Document ID: EPA-HQ-OPP-2003-0237-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-10T05:00Z

Page
1
of
120
Interim
Reregistration
Eligibility
Decision
for
Methyl
Parathion
Case
No.
0153
Page
2
of
120
Executive
Summary
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1
I.
Introduction
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4
II.
Chemical
Overview
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6
A.
Regulatory
History
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6
B.
Chemical
Identification
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6
C.
Use
Profile
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7
D.
Estimated
Usage
of
Pesticide
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9
E.
Uses
Deleted
by
the
1999
MOA
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10
III.
Summary
of
Methyl
Parathion
Risk
Assessment
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10
A.
Human
Health
Risk
Assessment
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11
1.
Dietary
Risk
from
Food
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11
a.
Toxicity
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11
b.
FQPA
Safety
Factor
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12
c.
Population
Adjusted
Dose
(
PAD)
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13
d.
Endpoints
and
Doses
for
Dietary
Risk
Assessment
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14
e.
Exposure
Assumptions
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14
f.
Acute
Dietary
Risk
from
Food
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15
2.
Chronic
Dietary
Risk
from
Food
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16
3.
Dietary
Risk
from
Drinking
Water
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16
a.
Surface
Water
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17
b.
Ground
Water
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18
c.
Drinking
Water
Levels
of
Comparison
(
DWLOCs)
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18
d.
Drinking
Water
Considerations
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21
4.
Aggregate
Risk
Assessment
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21
5.
Occupational
and
Residential
Risk
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22
a.
Current
Label
PPE
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22
b.
Toxicity
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22
c.
Exposure
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24
i.
Chemical
Specific
Data
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25
ii.
Surrogate
Data
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26
iii.
Data
Comparison
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26
d.
Summary
of
Risk
Concerns
for
Handlers
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27
6.
Post­
Application
Occupational
Risk
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32
a.
Chemical
Specific
Data
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32
b.
Exposure
and
Risk
Calculations
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33
c.
Occupational
Postapplication
Worker
Summary
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33
Page
3
of
120
7.
Human
Incident
Summary
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36
B.
Environmental
Risk
Assessment
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36
1.
Environmental
Fate
and
Transport
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37
2.
Toxicity
(
Hazard)
Assessment
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37
a.
Avian/
Mammalian
Toxicity
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37
b.
Toxicity
to
Aquatic
Animals
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39
c.
Toxicity
to
Plants
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41
3.
Exposure
and
Risk
Calculations
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41
a.
Levels
of
Concern
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41
b.
Exposure
and
Risk
to
Nontarget
Terrestrial
Animals
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42
c.
Exposure
and
Risk
to
Nontarget
Aquatic
Animals
.
.
.
44
i.
Surface
water
resource
assessment
.
.
44
ii.
Risk
Quotients
for
Aquatic
Animals
.
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45
d.
Exposure
and
Risk
to
Nontarget
Plants
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46
4.
Ecological
Incidents
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46
5.
Endangered
Species
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47
6.
Risk
Characterization
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47
a.
Terrestrial
Organisms
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47
i.
Avian
Risk
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47
ii.
Risks
to
Mammals
.
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49
iii.
Risk
to
Insects
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49
b.
Aquatic
Organisms
.
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50
i.
Risk
to
Fish
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50
ii.
Risk
to
Aquatic
Invertebrates
.
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50
IV.
Interim
Risk
Management
and
Reregistration
Decision
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51
A.
Determination
of
Interim
Reregistration
Eligibility
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51
B.
Summary
of
Phase
5
Comments
and
Responses
.
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52
C.
Regulatory
Position
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52
1.
FQPA
Assessment
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52
a.
"
Risk
Cup"
Determination
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52
b.
Interim
Tolerance
Reassessment
Summary
.
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53
2.
Endocrine
Disruptor
Effects
.
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54
3.
Labels
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54
4.
Mitigation
for
Agricultural
Uses
.
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55
D.
Benefits
Assessment
Summary
.
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56
E.
Regulatory
Rationale
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57
1.
Human
Health
Risk
Mitigation
.
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57
a.
Dietary
Mitigation
.
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57
i.
Dietary
(
Food)
.
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57
Page
4
of
120
ii.
Drinking
Water
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.
57
b.
Occupational
Risk
Mitigation
.
.
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.
.
58
i.
Handler
Risk
.
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.
58
ii.
Post­
Application
Risk
.
.
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.
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.
.
.
58
2.
Environmental
Risk
Mitigation
.
.
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.
59
F.
Other
Labeling
.
.
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.
59
1.
Endangered
Species
Statement
.
.
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.
59
2.
Spray
Drift
Management
.
.
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.
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.
60
V.
What
Registrants
Need
to
Do
.
.
.
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.
60
A.
Manufacturing
Use
Products
.
.
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.
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.
.
.
61
1.
Additional
Generic
Data
Requirements
.
.
.
.
.
.
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.
62
2.
Labeling
for
Manufacturing
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
62
B.
End­
Use
Products
.
.
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.
63
1.
Additional
Product­
Specific
Data
Requirements
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
63
2.
Labeling
for
End­
Use
Products
.
.
.
.
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.
63
C.
Existing
Stocks
.
.
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.
63
D.
Labeling
Changes
Summary
Table
.
.
.
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.
64
VI.
Related
Documents
and
How
to
Access
Them
.
.
.
.
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.

Appendix
A
Appendix
B
Appendix
C
Appendix
D
Appendix
E
Appendix
F
Appendix
G
Appendix
H
Appendix
I
Page
5
of
120
METHYL
PARATHION
TEAM
Office
of
Pesticide
Programs:

Health
Effects
Risk
Assessment
Jonathan
Becker
Bonnie
Cropp­
Kohlligian
Ken
Dockter
Diana
Locke
Sherie
Kinard
(
nee
Mason)
Kathleen
Raffaele
Renee
Sandvig
Jeffrey
Dawson
Environmental
Fate
Risk
Assessment
Kevin
Costello
James
Hetrick
Amer
Al­
Mudallal
Edward
Odenkirchen
Use
and
Usage
Analysis
David
Brassard
Timothy
Kiely
Donald
Atwood
Colwell
Cook
Nicole
Mosz
Nikhil
Mallampalli
Jihad
Alsadek
Bill
Gross
Registration
Support
Marilyn
Mautz
Risk
Management
Dennis
Deziel
Page
6
of
120
Jane
Mitchell
Laura
Parsons
GLOSSARY
OF
TERMS
AND
ABBREVIATIONS
AE
Acid
Equivalent
a.
i.
Active
Ingredient
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
ARC
Anticipated
Residue
Contribution
BCF
Bioconcentration
Factor
CAS
Chemical
Abstracts
Service
CI
Cation
CNS
Central
Nervous
System
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CFR
Code
of
Federal
Regulations
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DRES
Dietary
Risk
Evaluation
System
DWEL
Drinking
Water
Equivalent
Level
(
DWEL)
The
DWEL
represents
a
medium
specific
(
i.
e.,
drinking
water)
lifetime
exposure
at
which
adverse,
noncarcinogenic
health
effects
are
not
anticipated
to
occur.
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EEC
Estimated
Environmental
Concentration.
The
estimated
pesticide
concentration
in
an
environment,
such
as
a
terrestrial
ecosystem.
EP
End­
Use
Product
EPA
U.
S.
Environmental
Protection
Agency
FAO
Food
and
Agriculture
Organization
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
Page
7
of
120
GLC
Gas
Liquid
Chromatography
GLN
Guideline
Number
GM
Geometric
Mean
GRAS
Generally
Recognized
as
Safe
as
Designated
by
FDA
HA
Health
Advisory
(
HA).
The
HA
values
are
used
as
informal
guidance
to
municipalities
and
other
organizations
when
emergency
spills
or
contamination
situations
occur.
HAFT
Highest
Average
Field
Trial
HDT
Highest
Dose
Tested
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.
LEL
Lowest
Effect
Level
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
MCLG
Maximum
Contaminant
Level
Goal
(
MCLG)
The
MCLG
is
used
by
the
Agency
to
regulate
contaminants
in
drinking
water
under
the
Safe
Drinking
Water
Act.
ME
Microencapsulated
Formulation
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
MPI
Maximum
Permissible
Intake
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
NA
Not
Applicable
N/
A
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NOEC
No
Observable
Effect
Concentration
NOEL
No
Observed
Effect
Level
NOAEL
No
Observed
Adverse
Effect
Level
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
OP
Organophosphate
Page
8
of
120
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
Pa
pascal,
the
pressure
exerted
by
a
force
of
one
newton
acting
on
an
area
of
one
square
meter.
PAD
Population
Adjusted
Dose
PADI
Provisional
Acceptable
Daily
Intake
PAG
Pesticide
Assessment
Guideline
PAM
Pesticide
Analytical
Method
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRN
Pesticide
Registration
Notice
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
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
RS
Registration
Standard
RUP
Restricted
Use
Pesticide
SAP
Science
Advisory
Panel
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TC
Toxic
Concentration.
The
concentration
at
which
a
substance
produces
a
toxic
effect.
TD
Toxic
Dose.
The
dose
at
which
a
substance
produces
a
toxic
effect.
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TLC
Thin
Layer
Chromatography
TMRC
Theoretical
Maximum
Residue
Contribution
torr
A
unit
of
pressure
needed
to
support
a
column
of
mercury
1
mm
high
under
standard
conditions.
Page
9
of
120
TRR
Total
Radioactive
Residue
UF
Uncertainty
Factor
µ
g/
g
Micrograms
Per
Gram
µ
g/
L
Micrograms
Per
Liter
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UV
Ultraviolet
WHO
World
Health
Organization
WP
Wettable
Powder
WPS
Worker
Protection
Standard
Page
1
of
120
Executive
Summary
EPA
has
completed
its
review
of
public
comments
on
the
revised
risk
assessments
and
is
issuing
its
risk
management
decisions
for
methyl
parathion.
The
decisions
outlined
in
this
document
do
not
include
the
final
tolerance
reassessment
decision
for
methyl
parathion;
however,
thirty
tolerances
have
been
revoked
by
Federal
Register
notice,
published
January
5,
2001.
The
final
tolerance
reassessment
decision
for
this
chemical
will
be
issued
once
the
cumulative
assessment
for
all
of
the
organophosphates
is
complete.
The
Agency
may
need
to
pursue
further
risk
management
measures
for
methyl
parathion
once
the
cumulative
assessment
is
finalized.

