Eligibility
Decision
(
RED)
Document
for
MCPB
List
B
Case
2365
Approved
by:
/
S/
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
March
27,
2006
3
Table
of
Contents
Executive
Summary
...........................................................................................................................................
7
I.
Introduction
..........................................................................................................................................
9
II.
Chemical
Overview
............................................................................................................................
10
A.
Chemical
Identification........................................................................................................
10
B.
Use
Profile..............................................................................................................................
12
III.
Summary
of
MCPB
Risk
Assessments.............................................................................................
13
A.
Human
Health
Risk
Assessment
.........................................................................................
13
1.
Toxicity.....................................................................................................................
13
2.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
............................
16
3.
Residential
and
Other
Non­
occupational
Exposure
and
Risk
...........................
18
4.
Aggregate
Exposure
and
Risk...............................................................................
18
5.
Occupational
Exposure
and
Risk
Assessment
.....................................................
18
B.
Environmental
Risk
Assessment
.........................................................................................
20
1.
Environmental
Exposure........................................................................................
21
2.
Environmental
Effects
(
Hazard)
...........................................................................
23
3.
Ecological
Risk
Estimation
(
RQs).........................................................................
27
4.
Ecological
Incidents
................................................................................................
30
5.
Endangered
Species
Concerns...............................................................................
30
6.
Risk
Characterization.............................................................................................
31
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
................................
32
A.
Determination
of
Reregistration
Eligibility
.......................................................................
32
B.
Public
Comments
and
Responses........................................................................................
32
C.
Regulatory
Position
..............................................................................................................
33
1.
Food
Quality
Protection
Act
Findings
..................................................................
33
2.
Tolerance
Reassessment
Summary.......................................................................
35
D.
Regulatory
Rationale............................................................................................................
35
1.
Human
Health
Risk
Mitigation
.............................................................................
36
2.
Environmental
Risk
Mitigation.............................................................................
37
3.
Endangered
Species
Considerations
.....................................................................
37
5.
Spray
Drift
Management
.......................................................................................
38
V.
What
Registrants
Need
to
Do
...........................................................................................................
38
A.
Manufacturing
Use
Products...............................................................................................
39
1.
Additional
Generic
Data
Requirements
...............................................................
39
2.
Labeling
for
Manufacturing­
Use
Products
..........................................................
40
B.
End­
Use
Products
.................................................................................................................
40
1.
Additional
Product­
Specific
Data
Requirements
...............................................
40
2.
Labeling
for
End­
Use
Products
............................................................................
40
C.
Labeling
Changes
Summary
Table.....................................................................................
41
4
MCPB
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Biological
and
Economic
Analysis
Assessment
Elisa
Rim
Jenna
Carter
Alan
Halvorson
Sunil
Ratnayake
Environmental
Fate
and
Effects
Risk
Assessment
Marie
Janson
Ed
Odenkirchen
Kevin
Costello
Health
Effects
Risk
Assessment
Elizabeth
Mendez
Kit
Farwell
Felecia
Fort
Timothy
Dole
Registration
Support
Joanne
Miller
Risk
Management
James
Parker
Demson
Fuller
Thomas
Brennan
Kelly
Sherman
5
Glossary
of
Terms
and
Abbreviations
ai
Active
Ingredient
ae
Acid
Equivalent
AR
Anticipated
Residue
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
DNT
Developmental
Neurotoxicity
DWLOC
Drinking
Water
Level
of
Comparison
EC
Emulsifiable
Concentrate
Formulation
EDWC
Estimated
Drinking
Water
Concentration
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
GENEEC
Tier
I
Surface
Water
Computer
Model
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
LOAEL
Lowest
Observed
Adverse
Effect
Level
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
submitted
studies.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Ambient
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEL
No
Observed
Adverse
Effect
Level
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
6
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
SLN
Special
Local
Need
(
Registrations
Under
Section
24
©
)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
USDA
United
States
Department
of
Agriculture
UF
Uncertainty
Factor
WPS
Worker
Protection
Standard
7
Executive
Summary
This
document
presents
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
the
Agency
or
EPA)
decision
on
the
reregistration
eligibility
of
the
registered
uses
of
MCPB
[
4­
(
2­
methyl­
4­
chlorophenoxy)
butyric
acid].
MCPB
is
a
phenoxy
herbicide
used
for
postemergence
weed
control
to
protect
pea
crops
from
a
variety
of
weeds
including
Canadian
thistle,
common
lambsquarters,
pigweed,
smartweed,
sowthistle,
and
morning
glory.

The
Agency
made
its
reregistration
eligibility
determination
based
on
the
required
data,
and
the
current
guidelines
for
conducting
acceptable
studies
to
generate
such
data.
Confirmatory
studies
are
required
to
fulfill
some
guideline
data
requirements.
However,
the
Agency
has
found
that
currently
registered
uses
of
MCPB
are
eligible
for
reregistration.
There
is
currently
one
MCPB
tolerance,
which
is
being
reassessed
at
the
current
level.

Dietary
Risk
Acute
and
chronic
dietary
risks
for
food
and
drinking
water
do
not
exceed
the
Agency's
level
of
concern.
No
mitigation
is
required.

Occupational
Risk
Short­
and
intermediate­
term
inhalation
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
with
baseline
clothing
(
no
respirator).
Dermal
risks
associated
with
mixing
and
loading
for
groundboom
and
aerial
application
are
above
the
Agency's
level
of
concern
with
baseline
clothing,
but
are
below
the
Agency's
level
of
concern
when
chemicalresistant
gloves
are
added.
Therefore,
chemical­
resistant
gloves
will
be
required
on
all
MCPB
product
labels.

Residential
Risk
There
are
no
residential
uses
of
MCPB.
Thus,
EPA
did
not
conduct
a
residential
assessment.

Aggregate
Risk.

Short­
term
and
chronic
aggregate
risks
posed
by
the
use
of
MCPB
are
below
EPA's
level
of
concern.
No
mitigation
is
required.

Cumulative
Risk
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
MCPB,
and
therefore
the
Agency
did
not
conduct
a
cumulative
assessment.
8
9
Ecological
Risk
EPA's
level
of
concern
is
exceeded
for
acute
risk
to
terrestrial
plants,
acute
risk
to
small
birds
that
consume
short
grass,
and
chronic
risk
to
mammals.
EPA
has
determined
that
the
appropriate
risk
mitigation
for
environmental
concerns
at
this
time
is
to
require
medium
or
coarser
droplet
sizes
to
minimize
the
potential
for
spray
drift.

Endangered
Species
The
screening
level
ecological
risk
assessment
results
in
a
determination
that
the
use
of
MCPB
will
have
no
direct
acute
effects
on
freshwater
fish,
freshwater
invertebrates,
and
insects,
and
no
direct
chronic
effects
to
birds.
However,
the
Agency s
level
of
concern
for
direct
acute
effects
to
endangered
and
threatened
birds,
and
terrestrial
and
semi­
aquatic
plants,
and
for
direct
acute
and
chronic
effects
to
mammals,
is
exceeded
for
the
use
of
MCPB.
Potential
risks
to
endangered
species
identified
in
the
Environmental
Fate
and
Ecological
Risk
Assessment
and
reflected
in
this
Reregistration
Eligibility
Decision
(
RED)
for
MCPB
are
based
solely
on
EPA s
screening
level
ecological
risk
assessment
and
do
not
constitute
 
may
effect 
findings
under
the
Endangered
Species
Act.

Next
Steps
The
Agency
is
issuing
this
Reregistration
Eligibility
Decision
(
RED)
document
for
MCPB
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.

In
the
future,
EPA
will
issue
a
generic
DCI
for
additional
data
necessary
to
confirm
the
conclusions
of
this
RED
for
the
active
ingredient
MCPB.
EPA
will
also
issue
a
product­
specific
DCI
for
data
necessary
to
complete
product
reregistration
for
products
containing
MCPB.
10
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
submitted
data
to
the
EPA.
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
the
pesticide,
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.

On
August
3,
1996,
the
Food
Quality
Protection
Act
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
and
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA)
to
require
reassessment
of
all
existing
tolerances
for
pesticides
in
food.
FQPA
also
requires
that
by
August
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
enactment
of
the
FQPA,
which
was
August
2,
1996.
FQPA
also
amends
the
FFDCA
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
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
MCPB
and
any
other
substances.
For
the
purposes
of
this
tolerance
reassessment
action,
therefore,
EPA
has
not
assumed
that
MCPB
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
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
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

EPA
followed
a
four­
phase,
modified
public
participation
process
for
MCPB.
Consistent
with
this
process,
EPA
initiated
Phase
1
of
the
process
by
transmitting
the
human
health
and
ecological
risk
assessments
to
the
technical
registrants
for
a
30­
day
error­
correction
review.
In
Phase
2,
EPA
considered
the
errors
that
were
identified
by
the
registrants
and
made
changes
in
the
risk
assessments
as
appropriate.
To
initiate
Phase
3
of
the
process,
EPA
published
a
Federal
Register
notice
announcing
the
availability
of
the
revised
risk
assessments
and
supporting
documents
for
a
60­
day
public
review
and
comment
period.
During
the
60­
day
public
comment
period,
EPA
received
two
comments,
from
the
MCPB
Task
Force
and
a
public
citizen.

This
document
presents
EPA's
revised
human
health
and
environmental
fate
and
effects
11
risk
assessment,
its
progress
toward
tolerance
reassessment,
and
the
reregistration
eligibility
decision
for
MCPB.
The
document
consists
of
six
sections.
Section
I
contains
the
regulatory
framework
for
reregistration
and
tolerance
reassessment.
Section
II
provides
a
description
of
the
chemical
and
a
profile
of
the
use
and
usage
of
the
chemical.
Section
III
provides
a
summary
of
the
human
health
and
ecological
risk
assessments
which
have
been
revised
based
on
data,
public
comments,
and
other
information
received
in
response
to
the
preliminary
risk
assessments.
Section
IV
presents
the
Agency's
risk
management,
reregistration
eligibility,
and
tolerance
reassessment
decision.
Section
V
summarizes
any
data
requirements
necessary
to
confirm
the
reregistration
eligibility
decision
as
well
as
label
changes
and
language
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV.
Section
VI,
the
Appendices,
provides
related
information
and
supporting
documents.
The
preliminary
and
revised
risk
assessment
for
MCPB
are
available
in
the
public
docket
EPA­
HQ­
2005­
0263
located
on­
line
in
the
Federal
Docket
Management
System
(
FDMS)
at
http://
www.
regulations.
gov.

II.
Chemical
Overview
A.
Chemical
Identification
MCPB
was
first
registered
by
EPA
in
1964.
Currently,
there
are
five
products
containing
MCPB
registered
under
Section
3
of
FIFRA.
There
are
two
manufacturing
use
products
(
MCPB
Technical
Acid
and
MCPB
Technical
Grade)
and
the
three
end­
use
formulations
(
Sodium
MCPB
Herbicide,
Thistrol
Herbicide,
and
Sodium
MCPB
Solution).
There
are
no
Special
Local
Need
(
SLN)
registrations.

MCPB
(
sodium)

Chemical
Name:
[
Sodium
4­(
2­
methyl­
4­
chlorophenoxy)
buytrate]

Chemical
Structure:

CAS
Registry
Number:
6062­
26­
6
OPP
Chemical
Code:
019202
12
Case
Number:
2365
Molecular
Weight:
250.7
g/
mol
Vapor
Pressure:
4
x
10­
7
(
torr
at
25
degrees
Celsius)

Empirical
Formula:
C11H12ClNaO3
Basic
Manufacturers:
A.
H.
Marks
&
Co.
Ltd.,
Nufarm
BV
and
Nufarm,
Inc.

MCPB
(
acid)

Chemical
Name:
[
4­(
2­
methyl­
4­
chlorophenoxy)
butyric
acid]

Chemical
Structure:

CAS
Registry
Number:
94­
81­
5
OPP
Chemical
Code:
019201
Case
Number:
2365
Molecular
Weight:
228.6
g/
mol
Vapor
Pressure:
4
x
10­
7
(
torr
at
25
degrees
Celsius)

Empirical
Formula:
C11H13ClO3
Basic
Manufacturers:
A.
H.
Marks
&
Co.
Ltd.,
Nufarm
BV
and
Nufarm,
Inc.
13
B.
Use
Profile
The
following
is
information
on
the
currently
registered
MCPB
use
sites
and
application
methods.

Type
of
Pesticide:
MCPB
is
a
phenoxy
herbicide
produced
as
a
sodium
salt
and
an
acid.

Summary
of
Use:
MCPB
is
registered
for
use
on
peas
(
both
green
and
dry
peas)
before
flowering.
There
are
no
residential
uses
of
MCPB.

Target
Organisms:
Post­
emergence
control
of
Canadian
thistle,
buttercup,
mustard,
purslane,
ragweed,
common
lambsquarters,
pigweed,
smartweed,
sowthistle,
morning
glory
and
other
broad
leaf
weeds
Use
Classification:
General
Use
Formulation
Types:
Liquid
Application
Methods:
Methods
of
application
include
controlled
droplet
applicator,
high
volume
ground
sprayer,
low
volume
ground
sprayer,
hand
held
sprayer,
high
volume
spray
(
dilute),
low
volume
spray
(
concentrate),
aerial
and
ground
broadcast,
and
spot
treatment.

Application
Rates:
The
maximum
label
application
rate
is
1.5
pounds
acid
equivalent/
acre
(
lb
ae/
A),
applied
once
per
year.

Use
Locations:
MCPB
is
primarily
used
in
Delaware,
Idaho,
Illinois,
Maine,
Maryland,
Michigan,
Minnesota,
Montana,
New
Jersey,
New
York,
Oregon,
Pennsylvania,
Washington
and
Wisconsin.

Tolerances:
There
is
1
tolerance,
for
peas.

Annual
Pounds
Used:
Less
than
15,000
pounds
per
year
Percent
Crop
Treated:
Approximately
15
percent
of
green
pea
crops
are
treated
with
MCPB.
Less
than
2.5
percent
of
other
types
of
pea
crops
are
treated
with
MCPB.
14
III.
Summary
of
MCPB
Risk
Assessments
This
section
summarizes
EPA s
human
health
and
ecological
risk
findings
and
conclusions
for
MCPB.
This
information
is
presented
in
greater
detail
in
the
following
documents:
 
MCPB:
Revised
Occupational
and
Residential
Exposure
(
ORE)
and
Risk
Assessments
for
the
Reregistration
Eligibility
Decision
RED
Document 
(
Dole,
10/
19/
2005),
 
Revised
Environmental
Fate
and
Effects
Division
Preliminary
Risk
Assessment
for
MCPB 
(
Janson,
3/
07/
2006)
and
MCPB
HED
Chapter
of
the
Reregistration
Eligibility
Decision
(
RED)
Document 
(
Mendez,
10/
24/
2005).

The
purpose
of
this
section
is
to
highlight
the
key
features
and
findings
of
the
risk
assessments
in
order
to
help
the
reader
better
understand
the
risk
management
decisions
reached
by
the
Agency.
While
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
in
the
OPP
Public
Docket
http://
www.
regulations.
gov/
fdmspublic­
rel11/
component/
main
(
docket
number
EPA­
HQ­
OPP­
2005­
0263).