The
revised
risk
assessments
are
based
on
review
of
the
required
target
data
base
supporting
the
use
patterns
of
pre­
mitigation
registered
products
and
new
information
received.
The
Agency
invited
stakeholders
to
provide
proposals,
ideas
or
suggestions
on
appropriate
mitigation
measures
before
the
Agency
issued
its
risk
mitigation
decision
on
methyl
parathion.
After
considering
the
revised
risks,
as
well
as
mitigation
proposed
by
Cheminova,
Cerexagri,
and
Griffin,
the
technical
registrants
of
methyl
parathion,
EPA
developed
its
risk
management
decision
for
uses
of
methyl
parathion
that
pose
risks
of
concern.
Comments
on
the
risk
assessment
were
received
from
several
other
groups
such
as
the
Consumers
Union,
Environmental
Working
Group,
World
Wildlife
Fund,
Natural
Resources
Defense
Council,
several
grower
organizations,
and
agricultural
extension
agents,
but
these
groups
did
not
propose
any
additional
mitigation
measures.
The
risk
management
decision
is
discussed
fully
in
this
document.

Methyl
parathion
is
an
organophosphate
insecticide
which
was
registered
in
1954
as
an
insecticide/
acaricide.
Methyl
parathion
is
used
to
control
a
wide
variety
of
insect
pests.
Use
data
from
1987
to
1997
indicate
an
average
domestic
use
of
approximately
4
million
lbs
a.
i.
per
year.

Overall
Risk
Summary
EPA's
risk
assessments
for
methyl
parathion,
which
are
available
in
the
public
docket
and
on
the
Agency's
web
site
(
http://
www.
epa.
gov/
pesticides/
op),
were
based
on
a
review
of
the
required
target
database
supporting
the
registered
uses
of
methyl
parathion
products
before
the
Memorandum
of
Agreement
(
MOA)
signed
by
EPA
and
the
registrants
in
August
1999.
The
risk
of
concern
identified
in
the
human
health
risk
assessments
was
the
potential
of
methyl
parathion
to
cause
cholinesterase
inhibition
and
peripheral
neuropathology.
The
revised
human
health
risk
assessment
showed
that,
considering
the
food/
feed
uses
registered
at
that
time,
methyl
parathion
did
not
meet
the
FQPA
safety
standard
for
dietary
food
risk
for
any
population.
Limited
targeted
water
monitoring
indicated
that
there
also
may
be
a
drinking
water
dietary
concern.
Since
the
dietary
food
levels
alone
exceeded
the
Agency's
level
of
concern,
the
aggregated
dietary
food
and
drinking
water
risk
assessment
also
showed
unacceptable
risk.
The
occupational
risk
assessment
also
indicated
that
handlers
of
methyl
parathion
are
exposed
at
levels
which
pose
risk
concerns.
In
terms
of
ecological
risk,
methyl
parathion
exceeds
the
Agency's
levels
of
concern
for
all
aquatic
and
terrestrial
species
considered.
The
following
Page
2
of
120
paragraphs
discuss
these
dietary,
occupational
and
ecological
risks
as
well
as
some
of
the
mitigation
measures
which
were
implemented
with
the
MOA
or
are
proposed
by
this
document.

The
primary
mitigation
implemented
by
the
MOA
was
the
cancellation
of
several
fruit
and
vegetables
uses.
These
cancellations
account
for
approximately
10%
of
all
methyl
parathion
use,
but
significantly
reduced
dietary
risk
to
all
populations.
Additionally,
the
use
cancellations
are
also
believed
to
lessen
occupational
risk
since
fruits
and
vegetables
are
often
hand
labor
intensive.
Ecological
risk
is
also
lessened
since
bees
and
beneficial
insects
forage
on
many
fruit
and
vegetable
crops.
To
reduce
the
uncertainty
in
the
occupational
risk
assessment,
the
registrants
conducted
several
biomonitoring
studies.
Additional
mitigation
measures
to
be
implemented
by
the
MOA
and
this
interim
RED
are
lower
application
rates
and
fewer
applications
for
some
crops.

Dietary
Risk
The
refined
pre­
MOA
dietary
risk
assessment
which
is
provided
on
the
Agency's
website
indicated
that
the
acute
dietary
risk
to
children
one
to
six
years
of
age
exceeded
the
acute
population
adjusted
dose
(
or
amount
that
can
be
consumed
safely
in
one
day
or
less)
by
881%.
To
mitigate
the
high
dietary
risk
to
children,
EPA
accepted
voluntary
cancellation
of
those
crops
that
contributed
most
to
children's
diet.
These
canceled
uses
represented
90%
of
the
acute
dietary
risk
to
children.
Removing
these
crop
uses
brought
the
estimated
dietary
risk
for
children
1
to
6
years
in
age
down
to
75%
of
the
acute
population
adjusted
dose
(
PAD)
for
methyl
parathion.
The
voluntary
cancellation
was
accomplished
through
the
MOA
between
all
methyl
parathion
registrants
and
EPA,
signed
August
2,
1999.
These
use
changes,
along
with
certain
mitigation
measures
to
protect
workers,
such
as
longer
re­
entry
intervals,
have
been
implemented
through
the
registration
of
"
replacement"
methyl
parathion
products.

Based
on
the
post­
MOA
use
pattern
for
methyl
parathion,
the
Agency's
human
health
risk
assessment
for
the
most
sensitive
populations
of
infants
and
children
indicates
that
dietary
risks
do
not
exceed
75%
of
the
acute
PAD
while
chronic
risks
do
not
exceed
8%
of
the
chronic
PAD.
Limited
targeted
surface
water
monitoring
indicates
that
the
Drinking
Water
Level
of
Comparison
is
exceeded
for
children
1­
6
years
of
age
and
that
this
population
may
be
at
risk
from
acute
exposures
to
methyl
parathion
in
drinking
water.
This
monitoring
data
were
mostly
associated
with
areas
of
cotton
production;
therefore,
the
total
allowable
application
rate
to
cotton
as
well
as
some
other
crops
will
be
reduced.

Since
methyl
parathion
has
no
residential
uses,
the
Agency's
aggregate
risk
assessment
consists
of
dietary
and
drinking
water
risks.
Aggregate
risks
less
than
100%
of
the
PAD
do
not
exceed
the
Page
3
of
120
Agency's
level
of
concern.
The
aggregate
risk
estimates
presented
indicate
no
unreasonable
risks
to
the
general
population
or
to
infants.
However,
though
acute
exposure
to
methyl
parathion
from
food
sources
alone
does
not
exceed
the
Agency's
level
of
concern
(<
100%
acute
PAD),
limited
surface
water
monitoring
data
indicate
potential
exposures
at
unacceptable
levels
for
children
one
to
six
years
of
age.

For
the
emulsifiable
concentrate
formulation,
magnitude
of
residues/
field
crop
data
for
wheat
forage,
and
wheat
hay
and
sunflower
seed
processing
data
are
necessary.
Magnitude
of
residues/
field
crop
data
are
needed
for
rice
straw
for
the
microencapsulate
formulation.
Magnitude
of
residues
for
meat/
milk/
poultry/
eggs
data
are
required
for
both
formulations.

A
Developmental
Neurotoxicity
(
DNT)
Test
which
is
needed
to
thoroughly
evaluate
neurotoxicity
has
been
submitted
and
is
currently
in
review.
The
DNT
study
has
been
screened
and
is
considered
unlikely
to
change
the
dietary
endpoint.
The
screened
study
was
considered
in
the
safety
factor
decision
for
the
organophosphate
cumulative
assessment.

Residential
Risk
Methyl
parathion
is
a
restricted
use
pesticide
that
is
only
applied
by
certified
applicators
and
there
are
no
residential
uses.

Occupational
Risk
This
document
identifies
risk
mitigation
measures
necessary
to
provide
an
additional
margin
of
protection
for
handlers
for
aerial
applications
of
the
microencapsulated
formulation,
closed
systems
for
applicators,
and
extended
re­
entry
intervals
for
some
uses.
The
use
of
human
flaggers
is
also
prohibited.

With
the
MOA,
methyl
parathion
registrants
agreed
to
generate
chemical­
specific
exposure
studies
to
resolve
outstanding
potential
worker
exposure
issues.
The
following
worker
exposure
studies
were
conducted:
dislodgeable
foliar
residues
on
cotton,
sweet
corn,
and
walnuts;
monitoring
during
aerial
mixing/
loading,
groundboom
applications,
airblast
applications
to
walnuts,
walnut
harvesting,
cotton
scouting,
and
sweet
corn
harvesting.
Additionally,
the
registrant
has
conducted
a
28­
day
dermal
toxicity
study.

Ecological
Risk
In
addition
to
the
human
health
effects,
the
Agency
also
assessed
ecological
risks
potentially
caused
by
the
use
of
methyl
parathion
under
all
use
scenarios.
To
address
ecological
risk,
the
registrants
have
agreed
to
amend
label
requirements
to
minimize
ecological
concerns
by
reducing
rates
and
numbers
of
applications.
Also,
since
there
was
no
assessed
benefit
associated
with
use
on
Page
4
of
120
cabbage,
dried
beans,
dried
peas,
hops,
lentils,
pecans,
and
sugar
beets,
these
uses
are
considered
to
be
ineligible
for
reregistration.
Methyl
parathion
may
not
be
mixed/
loaded
or
otherwise
handled
in
areas
prone
to
runoff
to
aquatic
environments
based
on
uncertainties
in
the
drinking
water
assessment
and
toxicity
to
aquatic
organisms.
Anaerobic
aquatic
metabolism,
field
volatility,
aquatic
plant
growth,
vegetative
vigor,
and
seedling
emergence
studies
are
needed
to
better
assess
the
ecological
risk
and
refine
the
assessment.

Based
on
the
use
cancellation
on
tree
fruits
and
vegetables,
and
considering
the
implementation
of
mitigation
measures
discussed
above,
the
Agency
has
determined
that
pesticides
containing
methyl
parathion
generally
will
still
present
risk
to
humans
and
the
environment.
But
there
are
significant
benefits
associated
with
the
remaining
uses
which
balance
this
risk.

The
Agency
is
issuing
this
Interim
Reregistration
Eligibility
Document
(
IRED)
for
methyl
parathion,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
The
Notice
of
Availability
also
announces
the
beginning
of
a
30
day
public
comment
period.
During
this
comment
period,
interested
parties
may
submit
additional
information
on
methyl
parathion's
benefits,
usage,
risks
to
workers
and/
or
the
environment,
etc.
The
Agency
will
review
all
comments
and
if
warranted,
will
make
amendments
to
the
regulatory
decisions
contained
within
this
document.
Neither
the
tolerance
reassessment
nor
the
reregistration
eligibility
decision
for
methyl
parathion
can
be
considered
final,
however,
until
the
cumulative
risks
for
all
organophosphate
pesticides
is
considered.
The
cumulative
assessment
may
result
in
further
risk
mitigation
measures
for
methyl
parathion.

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
by
the
U.
S.
Environmental
Protection
Agency
(
referred
to
as
EPA
or
"
the
Agency").
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
hazards
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
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
tolerance
reassessment
of
all
existing
tolerances.
The
Agency
had
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
the
tolerance
reassessment
will
be
initiated
through
this
reregistration
process.
It
also
requires
that
by
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
date
of
the
enactment
of
the
FQPA,
which
was
August
3,
1996.
FQPA
also
amends
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
Page
5
of
120
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
an
assessment
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.
Methyl
parathion
belongs
to
a
group
of
pesticides
called
organophosphates,
which
share
a
common
mechanism
of
toxicity
­
they
all
affect
the
nervous
system
by
inhibiting
cholinesterase.
Although
FQPA
significantly
affects
the
Agency's
reregistration
process,
it
does
not
amend
any
of
the
existing
reregistration
deadlines.
Therefore,
the
Agency
is
continuing
its
reregistration
program
while
it
resolves
the
remaining
issues
associated
with
the
implementation
of
FQPA.

This
document
presents
the
Agency's
revised
human
health
and
ecological
risk
assessments;
its
progress
toward
tolerance
reassessment;
and
the
interim
decision
on
the
reregistration
eligibility
of
methyl
parathion.
It
is
intended
to
be
only
the
first
phase
in
the
reregistration
process
for
methyl
parathion.
The
Agency
will
eventually
proceed
with
its
assessment
of
the
cumulative
risk
of
the
OP
pesticides
and
issue
a
final
reregistration
eligibility
decision
for
methyl
parathion.

The
implementation
of
FQPA
has
required
the
Agency
to
revisit
some
of
its
existing
policies
relating
to
the
determination
and
regulation
of
dietary
risk,
and
has
also
raised
a
number
of
new
issues
for
which
policies
need
to
be
created.
These
issues
were
refined
and
developed
through
collaboration
between
the
Agency
and
the
Tolerance
Reassessment
Advisory
Committee
(
TRAC),
which
was
composed
of
representatives
from
industry,
environmental
groups,
and
other
interested
parties.
The
TRAC
identified
the
following
science
policy
issues
it
believed
were
key
to
the
implementation
of
FQPA
and
tolerance
reassessment:

C
Applying
the
FQPA
10­
Fold
Safety
Factor
C
Whether
and
How
to
Use
"
Monte
Carlo"
Analyses
in
Dietary
Exposure
Assessments
C
How
to
Interpret
"
No
Detectable
Residues"
in
Dietary
Exposure
Assessments
C
Refining
Dietary
(
Food)
Exposure
Estimates
C
Refining
Dietary
(
Drinking
Water)
Exposure
Estimates
C
Assessing
Residential
Exposure
C
Aggregating
Exposure
from
all
Non­
Occupational
Sources
C
How
to
Conduct
a
Cumulative
Risk
Assessment
for
Organophosphate
or
Other
Pesticides
with
a
Common
Mechanism
of
Toxicity
C
Selection
of
Appropriate
Toxicity
Endpoints
for
Risk
Assessments
of
Organophosphates
C
Whether
and
How
to
Use
Data
Derived
from
Human
Studies
The
process
developed
by
the
TRAC
calls
for
EPA
to
provide
one
or
more
documents
for
public
comment
on
each
of
the
policy
issues
described
above.
Each
of
these
issues
is
evolving
and
in
a
different
stage
of
refinement.
Some
issue
papers
have
already
been
published
for
comment
in
the
Federal
Register
and
others
will
be
published
shortly.

In
addition
to
the
policy
issues
that
resulted
from
the
TRAC
process,
the
Agency
published
in
Page
6
of
120
the
Federal
Register
on
August
12,
1999
a
draft
Pesticide
Registration
Notice
that
presents
EPA's
proposed
approach
for
managing
risks
from
organophosphate
pesticides
to
occupational
users.
This
notice
describes
the
Agency's
baseline
approach
to
managing
risks
to
handlers
and
workers
of
organophosphate
pesticides.
Generally,
basic
protective
measures
such
as
closed
mixing
and
loading
systems,
enclosed
cab
equipment,
or
protective
clothing,
as
well
as
increased
reentry
intervals
will
be
necessary
for
most
uses
where
current
risk
assessments
indicate
a
risk
and
such
protective
measures
are
feasible.
The
draft
guidance
policy
also
states
that
the
Agency
will
assess
each
pesticide
individually,
and
based
upon
the
risk
assessment,
determine
the
need
for
specific
measures
tailored
to
the
potential
risks
of
the
chemical.
The
measures
included
in
this
interim
RED
are
consistent
with
that
draft
Pesticide
Registration
Notice.

This
document
consists
of
six
sections.
This
section,
Section
I,
contains
the
regulatory
framework
for
reregistration/
tolerance
reassessment
as
well
as
descriptions
of
the
process
developed
by
TRAC
for
public
comment
on
science
policy
issues
for
the
organophosphate
pesticides
and
the
worker
risk
management
PR
notice.
Section
II
provides
a
profile
of
the
use
and
usage
of
the
chemical.
Section
III
gives
an
overview
of
the
revised
human
health
and
environmental
effects
risk
assessments
resulting
from
public
comments
and
other
information.
Section
IV
presents
the
Agency's
interim
decision
on
reregistration
eligibility
and
risk
management
decisions.
Section
V
summarizes
the
label
changes
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV.
Section
VI
provides
information
on
how
to
access
related
documents.
Finally,
the
Appendices
list
Data
Call
In
(
DCI)
information.
The
revised
risk
assessments
and
related
addenda
are
not
included
in
this
document,
but
are
available
on
the
Agency's
web
page
http://
www.
epa.
gov/
pesticides/
op,
and
in
the
Public
Docket.

II.
Chemical
Overview
A.
Regulatory
History
This
interim
reregistration
eligibility
document
is
a
full
review
of
methyl
parathion
by
the
Agency.
Methyl
parathion
was
first
registered
in
1954
for
use
as
an
insecticide/
acaricide.
In
December
1986,
the
Agency
published
Guidance
for
the
Reregistration
of
Pesticide
Products
Containing
Methyl
Parathion.
Some
label
changes
to
enhance
worker
safety
were
imposed
by
this
document
and
several
Data
Call
Ins
were
issued
to
support
continued
registration.
In
1996,
agreement
was
reached
with
the
registrants
producing
the
EC
formulation
to
make
various
changes
designed
to
end
illegal
home
use
of
methyl
parathion.
These
changes
included
tracking
of
all
containers
and
reuseable/
returnable
closed
containers
for
all
EC
products.
On
August
2,
1999,
a
Memorandum
of
Agreement
was
signed
by
methyl
parathion
registrants
and
EPA
to
voluntarily
cancel
a
number
of
crop
uses
to
address
dietary
concerns
and
to
commit
to
conducting
studies
to
refine
potential
occupational
risk
concerns.