A.
Human
Health
Risk
Assessment
Although
data
do
not
support
and
the
Agency
is
not
assuming
a
common
mechanism
of
toxicity
with
other
pesticides,
MCPB
is
similar
in
its
toxicity
to
the
structurally
related
compound
MCPA.
Also,
there
are
similarities
in
the
metabolism
of
MCPB
and
MCPA.
Thus,
studies
from
the
MCPA
database
were
used
as
a
surrogate
for
those
lacking
in
the
MCPB
database.

1.
Toxicity
MCPB
has
a
low
to
moderate
acute
toxicity
profile
(
Toxicity
Category
III
to
IV).
The
acute
dermal
toxicity
test
indicated
low
to
moderate
acute
toxicity
(
Toxicity
Category
III
to
IV).
The
acute
oral
and
inhalation
toxicity
studies
showed
moderate
toxicity
(
Toxicity
Category
III).
MCPB
is
not
a
dermal
sensitizer
nor
is
it
irritating
to
the
skin.
However,
it
does
cause
moderate
eye
irritation.
Please
see
Table
1,
below,
for
the
acute
toxicity
profile
for
MCPB.

Table
1.
Acute
Toxicity
Profile
for
MCPB
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
870.1100
Acute
oral
­
rat
116340
LD50
=
1570
mg/
kg
III
870.1100
Acute
oral
­
rat
144801
LD50
=
4300
mg/
kg
III
870.1200
Acute
dermal
­
rabbit
116342
LD50
>
10000
mg/
kg
IV
870.1200
Acute
dermal
­
rat
144799
LD50
>
2000
mg/
kg
III
870.1300
Acute
inhalation
­
rat
41630001
LC50
>
1.14
mg/
L
III
15
Table
1.
Acute
Toxicity
Profile
for
MCPB
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
870.2400
Acute
eye
irritation
­
rabbit
116343
Moderately
irritating
III
870.2400
Acute
eye
irritation
­
rabbit
144797
Moderately
irritating
III
870.2500
Acute
dermal
irritation
­
rabbit
144798
Non­
irritating
IV
870.2600
Skin
sensitization
­
guinea
pig
144800
Negative
IV
Kidney
and
liver
effects
appear
to
be
the
most
prevalent
hazard
concerns
for
MCPB,
based
on
the
effects
seen
throughout
the
MCPA
database.
Developmental
and
reproductive
toxicity
studies
did
not
indicate
an
enhanced
sensitivity
or
susceptibility
to
young
animals.
Neurotoxicity
effects
were
noted
in
studies
conducted
on
MCPA.
Therefore,
a
developmental
neurotoxicity
study
is
required
for
MCPB.

EPA
has
established
an
acute
reference
dose
(
RfD)
of
0.2
mg/
kg/
day
for
MCPB,
based
on
a
No
Observed
Adverse
Effect
Level
(
NOAEL)
of
200
mg/
kg/
day
in
an
acute
neurotoxicity
study
of
MCPA
in
rats.
The
main
effect
observed
at
the
Lowest
Observed
Adverse
Effect
Level
(
LOAEL)
was
gait
impairment
in
male
rats.
The
RfD
was
calculated
by
dividing
the
NOAEL
by
an
uncertainty
factor
of
1,000
(
10x
for
interspecies
variability,
10x
for
intraspecies
variability,
and
10x
FQPA
database
uncertainty
to
account
for
the
lack
of
a
developmental
neurotoxicity
study).
The
uncertainty
factors
are
discussed
in
more
detail
below.

EPA
has
established
a
chronic
RfD
of
0.015
mg/
kg/
day
for
MCPB,
based
on
a
NOAEL
of
4.4
mg/
kg/
day
in
a
chronic
toxicity
study
of
MCPA
in
rats.
Effects
observed
at
the
LOAEL
were
liver
and
kidney
toxicity.
The
RfD
was
calculated
by
dividing
the
NOAEL
by
an
uncertainty
factor
of
300
(
10x
for
interspecies
variability,
10x
for
intraspecies
variability,
and
3x
database
uncertainty
to
account
for
the
lack
of
a
developmental
neurotoxicity
study).
The
uncertainty
factors
are
discussed
in
more
detail,
below.

There
were
no
tumor
effects
observed
in
any
MCPA
or
MCPB
studies,
and
therefore
EPA
did
not
conduct
a
cancer
assessment.
Mutagenicity
tests
conducted
with
MCPB
and
MCPA
were
negative.

FQPA
Safety
Factor
FQPA
directs
EPA,
in
setting
pesticide
tolerances,
to
use
an
additional
tenfold
margin
of
safety
to
protect
infants
and
children,
taking
into
account
the
potential
for
pre­
and
post­
natal
toxicity
and
the
completeness
of
the
toxicology
and
exposure
databases.
The
statute
authorizes
EPA
to
modify
this
tenfold
FQPA
safety
factor
only
if
reliable
data
demonstrate
that
the
resulting
level
of
exposure
will
be
safe
for
infants
and
children.

The
toxicity
database
for
MCPB,
which
is
bridged
from
MCPA,
includes
acceptable
16
developmental
and
reproductive
toxicity
studies.
There
is
no
evidence
in
the
developmental
(
MCPB
and
MCPA)
or
reproductive
(
MCPA)
toxicity
studies
of
increased
sensitivity
or
susceptibility
to
newborns.
However,
EPA
has
determined
that
all
or
part
of
the
FQPA
safety
factor
must
be
retained
to
account
for
database
uncertainties.

Neurotoxicity
was
not
seen
in
the
MCPB
subchronic
studies
(
clinical
signs
of
neurotoxicity
in
a
rabbit
developmental
study
occurred
on
the
day
of
or
day
prior
to
death
or
moribund
sacrifice
and
were
attributed
to
agonal
death).
However,
neurotoxicity
was
noted
in
an
acute
and
subchronic
MCPA
rat
study
(
decreased
arousal,
impaired
coordination
and
gait,
reduced
motor
activity,
and
reduced
grip
strength).
Given
that
the
MCPA
database
was
used
to
evaluate
MCPB,
signs
of
neurotoxicity
are
expected
with
MCPB.
A
developmental
neurotoxicity
study
is
therefore
necessary
to
further
characterize
the
potential
for
pre­
and
post­
natal
neurotoxicity.
The
MCPB
and
MCPA
databases
do
not
include
a
DNT
study,
and
therefore
an
FQPA
database
uncertainty
factor
must
be
retained
for
exposure
scenarios
through
which
exposure
to
children
or
pregnant
women
is
expected.

The
size
of
the
FQPA
database
uncertainty
factor
is
based
on
an
analysis
of
DNT
studies
previously
submitted
to
the
Agency
which
suggests
that
NOAELs
from
a
DNT
study
could
be
lower
than
the
lowest
dose
tested
in
the
studies
currently
used
in
the
risk
assessment.
For
MCPB,
a
10x
FQPA
database
uncertainty
factor
is
retained
for
the
acute
dietary
risk
assessment
because
it
is
anticipated
that
the
DNT
may
yield
a
NOAEL
approximately
ten
times
lower
than
the
one
currently
used
for
the
risk
assessment.
A
3x
FQPA
database
uncertainty
factor
is
retained
for
the
chronic
dietary
risk
assessment
because
it
is
expected
that
the
DNT
could
yield
a
NOAEL
approximately
three
times
lower
than
the
one
currently
used
for
this
risk
assessment.

The
toxicological
endpoints
and
uncertainty
factors
used
in
the
human
health
risk
assessment
for
MCPB
are
listed
below
in
Table
2.

Table
2.
Summary
of
Toxicological
Doses
and
Endpoints
for
the
MCPB
Dietary
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Uncertainty
Factor
FQPA
Safety
Factor
PAD
(
mg/
kg/
day
)

Acute
Dietary
(
general
population)
NOAEL
=
200
mg/
kg/
day
Clinical
signs
of
neurotoxicity
Acute
neurotoxicity
study
(
MCPA)
in
rats
with
a
LOAEL
of
400
mg/
kg/
day
based
on
gait
impairment
in
males
[
MRID
No.
43562602]
100x
(
10x
for
intraspecies
variation
and
10x
for
interspecies
extrapolation)
10x
(
for
database
uncertainty)
0.2
Chronic
Dietary
(
general
population)
NOAEL=
4.4
mg/
kg/
day
Hepatotoxicity
and
nephrotoxicity
Chronic
toxicity
study
(
MCPA)
in
rats
with
a
LOAEL
of
17.6
mg/
kg/
day
[
MRID
No.
100x
(
10x
for
intraspecies
variation
and
10x
for
3x
(
for
database
uncertainty)
0.015
17
Table
2.
Summary
of
Toxicological
Doses
and
Endpoints
for
the
MCPB
Dietary
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Uncertainty
Factor
FQPA
Safety
Factor
PAD
(
mg/
kg/
day
)

40634101]
interspecies
extrapolation)

Cancer
Classification:
Not
likely
to
be
carcinogenic
to
humans
18
2.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
EPA
conducted
acute
and
chronic
dietary
(
food
and
drinking
water)
risk
assessments
for
MCPB
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
2.03).
To
conduct
the
assessments,
both
food
consumption
data
from
USDA's
Continuing
Survey
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998,
and
screening­
level
model
results
for
drinking
water
exposure
were
incorporated
in
the
DEEM­
FCID
 
to
estimate
combined
food
and
drinking
water
dietary
risks.

a.
Dietary
Exposure
and
Risk
from
Food
The
acute
and
chronic
dietary
(
food
only)
risk
assessments
assumed
100%
crop
treated
and
tolerance­
level
residues
for
all
commodities.
This
analysis
is
known
as
an
unrefined
(
Tier
1)
assessment,
which
provides
an
upper­
bound
estimate
of
potential
risks.

The
results
of
the
dietary
(
food
only)
exposure
and
risk
estimates
for
MCPB
for
the
general
population
and
the
most
highly­
exposed
population
subgroup
(
all
infants
<
1
year
old)
are
summarized
below
in
Table
3.
The
acute
assessment
shows
that
at
the
95th
percentile
of
exposure,
the
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
acute
Population
Adjusted
Dose
[
aPAD])
for
the
general
U.
S.
population
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
infants
(<
1
years
old)
at
2%
of
the
aPAD.
Note
that
for
MCPB
and
other
pesticides
for
which
EPA
conducts
an
unrefined
Tier
1
analysis,
the
Agency
presents
acute
dietary
exposure
results
at
the
95th
percentile
of
exposure,
which
provides
a
more
realistic
though
still
high­
end
estimate
of
risk.
The
chronic
risk
estimates
were
also
below
the
Agency's
level
of
concern
(<
100%
of
the
chronic
Population
Adjusted
Dose
[
cPAD])
for
the
general
U.
S.
population
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
infants
(<
1
years
old)
at
<
4%
of
the
cPAD.

Table
3.
Summary
of
dietary
(
food
only)
exposure
and
risk
for
MCPB
Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD*
cPAD
(
mg/
kg/
day)
Exposure,
mg/
kg/
day
%
cPAD*

General
U.
S.
Population
0.2
0.000754
0.4
0.015
0.000128
0.9
All
Infants
(<
1
yr)
0.2
0.003971
2
0.015
0.000568
3.8
*
Risks
>
100%
of
the
aPAD
or
cPAD
exceed
EPA's
level
of
concern.

b.
Dietary
Exposure
from
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
surface
and
ground
water
contamination.
EPA
considers
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
modeling
(
or
monitoring
data,
if
available
and
of
sufficient
quality)
to
estimate
those
exposures.
For
MCPB,
EPA
used
modeling
to
calculate
Estimated
Drinking
Water
19
Concentrations
(
EDWCs)
for
groundwater
and
surface
water
sources
of
drinking
water
for
use
in
the
human
health
risk
assessment.

EPA
used
the
Tier
II
screening
model,
Pesticide
Root
Zone
Model
and
Exposure
Analysis
Modeling
System
(
PRZM­
EXAMS),
to
estimate
MCPB
residues
in
surface
water.
The
Agency
assumed
MCPB
would
be
applied
once
a
year
at
1.5
pounds
of
acid
equivalent
per
acre
(
lb
ae/
A).
EPA
used
the
Tier
I
Screening
Concentrations
in
Ground
Water
(
SCI­
GROW)
model
to
estimate
MCPB
concentrations
in
ground
water,
assuming
a
maximum
seasonal
use
rate
of
1.5
lb
ae/
A.
The
EDWCs
in
surface
water
and
ground
water
for
MCPB
are
provided
below,
in
Table
4.
EPA
used
these
EDWCs
for
the
aggregate
(
food
+
water)
risk
assessments.

Table
4.
Surface
and
Ground
Water
EDWCs
for
MCPB
Exposure
Duration
Surface
Water
Concentration
a
(
ppb)
Ground
Water
Concentration
b
(
ppb)

Acute
54.7
0.86
Chronic
(
non­
cancer)
13.5
0.86
a
From
the
Tier
II
PRZM­
EXAMS
­
Index
Reservoir
model.
Input
parameters
are
based
on
use
of
MCPB
on
pea
crops
once
a
year
at
the
rate
of
1.5
lbs
ae/
A.
b
From
the
SCI­
GROW
model
assuming
a
maximum
seasonal
use
rate
of
1.5
lbs
ae/
A
c.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
MCPB
concentrations
are
predicted
to
be
higher
in
surface
water
than
in
ground
water,
and
therefore
EPA
used
the
surface
water
EDWCs
to
calculate
exposure
and
risk
from
combined
dietary
exposures
from
food
and
drinking
water.
The
results
of
the
acute
and
chronic
dietary
exposure
analyses
are
summarized
in
Table
5,
below.

At
the
95th
percentile
of
exposure,
the
acute
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
aPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
was
infants
(<
1
years
old)
at
approximately
6%
of
the
aPAD.
The
chronic
risk
estimates
were
also
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
highest
exposed
population
subgroup
was
infants
(<
1
years
old)
at
10%
of
the
cPAD.

Table
5.
Acute
and
Chronic
Dietary
(
food
plus
drinking
water
from
surface
water
sources)
Exposure
and
Risk
Estimates
for
MCPB
Acute
(
95th
Percentile)
Chronic
Population
Subgroup
Exposure
(
mg/
kg/
day)
%
aPAD*
Exposure
(
mg/
kg/
day)
%
cPAD*

General
U.
S.
Population
0.003356
1.7
0.00041
2.8
20
Table
5.
Acute
and
Chronic
Dietary
(
food
plus
drinking
water
from
surface
water
sources)
Exposure
and
Risk
Estimates
for
MCPB
All
Infants
(<
1
year
old)
0.011869
5.9
0.001501
10
*
Risks
>
100%
of
the
aPAD
or
cPAD
exceed
EPA's
level
of
concern.

3.
Residential
and
Other
Non­
Occupational
Exposure
and
Risk
There
are
no
residential
uses
of
MCPB,
and
therefore
EPA
did
not
conduct
a
residential
risk
assessment.

4.
Aggregate
Exposure
and
Risk
The
FQPA
amendments
to
the
FFDCA
(
Section
408(
b)(
2)(
A)(
ii))
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure.
In
the
case
of
MCPB,
the
aggregate
risk
estimates
are
the
same
as
those
presented
in
the
dietary
(
combined
food
and
drinking
water)
risk
section
of
this
document
(
see
Table
5),
because
there
are
no
registered
residential
uses
and
no
residential
exposures
are
expected
to
occur.