B.
Chemical
Identification
Page
7
of
120
O
2
N
P
S
O
OCH
3
OCH
3
Methyl
parathion
[
O,
O­
dimethyl
O­
p­
nitrophenyl
phosphorothioate]:

!
Common
Name:
methyl
parathion
!
Chemical
Name:
O,
O­
dimethyl
O­
p­
nitrophenyl
phosphorothioate
!
Chemical
Family:
Organophosphate
!
CAS
Registry
Number:
298­
00­
0
!
OPP
Chemical
Code:
053501
!
Empirical
Formula:
C8H10O5NPS
!
Molecular
Weight:
263.2
g/
mole
!
Trade
and
Other
Names:
Methyl
Parathion
4EC,
Penncap­
M,
Declare
!
Basic
Manufacturers:
Cheminova
Agro
A/
S,
Elf
Atochem
North
America,
Griffin
L.
L.
C
Pure
methyl
parathion
is
a
white
crystalline
solid
with
a
melting
point
of
35­
36
C,
bulk
density
of
1.358
g/
mL
at
25
C,
vapor
pressure
of
9.7
x
10­
6
mm
Hg
at
20
C,
and
octanol/
water
partition
coefficient
(
Pow)
of
3300.
Methyl
parathion
is
only
slightly
soluble
in
water
(
55­
60
mg/
L
at
20
C);
readily
soluble
in
dichloromethane,
2­
propanol,
and
toluene;
and
practically
insoluble
in
n­
hexane.
Methyl
parathion
is
formulated
with
inert
ingredients
for
manufacturing
use
to
produce
an
80%
tancolored
liquid.
(
See
"
Human
Health
Risk
Assessment,
Methyl
Parathion,
August
2,
1999".)

C.
Use
Profile
The
following
information
is
based
on
the
currently
registered
use
of
methyl
parathion,
consistent
with
Page
8
of
120
the
methyl
parathion
MOA
signed
August
2,
1999.

Type
of
Pesticide:
Insecticide/
miticide
Summary
of
Use:

Sites:
Terrestrial
food
and
feed
crops;

Food/
Feed:
Alfalfa,
almonds,
barley,
dried
beans,
cabbage,
corn,
cotton,
grass
forage/
fodder/
hay,
hops,
lentils,
oats,
onion,
pastures,
dried
peas,
pecans,
rangeland,
rape
seed
(
canola),
rice,
rye,
soybeans,
sugar
beets,
sunflower,
sweet
potatoes,
walnuts,
wheat,
white
potatoes,
and
yams.

Residential:
None;

Nonfood/
Nonfeed:
None;

Target
Pests:
Methyl
parathion
is
used
to
control
many
types
of
pests,
including
mites,
thrips,
weevils,
aphids,
and
leafhoppers.

Formulation
Types:

Registered:
Methyl
parathion
is
formulated
as
a
microencapsulate
(
ME)
(
20.9%
a.
i.)
and
as
an
emulsifiable
concentrate
(
EC)
(
ranges
from
27.59
to
52.7%
a.
i.).
The
EC
products
contain
a
stenching
agent
to
deter
indoor
misuse.
Methyl
parathion
is
formulated
with
other
active
ingredients
including
malathion.

Method
and
Rates
of
Application:

Equipment:
Applied
by
aerial
equipment
and
with
groundboom
equipment.
The
ME
formulation
can
also
be
applied
by
airblast
equipment
or
by
chemigation.

Method
and
Rate:
Maximum
label
application
rates
vary
from
0.25
to
3.0
lbs.
a.
i./
acre.
Currently,
methyl
parathion
containers
(
EC
formulation
only)
are
designed
for
closed­
system
mixing/
loading.
These
returnable/
refillable
containers
are
bar­
coded
for
tracking
purposes.

Use
Classification:
Methyl
parathion
is
a
"
restricted
use"
chemical
due
to
toxicity
to
humans,
avian
species
and
honey
bees.
Page
9
of
120
Proposed
rates:
Based
on
worker
and
ecological
risks
which
were
highlighted
in
the
risk
assessments
released
prior
to
the
1999
MOA,
the
methyl
parathion
technical
registrants
submitted
written
requests
to
have
the
risk
assessments
revised
to
lower
some
rates
and
numbers
of
applications
even
though
the
labels
have
not
been
revised
to
include
these
changes.
The
worker
biomonitoring
studies
were
conducted
at
these
proposed
lower
rates.
Additionally,
to
address
ecological
risks,
the
maximum
number
of
applications
has
been
lowered
for
several
crops.
The
occupational
and
ecological
risk
assessments
take
into
account
these
proposed
rates.
Any
end­
use
product
that
does
not
conform
with
these
revised
agreed­
upon
rates
and
number
of
applications
will
not
be
eligible
for
reregistration.
Table
1
provides
the
new
rates
on
which
the
risks
assessments
are
based
and
gives
the
pre­
harvest
intervals
(
PHI).
Page
10
of
120
Table
1.
Proposed
rates
(
lb
ai/
A)
for
each
formulation.

Crop
Emulsifiable
Concentrate
Microenpasulated
max
rate
max
#
app
PHI
max
rate
max
#
app
PHI
alfalfa
1.0
6a
15
­­
­­
­­

almonds
__
 
b
­­
­­
2.0
4
28
barley,
oats,
rice,
wheat
0.75
2
14
0.75
2
14
beans,
dried
1.5
2
15
1.0
3
15
cabbage
1.5
2
21
­­
­­
­­

corn
0.5
2
12
1.0
3
12
sweet
corn
0.5
2
12
0.75
4
12
cotton
0.75
5
7
1.0
4
14
grass
(
forage,
fodder,
hay,
range)
0.75
4a
15
­­
­­
­­­­

lentils
­­
­­
­­
0.5
2
14
onions
0.5
2
15
0.5
4
15
peas,
dried
1.0
3
15
0.5
2
15
pecans
­­
­­
­­
2.0
8
51
rapeseed
(
canola)
0.5
2
28
­­
­­
­­

rye
0.75
2
15
­­
­­
­­

soybeans
0.5
2
30
0.75
2
30
sugar
beets
0.375
2
20
­­
­­
­­

sunflower
1.0
2
30
­­
­­
­­

sweet
potatoes
and
yams
­­
­­
­­
0.75
8
5
walnuts
­­
­­
­­
2.0
4
14
white
potatoes
0.75
3
5
1.5
4
5
hops
1.0
3
15
­­
­­
­­
a
for
hay,
there
can
be
two
applications
per
cutting.
b
 
indicates
that
the
formulation
is
not
registered
for
use
on
that
crop
D.
Estimated
Usage
of
Pesticide
This
section
summarizes
the
best
estimates
available
for
many
of
the
pesticide
uses
of
methyl
parathion,
based
on
available
pesticide
usage
information
for
1987­
1997.
A
full
listing
of
all
uses
of
methyl
parathion,
with
the
corresponding
use
and
usage
data
for
each
site,
has
been
completed
and
is
in
the
"
Quantitative
Usage
Analysis"
document,
which
is
available
in
the
public
docket.
The
data,
reported
on
an
aggregate
and
site
(
crop)
basis,
reflect
annual
fluctuations
in
use
patterns
as
well
as
the
variability
in
using
data
from
various
information
sources.
Approximately
4
million
lbs
a.
i.
on
approximately
5
million
acres
treated
are
used
annually,
according
to
Agency
and
registrant
estimates.
This
value
includes
use
on
crops
which
were
canceled
in
August
1999.
The
largest
uses
for
methyl
parathion
in
terms
of
total
pounds
active
ingredient
are:
cotton,
corn,
wheat,
soybeans,
and
rice.
Page
11
of
120
Table
2.
Methyl
Parathion
Estimated
Usage
for
Representative
Sites.

Crop
Lbs
Active
Ingredient
Applied
(
Wt.
Avg.)
1
Percent
Crop
Treated
(
Wt.
Avg.)
Percent
Crop
Treated
(
Likely
Maximum)

cotton
1,960,000
12
17
corn
770,000
2
3
wheat
445,000
1
2
rice
147,000
8
12
soybeans
270,000
1
1
1
Weighted
Average
is
based
on
data
for
1987­
1997;
the
most
recent
years
and
more
reliable
data
are
weighted
more
heavily.

Most
other
uses
have
less
than
or
equal
to
1%
of
the
crop
treated
with
methyl
parathion.

E.
Uses
Deleted
by
the
1999
MOA
Food
uses:
apples,
artichokes,
broccoli,
Brussels
sprouts,
carrots,
cauliflower,
celery,
cherries,
clover,
collards,
filberts,
garden
beets,
grapes,
kale,
kohlrabi,
lettuce,
mustard
greens,
nectarines,
peaches,
pears,
plums,
rutabagas,
sorghum,
spinach,
succulent
beans,
succulent
peas,
tomatoes,
turnips,
vetch
Non­
Food/
Feed
Uses:
birdsfoot
trefoil,
Christmas
trees,
chrysanthemums,
daisies,
field
grown
ornamentals,
flowering
plants,
forest,
grasses
grown
for
seed,
guayule,
jojoba,
marigolds,
any
mosquito
larvicide
use,
nursery
stock,
non­
agricultural
land,
roadside
areas,
and
wasteland.

III.
Summary
of
Methyl
Parathion
Risk
Assessment
Following
is
a
summary
of
EPA's
revised
human
health
and
ecological
risk
findings
and
conclusions
for
the
organophosphate
pesticide
methyl
parathion
as
fully
presented
in
the
documents,
"
Methyl
Parathion
Revised
Human
Health
Risk
Assessment,"
dated
August
2,
1999,
"
2
nd
Revised
HED
Risk
Assessment"
dated
June
12,
2002,
and,
"
Methyl
Parathion
Revised
Environmental
Fate
and
Effects
Risk
Assessment,"
dated
July
30,
1999
(
and
addendums
thereto).
The
purpose
of
this
summary
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
these
risk
assessments,
and
to
enhance
understanding
of
the
conclusions
reached
in
the
assessments.

These
risk
assessments
for
methyl
parathion
were
presented
at
an
August
2,
1999,
technical
briefing,
which
was
followed
by
an
opportunity
for
public
comment
on
risk
management
for
this
pesticide.
The
risk
assessments
presented
here
form
the
basis
of
the
Agency's
interim
risk
management
decisions
for
methyl
parathion
only;
the
Agency
must
still
consider
cumulative
risks
of
all
the
organophosphate
pesticides
before
other
final
decisions
can
be
made.
Page
12
of
120
A.
Human
Health
Risk
Assessment
EPA
issued
its
preliminary
risk
assessments
for
methyl
parathion
on
December
18,
1998
(
Phase
3
of
the
TRAC
process).
In
response
to
comments
and
studies
submitted
during
Phase
3,
the
risk
assessments
were
updated
and
refined.
Major
revisions
to
the
human
health
risk
assessment
are
included
in
the
summary
below:

The
Agency
conducted
the
human
health
risk
assessment
for
all
registered
uses
of
methyl
parathion
which
were
being
supported
under
reregistration,
as
well
as
for
the
use
changes
which
reflect
mitigation
measures.
The
toxicity
endpoints
selected
for
the
risk
assessment
are
based
primarily
on
neurotoxic
effects,
including
neuropathology
and
cholinesterase
(
ChE)
inhibition
in
the
brain,
red
blood
cells
(
RBC),
and
plasma,
as
well
as
behavioral
effects
and
systemic
toxicity
(
decreased
hematocrit
and
erythrocyte
levels).
In
addition,
a
single
oral
exposure
to
methyl
parathion
(
7.5
mg/
kg
or
higher)
in
rodents
resulted
in
peripheral
nerve
demyelination
(
tibial
and
sural
nerves,
dorsal
and
ventral
root
fibers).
Additional
effects
of
chronic
exposure
include
retinal
degeneration
and
sciatic
nerve
degeneration.
No
evidence
of
carcinogenicity
was
seen
in
any
study.
The
endpoints
selected
for
the
methyl
parathion
human
health
dietary
risk
assessment
are
listed
in
Table
3
and
for
the
occupational
risk
assessment
in
Table
9.

An
uncertainty
factor
(
UF)
of
100
was
applied
to
the
doses
selected
for
risk
assessment
to
account
for
both
interspecies
extrapolation
and
intraspecies
variability.
An
additional
factor
of
10X
was
retained
in
accordance
with
the
FQPA
for
the
dietary
risk
assessment.
In
accordance
with
current
EPA
policy,
the
FQPA
factor
is
not
retained
for
the
occupational
risk
assessment.

1.
Dietary
Risk
from
Food
a.
Toxicity
The
Agency
has
reviewed
all
toxicity
studies
submitted
and
has
determined
that
the
toxicity
database
is
adequate,
and
that
it
supports
an
interim
reregistration
eligibility
determination
for
all
currently
registered
uses.
Further
details
on
the
toxicity
of
methyl
parathion
can
be
found
in
the
June
1,
1999
Toxicology
Chapter,
June
4,
1999
Human
Health
Risk
Assessment
and
the
June
14,
2002:
2nd
Revised
HED
Chapter.
A
brief
overview
of
the
studies
used
for
the
dietary
risk
assessment
is
outlined
in
Table
3
in
this
document.

b.
FQPA
Safety
Factor
The
decision
to
retain
the
full
10X
FOPA
Safety
Factor
was
based
on
a
weight­
of­
evidence
that
included
a
data
gap
that
could
be
filled
with
the
submission
of
a
Developmental
Neurotoxicity
Study
(
DNT).
The
DNT
has
been
received
and
is
under
review.
A
reevaluation
of
the
need
to
retain
or
Page
13
of
120
reduce
the
FQPA
factor
will
follow
the
completion
of
the
DNT
review.
The
data
that
were
instrumental
in
the
decision
to
retain
the
10X
are
discussed
below
and
in
"
METHYL
PARATHION
­
Report
of
the
FQPA
Safety
Factor
Committee.
Brenda
Tarplee.
July
21,
1999").

Neuropathology
is
reported
in
acceptable
studies
submitted
by
the
registrant.

°
Neuropathology
seen
in
experimental
animals
in
the
guideline
acute
neurotoxicity
study;
°
Neuropathology
seen
in
experimental
animals
in
the
guideline
chronic/
carcinogenicity
study;
°
Neuropathology
seen
in
experimental
animals
in
the
non­
guideline,
but
acceptable
one
year
neurotoxicity
study.
*
The
registrant
has
submitted
a
re­
read
of
the
neuropathology
slides
from
several
of
these
studies.
These
submissions
are
currently
under
review.

Fetal/
neonate
susceptibility
is
reported
in
open
literature
citations
which
were
retrieved
and
reviewed
by
the
Agency.

°
An
open
literature
citation
which
assessed
postnatal
functional
toxicity
following
prenatal
exposure
reported
the
inhibition
of
acetyl
cholinesterase
and
other
neurochemical
biomarkers
in
pups
which
persisted
to
day
28
and
impaired
behavioral
parameters
(
Gupta
et.
al.
1985);
°
Additional
open
literature
citations
reported
that
neonates
were
more
sensitive
to
acute
lethality
from
methyl
parathion
than
adults
and
that
significant
compound­
related
and
age­
related
differences
in
duration
of
ChEI
can
occur
(
Pope
et.
al.
1991;
Pope
and
Chakraborti
1992);
°
Possible
endocrine
disruption
in
mammals
(
Dhondup
and
Basavanneppa
1997,
Lukaszewica­
Hussain,
Moniuszko­
Jakoniuk
and
Pawlowska
1985).

Fetal/
neonate
sensitivity/
susceptibility
is
reported
in
studies
submitted
by
the
registrant
during
the
comment
period.

°
Decreased
survival
and
convulsions
in
the
surviving
F1b
pups
were
reported
in
a
non­
guideline
multi­
generation
reproduction
study
in
rats;
°
Embryotoxicity
or
fetotoxicity
was
observed
at
non­
maternally
toxic
levels
in
an
additional
supplementary
developmental
study
in
rats
which
had
previously
been
submitted
to
the
Agency.

The
standard
guideline
studies
for
developmental
and
reproductive
toxicity,
which
have
been
submitted
by
the
registrant
and
are
acceptable,
are
not
required
to
measure
ChEI,
behavioral
effects,
neuropathology,
or
increased
sensitivity
to
lethal
effects
in
pups.
Thus,
these
studies
are
silent
on
effects
that
have
been
reported
in
the
open
literature.
Even
though
the
open
literature
studies
have
a
number
of
deficiencies,
the
fact
that
several
studies
have
reported
adverse
effects
on
neonates
raises
concern.
The
suggestive
evidence
of
possible
endocrine
disruption,
although
not
heavily
weighted,
was
also
taken
into
account.
If
the
information
from
these
studies
is
considered
together
with
the
reported
neuropathology
seen
in
adult
animals
after
a
single
and
multiple
doses
of
methyl
parathion
and
the
results
from
the
Page
14
of
120
supplementary
developmental
and
reproduction
studies
submitted
by
the
registrant
which
demonstrate
fetal
and
neonate
sensitivity,
the
concern
for
effects
on
the
developing
organism
increases.
Thus
all
of
these
data,
taken
in
toto
require
that
the
10X
FQPA
Safety
Factor
be
retained
until
such
time
as
the
Agency
completes
the
review
of
the
submitted
DNT.
When
the
study
review
is
completed,
the
final
decision
on
the
retention,
reduction,
or
removal
of
the
10X
FQPA
Safety
Factor
will
be
made
based
upon
the
weight
of
the
evidence.

c.
Population
Adjusted
Dose
(
PAD)

The
PAD
is
a
term
that
characterizes
the
dietary
risk
of
a
chemical,
and
reflects
the
Reference
Dose,
either
acute
or
chronic,
that
has
been
adjusted
to
account
for
the
FQPA
safety
factor
(
i.
e.,
RfD/
FQPA
safety
factor).
A
risk
estimate
that
is
less
than
100%
of
the
acute
or
chronic
PAD
does
not
exceed
the
Agency's
risk
concern.

Acute
PAD
The
dose
and
endpoint
for
establishing
the
RfD
is
the
NOAEL
=
0.11
mg/
kg
based
on
plasma,
brain
and
RBC
ChEI,
and
neuropathology
at
0.53
mg/
kg
(
LOAEL).
A
UF
of
100
was
applied
to
account
for
inter­
species
variation
(
10x)
and
for
intra­
species
extrapolation
(
10x).