While
the
Agency
has
concluded
that
MCPB
converts
to
MCPA
in
the
environment,
and
that
MCPA
may
be
present
in
crops,
residues
of
MCPA
resulting
from
MCPB
use
are
expected
to
be
negligible,
and
significantly
below
analytical
method
limits
of
detection.
These
residues
will
not
contribute
significantly
to
the
aggregate
exposure
to
MCPA
from
other
sources,
and
therefore
EPA
did
not
conduct
an
aggregate
assessment
combining
MCPA
exposures
from
MCPA
and
MCPB
uses.

5.
Occupational
Exposure
and
Risk
Assessment
Workers
may
be
exposed
to
MCPB
while
handling,
mixing,
loading,
or
applying
MCPB,
and
when
entering
treated
sites.
Handler
and
worker
risks
are
measured
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(
NOAEL)
taken
from
animal
studies.
Generally,
MOEs
greater
than
100
do
not
exceed
the
Agency's
level
of
concern.

For
MCPB,
only
short­
and
intermediate­
term
occupational
exposures
are
expected
based
on
label­
specified
use
patterns.
The
Agency
determined
that
pesticide
handlers
and
applicators
are
likely
to
be
exposed
during
MCPB
use
resulting
in
short­
(
one
day
to
one
month)
and
intermediate­
term
(
one
to
six
month)
exposures.
Chronic
exposures
(
longer
than
six
months)
are
not
expected
because
MCPB
is
used
only
once
a
year.
21
For
the
occupational
assessment,
the
short­
and
intermediate­
term
dermal
endpoint
was
selected
from
an
MCPA
21­
day
dermal
toxicity
study
in
rabbits.
The
short­
and
intermediateterm
inhalation
endpoint
was
selected
from
an
MCPB
developmental
toxicity
in
rabbits.
Table
6,
below,
provides
a
listing
of
the
toxicological
endpoints
used
in
the
MCPB
occupational
risk
assessment.
22
Table
6.
MCPB
Toxicological
Endpoints
Used
for
Occupational
Risk
Assessment
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Uncertainty
Factor
Level
of
Concern
Dermal
(
Shortand
Intermediateterm
Dermal
NOAEL
=
100
mg/
kg/
day
Kidney
toxicity
and
decreased
body
weight
gain
21­
day
dermal
toxicity
study
(
MCPA)
in
rats
with
a
LOAEL
of
1,000
mg/
kg/
day
[
MRID
No.
42715001]
100x
(
10x
for
intraspecies
variation
and
10x
for
interspecies
extrapolation)
100
Inhalation
(
Short­
and
Intermediate­
Term)
Oral
NOAEL
=
5
mg/
kg/
day*
Maternal
mortality
Developmental
toxicity
study
in
rabbits
(
MCPB)
with
a
LOAEL
of
20
mg/
kg/
day
[
MRID
No.
40865401]
100x
(
10x
for
intraspecies
variation
and
10x
for
interspecies
extrapolation)
100
*
Inhalation
absorption
is
assumed
to
be
equivalent
to
oral
absorption
(
100
percent
default
value).

a.
Short­
and
Intermediate­
Term
Handler
Risk
EPA
has
determined
that
there
are
potential
short­
and
intermediate­
term
exposures
to
workers
who
handle
MCPB.
The
four
major
occupational
handler
exposure
scenarios
are
as
follows:

2.
Mixing/
loading
liquid
formulations;
3.
Performing
aerial
applications;
4.
Performing
groundboom
applications;
and
5.
Flagging
for
aerial
applications.

For
MCPB,
the
target
MOE
for
occupational
exposures
is
100,
which
includes
the
default
uncertainty
factors
for
interspecies
extrapolation
and
intraspecies
variation.
The
MOEs
for
handlers
are
summarized
in
Table
7.
All
of
the
MOEs
for
dermal
exposure
are
greater
than
100
(
and
therefore
do
not
exceed
the
Agency's
level
of
concern)
if
single
layer
PPE
(
i.
e.,
baseline
clothing
with
chemical
resistant
gloves)
is
worn.
All
inhalation
MOEs
are
greater
than
100
at
baseline
(
i.
e.,
respirators
not
needed),
and
therefore
do
not
exceed
the
Agency's
level
of
concern.

Table
7.
MCPB
MOEs
for
Handlers
Exposure
Scenario
Application
Rate
(
lb
ae/
acre)
Acres/
Day
Dermal
MOE
(
Single
Layer
PPE)
Inhalation
MOE
(
Baseline)

Mixing
and
Loading
Liquids
for
Aerial
Application
1.5
350
580
560
Mixing
and
Loading
Liquids
for
Groundboom
Application
1.5
200
1000
970
23
Table
7.
MCPB
MOEs
for
Handlers
Exposure
Scenario
Application
Rate
(
lb
ae/
acre)
Acres/
Day
Dermal
MOE
(
Single
Layer
PPE)
Inhalation
MOE
(
Baseline)

Applying
Aerially
1.5
350
N/
A
9800
Applying
via
Groundboom
Equipment
1.5
200
1700
1600
Flagging
for
Aerial
Applications
1.5
350
1100
1900
b.
Short­
and
Intermediate­
Term
Postapplication
Risk
Post­
application
exposures
to
MCPB
can
occur
when
workers
enter
pea
fields
recently
treated
with
MCPB
to
conduct
tasks
such
as
scouting
and
irrigation.

Since
no
chemical­
specific
data
were
available
for
MCPB,
standard
values
and
assumptions
were
used
to
evaluate
post­
application
risks
(
e.
g.,
maximum
application
rates,
default
dislodgeable
foliar
residue
value
of
20
percent).

A
summary
of
worker
risks
for
post­
application
exposures
is
presented
in
Table
8.
All
of
the
MOEs
are
above
100
on
Day
0
(
12
hours
after
application)
for
all
activities
which
indicates
that
the
risks
are
below
the
Agency's
level
of
concern.

Table
8.
MCPB
Post­
Application
Worker
Risks
Crop
Application
Rate
(
lb
ae/
acre)
Task
Transfer
Coefficient
(
cm2/
hr)
Day
0
Dermal
MOE
Peas
1.5
Irrigation,
scouting,
immature
plants
100
2600
B.
Environmental
Risk
Assessment
A
summary
of
the
Agency s
environmental
risk
assessment
for
MCPB
is
presented
below.
The
complete
environmental
risk
assessment
may
be
accessed
in
the
OPP
Public
Docket
(
EPA­
HQ­
OPP­
2005­
0263)
at
www.
regulations.
gov
and
on
the
Agency s
website
at
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

MCPB
is
a
phenoxy
herbicide
that
disrupts
hormone
(
auxin)
and
protein
synthesis
within
various
sites
in
sensitive
plants
to
cause
growth
abnormalities
in
addition
to
non­
lethal
effects
(
such
as
brown
leaf
tips,
necrosis,
decrease
in
size,
leaf
curling,
chlorosis,
and
stem
tumors).
The
use
of
MCPB
produces
potential
risks
to
non­
target
plants
within
close
proximity
to
target
areas
24
and
along
streams
and/
or
ponds
near
sprayed
fields.

The
environmental
fate
database
is
sufficient
to
characterize
the
environmental
exposure
associated
with
MCPB
use.
However,
EPA
does
intend
to
issue
a
DCI
as
part
of
this
RED
to
require
submission
of
additional
data
for
the
parent
compound
to
address
areas
of
uncertainty.
Studies
on
environmental
fate,
aquatic
invertebrates,
and
marine/
estuarine
fish
will
help
provide
the
Agency
with
data
to
refine
the
environmental
risk
assessments
and
to
confirm
the
conclusions
reached
in
this
RED.
As
previously
discussed,
MCPB
has
similiar
effects
as
MCPA.
Therefore,
EPA
took
into
consideration
both
MCPB
and
MCPA
data
for
the
purpose
of
this
environmental
assessment.

1.
Environmental
Exposure
a.
Environmental
Fate
and
Transport
MCPA
and
the
CHPA­
hexose
conjugate
are
byproducts
of
MCPB
detected
in
fate
studies.
MCPA,
MCPB,
and
the
CHPA­
hexose
conjugate
have
similar
fate
characteristics
as
evidenced
by
fate
studies
and
chemical
structure.
The
inclusion
or
exclusion
of
these
metabolites
had
little
influence
on
the
overall
risk
assessment
because
of
their
relatively
minor
presence
and
lack
of
persistence.
However,
the
Agency
has
included
both
metabolites
in
combination
with
parent
MCPB
as
total
toxic
residues
with
a
combined
half­
life
of
26
days.
The
Agency
assumed
that
the
toxicity
and
environmental
fate
properties
for
the
two
metabolites
are
equivalent
to
parent
MCPB.

Based
on
laboratory
studies
and
physicochemical
properties,
MCPB
is
not
volatile,
not
persistent,
and
not
likely
to
bioconcentrate.
Its
acidic/
anionic
nature,
physicochemical
properties,
and
relatively
low
sorption
to
soil
(
average
soil
sorption
coefficient
of
0.85
mL/
g)
indicate
that
MCPB
is
prone
to
leaching
and
runoff.

MCPB
is
essentially
stable
to
hydrolysis,
but
photolyzed
in
laboratory
water
under
optimal
light
exposure
conditions
with
half­
lives
of
approximately
2
to
3
days.
Phototransformation
products
included
4
­(
4­
hydroxy­
o­
tolyloxy)
butyric
acid,
2,4­
dihyroxyphenyl
formate,
o­
cresol,
benzoic
acid,
and
2­
hydroxyphenyl
formate.
Specific
study
information
is
not
available
concerning
the
fate
of
these
products,
and
the
Agency
has
not
included
any
potential
effects
of
aqueous
photolysis
products
in
the
risk
assessment
based
on
their
expected
toxicity
and
persistence.

b.
Aquatic
Organism
Exposure
EPA
used
the
PRZM
3.12
and
EXAMS
2.98
models
in
tandem
to
estimate
aquatic
exposure
concentrations
for
MCPB.
PRZM/
EXAMS
is
a
Tier
II
screening
model
designed
to
estimate
pesticide
concentrations
found
in
water
at
the
edge
of
a
treated
field.
As
such,
it
provides
high­
end
values
of
the
pesticide
concentrations
that
might
be
found
in
ecologically
sensitive
environments
following
pesticide
application.
The
acute
risk
assessments
were
performed
using
1­
in­
10­
year
peak
estimated
environmental
concentration
25
(
EEC)
values
for
single
applications
of
MCPB.
EPA
performed
chronic
risk
assessments
for
aquatic
invertebrates
and
fish
using
the
average
21­
day
and
60­
day
EECs,
respectively.

To
simulate
field
application
of
MCPB
to
peas,
EPA
selected
a
California
lettuce
scenario
and
an
Oregon
snap
bean
scenario
based
on
similarity
in
agricultural
practices
and
usage
areas.
The
EECs
from
the
two
scenarios
are
provided
in
Table
9.
The
Oregon
scenario
represents
the
typical
use
of
MCPB
application
to
peas,
and
the
California
scenario
represents
a
reasonable
upper
bound
estimate.

Table
9.
Estimated
Environmental
Concentrations
(
µ
g
ae/
L)
of
MCPB
+
Metabolites
(
MCPA
and
CHPA/
CHPA­
hexose)
in
Surface
Water
(
PRZM­
EXAMS)

Simulation
Scenario
Concentration
(
µ
g
ae/
L)

Crop
and
Location
Rate
Application
Method
Peak
21­
Day
Average
60­
Day
Average
Lettuce
(
CA)
(
Surrogate
for
Peas)
1.5
lbs
ae/
acre
(
1.68
kg
ae/
ha)
Ground
spray
Aerial
spray
40.4
43.2
39.0
41.7
36.4
38.9
Snap
Beans
(
OR)
(
Surrogate
for
Peas)
1.5
lbs
ae/
acre
(
1.68
kg
ae/
ha)
Ground
spray
Aerial
spray
29.5
33.1
29.0
32.5
28.1
31.5
Surface
water
and
groundwater
monitoring
data
were
not
available
for
evaluation
in
this
risk
assessment.

c.
Terrestrial
Organism
Exposure
(
1)
Exposure
to
Terrestrial
Birds
and
Mammals
EPA
estimated
exposure
to
birds
and
mammals
by
first
predicting
the
amount
of
MCPB
residues
found
on
animal
food
items,
and
then
using
information
on
typical
food
consumption
by
various
species
of
birds
and
mammals
to
determine
the
amount
of
pesticide
consumed.
The
amount
of
residues
on
animal
feed
items
are
based
on
the
Fletcher
nomogram,
which
is
a
model
developed
by
Hoerger
and
Kenaga
(
1972)
and
modified
by
Fletcher
(
1994),
and
the
current
maximum
application
rate
for
MCPB
(
1.5
lb
ae/
acre).

EPA
used
the
terrestrial
exposure
(
T­
REX)
model
Ver.
1.1
to
predict
mean
EECs
from
a
single
application
of
MCPB.
The
predicted
EECs
are
provided
in
Table
10,
below.
EPA
calculated
acute
and
chronic
RQs
using
these
EECs
and
appropriate
toxicity
data.

Table
10.
Mean
EECs
on
Terrestrial
Food
Items
from
Use
of
MCPB
on
Peas
Simulation
Scenario
Concentration
(
ppm
ae)

Crop
Food
item
Mean
26
Table
10.
Mean
EECs
on
Terrestrial
Food
Items
from
Use
of
MCPB
on
Peas
Simulation
Scenario
Concentration
(
ppm
ae)

Crop
Food
item
Mean
Short
Grass
127.5
Tall
Grass
54
Broadleaf
Plants/
Small
Insects
67.5
Peas
Fruits/
Pods/
Seeds/
Large
Insects
10.5
(
2)
Exposure
to
Non­
target
Insects
There
is
a
potential
for
exposure
to
non­
target
insects
as
a
result
of
spray
drift
from
aerial
and
ground
applications
of
the
liquid
formulation.

(
3)
Exposure
to
Non­
target
Terrestrial
Plants
Exposure
to
non­
target
terrestrial
plants
is
most
likely
to
occur
as
a
result
of
spray
drift
from
aerial
and
ground
applications
of
the
liquid
formulation.
Spray
drift
is
an
important
factor
in
characterizing
the
risk
of
MCPB
to
non­
target
plants.
EPA
used
the
TerrPlant
model
(
Ver.
1.0)
to
predict
EECs
for
terrestrial
plants
located
adjacent
to
the
treated
field.
MCPB
applied
according
to
label
directions
as
a
liquid
for
ground
or
aerial
applications
may
impact
non­
target
plants
for
some
distance
from
the
application
site
depending
on
droplet
size,
wind
speed,
and
other
factors.
In
addition,
the
Agency
used
the
AgDrift
model
(
Ver.
2.0.1)
to
estimate
drift
dispersion
and
deposition
as
a
result
of
ground
and
aerial
spray
droplet
and
nozzle
size,
wind
speed,
and
distance
from
the
treated
field.

2.
Environmental
Effects
(
Hazard)

a.
Toxicity
to
Aquatic
Organisms
(
1)
Freshwater
and
Estuarine/
Marine
Fish
Available
acute
toxicity
data,
listed
below
in
Table
11,
indicate
that
MCPB
is
slightly
to
moderately
toxic
to
freshwater
fish.
The
median
lethal
concentration
(
LC
50
)
value
from
the
rainbow
trout
study
(
the
more
sensitive
species)
was
used
to
evaluate
acute
risk
to
freshwater
fish.

Table
11.
Freshwater
Fish
Acute
Toxicity
for
MCPB
Sodium
27
Species
96­
hour
LC50
(
mg
ae/
L)
(
nominal
)
Toxicity
Category
MRID
Number
Bluegill
sunfish
(
Lepomis
macrochirus)
12.7
Slightly
toxic
42532601
Rainbow
trout
(
Oncorhynchus
mykiss)
3.9
Moderately
toxic
42532608
No
chronic
data
for
freshwater
fish
are
available.
These
studies
were
not
previously
required
by
the
Agency.

No
acute
or
chronic
data
for
estuarine/
marine
fish
are
available.
These
studies
were
not
previously
required
by
the
Agency.
A
study
with
the
degradate
MCPA
indicates
that
MCPA
is
practically
non­
toxic
to
estuarine/
marine
fish
for
acute
exposures.
However,
a
comparison
between
freshwater
fish
acute
exposure
studies
with
MCPB
and
MCPA
indicates
that
MCPB
is
potentially
more
toxic
to
fish
than
MCPA.

(
2)
Freshwater
and
Estuarine/
Marine
Invertebrates
A
toxicity
study
with
the
test
species
Daphnia
magna
demonstrated
that
MCPB
is
slightly
toxic
to
freshwater
invertebrates
under
acute
exposure.
The
study
results
are
provided
below,
in
Table
12.

Table
12.
Freshwater
Invertebrate
Acute
Toxicity
for
MCPB
Sodium
Species
48­
hour
EC50
(
mg
ae/
L)
Toxicity
category
MRID
Number
Waterflea
(
Daphnia
magna)
50
Slightly
toxic
42532602
No
freshwater
aquatic
invertebrate
life­
cycle
studies
or
estuarine/
marine
invertebrate
toxicity
studies
are
available.
These
studies
were
not
previously
required
by
the
Agency.

Studies
with
the
degradate
MCPA
indicate
that
MCPA
is
practically
non­
toxic
to
freshwater
and
estuarine/
marine
invertebrates.
However,
a
comparison
between
freshwater
invertebrate
acute
exposure
studies
with
MCPB
and
MCPA
indicates
that
MCPB
is
potentially
more
toxic
to
aquatic
invertebrates
than
MCPA.

(
3)
Aquatic
Plants
EPA
has
reviewed
several
aquatic
plant
toxicity
studies
to
establish
the
toxicity
of
MCPB
to
aquatic
plants.
The
results
of
these
studies
are
provided
in
Table
13,
below.
28
Table
13.
Non­
target
Aquatic
Plant
Toxicity
for
MCPB
Species
[
Study
Type]
EC50/
NOEC
(
mg
ae/
L)
Endpoints
Affected
MRID
Number
Duckweed
(
Lemna
gibba)
[
Tier
I]
0.21/<
0.01
1.55/
0.15
Frond
production
Frond
biomass
42532604
Green
Algae
(
Selenastrum
capricornutum)
[
Tier
I]
0.38/<
0.31
Cell
density
42532605
Blue­
green
Algae
(
Anabaena
flos­
aquae)
[
Tier
I]
>
1.9/
1.9
Cell
density
42532603
Diatom
(
Navicula
pelliculosa)
[
Tier
I
&
II]
0.65/
0.044
Cell
density
42532609
Diatom
(
Skeletonema
costatum)
[
Tier
I
&
II]
1.36/
0.10
Cell
density
42532606
b.
Toxicity
to
Terrestrial
Organisms
(
1)
Birds
MCPB
is
classified
as
moderately
toxic
to
birds
on
an
acute
oral
basis,
based
on
a
gavage
study
with
bobwhite
quail
with
a
median
lethal
dose
(
LD
50
)
of
257
mg
ae/
kg.
MCPB
is
classified
as
practically
non­
toxic
to
avian
species
on
an
acute
dietary
basis,
based
on
an
8­
day
acute
dietary
LD
50
of
greater
than
4,550
ppm
ae
for
both
mallard
duck
and
bobwhite
quail.
Table
14,
below,
summarizes
the
data
that
support
the
acute
toxicity
endpoints
used
in
assessing
acute
risks
to
birds.

Table
14.
Avian
Toxicity
Studies
for
MCPB
Acute
Oral
Gavage
Species
LD50
(
mg
ae/
kg)
Toxicity
Category
MRID
No.

Northern
bobwhite
quail
(
Colinus
virginianus)
257
Moderately
toxic
42560801
Acute
Dietary
Species
8­
Day
LD50
(
ppm
ae)
Toxicity
Category
MRID
No.

Northern
bobwhite
quail
(
Colinus
virginianus)
>
4,550
Practically
nontoxic
42560802
Practically
non
29
Acute
Dietary
Species
8­
Day
LD50
(
ppm
ae)
Toxicity
Category
MRID
No.

Mallard
duck
(
Anas
platyrhynchos)
>
4,550
toxic
42560803
No
chronic
avian
data
on
MCPB
are
available.
These
data
were
not
previously
required
by
the
Agency.
A
chronic
avian
reproduction
study
with
the
degradate
MCPA
resulted
in
a
no
observed
adverse
effect
concentration
(
NOAEC)
of
1,000
mg
ae/
kg­
diet
(
the
highest
dose
tested).
No
negative
effects
were
observed
in
that
study.
EPA
used
the
MCPA
chronic
avian
study
to
estimate
chronic
avian
risks
from
MCPB.
The
MCPA
study
is
an
appropriate
surrogate
because
MCPB
is
expected
to
rapidly
dissociate
to
MCPA
in
a
bird's
gut
due
to
the
chemical
properties
of
MCPB.
Further,
a
comparison
of
the
MCPB
and
MCPA
avian
acute
toxicity
studies
with
bobwhite
quail
indicates
that
the
two
compounds
have
an
approximately
equivalent
acute
toxic
potential
to
birds.

(
2)
Mammals
MCPB
is
classified
as
slightly
toxic
to
practically
non­
toxic
to
small
mammals
on
an
acute
oral
basis
(
LD
50
values
range
from
912
to
7,400
mg
ai/
kg/
day).
However,
adverse
effects
were
demonstrated
in
the
mammalian
subchronic
and
developmental
toxicity
studies.
See
Table
15,
below,
for
a
summary
of
the
data.

Table
15.
Summary
of
Mammalian
Toxicity
Endpoints
for
MCPB
Species
Purity
Test
Type
Dose
Affected
Endpoints
MRID
No.

Rat
Technic
al
Acute
oral
LD50
=
912­
2700
mg/
kg/
day
(
males)
LD50
=
969­
2981
mg/
kg/
day
(
females)
Mortality
116340
Rabbit
97.6%
Developmental
NOAEL
=
5
mg/
kg/
day
LOAEL
=
20
mg/
kg/
day
Maternal
toxicity;
developmental
effects
4086540
1
(
3)
Non­
Target
Insects
There
is
a
potential
for
exposure
to
non­
target
insects
from
the
use
of
MCPB.
In
particular,
MCPB s
foliar
application
will
result
in
honey
bee
exposure.
Available
data
from
a
honey
bee
acute
toxicity
study
indicated
that
technical
MCPB
is
practically
nontoxic
to
the
honey
bee
(
with
an
LD
50
greater
than
23
micrograms
per
bee).
30
(
4)
Non­
target
Terrestrial
Plants
MCPB
is
an
herbicide,
and
therefore
plant
toxicity
is
expected.
Terrestrial
plant
toxicity
studies
indicate
that
the
most
sensitive
monocot
species
in
seedling
emergence
tests
is
the
onion
with
the
lowest
EC
25
of
0.02
lb
ae/
acre
based
on
shoot
length.
This
value
represents
0.093%
of
the
maximum
application
rate
for
MCPB.
The
most
sensitive
dicot
species
is
cabbage
with
an
EC
25
of
0.016
lb
ae/
acre
in
the
seedling
emergence
study
based
on
shoot
length.
The
most
sensitive
monocot
in
the
vegetative
vigor
test
is
onion,
with
an
EC
25
of
0.016
lb
ae/
acre
based
on
shoot
weight.
The
most
sensitive
dicot
species
in
the
seedling
emergence
study
is
tomato
with
an
extrapolated
EC
25
of
0.0017
lb
ae/
acre
based
on
shoot
weight.
The
observed
non­
lethal
effects
included
brown
leaf
tips
in
cabbage,
corn,
onion,
ryegrass,
radish,
and
soybean;
necrosis
in
corn,
radish,
onion,
and
soybean;
chlorosis
in
onion,
cucumber,
and
lettuce;
stem
tumors
in
soybean
and
tomato;
leaf
curl
in
tomato,
and
decreased
size
in
cabbage,
cucumber,
lettuce,
onion,
and
ryegrass.
31
3.
Ecological
Risk
Estimation
(
RQs)

The
Agency s
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
EECs
which
are
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
non­
target
organisms
from
the
use
of
MCPB
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
(
LD
50
)
or
the
median
lethal
concentration
(
LC
50
).
These
RQ
values
are
then
compared
to
the
Agency s
levels
of
concern
(
LOCs),
shown
in
Table
16,
which
indicate
whether
a
pesticide,
when
used
as
directed,
has
the
potential
to
cause
adverse
effects
to
non­
target
organisms.
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
16.
EPA s
Levels
of
Concern
and
Associated
Risk
Presumptions
Risk
Presumption
LOC
for
Terrestrial
Animals
LOC
for
Aquatic
Animals
LOC
for
Plants
Acute
Risk
­
there
is
potential
for
acute
risk;
regulatory
action
may
be
warranted.
0.5
0.5
1
Acute
Endangered
Species
­
endangered
species
may
be
adversely
affected;
regulatory
action
may
be
warranted.
0.1
0.05
1
Chronic
Risk
­
there
is
potential
for
chronic
risk;
regulatory
action
may
be
warranted.
1
1
N/
A
a.
Risk
to
Aquatic
Organisms
(
1)
Fish
and
Aquatic
Invertebrates
No
acute
risks
are
predicted
for
freshwater
fish
and
invertebrates
at
the
maximum
predicted
estimated
concentration
of
MCPB
in
water
bodies.
All
acute
freshwater
fish
and
invertebrate
RQs
are
less
than
0.01.

There
are
no
LOC
exceedences
for
acute
risks
to
estuarine/
marine
fish
and
chronic
risks
to
freshwater
fish,
freshwater
invertebrates,
and
estuarine/
marine
fish
for
MCPB
based
on
RQ
values
calculated
using
acute­
to­
chronic
ratios
derived
from
MCPA
data.
32
33
(
2)
Aquatic
Plants
For
MCPB
acid
runoff/
drift,
there
are
no
exceedances
of
the
acute
risk
LOCs
for
the
pea
scenarios
that
were
modeled.
The
RQs
range
from
0.08
to
0.21.

b.
Risk
to
Non­
target
Terrestrial
Organisms
(
1)
Birds
Assuming
mean
predicted
residues
at
the
maximum
application
rate
(
1.5
lb
ae/
A),
there
are
potential
acute
risks
to
small
(
20
gram)
birds
that
consume
short
grass
(
RQ
is
0.80).
All
other
avian
RQs
are
below
the
Agency s
level
of
concern.
The
avian
acute
risk
quotients
are
presented
in
Table
17,
below.

No
chronic
avian
risks
are
predicted
for
MCPB.
Chronic
RQs
for
MCPB
were
calculated
using
the
NOEC
of
1,000
mg/
kg­
diet
from
an
MCPA
avian
reproduction
study.
The
chronic
RQs
range
from
0.02
to
0.36,
which
is
below
EPA s
level
of
concern.

Table
17.
Avian
Acute
Risk
Quotients
(
RQs)

Food
type
Weight
class
(
g)
RQs
at
Predicted
Mean
Residues
20
0.8
100
0.36
short
grass
1000
0.11
20
0.34
100
0.15
tall
grass
1000
0.05
20
0.42
100
0.19
broadleaf
forage,
small
insects
1000
0.06
20
0.07
100
0.03
fruit,
pods,
seeds,
large
insects
1000
0.01
(
2)
Mammals
Assuming
mean
residue
levels
at
the
maximum
MCPB
application
rate
of
1.5
lb
ae/
A,
there
are
no
exceedances
of
any
acute
LOCs
for
mammals
(
RQs
range
from
<
0.01
to
0.07).
However,
chronic
LOCs
are
exceeded
for
mammals
of
all
weight
classes
that
34
consume
grasses,
broadleaf
forage,
and
small
insects
(
RQs
range
from
1.23
to
6.44).
Table
18,
below,
provides
the
mammalian
chronic
RQs.

Table
18.
Mammalian
Chronic
Risk
Quotients
(
RQs)
based
on
NOAEC
of
91.2
mg/
kg­
diet
Food
type
Weight
class
(
g)
RQs
at
Predicted
Mean
Residues
15
6.44
35
5.53
Short
grass
1000
2.91
15
2.73
35
2.34
Tall
grass
1000
1.23
15
3.41
35
2.93
Broadleaf
forage,
small
insects
1000
1.54
15
0.53
35
0.46
Fruit,
large
insects
100
0.24
15
0.12
35
0.1
Seeds,
pods
1000
0.08
(
3)
Non­
Target
Insects
EPA
does
not
currently
quantify
risks
to
terrestrial
non­
target
insects.
RQs
are
therefore
not
calculated
for
these
organisms.
Since
MCPB
is
practically
non­
toxic
to
bees
on
a
contact
exposure
basis
(
LD
50
of
>
23
µ
g/
bee),
the
potential
for
MCPB
to
have
adverse
effects
on
pollinators
and
other
beneficial
insects
is
low.

(
4)
Non­
Target
Terrestrial
Plants
EPA
used
the
most
sensitive
seedling
emergence
values
(
0.02
and
0.016
lb
ae/
acre,
respectively)
for
monocots
and
dicots,
to
calculate
RQs
for
exposure
to
terrestrial
plants
near
MCPB­
treated
fields.
Exposure
is
expected
due
to
runoff
and
spray
drift.
The
acute
LOCs
for
non­
target
terrestrial
plants
are
exceeded
for
nonendangered
monocots
and
dicots
in
dryland
and
semi­
aquatic
areas
located
near
treated
areas.
Acute
LOCs
are
also
exceeded
for
monocots
and
dicots
due
to
exposure
from
spray
drift.
Table
19,
below,
provides
the
terrestrial
plant
risk
quotients.
35
Table
19.
Terrestrial
Plant
Risk
Quotients
(
RQs)

Acute
Non­
Endangered
RQs
Acute
Endangered
RQs
Scenario
Adjacent
to
treated
sites
Semi­
Aquatic
areas
Drift
Adjacent
to
treated
sites
Semi­
Aquatic
areas
Drift
Ground
spray
application
(
1.5
lbs
ae/
acre)

Monocot
4.50
38.25
0.94
9.00
76.50
­­

Dicot
5.63
47.81
2.08
9.00
76.50
­­

Aerial
spray
application
(
1.5
lbs
ae/
acre)

Monocot
6.00
26.25
4.69
12.00
52.50
­­

Dicot
7.50
32.81
10.42
12.00
52.50
 

4.
Ecological
Incidents
The
Agency
has
not
received
any
ecological
incident
reports
for
MCPB.

5.
Endangered
Species
Concerns
The
screening
level
ecological
risk
assessment
results
in
a
determination
that
the
use
of
MCPB
will
have
no
direct
acute
effects
on
freshwater
fish,
freshwater
invertebrates,
and
insects,
and
no
direct
chronic
effect
to
birds.
However,
the
Agency s
level
of
concern
for
direct
acute
effects
to
endangered
and
threatened
birds,
and
terrestrial
and
semi­
aquatic
plants,
and
for
direct
acute
and
chronic
effects
to
mammals,
is
exceeded
for
the
use
of
MCPB.
Further,
potential
indirect
effects
to
any
species
dependent
upon
a
species
that
experiences
effects
from
use
of
MCPB
can
not
be
precluded
based
on
the
screening
level
ecological
risk
assessment.

a.
Risk
to
Endangered
Species
The
screening
level
risk
assessment
for
listed
species
indicates
that
MCPB
exceeds
the
acute
endangered
species
LOCs
for
birds
that
feed
on
grasses,
broadleaf
forage,
and
small
insects
(
RQs
range
up
to
2.26
at
maximum
predicted
residues)
and
terrestrial
and
semi­
aquatic
plants
(
RQs
range
up
to
77).
Also,
the
chronic
LOC
of
1.0
is
exceeded
for
mammals
foraging
on
grasses,
broadleaf
forage,
small
insects,
fruit,
and
large
insects
(
RQs
range
up
to
20
at
maximum
predicted
residues).
In
addition
to
36
potential
direct
effects,
there
may
be
potential
for
indirect
effects
to
listed
species
that
are
dependent
upon
a
taxa
that
may
experience
effects
from
the
use
of
this
pesticide.