Acute
RfD:
0.11
mg/
kg
÷
100
(
UF)
=
0.0011
mg/
kg
Acute
PAD
(
aPAD):
0.001
÷
10
(
FQPA)
=
0.00011
mg/
kg
Chronic
PAD
The
dose
and
endpoint
for
establishing
the
RfD
is
the
NOAEL
=
0.02
mg/
kg
based
on
RBC
ChEI,
neuropathology,
and
hematologic
effects
seen
at
0.21
mg/
kg
(
LOAEL).
A
UF
of
100
was
applied
to
account
for
inter­
species
variation
(
10x)
and
for
intra­
species
extrapolation
(
10x).

Chronic
RfD:
0.02
mg/
kg
÷
100
(
UF)
=
0.0002
mg/
kg
Chronic
PAD
(
cPAD):
0.0002
÷
10
(
FQPA)
=
0.00002
mg/
kg
Page
15
of
120
d.
Endpoints
and
Doses
for
Dietary
Risk
Assessment
Table
3.
Summary
of
Toxicological
Endpoints
and
Other
Factors
Used
in
the
Human
Dietary
Risk
Assessment
of
Methyl
Parathion.

Assessment
Dose
mg/
kg/
d
Endpoint
Study
UF
FQPA
Safety
Factor
PAD
mg/
kg/
d
Acute
Dietary
0.53
neuropathology
and
inhibition
of
brain,
plasma,
and
RBC
ChE
NOAEL
0.11
mg/
kg/
d
41853801
44204501
100
10
0.00011
Chronic
Dietary
0.21
systemic
toxicity,
neuropathology
and
inhibition
of
RBC
ChE
NOAEL
0.02
mg/
kg/
d
00074299
100
10
0.00002
e.
Exposure
Assumptions
Revised
acute
and
chronic
dietary
risk
analyses
for
methyl
parathion
were
conducted
with
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
.
DEEM
incorporates
consumption
data
generated
in
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1989­
92.

The
methyl
parathion
residues
of
concern
for
plant
and
animal
commodities
included
in
this
risk
assessment
are
based
on
ChEI,
and
are
methyl
parathion
and
methyl
paraoxon.
Although
tolerances
for
residues
of
methyl
parathion
have
been
established
on
numerous
animal
feed
items,
no
tolerances
for
residues
of
methyl
parathion
have
been
established
in
animal
commodities
of
meat,
milk,
poultry,
and
eggs
[
Category
3,
40CFR
§
180.6(
a)]
because
there
is
no
reasonable
expectation
of
finite
residues.
Residues
of
methyl
parathion
or
paraoxon
were
not
detected
in
ruminant
tissue,
milk,
and
egg
samples
collected
from
the
ruminant
and
poultry
metabolism
studies
or
in
USDA
monitored
samples
(
1304
samples)
of
milk
(
1996­
1998).
Residues
of
methyl
parathion
detected
in
poultry
tissue
samples
collected
from
the
poultry
metabolism
study
were
very
low.
Based
on
available
data,
estimates
for
residues
of
methyl
parathion
and
methyl
paraoxon
in
animal
commodities
were
not
included
in
the
dietary
risk
assessment
for
methyl
parathion.
If
required,
appropriate
tolerances
for
methyl
parathion
residues
in
animal
commodities
will
be
determined
once
data
are
available
from
outstanding
livestock
feeding
studies.

The
dietary
assessment
is
highly
refined,
using
all
available
monitoring,
processing
and
cooking
factors.
Methyl
parathion
residue
estimates
in
this
assessment
are
based
primarily
on
three
data
sources:
1)
field
trial
data,
submitted
by
the
registrant
to
support
tolerances;
2)
USDA
Pesticide
Data
Program
(
PDP)
food
sampling
data;
and
3)
Food
and
Drug
Administration
(
FDA)
Surveillance
Monitoring
data.
Field
trial
data
are
normalized
for
percent
crop
treated
and
processing
data.
Field­
trial
data
were
used
for
the
following
commodities:
sugar
beets,
green
onions,
almonds,
pecans,
walnuts,
cottonseed,
hops,
canola,
and
sunflowers.
Page
16
of
120
f.
Acute
Dietary
Risk
from
Food
The
Agency
conducted
the
dietary
risk
assessment
for
methyl
parathion
using
available
data
and
updated
methods
for
estimating
acute
dietary
exposure.
The
uses/
crops
included
in
this
assessment
reflect
the
MOA
between
the
Agency
and
the
registrants
(
August
2,
1999)
in
which
it
was
agreed
that
some
uses/
crops
would
be
canceled.
Risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups,
including
estimates
for
infants
and
children.
This
assessment
concluded
that
the
dietary
risks
for
the
post­
MOA
remaining
uses
do
not
exceed
the
aPAD
for
any
population
subgroup.

The
uses
for
methyl
parathion
included
in
this
assessment
(
reflecting
the
MOA)
are:
almonds,
barley,
dried
beans,
cabbage,
canola
oil
(
rape
seed
oil),
field
corn,
sweet
corn,
cottonseed,
hops,
lentils,
oats,
onions,
peanuts,
dried
peas,
pecans,
potatoes,
rice,
rye,
soybeans,
sugar
beets,
sunflowers,
sweet
potatoes,
walnuts,
and
wheat.

Based
on
the
acute
dietary
exposure
analysis
as
described
above
and
using
an
aPAD
of
0.00011
mg/
kg/
d,
acute
dietary
exposure
to
all
population
subgroups
does
not
exceed
the
aPAD
at
the
99.9th
exposure
percentile
(
Table
4).

Table
4.
Post­
mitigation
Acute
Dietary
Risk
Estimates.

Population
(
99.9th
percentile)

Exposure
%
aPAD
U.
S.
Population
0.000066
mg/
kg/
day
60
All
Infants
<
1
year
0.000067
mg/
kg/
day
61
Children
1­
6
years
0.000082
mg/
kg/
day
75
Children
7­
12
years
0.000085
mg/
kg/
day
77
Females
13­
50
years
0.000058
mg/
kg/
day
53
2.
Chronic
Dietary
Risk
from
Food
For
chronic
risk
assessment,
reported
residues
were
averaged,
whether
based
on
PDP,
FDA,
or
field
trials.
If
a
commodity
had
no
reported
detections
by
the
PDP
and
FDA
programs,
and
the
expectation
of
no
detection
was
confirmed
by
field
trial
data,
the
weighted
average
of
the
Limits
of
Page
17
of
120
Detection
(
LOD)
were
used
to
account
for
possible
exposure
that
could
not
be
more
precisely
quantified
(
½
LOD
methyl
parathion
+
½
LOD
methyl
paraoxon).

Based
on
the
chronic
dietary
exposure
analysis
reflecting
mitigation
measures
and
using
a
cPAD
of
0.00002
mg/
kg/
d,
chronic
dietary
exposure
to
all
population
subgroups
does
not
exceed
the
cPAD
(
See
Table
5
following).

Table
5.
Post­
mitigation
Chronic
Dietary
Risk
Estimates
Population
Exposure
(
mg/
kg/
day)
%
Chronic
PAD
U.
S.
Population
0.000001
4
All
Infants
(<
1
year)
0.000001
3
Children
1­
6
years
0.000002
8
Children
7­
12
years
0.000001
6
Females
13­
50
years
0.000001
3
The
mitigation
measures,
including
the
deletion
of
fruits
and
most
vegetables,
removed
many
of
the
substantial
contributors,
and
therefore
greatly
lowers
the
potential
dietary
exposures
to
the
US
population
and
all
population
subgroups.

3.
Dietary
Risk
from
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
ground
water
and
surface
water
contamination.
EPA
considers
both
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
either
modeling
or
monitoring
data,
if
available,
to
estimate
those
risks.

While
the
Agency's
Office
of
Water
(
OW)
has
established
a
lifetime
Health
Advisory
(
HA)
Level
of
2
ppb,
methyl
parathion
does
not
have
an
established
Maximum
Contaminant
Level,
and
is
not
included
on
the
OW's
Unregulated
Contaminant
Monitoring
List.
Therefore,
public
drinking
water
supply
systems
are
not
required
to
analyze
for
methyl
parathion.
Consequently,
EPA
has
relied
on
simulation
models
and
other
surface­
and
ground­
water
monitoring
data
for
this
revised
risk
assessment.
Drinking
water
concentrations
for
ground
water
were
estimated
after
considering
model
estimates
from
the
Tier
1
SCI­
GROW
model
and
ground­
water
monitoring
data.
Drinking
water
concentrations
for
surface
water
were
estimated
after
considering
the
Tier
2
PRZM/
EXAMS
surface
water
model
estimates
and
limited
targeted
surface
water
monitoring
data.
Please
see
the
EFED
Risk
Assessment
chapter
for
a
complete
discussion
of
the
ground
and
surface
water
monitoring
studies.