The
Agency
can
not
quantitatively
predict
potential
acute
direct
effects
to
endangered
and
threatened
estuarine/
marine
fish
or
aquatic
vascular
and
non­
vascular
plants;
nor
direct
chronic
effects
to
endangerd
and
threatened
fresh
water
fish
and
invertebrates,
and
estuarine/
marine
fish
and
invertebrates
and
therefore
the
potential
for
effects
can
not
be
precluded
based
on
EPA's
screening
level
ecological
risk
assessment.
In
the
case
of
the
current
lack
of
effects
thresholds
for
listed
aquatic
plants,
the
potential
for
indirect
effects
on
listed
species
with
obligate
relationships
on
a
given
species
of
aquatic
plant
cannot
be
discounted
because
definitive
RQs
for
comparison
to
the
listed
species
LOCs
are
unavailable.
Potential
risks
to
endangered
species
identified
in
the
Environmental
Fate
and
Ecological
Risk
Assessment
and
reflected
in
this
RED
for
MCPB
are
based
solely
on
EPA s
screening
level
ecological
risk
assessment
and
do
not
constitute
 
may
effect 
findings
under
the
Endangered
Species
Act.

6.
Risk
Characterization
The
risk
assessment
for
MCPB
is
a
conservative,
screening­
level
assessment
conducted
with
the
maximum
application
rate
of
1.5
lb
ae/
A.

Freshwater
and
estuarine/
marine
fish
and
aquatic
invertebrates
do
not
appear
to
be
at
acute
risk
from
exposure
to
MCPB,
and
there
are
no
risk
concerns
for
non­
endangered
aquatic
plants
for
the
pea
scenarios
that
were
modeled.

EPA's
level
of
concern
is
exceeded
for
chronic
risk
to
mammals
that
consume
grasses,
broadleaf
plants,
and
small
insects,
although
the
exceedances
are
relatively
small
(
RQs
range
from
1.23
to
6.44;
chronic
LOC
is
exceeded
if
RQ
>
1.0).
This
screening­
level
assessment
assumes
that
100
percent
of
the
diet
is
comprised
of
single
food
types
foraged
only
from
treated
fields.
The
assumption
of
100
percent
diet
from
a
single
food
type
may
not
be
realistic
for
chronic
exposures
from
the
single
annual
application
of
MCPB
to
peas
because
diets
are
likely
to
be
more
variable
over
longer
periods
of
time
depending
on
size
and
forage
range
of
animals.

EPA's
level
of
concern
is
also
exceeded
for
acute
risk
to
small
birds
that
consume
short
grasses,
although
the
exceedances
are
relatively
small
(
RQs
range
from
0.34
to
0.80).
The
screening­
level
assessment
assumes
that
100
percent
of
the
diet
is
comprised
of
single
food
types.
This
assumption
may
be
more
realistic
for
acute
risks
than
chronic
risks.
MCPB
is
categorized
as
moderately
toxic
to
avian
species
on
an
acute
oral
basis,
but
it
is
practically
non­
toxic
to
avian
species
on
an
acute
dietary
basis.
Based
on
these
acute
toxicity
data,
there
is
a
large
differential
in
the
acute
lethality
when
MCPB
is
administered
as
a
single
gavage
for
acute
oral
studies,
as
compared
to
when
MCPB
is
mixed
in
the
feed
for
acute
dietary
studies.
There
are
limitations
to
both
the
dose­
based
and
dietary­
based
method
of
calculating
risk
quotients;
however,
for
many
compounds
a
gavage
dose
represents
a
very
short­
term,
high­
intensity
exposure,
whereas
dietary
exposure
may
be
of
a
more
prolonged
nature.
The
disparity
in
mortality
between
the
two
types
of
37
studies
suggests
that
the
dietary
matrix
may
have
a
lowering
effect
for
the
toxicity
of
MCPB.

EPA's
level
of
concern
is
exceeded
for
terrestrial
plants,
which
is
expected
based
on
MCPB's
herbicidal
properties.
Risks
are
expected
if
exposure
occurs,
but
there
is
very
limited
use
of
MCPB.
It
is
only
registered
for
use
on
pea
crops,
and
it
is
approved
for
use
only
once
per
year,
at
a
maximum
rate
of
1.5
lb
ae/
acre.
Total
annual
use
is
less
than
15,000
pounds.

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
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
to
support
reregistration
of
products
containing
MCPB
as
an
active
ingredient.

The
Agency
has
completed
its
review
of
submitted
data
and
its
assessment
of
the
human
and
ecological
risks
associated
with
the
use
of
pesticide
products
containing
the
active
ingredient
MCPB.
Based
on
a
review
of
these
data,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
MCPB
to
make
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
the
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
MCPB­
containing
products
are
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.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
MCPB
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
that
the
Agency
reviewed
as
part
of
its
determination
for
reregistration
eligibility
of
MCPB,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

Based
on
its
evaluation
of
MCPB,
the
Agency
has
determined
that
MCPB
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
MCPB.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
MCPB
will
be
adequately
mitigated
for
the
purposes
of
this
determination
under
FIFRA.
Once
the
Endangered
Species
assessment
is
completed,
further
changes
to
these
registrations
may
be
necessary
as
explained
in
Section
IV.
D.
3.

B.
Public
Comments
and
Responses
38
Through
the
Agency's
public
participation
process,
EPA
worked
extensively
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
MCPB.
During
the
public
comment
period
on
the
risk
assessments,
which
closed
on
January
3,
2006,
the
Agency
received
comments
from
one
private
citizen,
and
the
MCPB
Task
Force.
These
comments
in
their
entirety
are
available
in
the
public
docket
(
EPA­
HQ­
OPP­
2005­
0263)
at
http://
www.
regulations.
gov.
A
detailed
Response
to
Comments
document
is
available
in
the
public
docket
as
well.

The
RED
and
technical
supporting
documents
for
MCPB
are
available
to
the
public
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets,
under
docket
identification
(
ID)
number
EPA­
HQ­
OPP­
2005­
0263.
The
public
may
access
EPA
Dockets
at
http://
www.
regulations.
gov/
fdmspublic­
rel11/
component/
main.
In
addition,
the
MCPB
RED
may
be
downloaded
or
viewed
through
the
Agency's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
MCPB.
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
drinking
water.
(
Residential
exposures
were
not
aggregated
because
MCPB
is
not
registered
for
residential
use.)
EPA
has
determined
that
risk
from
dietary
(
food
and
water
sources)
exposure
to
MCPB
is
within
its
own
"
risk
cup."
The
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
MCPB
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
and
water.

b.
Determination
of
Safety
to
the
U.
S.
Population
The
Agency
has
determined
that
the
established
tolerances
for
MCPB
meet
the
safety
standards
under
the
FQPA
amendments
to
Section
408(
b)(
2)(
D)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
no
harm
will
result
to
the
general
population
or
any
other
population
from
the
use
of
MCPB.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
MCPB.
As
discussed
in
Chapter
3,
the
total
acute
and
chronic
dietary
(
food
plus
water)
risks
are
below
the
Agency's
level
of
concern
(<
100%
of
the
PAD)
for
the
general
population
and
all
subgroups.
The
highest
exposed
population
subgroup
was
infants
(<
1
years
old)
at
<
4%
of
the
aPAD
and
10%
of
the
cPAD.

c.
Determination
of
Safety
to
Infants
and
children
39
The
Agency
has
determined
that
the
established
tolerances
for
MCPB
meet
the
safety
standards
under
the
FQPA
amendments
to
Section
408(
b)(
2)(
C)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children.
The
safety
determination
for
infants
and
children
considers
the
toxicity,
use
practices,
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
MCPB
residues
in
this
population
subgroup.
In
determining
whether
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
MCPB
residues,
the
Agency
considered
the
completeness
of
the
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
other
information.
The
FQPA
safety
factor
for
MCPB
has
been
retained
for
acute
exposures
and
partially
retained
for
chronic
exposures
due
to
uncertainty
in
the
toxicology
database
(
lack
of
a
DNT
study).
However,
the
toxicity
database
for
MCPB,
which
is
bridged
from
MCPA,
includes
acceptable
developmental
and
reproductive
toxicity
studies
and
there
is
no
evidence
in
the
developmental
or
reproductive
toxicity
studies
of
sensitivity
or
susceptibility
to
newborns.

As
discussed
in
Chapter
3,
the
total
acute
and
chronic
dietary
(
food
plus
water)
risks
are
below
the
Agency's
level
of
concern
(<
100%
of
the
PAD)
for
the
general
population
and
all
subgroups.
The
highest
exposed
population
subgroup
was
infants
(<
1
years
old)
at
<
4%
of
the
aPAD
and
10%
of
the
cPAD.

d.
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
(
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.
Furthermore,
as
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP)
and
MCPB
may
be
subject
to
additional
screening.

e.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
MCPB.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide s
40
residues
and
 
other
substances
that
have
a
common
mechanism
of
toxicity. 
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
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
for
MCPB.
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
on
EPA s
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

2.
Tolerance
Reassessment
Summary
a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.318
Tolerances
are
currently
established
under
40
CFR
§
180.318
for
residues
of
MCPB
[
4­(
2­
methyl­
4­
chlorophenoxy)
butyric
acid)]
per
se
in/
on
peas
at
0.1
ppm.
The
Agency
has
concluded
that
the
residue
of
concern
for
both
tolerance
enforcement
and
for
dietary
risk
analysis
consists
of
MCPB
and
MCPA,
free
and
conjugated.
The
tolerance
expression
will
be
revised
accordingly,
once
all
data
have
been
submitted
(
see
Table
20).
EPA
notes
that
although
additional
data
are
required,
there
are
no
dietary
risks
associated
with
the
tolerance
for
peas
and
EPA
considers
it
reassessed
at
the
current
level.

No
maximum
residue
limits
(
MRLs)
for
MCPB
have
been
established
by
Codex
for
any
agricultural
commodity.
Additionally,
no
Canadian
or
Mexican
MRLs
have
been
established
for
MCPB.

Table
20.
Tolerance
Reassessment
Summary
for
Registered
MCPB
Uses
Commodity
Current
Tolerance
(
ppm)
Range
of
Residues
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
Tolerances
Listed
Under
40
CFR
§
180.318
Pea
0.1(
N)*
<
0.05
0.1
Residue
studies
must
be
submitted
depicting
the
magnitude
of
both
MCPB
and
MCPA
residues
in/
on
peas.

*
The
 (
N) 
designation
indicates
negligible
residues
and
EPA
will
propose
to
remove
the
 (
N) 
designation
from
all
entries
to
conform
to
current
Agency
administrative
practice.

D.
Regulatory
Rationale
41
The
Agency
has
determined
that
MCPB
is
eligible
for
reregistration
provided
that
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
label
amendments
are
made
to
reflect
these
measures.

The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
MCPB.
Where
labeling
revisions
are
warranted,
specific
language
is
set
forth
in
the
summary
tables
of
Section
V
of
this
document.
42
1.
Human
Health
Risk
Mitigation
a.
Dietary
(
Food)
Risk
Mitigation
The
Agency's
unrefined
Tier
1
(
100%
crop
treated)
acute
and
chronic
dietary
(
food
only)
risk
assessments
for
MCPB
indicated
that
acute
and
chronic
risk
estimates
are
below
the
Agency's
level
of
concern.
Therefore,
no
dietary
risk
reduction
measures
are
required.

b.
Drinking
Water
Risk
Mitigation
Estimated
environmental
concentrations
(
EECs)
of
MCPB
and
its
degradates
for
both
ground
water
and
surface
water
sources
of
drinking
water
are
below
the
Agency's
level
of
concern.
Therefore,
no
mitigation
is
needed
for
drinking
water.

c.
Aggregate
Risk
Mitigation
EPA
must
consider
and
aggregate
(
add)
pesticide
exposures
and
risks
from
three
major
sources:
food,
drinking
water,
and
residential.
MCPB
has
no
residential
uses.
Therefore,
the
aggregate
exposure
risk
assessments
for
MCPB
only
incorporate
exposures
and
risks
from
food
and
drinking
water.
(
1)
Acute
Aggregate
Risk
The
Agency's
acute
dietary
(
food
plus
water)
risk
assessment
indicated
that
acute
dietary
risks
are
below
the
Agency's
level
of
concern.
Therefore,
no
mitigation
is
required.

(
2)
Chronic
Aggregate
Risk
The
Agency's
chronic
dietary
(
food
plus
water)
risk
assessment
indicated
that
chronic
dietary
risks
are
below
the
Agency's
level
of
concern.
Therefore,
no
mitigation
is
required.

d.
Occupational
Risk
Mitigation
(
1)
Handler
Exposure
EPA
completes
handler
exposure
assessments
by
using
a
baseline
(
long­
sleeved
shirt
and
long
pants)
exposure
scenario
and,
if
required,
increasing
levels
of
mitigation
such
as
Personal
Protective
Equipment
(
PPE)
or
engineering
controls
to
achieve
an
adequate
margin
of
exposure
(
MOE).
For
MCPB,
short­
and
intermediate­
term
inhalation
risks
to
occupational
handlers
are
below
the
Agency's
level
of
concern
(
i.
e.,
MOE
 
100)
at
baseline
(
i.
e.,
no
respirator)
for
mixers,
loaders,
and
applicators.
For
dermal
risks
associated
with
mixing
and
loading
for
groundboom
and
aerial
application,
MOEs
are
above
the
Agency's
level
of
concern
(
i.
e.,
MOE
<
100)
at
baseline,
but
are
below
EPA's
level
of
concern
(
i.
e.,
MOE
 
100)
when
chemical­
resistant
gloves
43
are
added.
To
mitigate
the
potential
dermal
risks
to
mixers
and
loaders,
chemical­
resistant
gloves
will
be
required.

(
2)
Post­
Application
Risk
Mitigation
EPA
assessed
short/
intermediate­
term
post­
application
risks
to
workers
who
enter
pea
fields
recently
treated
with
MCPB
to
conduct
tasks
such
as
scouting
and
irrigation.
EPA
did
not
assess
long­
term
post­
application
exposure
risks
because
MCPB
is
used
only
once
per
season.
Using
the
maximum
application
rate
of
1.5
lb
ae/
A
and
the
default
dislodgeable
foliar
residue
value
of
20
percent,
post­
application
risks
are
below
the
Agency's
level
of
concern
(
i.
e.,
MOEs
 
100)
on
day
zero,
or
12
hours
after
application.
EPA
has
determined
that
a
12­
hour
restricted
entry
interval
is
appropriate
for
MCPB.

2.
Environmental
Risk
Mitigation
EPA's
levels
of
concern
are
exceeded
for
acute
risk
to
small­
sized
birds
and
terrestrial
plants,
and
chronic
risk
to
mammals.
EPA
has
determined
that
the
risk
mitigation
that
is
appropriate
for
environmental
concerns
at
this
time
is
to
require
medium
or
coarser
droplet
sizes
to
minimize
the
potential
for
spray
drift.

3.
Endangered
Species
Considerations
From
the
screening­
level
assessment,
RQs
exceeded
the
LOCs
for
endangered
species
for
some
of
the
exposure
scenarios.
Chronic
RQs
exceed
the
LOCs
for
endangered
mammals
(
RQs
range
from
2
to
20
at
maximum
residue
levels),
acute
RQs
exceed
LOCs
for
endangered
birds
(
RQs
range
from
0.2
to
2.26
at
maximum
residue
levels),
and
acute
RQs
exceed
the
endangered
terrestrial
plant
LOCs
for
monocots
and
dicots
(
RQs
range
from
9
to
77).

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.
44
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
MCPB,
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
MCPB
 
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
MCPB
at
levels
of
concern.
EPA
is
not
requiring
specific
MCPB
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.

4.
Spray
Drift
Management
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices,
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
database
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
methods
where
appropriate.

Spray
drift
is
a
potential
source
of
MCPB
non­
target
exposure
near
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but
spray
drift
exposure
may
also
result
from
ground
application
of
MCPB.
To
minimize
the
potential
for
spray
drift,
the
Agency
is
requiring
medium
or
coarser
droplet
sizes
for
all
MCPB
end­
use
products.
Additionally,
the
Agency
encourages
the
inclusion
of
best
management
practices
on
labels
to
reduce
spray
drift.
In
the
future,
MCPB
labels
may
need
to
be
revised
to
include
additional
or
different
drift
label
statements.

V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
MCPB
is
eligible
for
reregistration
provided
that
product­
specific
data
are
submitted
and
the
mitigation
measures
stated
in
this
document
are
included
in
upcoming
label
submissions.
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
(
DCI)
notices
requiring
product­
specific
data
and
generic
confirmatory
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extensions
and/
or
waivers
with
a
full
written
justification.
For
product­
specific
data,
45
the
registrant
will
have
eight
months
to
submit
data
and
amended
labels.
For
generic
data,
due
dates
can
vary
depending
on
the
specific
studies
being
required.
Listed
below
are
the
additional
generic
data
that
the
Agency
intends
to
require.
46
F.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
MCPB
for
the
above
eligible
use
has
been
reviewed
and
determined
to
be
substantially
complete
based
on
bridging
from
MCPA
data.
However,
the
data
listed
below,
in
Tables
21
and
22,
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.

Table
21.
Toxicology
and
Residue
Chemistry
Data
Requirements
Study
Required
Guideline
Number
Comment
Confined
Accumulation
in
Rotational
Crops
Study
860.1850
Must
be
conducted
with
MCPB
Magnitude
of
Residues
in
Plants
860.1300
Must
be
conducted
with
MCPB
and
MCPA
Enforcement
Analytical
Methods
860.1340
Must
be
conducted
with
MCPB
and
MCPA
Developmental
neurotoxicity
study
in
rats
[
Reserved]
870.6300
Reserved
pending
outcome
of
developmental
neurotoxicity
study
in
rats
with
MCPA
2­
EHE
28­
day
Inhalation
Study
(
abbreviated
90­
day
protocol)
[
Reserved]
870.3465
Reserved
pending
outcome
of
28­
day
Inhalation
Study
with
MCPA
Table
22.
Environmental
Fate
and
Ecological
Toxicity
Data
Requirements
Study
Required
Guideline
Number
Comment
Terrestrial
Field
Dissipation
835.1600
Estuarine/
marine
invertebrate
acute
EC50
(
eastern
oyster)
850.1025
Estuarine/
marine
fish
acute
LC50
(
sheepshead
minnow)
850.1075
Freshwater
fish
early
life
stage
(
fathead
minnow)
850.1400
Freshwater
invertebrate
life
cycle
(
daphnia)
[
Reserved]
850.1300
R
eserved
pending
the
outcome
of
acute
estuarine/
marine
fish
and
invertebrate
studies.

Estuarine/
marine
life
cycle
(
mysid)
[
Reserved]
850.1350
R
eserved
pending
the
outcome
of
acute
estuarine/
marine
fish
and
invertebrate
studies.

Estuarine/
marine
life
cycle
(
fish)
[
Reserved]
850.1400
Reserved
pending
the
outcome
of
acute
estuarine/
marine
fish
and
invertebrate
studies.

Reserved
pending
the
outcome
of
acute
47
Study
Required
Guideline
Number
Comment
Freshwater
fish
full
life
cycle
[
Reserved]
850.1500
estuarine/
marine
fish
and
invertebrate
studies.

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.
The
MUP
labeling
should
bear
the
labeling
contained
in
Table
23
at
the
end
of
this
section.

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
productspecific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
registrant
must
review
previous
data
submissions
to
ensure
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
instructions
in
the
Requirement
Status
and
Registrations
Response
Form
provided
for
each
product.
The
Agency
intends
to
issue
a
separate
product­
specific
Data
Call­
In
outlining
specific
data
requirements.

2.
Labeling
for
End­
Use
Products
Labeling
changes
are
necessary
to
implement
measures
outlined
in
Section
IV
above.
The
specific
changes
and
language
required
are
presented
in
Table
23
below.

Existing
stocks
time
frames
will
be
established
case­
by­
case,
depending
on
the
number
of
products
involved,
the
number
of
label
changes,
and
other
factors.
Please
refer
to
 
Existing
Stocks
of
Pesticide
Products;
Statement
of
Policy, 
Federal
Register,
Volume
56,
No.
123,
June
26,
1991.
48
C.
Labeling
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
registrants
must
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
23:
Summary
of
Labeling
Changes
for
MCPB
Description
Amended
Labeling
Language
Placement
on
Label
Manufacturing
Use
Products
"
Only
for
formulation
into
an
herbicide
for
use
on
peas."
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
MUP
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
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
into
sewer
systems
without
previously
notifying
the
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
Environmental
Protection
Agency."
Precautionary
Statements
End
Use
Products
Intended
for
Occupational
Use
(
WPS)

PPE
Requirements
Established
by
the
RED1
"
Personal
Protective
Equipment
(
PPE)
Immediately
following/
below
49
for
liquid
formulations
Some
materials
that
are
chemical­
resistant
to
this
product
are
(
registrant
inserts
correct
chemicalresistant
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.

Mixers,
loaders,
and
other
handlers
must
wear:

·
Long­
sleeved
shirt
·
Long
pants
·
Shoes
plus
socks
·
Chemical­
resistant
gloves
when
mixing,
loading
or
exposed
to
the
concentrate.
"
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."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
Engineering
Controls
"
Engineering
Controls:

Pilots
must
use
an
enclosed
cockpit
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240
(
d)(
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
with
plenty
of
soap
and
water
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet.

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

Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)

Environmental
Hazards
"
Environmental
Hazards
Precautionary
Statements
immediately
50
Avoid
spray
drift
as
this
product
may
injure
susceptible
crops
and
plants
such
as
cotton,
beans,
grapes,

tomatoes
and
ornamentals.
(
Course
sprays
are
less
likely
to
drift.)
Do
not
use
same
spray
equipment
for
other
purposes
unless
thoroughly
cleaned
prior
to
use.
Do
not
apply
this
product
through
any
type
of
irrigation
system."
following
the
User
Safety
Recommendations
Restricted­
Entry
Interval
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted­
entry
interval
(
REI)
of
12
hours."

Early
Re­
entry
Personal
Protective
Equipment
established
by
the
RED.
"
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,

Shoes
plus
socks,

Chemical­
resistant
gloves
made
of
any
waterproof
material"
Directions
for
Use,

Agricultural
Use
Requirements
Box
General
Application
Restrictions
"
It
is
a
violation
of
Federal
Law
to
use
this
product
in
a
manner
inconsistent
with
its
labeling.
Read
entire
label
before
using
this
product."

"
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.
For
any
requirement
specific
to
your
State
or
Tribe,
consult
the
agency
responsible
for
pesticide
regulations."
Place
in
the
Direction
for
Use
directly
above
the
Agricultural
Use
Box.

Spray
Drift
Label
Language
for
Products
Applied
as
a
Spray
"
Apply
only
as
a
medium
or
coarser
spray
(
ASAE
standard
572)
or
a
volume
mean
diameter
of
300
microns
or
greater
for
spinning
atomizer
nozzles."

"
A
variety
of
factors
including
weather
conditions
(
e.
g.,
wind
direction,
wind
speed,
temperature,
relative
humidity)
and
method
of
application
(
e.
g.,
ground,
aerial,
airblast,
chemigation)
can
influence
pesticide
drift.
The
applicator
and
grower
must
evaluate
all
factors
and
make
appropriate
adjustments
when
applying
this
product.

WIND
SPEED:

Do
not
apply
at
wind
speeds
greater
than
10
mph
at
the
application
site."

DROPLET
SIZE:

"
Apply
as
a
medium
or
coarser
spray
(
ASAE
standard
572)."

RELEASE
HEIGHT
(
GROUND
APPLICATION):
Directions
for
Use
under
General
Precaution
and
Restrictions
51
"
Apply
using
a
nozzle
height
of
no
more
than
4
feet
above
the
ground
or
crop
canopy."

RELEASE
HEIGHT
(
AERIAL
APPLICATION):

"
Do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground
or
crop
canopy."

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.

Instructions
in
the
Labeling
section
appearing
in
quotations
represent
the
exact
language
that
should
appear
on
the
label.

Instructions
in
the
Labeling
section
not
in
quotes
represents
actions
that
the
registrant
should
take
to
amend
their
labels
or
product
registrations.
52
VI.
Related
Documents
and
How
to
Access
Them
This
interim
Reregistration
Eligibility
Document
is
supported
by
documents
that
are
presently
maintained
in
the
OPP
docket
under
docket
number
EPA­
HQ­
2005­
0263.
The
OPP
docket
is
located
in
Room
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays
from
8:
30
am
to
4
pm.
The
documents
are
also
available
on­
line
in
the
Federal
Docket
Management
System
(
FDMS)
at
http://
www.
regulations.
gov.

The
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
November
2,
2005.
Sixty
days
later,
on
January
3,
2006,
the
public
comment
period
closed.
The
EPA
then
considered
the
comments
received,
revised
the
risk
assessments
as
necessary.
EPA
then
added
formal
"
Response
to
Comments"
documents,
the
Reregistration
Eligibility
Decision
(
RED)
document,
and
the
revised
risk
assessments
to
the
docket
on
July
21,
2006.

All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
http://
www.
regulations.
gov.
53
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
for
use
on
Peas
Table
1.
MCPB
use
on
Peas
Application
Type,
Equipment
Formulation
Max.
Single
App.
Rate
(
lbs
ae/
A)
Seasonal
Max.
(
lbs
ae/
A/
Yr)
PHII
(
Days)
REI
(
Hours)
Restrictions/
Comments
Spray/
ground
and
Aerial
Thistrol
Herbicide
(
71368­
5)
and
Sodium
MCPB
Solution
(
71368­
7)
1.5
1.5
1
24
Use
single
layer
PPE
54
Appendix
B:
Data
Supporting
Guideline
Requirements
of
the
Reregistration
of
MCPB
Table
1.
Product
Chemistry
New
Guideline
Number
Old
Guideline
Number
Requirement
Use
Citation(
s)

860.1400
171­
4H
Magnitude
of
Residue
in
Irrigated
Crops
Peas
44754101
Table
2.
Ecological
Effects
New
Guideline
Number
Old
Guideline
Number
Requirement
Use
Citation(
s)

850.2100
71­
1
Bobwhite
Quail
Peas
42560801
850.2200
71­
2A
Avian
Acute
Dietary
Toxicity
Test,
Bobwhite
quail
Peas
42560802
850.2200
71­
2B
Avian
Acute
Dietary
Toxicity
Test,
Mallard
Peas
42560803
850.1075
72­
1C
Fish
Acute
Toxicity
Test
Rainbow
Trout
Peas
42532608
850.1075
72­
1A
Fish
Acute
Toxicity
Test,
Bluegill
Sunfish
Peas
42532601
850.1010
72­
2A
Invertebrate
Acute
Toxicity
Test,
Freshwater
Daphnids
Peas
42532602
850.1100
82­
1
Acute
Oral
Toxicity
Test,
Rat
Peas
144801,
116340
870.3100
82­
1A
Subchronic
Oral
Toxicity
Test,
(
90­
day
Feeding,
rodent)
Peas
42883602,
42883601
870.3150
82­
1B
Subchronic
Oral
Toxicity
Test,
(
90day
­
Feeding,
non­
rodent)
Peas
116345,
116344,
42883603
870.3700
83­
3A
Prenatal
Developmental
Toxicity
(
Teratogenicity),
RAP
Peas
40865402
870.3700
83­
3B
Prenatal
Developmental
Toxicity
(
Teratogenicity),
Rabbit
Peas
40865401
870.3800
83­
4A
(
MCPA)
2­
generation
Reprodution
and
Fertility
Peas
40041701
850.4150
122­
1B
Terrestrail
Plant,
Tier
1
(
Vegetative
Vigor)
Peas
42560804,
43083205
(
MCPA)

850.5400
122­
2A
Algal
Toxicity,
Tier
1
Peas
42532605,42532603,4
2532609,
42532606
850.5400
122­
2B
Algal
Toxicity,
Tier
2
Peas
42532605,
42532609,
42532603,
42532606
55
850.4225
123­
1A
Seedling
Germination
and
Seedling
Emergence,
Tier
2
Peas
42560804
850.4250
123­
1B
Vegetative
Vigor,
Tier
2
Peas
42560804
850.4400
123­
2
Aquatic
Plant
Toxicity
Test
Using
Duckweed
Lemma
Peas
42532604
850.3020
141­
1
Honey
Bee
Acute
Contact
Toxicity
Peas
42532607
Table
3.
Toxicology
New
Guideline
Number
Old
Guideline
Number
Requirement
Use
Citation(
s)

870.1100
81­
1
Acute
Oral
Toxicity­
Rat
Peas
116340,
144801
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit/
Rat
Peas
116342,
144799
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
Peas
41630001
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
Peas
116343,
144797
870.2500
81­
5
Primary
Skin
Irritation
­
Rabbit
Peas
144798
870.2600
81­
6
Dermal
Sensitization,
Guinea
Pig
Peas
144800
870.3100
82­
1A
Subchronic
Oral
Toxicity
Test
(
90
Day
Feeding
­
Rodent)
Peas
42883602
870.3150
81­
1B
Subchronic
Oral
Toxicity
Test
(
90
Day
Feeding
­
Non­
Rodent)
Peas
42883603
870.3200
82­
3
Repeated
Dose
Dermal
Toxicity
Test
(
21
Day),
Rabbit
Peas
116346
870.3700a
83­
3A
Prenatal
Developmental
Toxicity,
(
Teratogenicity),
Rat
Peas
40865402
870.3700b
83­
3B
Prenatal
Developmental
Toxicity,
(
Teratogenicity),
Rabbit
Peas
40865401
870.5100
84­
2
Bacterial
(
Escherichia
Coll
Wp2
and
Wp2
uvrA)
Reverse
Gene
Mutation
Assay
Test
Peas
40564302,
40564303
870.5375
84­
2B
In
Vitro
Mammalian
Cytogenetics
Tests
(
Structural
Chromosomal
Aberration
Test)
Peas
40564301
870.5550
84­
2
Unscheduled
DNA
synthesis
in
Mammalian
Cells
in
Culture
Peas
40564304
870.7485
85­
1
Metabolism
and
Pharmacokinetics
(
General
Metabolism)
Peas
44818101
56
Table
4.
Environmental
Fate
N
ew
Guideline
Number
Old
Guideline
Number
Requirement
Use
Citation(
s)

835.2120
161­
1
Hydrolysis
of
Parent
and
Degradates
as
a
Function
of
pH
at
25
°
C
(
Hydrolysis)
Peas
42574301
835.2240
161­
2
Direct
Photolysis
Rate
of
Parent
and
Degradates
in
Water
(
Photodegradation
in
water)
Peas
42574302
835.2410
161­
3
Photodegradation
of
Parent
and
Degradates
in
Soil
(
Photodegradation
in
soil)
Peas
43829901
835.4100
162­
1
Aerobic
Soil
Metabolism
Study
Peas
43247601
835.4200
162­
2
Anaerobic
Soil
Metabolism
Study
Peas
43015501
835.1230
163­
1
Sediment
(
Leaching)
and
Soil
Absorption/
desorption
for
Parent
and
Degradates
Peas
42693701,
43466401
57
Appendix
C:
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
2777
Crystal
Drive
(
One
Potomac
Yard)
Arlington,
VA
22202.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
AM
to
4:
30
PM.