The
only
environmental
degradate
of
human
toxicological
concern
included
in
the
assessment
is
the
metabolite
methyl
paraoxon.
Although
there
are
not
extensive
monitoring
data
for
methyl
paraoxon
in
raw
and
finished
drinking
waters,
methyl
paraoxon
was
not
detected
(
LOD
=
0.031
ppb)
in
raw
or
Page
18
of
120
finished
water
samples
in
the
United
States
Geological
Survey
(
USGS)/
EPA
Reservoir
Monitoring
Program.
Methyl
parathion,
however,
was
detected
(
0.061
ug/
L)
in
a
single
raw
water
sample
at
the
Lake
Bruin
water
treatment
plant.
It
is
important
to
note
the
monitoring
study
was
not
targeted
to
methyl
parathion
use
areas.
The
Agency
does
not
currently
have
any
data
available
with
which
to
predict
the
rate
of
formation
or
the
half­
life
of
methyl
paraoxon.
Though
there
are
data
to
show
that
other
organophosphate
pesticides
such
as
diazinon
and
malathion,
degrade
to
their
oxon
metabolites
during
drinking
water
treatment,
it
is
unknown
if
methyl
parathion
would
behave
in
a
similar
manner.

a.
Surface
Water
Methyl
parathion
has
been
included
as
an
analyte
in
several
national­
scale
surface­
water
(
nondrinking
water)
monitoring
studies
since
the
early
1970'
s.
Methyl
parathion
was
detected
in
2%
or
fewer
of
the
samples
taken
in
these
studies,
with
a
maximum
concentration
of
1
ppb.
However,
these
survey
studies
were
not
targeted
specifically
to
methyl
parathion,
and
therefore
are
not
well­
suited
for
the
determination
of
potential
acute
exposure.

Limited
targeted
monitoring
data
have
been
collected
for
methyl
parathion,
most
recently
in
the
Mississippi
Embayment
NAWQA
study
undertaken
by
the
USGS.
Samples
were
taken
from
five
rivers
in
this
cotton­
growing
region,
and
methyl
parathion
was
detected
in
all
five.
The
maximum
concentration
detected
was
0.422
ppb.

Targeted
monitoring
has
also
been
performed
in
California
to
evaluate
the
effect
of
management
measures
on
the
concentration
of
methyl
parathion
in
surface
water
due
to
use
on
rice.
Before
these
measures
were
instituted
in
the
early
1990'
s,
methyl
parathion
was
detected
at
concentrations
up
to
6
ppb
in
the
Colusa
Basin
Drain,
which
drains
to
the
Sacramento
River.
The
California
Environmental
Protection
Agency
determined
that
spray
drift
from
aerial
applications
led
to
as
much
as
15%
deposition
directly
to
water
bodies
adjacent
to
treated
rice
fields.
However,
since
the
imposition
of
irrigation
and
application
controls
along
with
a
reduction
in
the
use
of
methyl
parathion
on
rice,
the
maximum
detection
has
been
0.12
ppb.

The
Agency
cannot
state
with
confidence
that
the
concentrations
detected
in
the
limited
targeted
monitoring
studies
represent
the
highest
surface­
water
concentrations
that
might
occur
in
areas
of
methyl
parathion
use.
However,
given
the
lack
of
direct
drinking
water
data,
and
uncertainties
related
to
the
effects
of
water
treatment
on
methyl
parathion,
the
Agency
also
cannot
state
with
certainty
that
concentrations
of
methyl
parathion
detected
in
surface
water
correspond
to
the
concentrations
that
might
be
detected
in
drinking
water
derived
from
surface
water.

Surface
water
monitoring
studies
performed
over
the
past
30
years
have
not
shown
concentrations
of
methyl
parathion
at
levels
predicted
in
the
chronic
modeling
assessments
using
PRZMEXAMS
(
4.2
ppb).
A
single
study
at
two
drinking
water
intakes
on
the
Mississippi
River
yielded
an
average
detection
of
0.009
ppb
in
weekly
composite
samples.
While
the
chronic
monitoring
data
were
Page
19
of
120
very
limited,
the
data
from
the
Mississippi
River
study
were
collected
closer
to
drinking
water
intake
over
a
period
of
a
year
from
a
high­
use
area
and
therefore
may
be
approaching
what
may
be
actual
residues
in
surface
source
drinking
water.
The
Agency
recognizes
that
long­
term,
targeted
monitoring
studies
would
be
required
to
more
accurately
quantify
the
spatial
and
temporal
variability
of
methyl
parathion
concentrations
in
drinking
water.

b.
Ground
Water
Methyl
parathion
has
been
detected
in
ground
water,
but
these
detections
have
been
rare,
and
at
low
concentrations.
Although
targeted
ground­
water
monitoring
data
for
methyl
parathion
are
limited,
an
extensive
body
of
ground­
water
monitoring
data
is
available,
with
a
maximum
reported
concentration
of
0.256
ppb.
EPA
considers
the
concentration
of
0.6
ppb
estimated
with
the
SCI­
GROW
screening
model
to
be
a
reasonable
conservative
estimate
of
possible
acute
concentrations
of
methyl
parathion
in
drinking
water
derived
from
ground­
water.

However,
given
the
rarity
of
detections
of
methyl
parathion
in
ground
water,
the
estimate
of
0.6
ppb
does
not
seem
appropriate
for
use
in
the
chronic
drinking
water
assessment.
The
Agency
does
not
currently
have
a
second­
tier
model
with
which
to
refine
the
ground­
water
assessment.
However,
EPA
concludes
that
methyl
parathion
does
not
pose
a
chronic
concern
for
drinking
water
derived
from
ground
water.

c.
Drinking
Water
Levels
of
Comparison
(
DWLOCs)

Generally,
the
Agency
calculates
Drinking
Water
Levels
of
Comparison
(
DWLOC)
for
comparison
to
measured
or
modeled
drinking
water
concentrations
for
the
risk
analysis.
The
DWLOC
is
the
concentration
in
drinking
water,
as
part
of
the
aggregate
exposure,
that
occupies
no
more
than
100%
of
the
PAD.
The
dietary
exposure
from
food
and
DWLOC
together,
cannot
be
greater
than
100%
of
the
PAD.
Any
measured
or
modeled
drinking
water
estimates
that
are
less
than
the
DWLOC
are
not
of
concern.

ACUTE
An
acute
DWLOC
(
DWLOCacute)
was
calculated
using
the
following
formulae:

DWLOCacute
(
:
g/
L)
=
acute
water
exposure
(
mg/
kg/
d)
x
body
weight
(
kg)
consumption
(
L/
d)
x
10­
3
mg/
:
g
where
acute
water
exposure
(
mg/
kg/
d)
=
[
aPAD
­
acute
food
(
mg/
kg/
d)]

The
current
Agency
default
body
weight
and
consumption
values
are
10
kg
and
1
liter/
day,
respectively,
for
all
infants
and
children,
70
kg
and
2
liters/
day
for
adult
males,
and
60
kg
and
2
Page
20
of
120
liters/
day
for
adult
females.
These
default
values
and
others
are
presently
under
review
in
the
Agency
(
Office
of
Research
and
Development).
If
at
a
future
time,
the
Agency
decides
to
change
the
default
assumptions
used,
the
impact
of
the
changes
on
the
methyl
parathion
risk
assessment
will
be
considered.

Surface
water
monitoring
data
range
between
6
ppb
from
methyl
parathion
applications
to
rice
fields
in
California
to
0.42
ppb
from
applications
to
cotton
in
Mississippi.
After
the
monitoring
data
were
recorded
in
California,
the
state
instituted
a
number
of
its
own
mitigation
measures
to
reduce
contamination
of
surface
waters
and
therefore,
present­
day
concentrations
would
be
expected
to
be
lower.
As
a
result
of
these
mitigation
measures,
the
peak
surface
water
concentration
from
targeted
monitoring
studies
in
Mississippi
(
0.42
ppb)
may
represent
a
conservative
peak
concentration
of
methyl
parathion
in
surface
source
waters.
EPA
has
more
confidence
in
the
surface
water
concentrations
from
Mississippi
(
0.42
ppb).
It
should
also
be
noted
that
cotton
has
the
highest
application
rate
for
methyl
parathion
of
all
remaining
uses.

Table
6.
Acute
Surface
Water
Reflecting
Use
from
the
1999
MOA
Mitigation
Measures
Population
Monitoring
Data
(
ug/
L)
aPAD
(
mg/
kg/
d)
Acute
Food
Exposure
(
mg/
kg/
d)
Acute
H2O
Exposure
(
mg/
kg/
d)
DWLOCacute
(
ug/
L)

General
U.
S.
Population
0.42
0.00011
0.000066
0.000044
1.54
Females
13­
50
years
0.42
0.00011
0.000058
0.000052
1.56
Infants
<
1
year
0.42
0.00011
0.000067
0.000043
0.43
Children
1­
6
years
0.42
0.00011
0.000082
0.000028
0.28
Though
comparisons
between
the
surface
water
monitoring
data
and
the
DWLOCacute
for
children
1­
6
years
of
age
raise
some
concerns,
it
is
uncertain
what
the
effects
of
water
treatment
have
on
residues
in
finished
drinking
water.
Since
these
Mississippi
monitoring
data
come
from
a
high
use
region
(
cotton
has
the
highest
application
rate)
and
represent
source
water
concentrations
only,
the
Agency
believes
that
they
are
somewhat
conservative,
though
recognizably
limited
in
their
ability
to
capture
spatial
and
temporal
variability
of
methyl
parathion
residues
in
drinking
water.