The
docket
initially
contained
preliminary
human
health
and
ecological
effects
risk
assessments
and
related
documents
that
were
published
November
2,
2005.
The
public
comment
period
closed
sixty
days
later,
on
January
3,
2006.
The
EPA
then
considered
the
comments
received
and
revised
the
risk
assessments
where
appropriate.
Revised
ecological
risk
assessments,
as
well
as
additional
supporting
documents
will
be
published
in
the
docket
with
this
RED.
58
Appendix
D:
Citation
Considered
to
be
Part
of
the
Database
Supporting
the
Reregistration
Eligibility
Decision
(
Bibliography)

Open
Literature
Books
Howard,
P.
H.
and
W.
M.
Meylan.
1997
Handbook
of
Physical
Properties
of
Organic
Chemicals.
Lewis
Publishers,
New
York.
Page
121.

Podall,
H.
2002.
CBI
Product
Chemistry
Review,
March
8,
2002
Tomlin,
C.
D.
S.,
ed.
1997.
The
Pesticide
Manual
#
65
MCPB
Sodium
Salt,
British
Corp
Protection
Council,
11th
ed,
Farnham,
Surrey,
UK.
Page
254.

WSSA
(
Weed
Science
Society
of
America).
1994.
Herbicide
Mode
of
Action
and
Sugarbeet
Injury
Symptoms.
North
Dakota
State
University
of
Agriculture
and
Applied
Science
Fargo,
ND.

Ferrell,
J.
A.,
G.
E.
Mac
Donald,
B.
J.
Brecke,
A.
C.
Bennett,
and
J.
Tredaway
Ducar.
2005.
Florida's
Organo­
Auxin
Herbicide
Rule­
2005.
University
of
Florida,
Institute
of
Food
and
Agricultural
Sciences,
Gainesville,
FL.

Heimann,
M.
F.
and
R.
C.
Newman.
1997.
Plant
injury
due
to
turfgrass
broadleaf
weed
herbicides.
University
of
Wisconsin
­
Cooperative
Extension,
Madison,
WI.

Lingenfelter,
D.
D.
and
N.
L.
Hartwig.
2003.
Introduction
to
Weeds
and
Herbicides.
Penn
State
Colloge
of
Agricultural
Sciences
­
Agricultural
Research
and
Cooperative
Extension
Page
1­
20.

Bibliography
PC
Code:
019201
MRID
CITATION
116340
Holsing,
G.
(
1969)
Acute
Oral­­
Rats:
MCPB
Technical:
Project
No.
517­
102.
Final
rept.
(
Unpublished
study
received
on
un­
known
date
under
1F1051;
prepared
by
TRW,
Inc.,
submitted
by
Rhodia,
Inc.,
New
Brunswick,
NJ;
CDL:
091885­
B)

116342
Holsing,
G.
(
1969)
Acute
Dermal­­
Rabbits:
MCPB
Technical:
Project
No.
517­
103.
Final
rept.
(
Unpublished
study
received
on
un­
known
date
under
59
1F1051;
prepared
by
TRW,
Inc.,
submitted
by
Rhodia,
Inc.,
New
Brunswick,
NJ;
CDL:
091885­
D)

116343
Holsing,
G.
(
1969)
Draize
Eye­­
Rabbits:
MCPB
Technical:
Project
No.
517­
105.
Final
rept.
(
Unpublished
study
received
on
un­
known
date
under
1F1051;
prepared
by
TRW,
Inc.,
submitted
by
Rhodia,
Inc.,
New
Brunswick,
NJ;
CDL:
091885­
E)

116345
Holsing,
G.;
Ferrell,
J.
(
1970)
13­
week
Dietary
Administration­­
Dogs:
MCPB:
Project
No.
517­
107.
Final
rept.
(
Unpublished
study
received
on
unknown
date
under
1F1051;
prepared
by
TRW,
Inc.,
submitted
by
Rhodia,
Inc.,
New
Brunswick,
NJ;
CDL:
091885­
G)

116346
Weatherholtz,
W.;
Voelker,
R.
(
1970)
Three­
week
Repeated
Dermal­­
Rabbits:
MCPB:
Project
No.
517­
104.
Final
rept.
(
Unpublished
study
received
on
unknown
date
under
1F1051;
prepared
by
TRW,
Inc.,
submitted
by
Rhodia,
Inc.,
New
Brunswick,
NJ;
CDL:
091885­
H)

144797
Liggett,
M.;
Parcell,
B.
(
1985)
Irritant
Effects
on
the
Rabbit
Eye
of
MCPB
Technical
Acid:
841198D/
AHM
19/
SE.
Unpublished
study
prepared
by
Huntingdon
Research
Centre
plc.
7
p.

144798
Liggett,
M.;
Parcell,
B.
(
1984)
Irritant
Effects
on
Rabbit
Skin
of
MCPB
Technical
Acid:
841126D/
AHM
18/
SE.
Unpublished
study
pre­
pared
by
Huntingdon
Research
Centre
plc.
6
p.

144799
Kynoch,
S.
(
1985)
Acute
Dermal
Toxicity
to
Rats
of
MCPB
Technical
Acid:
85150D/
AHM
16/
AC.
Unpublished
study
prepared
by
Hunting­
don
Research
Centre
plc.
7
p.

144800
Seaber,
J.
(
1985)
Delayed
Contact
Hypersensitivity
in
the
Guinea­
Pig
with
MCPB
Technical
Acid:
85119D/
AHM
20/
SS.
Unpublished
study
prepared
by
Huntingdon
Research
Centre
plc.
14
p.

144801
Kynoch,
S.
(
1985)
Acute
Oral
Toxicity
to
Rats
of
MCPB
Technical
Acid:
85131D/
AHM
15/
AC.
Unpublished
study
prepared
by
Hunting­
don
Research
Centre
plc.
12
p.

40564301
SanSebastian,
J.
(
1987)
2­
Methyl­
4­
chlorophenoxybutyric
Acid
(
MCPB
Acid):
In
vitro
Chromosome
Aberration
Analysis
in
Chinese
Hamster
Ovary
(
CHO)
Cells:
Laboratory
Project
ID
PH
320­
RP­
001­
87.
Unpublished
study
prepared
by
Pharmakon
Research
Interna­
tional,
Inc.
34
p.
60
40564302
Stankowski,
L.
(
1987)
2­
Methyl­
4­
chlorophenoxybutyric
Acid
(
MCPB
Acid):
Ames/
Salmonella
Plate
Incorporation
Assay:
Laboratory
Project
ID
PH
301­
RP­
001­
87.
Unpublished
study
prepared
by
Pharmakon
Research
International,
Inc.
22
p.

40564303
Stankowski,
L.
(
1988)
@­
Methyl­
4­
chlorophenoxybutyric
acid
(
MCPB
Acid):
CHO/
HPRT
Mammalian
Cell
Forward
Gene
Mutation
Assay:
Laboratory
Project
ID
PH
317­
RP­
001­
87.
Unpublished
study
pre­
pared
by
Pharmakon
Research
International,
Inc.
67
p.

40564604
Barfknecht,
T.
(
1987)
@­
Methyl­
4­
chlorophenoxybutyric
Acid
(
MCPB
Acid):
Rat
Hepatocyte
Primary
Culture/
DNA
Repair
Test:
Laboratory
Project
ID
PH
311­
RP­
001­
87.
Unpublished
study
pre­
pared
by
Pharmakon
Research
International,
Inc.
68
p.

40865401
Tyl,
R.;
Neeper­
Bradley,
T.
(
1988)
Developmental
Toxicity
Evaluati­
on
of
MCPB
Administered
by
Gavage
to
New
Zealand
White
Rabbits:
Laboratory
Project
ID
51­
547.
Unpublished
study
prepared
by
Bu­
shy
Run
Research
Center.
241
p.

40865402
Tyl,
R.
(
1988)
Developmental
Toxicity
Evaluation
of
MCPB
Administe­
red
by
Gavage
to
CD
(
Sprague
Dawley)
Rats:
Laboratory
Project
ID
51­
532.
Unpublished
study
prepared
by
Bushy
Run
Research
Cente­
r.
299
p.

41630001
Jackson,
G.;
Hardy,
C.;
Lewis,
D.;
et
al.
(
1985)
MCPB
Technical
Acid
Acute
Inhalation
Toxicity
Study
in
Rats
4­
Hour
Exposure:
Lab
Project
Number:
AHM17/
85188.
Unpublished
study
prepared
by
Hungtindon
Research
Centre,
Ltd.
47
p.

42574301
Das,
Y.
(
1992)
Hydrolysis
of
(
carbon
14)
MCPB
in
Aqueous
Solutions
Buffered
at
pH
5,
7
and
9:
Lab
Project
Number:
92010:
92­
06.
Unpublished
study
prepared
by
Innovative
Scientific
Services,
Inc.
77
p.

42574302
Das,
Y.
(
1992)
Photodegradation
of
(
carbon
14)
MCPB
in
Aqueous
Solutions
Buffered
at
pH
5,
7
and
9
under
Artificial
Sunlight:
Lab
Project
Number:
92011:
92­
07.
Unpublished
study
prepared
by
Innovative
Scientific
Services,
Inc.
174
p.

42693701
Robson,
M.
(
1993)
Determination
of
Adsorption/
Desorption
Characteristics
of
4­(
2­
Methyl,
4­
Chlorophenoxy)
Butyric
Acid
(
MCPB)
in
Soil:
Final
Report:
Lab
Project
Number:
68/
127:
7414.
Unpublished
study
prepared
by
61
Hazleton
UK.
81
p.

42883601
Trutter,
J.
(
1993)
Range­
Finding
Dietary
Toxicity
Study
with
MCPB
in
Rats:
Final
Report:
Lab
Project
Number:
HWA
656­
173.
Unpublished
study
prepared
by
Hazleton
Washington,
Inc.
275
p.

42883602
Trutter,
J.
(
1993)
13­
Week
Dietary
Toxicity
Study
with
MCPB
in
Rats:
Final
Report:
Lab
Project
Number:
HWA
656­
174.
Unpublished
study
prepared
by
Hazleton
Washington,
Inc.
439
p.

42883603
Dalgard,
D.
(
1993)
13­
Week
Dietary
Toxicity
Study
with
MCPB
in
Dogs:
Final
Report:
Lab
Project
Number:
HWA
656­
172.
Unpublished
study
prepared
by
Hazleton
Washington,
Inc.
406
p.

43015501
Goodyear,
A.
(
1993)
Carbon
14­
MCPB:
Anaerobic
Soil
Metabolism:
Final
Report:
Lab
Project
Number:
68/
131­
1015:
68/
131:
200352.
Unpublished
study
prepared
by
Hazleton
UK.
90
p.

43247601
John,
A.;
Jones,
M.;
Lowden,
P.;
et
al.
(
1994)
MCPB:
Aerobic
Soil
Metabolism:
Lab
Project
Number:
P/
93/
194.
Unpublished
study
prepared
by
Rhone­
Poulenc
Agriculture
Ltd.
108
p.

43466401
John,
A.;
Jones,
M.;
Lowden,
P.
(
1994)
MCPB:
Fresh
and
Aged
Leaching
Study
in
Five
Soils:
Lab
Project
Number:
P
92/
333:
200724:
RPAL
P92/
333.
Unpublished
study
prepared
by
Rhone­
Poulenc
Agriculture
Ltd.
142
p.

43829901
Ferreira,
E.;
John,
A.;
Lowden,
P.;
et
al.
(
1995)
MCPB
Soil
Photolysis
Study:
Amended
Report:
Lab
Project
Number:
P92/
126
Unpublished
study
prepared
by
Rhone­
Poulenc
Agriculture
Ltd.
75
p.
(
Amended
version
of
42519101).

44754101
Corley,
J.;
Kunkel,
D.
(
1999)
MCPB:
Magnitude
of
Residue
on
Pea
(
Reregistration):
Lab
Project
Number:
05470.94­
CAR23:
05470.94­
CA52:
05470.94­
NY17.
Unpublished
study
prepared
by
University
of
California.
423
p.

44818101
Thornley,
K.
(
1998)
(
Carbon­
14)­
MCPB:
A
Study
of
Adsorption,
Distribution,
Metabolism,
and
Excretion
Following
Oral
Administration
to
the
Rat:
Final
Report:
Lab
Project
Number:
785/
10­
D1141.
Unpublished
study
prepared
by
Covance.
195
p.
62
PC
Code:
019202
MRID
CITATION
42532601
Bettencourt,
M.
(
1992)
MCPB
Sodium­­
Acute
Toxicity
to
Bluegill
Sunfish
(
Lepomis
macrochirus)
under
Flow­
through
Conditions:
Final
Report:
Lab
Project
Number:
92­
8­
4363:
10566.0392.6226.105.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
64
p.

42532602
Putt,
A.
(
1992)
MCPB
Sodium­­
Acute
Toxicity
to
Daphnids
(
Daphnia
magna)
under
Flow­
through
Conditions:
Final
Report:
Lab
Project
Number:
92­
7­
4351:
10566.
0392.
6228.
115.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
2
p.

42532603
Hoberg,
J.
(
1992)
MCPB
Sodium­­
Toxicity
to
the
Freshwater
Blue­
green
Alga,
Anabaena
flos­
aquae:
Final
Report:
Lab
Project
Number:
92­
8­
4381:
10566.0392.6230.420.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
54
p.

42532604
Hoberg,
J.
(
1992)
MCPB
Sodium­­
Toxicity
to
the
Duckweed
Lemna
gibba:
Final
Report:
Lab
Project
Number:
92­
8­
5368:
10566.
0392.6229.410.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
61
p.

42532605
Hoberg,
J.
(
1992)
MCPB
Sodium­­
Toxicity
to
the
Freshwater
Green
Alga,
Selenastrum
capricornutum:
Final
Report:
Lab
Project
Number:
92­
8­
4361:
10566.0392.6232.430.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
58
p.

42532606
Hoberg,
J.
(
1992)
MCPB
Sodium­­
Toxicity
to
the
Marine
Diatom,
Skeletonema
costatum:
Final
Report:
Lab
Project
Number:
92­
8­
4372:
10566.0392.6233.450.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
59
p.

42532607
Maggi,
V.
(
1992)
Acute
Contact
Toxicity
of
MCPB
Sodium
Salt
to
Honey
Bees
(
Apis
melliflora
L.):
Lab
Project
Number:
CAR
169­
92.
Unpublished
study
prepared
by
California
Agricultural
Research,
Inc.
22
p.

42532608
Bettancourt,
M.
(
1992)
MCPB
Sodium­­
Acute
Toxicity
to
Rainbow
Trout
(
Oncorrhynchus
mykiss)
under
Flow­
through
Conditions:
Final
Report:
63
Lab
Project
Number:
92­
7­
4338:
10566.0392.6227.
108.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
64
p.

42532609
Hoberg,
J.
(
1992)
MCPB
Sodium­­
Toxicity
to
the
Freshwater
Diatom,
Navicula
pelliculosa:
Final
Report:
Lab
Project
Number:
92­
10­
4448:
10566.0392.6231.440.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
60
p.

42560801
Pedersen,
C.;
Helsten,
B.
(
1992)
MCPB
Sodium:
14­
day
Acute
Oral
LD50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
108­
016­
03.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
59
p.

42560802
Pedersen,
C.;
Helsten,
B.
(
1992)
MCPB
Sodium:
8­
day
Acute
Dietary
LC50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
108­
014­
01.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
103
p.

42560803
Pedersen,
C.;
Helsten,
B.
(
1992)
MCPB
Sodium:
8­
day
Acute
Dietary
LC50
Study
in
Mallard
Ducklings:
Lab
Project
Number:
108­
015­
02.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
103
p.

42560804
Christensen,
K.
(
1992)
MCPB
Sodium:
Determination
of
Effects
on
Seed
Germination,
Seedling
Emergence
and
Vegetative
Vigor
of
Ten
Plant
Species:
Final
Report:
Lab
Project
Number:
92­
8­
4377.
Unpublished
study
prepared
by
Springborn
Labs,
Inc.
208
p.

44754101
Corley,
J.;
Kunkel,
D.
(
1999)
MCPB:
Magnitude
of
Residue
on
Pea
(
Reregistration):
Lab
Project
Number:
05470.94­
CAR23:
05470.94­
CA52:
05470.94­
NY17.
Unpublished
study
prepared
by
University
of
California.
423
p.

PC
Code:
030501
MRID
CITATION
40041701
MacKenzie,
K.
(
1986)
Two­
Generation
Reproduction
Study
with
MCPA
in
Rats:
Final
Report:
Study
No.
6148­
100.
Unpublished
study
pre­
pared
by
Hazleton
Laboratories
America,
Inc.
1304
p.

43083205
Hoberg,
J.
(
1993)
MCPA
Acid­­
Determination
of
Effects
on
Seed
Germination,
Seedling
Emergence
and
Vegetative
Vigor
of
Ten
Plant
64
Species:
Final
Report:
Lab
Project
Number:
10566.0493.
6280.610:
93­
8­
4888.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
246
p.

106595
Reuzel,
P.;
Hendriksen,
C.;
Feron,
V.;
et
al.
(
1980)
Subchronic
(
13­
week)
Oral
Toxicity
Study
of
MCPA
in
Beagle
Dogs:
Report
No.
R
6478.
Final
rept.
(
Unpublished
study
received
Jul
6,
1982
under
unknown
admin.
no.;
prepared
by
Centraal
Instituut
Voor
Voedingsonderzoek,
TNO,
Neth.,
submitted
by
Diamond
Shamrock
Agricultural
Chemicals,
Cleveland,
OH;
CDL:
247854­
A;
247855;
247856)

165471
Kirsch,
P.
(
1985)
Report
on
the
Study
of
the
Toxicity
of
MCPA
in
Rats
after
3
Months
Administration
in
the
Diet:
[
Range­
finding
Study
for
2­
year
Oncogenicity
Study
in
Rats]:
Project
No.
31S0046/
8302.
Unpublished
study
prepared
by
BASF
Ag.
381
p.

42723801
Hellwig,
J.;
Hildebrand,
B.
(
1993)
Study
of
the
Prenatal
Toxicity
of
MCPAAcid
in
Rats
after
Oral
Administration
(
Gavage):
Lab
Project
Number:
30R0374/
91096.
Unpublished
study
prepared
by
BASF
Aktiengesellshaft.
302
p.

42723802
Hellwig,
J.;
Hildebrand,
B.
(
1993)
Study
of
the
Prenatal
Toxicity
of
MCPAAcid
in
Rabbits
after
Oral
Administration
(
Gavage):
Lab
Project
No.
40R0374/
91095.
Unpublished
study
prepared
by
BASF
Aktiengesellshaft.
230
p.

43562601
Mellert,
W.;
Deckardt,
K.;
Kaufmann,
W.;
et
al.
(
1994)
MCPA­
Acid­­
Subchronic
Oral
Dietary
Toxicity
and
Neurotoxicity
Study
in
Wistar
Rats:
Lab
Project
Number:
50C0374/
91133.
Unpublished
study
prepared
by
BASF
Aktiengesellschaft.
723
p.
65
Appendix
E:
Generic
Data
Call­
In
The
Generic
Data
Call­
In
will
be
posted
at
a
later
date.
See
Chapter
V
of
the
MCPB
RED
for
a
list
of
studies
required.
66
Appendix
F:
Product
Specific
Data
Call­
In
The
product
specific
Data
Call­
In
will
be
posted
at
a
later
date.
67
Appendix
G:
EPA's
Batching
of
MCPB
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
EPA'S
BATCHING
OF
MCPB
PRODUCTS
FOR
MEETING
ACUTE
TOXICITY
DATA
REQUIREMENTS
FOR
REREGISTRATION
In
an
effort
to
reduce
the
time,
resources
and
number
of
animals
needed
to
fulfill
the
acute
toxicity
data
requirements
for
reregistration
of
products
containing
MCPB
as
the
active
ingredient,
the
Agency
has
batched
products
which
can
be
considered
similar
for
purposes
of
acute
toxicity.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
identity,
percent
composition
and
biological
activity),
type
of
formulation
(
e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular,
etc.),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling,
etc.).
Note
that
the
Agency
is
not
describing
batched
products
as
"
substantially
similar"
since
some
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Notwithstanding
the
batching
process,
the
Agency
reserves
the
right
to
require,
at
any
time,
acute
toxicity
data
for
an
individual
product
should
the
need
arise.

Registrants
of
products
within
a
batch
may
choose
to
cooperatively
generate,
submit
or
cite
a
single
battery
of
six
acute
toxicological
studies
to
represent
all
the
products
within
that
batch.
It
is
the
registrants'
option
to
participate
in
the
process
with
all
other
registrants,
only
some
of
the
other
registrants,
or
only
their
own
products
within
a
batch,
or
to
generate
all
the
required
acute
toxicological
studies
for
each
of
their
own
products.
If
a
registrant
chooses
to
generate
the
data
for
a
batch,
he/
she
must
use
one
of
the
products
within
the
batch
as
the
test
material.
If
a
registrant
chooses
to
rely
upon
previously
submitted
acute
toxicity
data,
he/
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards
(
see
acceptance
criteria
attached),
the
formulation
tested
is
considered
by
EPA
to
be
similar
for
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material
by
EPA
Registration
Number.
If
more
than
one
confidential
statement
of
formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
which
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"
Data
Call­
In
68
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"
Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
A
registrant
who
wishes
to
participate
in
a
batch
must
decide
whether
he/
she
will
provide
the
data
or
depend
on
someone
else
to
do
so.
If
a
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
select
one
of
the
following
options:
Developing
Data
(
Option
1),
Submitting
an
Existing
Study
(
Option
4),
Upgrading
an
Existing
Study
(
Option
5)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
Cost
Sharing
(
Option
2),
Offers
to
Cost
Share
(
Option
3)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
does
not
want
to
participate
in
a
batch,
the
choices
are
Options
1,
4,
5
or
6.
However,
a
registrant
should
know
that
choosing
not
to
participate
in
a
batch
does
not
preclude
other
registrants
in
the
batch
from
citing
his/
her
studies
and
offering
to
cost
share
(
Option
3)
those
studies.

Five
products
were
found
which
contain
MCPB
as
the
active
ingredient.
These
products
have
been
placed
in
one
batch
and
a
no
batch
group
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation..

Batching
Instructions:

No
Batch:
Each
product
in
this
Batch
should
have
its
own
data
generated.

NOTE:
The
technical
acute
toxicity
values
included
in
this
document
are
for
informational
purposes
only.
The
data
supporting
these
values
may
or
may
not
meet
the
current
acceptance
criteria.

Batch
1
EPA
Reg.
No.
%
Active
Ingredient
15440­
28
95.5
71368­
8
97
No
Batch
EPA
Reg.
No.
%
Active
Ingredient
15440­
38
23.5
71368­
5
23.5
69
No
Batch
EPA
Reg.
No.
%
Active
Ingredient
71368­
7
43.85
70
Appendix
H:
List
of
Registrants
Sent
This
Data
Call­
In
A
list
of
registrants
sent
this
Data
Call­
In
will
be
posted
at
a
later
date
A
H
MARKS
&
CO
LTD
Richard
J.
Otten
Official
Address:
PMB
239,
7474
Creedmoor
Road
Raleigh,
North
Carolina
27613
United
States
Agent
Phone:
(
919)
846­
7860
NUFARM,
INC.
Theodore
D.
Head
Official
Address
150
Harvester
Drive
Suite
200
Burr
Ridge,
Illinois
60527
United
States
Agent
Phone:
(
630)
455­
2000
71
Appendix
I:
List
of
Available
Related
Documents
and
Electronically
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:

http://
www.
epa.
gov/
opprd001/
forms/

Pesticide
Registration
Forms
(
These
forms
are
in
PDF
format
and
require
the
Acrobat
reader)

Instructions
1.
Print
out
and
complete
the
forms.
(
Note:
Form
numbers
that
are
bolded
can
be
filled
out
on
your
computer
then
printed.)

2.
The
completed
form(
s)
should
be
submitted
in
hardcopy
in
accord
with
the
existing
policy.

3.
Mail
the
forms,
along
with
any
additional
documents
necessary
to
comply
with
EPA
regulations
covering
your
request,
to
the
address
below
for
the
Document
Processing
Desk.

DO
NOT
fax
or
e­
mail
any
form
containing
'
Confidential
Business
Information'
or
'
Sensitive
Information.'

If
you
have
any
problems
accessing
these
forms,
please
contact
Nicole
Williams
at
(
703)
308­
5551
or
by
e­
mail
at
williams.
nicole@
epa.
gov.

The
following
Agency
Pesticide
Registration
Forms
are
currently
available
via
the
internet:
at
the
following
locations:

8570­
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
1.
pdf
8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
4.
pdf
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
5.
pdf
8570­
1
7
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
17.
pdf
8570­
2
Application
for/
Notification
of
http://
www.
epa.
gov/
opprd001/
forms/
857
72
5
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
0­
25.
pdf
8570­
2
7
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
27.
pdf
8570­
2
8
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
28.
pdf
8570­
3
0
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
30.
pdf
8570­
3
2
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
857
0­
32.
pdf
8570­
3
4
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notice
s/
pr98­
5.
pdf
8570­
3
5
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notice
s/
pr98­
5.
pdf
8570­
3
6
Summary
of
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notice
s/
pr98­
1.
pdf
8570­
3
7
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notice
s/
pr98­
1.
pdf
Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/

Dear
Registrant:

For
your
convenience,
we
have
assembled
an
online
registration
kit
which
contains
the
following
pertinent
forms
and
information
needed
to
register
a
pesticide
product
with
the
U.
S.
Environmental
Protection
Agency's
Office
of
Pesticide
Programs
(
OPP):

1.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
as
Amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

2.
Pesticide
Registration
(
PR)
Notices
a.
83­
3
Label
Improvement
Program­­
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
73
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(
Chemigation)
e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
the
Acrobat
reader.)

Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices
3.
Pesticide
Product
Registration
Application
Forms
(
These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
EPA
Form
No.
8570­
1,
Application
for
Pesticide
Registration/
Amendment
b.
EPA
Form
No.
8570­
4,
Confidential
Statement
of
Formula
c.
EPA
Form
No.
8570­
27,
Formulator's
Exemption
Statement
d.
EPA
Form
No.
8570­
34,
Certification
with
Respect
to
Citations
of
Data
e.
EPA
Form
No.
8570­
35,
Data
Matrix
4.
General
Pesticide
Information
(
Some
of
these
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
Registration
Division
Personnel
Contact
List
b.
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
Contacts
c.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(
PDF
format)
e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(
PDF
format)
f.
40
CFR
Part
158,
Data
Requirements
for
Registration
(
PDF
format)
g.
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(
November
27,
1985)

Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:

1.
The
Office
of
Pesticide
Programs'
website.

2.
The
booklet
"
General
Information
on
Applying
for
Registration
of
Pesticides
in
the
United
States",
PB92­
221811,
available
through
the
National
Technical
Information
Service
(
NTIS)
at
the
following
address:

National
Technical
Information
Service
(
NTIS)
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(
703)
605­
6000.
74
3.
The
National
Pesticide
Information
Retrieval
System
(
NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(
765)
494­
6614
or
through
their
website.

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
website:
ace.
orst.
edu/
info/
nptn.

The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self­
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

·
Date
of
receipt;
·
EPA
identifying
number;
and
·
Product
Manager
assignment.

Other
identifying
information
may
be
included
by
the
applicant
to
link
the
acknowledgment
of
receipt
to
the
specific
application
submitted.
EPA
will
stamp
the
date
of
receipt
and
provide
the
EPA
identifying
file
symbol
or
petition
number
for
the
new
submission.
The
identifying
number
should
be
used
whenever
you
contact
the
Agency
concerning
an
application
for
registration,
experimental
use
permit,
or
tolerance
petition.

To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(
including
"
blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
chemical
abstract
system
(
CAS)
number
if
one
has
been
assigned.
75
Documents
Associated
with
this
RED
The
following
documents
are
part
of
the
Administrative
Record
for
this
RED
document
and
may
be
included
in
the
EPA's
Office
of
Pesticide
Programs
Public
Docket.
Copies
of
these
documents
are
not
available
electronically,
but
may
be
obtained
by
contacting
the
person
listed
on
the
respective
Chemical
Status
Sheet.

1.
Health
Effects
Division
and
Environmental
Fate
and
Effects
Division
Science
Chapters,
which
include
the
complete
risk
assessments
and
supporting
documents.
2.
Detailed
Label
Usage
Information
System
(
LUIS)
Report.