It
is
uncertain
whether
exposures
from
ground
water
would
pose
a
risk
concern
without
any
targeted
monitoring
studies.
The
highly
conservative
modeled
ground
water
concentration
of
0.6
ppb
from
the
acute
model
is
the
estimated
concentration
for
both
the
acute
and
chronic
ground
water
drinking
water
estimates.
However,
EPA
believes
it
is
very
unlikely
that
any
ground
water
exposures
would
be
as
high
as
0.6
ppb,
based
on
fate
information
and
therefore
is
confident
that
this
is
a
reasonable
conservative
estimate.
CHRONIC
A
chronic
DWLOC
(
DWLOCchronic)
was
calculated
using
the
following
formulae:
Page
21
of
120
DWLOCchronic
(
:
g/
L)
=
chronic
water
exposure
(
mg/
kg/
d)
x
body
weight
(
kg)
consumption
(
L/
d)
x
10­
3
mg/
:
g
where
chronic
water
exposure
(
mg/
kg/
d)
=
[
cPAD
­
(
chronic
food
+
residential(
ADD)(
mg/
kg/
d)],
and
ADD
=
average
daily
dose
Residential
exposures
were
not
factored
into
the
DWLOCchronic
since
there
are
no
residential
uses
of
methyl
parathion.

Non­
targeted
surface
water
survey
studies
performed
over
the
past
30
years
have
not
shown
concentrations
of
methyl
parathion
at
levels
predicted
in
the
chronic
modeling
assessments
(
4.2
ppb).
Concentrations
from
available
monitoring
studies
were
well
below
the
OW's
2
ppb
HA.
Although
the
available
chronic
monitoring
data
do
not
allow
a
comprehensive
assessment,
EPA
believes
that
chronic
concentrations
of
methyl
parathion
in
surface
water
will
be
below
the
2
ppb
HA.
The
table
below
shows
the
limited
monitoring
concentration
of
0.009
ppb
does
not
exceed
the
DWLOCchronic.

Table
7:
Chronic
Dietary
Exposure
from
Food
(
post­
MOA)
and
Surface
Water
Population
Monitoring
Data
(
ug/
L)
cPAD
(
mg/
kg/
d)
Chronic
Food
Exposure
(
mg/
kg/
d)
Chronic
H2O
Exposure
(
mg/
kg/
d)
DWLOCchronic
(
ug/
L)

General
U.
S.
population
0.009
0.00002
0.000001
0.000019
0.67
Females
13­
50
years
0.009
0.00002
0.000001
0.000019
0.57
Infants
<
1
year
0.009
0.00002
0.000001
0.000019
0.19
Children
1­
6
years
0.009
0.00002
0.000002
0.000018
0.18
Based
on
the
limited
chronic
drinking
water
monitoring
data,
potential
residues
of
methyl
parathion
in
surface
water
are
not
of
concern.
The
chronic
monitoring
data
were
collected
closer
to
the
tap
(
drinking
water
intake)
over
a
period
of
a
year
from
a
high
use
area
and
therefore,
are
approaching
what
may
be
actual
residues
in
"
at
the
tap"
drinking
water.

Again,
it
is
uncertain
whether
exposures
from
ground
water
would
pose
a
risk
concern
without
any
targeted
monitoring
studies.
The
highly
conservative
modeled
ground
water
concentration
of
0.6
ppb
from
the
acute
model
is
the
estimated
concentration
for
both
the
acute
and
chronic
ground
water
drinking
water
estimates.
However,
EPA
believes
it
is
very
unlikely
that
any
ground
water
concentrations
would
be
as
high
as
0.6
ppb,
based
on
fate
and
monitoring
information.
Page
22
of
120
d.
Drinking
Water
Considerations
There
are
several
things
to
consider
when
weighing
the
potential
contribution
to
the
total
dietary
risk
from
drinking
water
contaminated
with
methyl
parathion.
The
monitoring
data
available
to
the
Agency
indicate
that
exposures
would
be
expected
to
be
lower
than
the
modeled
estimates.
In
addition,
neither
the
models
nor
the
monitoring
data
reflect
concentrations
after
drinking
water
treatment.
There
are
currently
little
data
on
the
efficacy
of
other
more
common
treatment
technologies
in
removing
methyl
parathion.

When
the
available
monitoring
data
were
gathered,
methyl
parathion
was
measured,
but
methyl
paraoxon
usually
was
not.
EPA
does
not
have
any
data
available
with
which
to
predict
the
rate
of
formation,
or
the
half­
life
of,
methyl
paraoxon.
Though
there
are
data
to
show
that
another
organophosphate,
malathion,
degrades
to
its
oxon
metabolite
during
drinking
water
treatment,
it
is
unknown
if
methyl
parathion
would
behave
in
a
similar
manner.
Methyl
paraoxon
was
not
included
in
the
drinking
water
assessment
since
there
are
no
monitoring
detections.

Given
the
fact
that
the
monitoring
data
represent
only
a
very
small
range
of
conditions
(
regional
weather,
streamflow,
application
rates
and
methods),
it
cannot
be
assumed
that
they
represent
surface
water
concentrations
or
conditions
elsewhere
in
the
United
States.
The
data
collected
closest
to
the
tap
(
treatment
plant
intake)
in
Louisiana
do
not
indicate
exposures
that
would
be
of
concern.
Though
the
Agency
considers
it
unlikely
that
drinking
water
concentrations
"
at
the
tap,"
will
make
the
largest,
or
a
significant,
contribution
to
the
total
dietary
burden,
there
is
sufficient
information
from
available
monitoring
data
and
models
to
warrant
close
monitoring
of
potential
surface
and
ground
water
sources
of
methyl
parathion
exposure.

Even
though
the
monitoring
data
exceeds
the
DWLOC
for
some
populations,
the
Agency
believes
that
this
acute
drinking
water
risk
estimate
from
the
uses
of
methyl
parathion
may
be
mitigated
by
provisions
cited
in
this
document
such
as
reduced
application
rates
and
numbers
of
applications.

4.
Aggregate
Risk
Assessment
Under
the
Food
Quality
Protection
Act,
the
Agency
considers
contributions
to
risk
from
various
exposure
sources
for
aggregate
chronic
risk,
specifically;
food,
drinking
water,
and
residential.
Methyl
parathion
has
no
registered
residential
uses,
therefore
only
exposures
through
food
and
drinking
water
were
considered
in
the
aggregate
risk
assessment.
Therefore,
the
aggregate
risks
are
the
same
as
those
presented
in
Section
2
above.

Although
methyl
parathion
is
a
restricted
use
pesticide
that
is
only
to
be
applied
by
certified
applicators,
residential
exposures
may
occur
from
spray
drift
from
the
application
of
methyl
parathion
to
agricultural
fields.
Spray
drift
is
always
a
potential
source
of
exposure
to
residents
nearby
to
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
Page
23
of
120
potential
source
of
exposure
from
ground
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off­
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.

5.
Occupational
and
Residential
Risk
Occupational
workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
pesticide,
or
re­
entering
treated
sites.
Residents
or
homeowners
can
be
exposed
to
a
pesticide
through
mixing,
loading,
or
applying
a
pesticide,
or
through
entering
or
performing
other
activities
on
treated
areas.
However,
as
noted
above,
there
are
no
residential
uses.
Occupational
handlers
of
methyl
parathion
include:
individual
farmers
or
growers
who
mix,
load,
and/
or
apply
pesticides,
and
professional
or
custom
agricultural
applicators.
Risk
for
all
of
these
potentially
exposed
populations
is
measured
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
or
residential
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(
NOAEL).
Generally,
MOEs
greater
than
100
do
not
exceed
the
Agency's
risk
concern.

The
Agency
has
determined
that
there
are
potential
short­
and
intermediate­
term
exposures
to
mixers,
loaders,
applicators,
and
other
occupational
handlers
during
the
usual
use­
patterns
associated
with
methyl
parathion.
Based
on
the
use
patterns
of
methyl
parathion,
nineteen
major
exposure
scenarios
were
identified
for
the
ME
and
EC
formulations.
See
details
in
"
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Methyl
Parathion.
By
Renee
Sandvig.
May
29,
2002".

a.
Current
Label
PPE
Current
label
PPE
for
handlers
includes
coveralls
over
long
sleeved
shirt
and
long
pants,
waterproof
or
chemical
resistant
gloves,
chemical
resistant
footwear
plus
socks,
protective
eye
wear,
and
chemical
resistant
headgear
to
protect
against
overhead
exposure.
For
exposure
in
enclosed
areas,
a
respirator
with
an
organic
vapor
removing
cartridge
with
a
prefilter
or
canister
approved
for
pesticides
is
required.
For
outdoor
exposures,
a
dust/
mist
filtering
respirator
is
required.
Some
labels
also
require
a
chemical
resistant
apron
when
cleaning
equipment
or
mixing/
loading
the
product.
The
1999
MOA
restricts
the
application
of
EC
methyl
parathion
products
to
handlers
using
enclosed
cabs/
cockpits
only
and
prohibits
human
flaggers.
Most
EC
products
are
packaged
Micromatic
"
DV"
liquid
transfer
enclosed
mixing/
loading
systems.

b.
Toxicity
The
toxicity
of
methyl
parathion
is
integral
to
assessing
the
occupational
risk.
All
risk
calculations
are
based
on
the
most
current
toxicity
information
available
for
methyl
parathion.
The
Page
24
of
120
toxicological
endpoints,
and
other
factors
used
in
the
occupational
and
residential
risk
assessments
for
methyl
parathion
are
listed
below.
Methyl
parathion
is
very
toxic
by
oral,
dermal,
and
inhalation
routes,
but
is
not
a
strong
eye
or
dermal
irritant
and
is
not
a
skin
sensitizer.

Table
8:
Acute
Toxicological
Categories
for
Methyl
Parathion.

Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
870.1100
Acute
Oral
(
rat)
LD50
=
4.5­
24
mg/
kg
I
870.1200
Acute
Dermal
(
rat)
LD50
=
6
mg/
kg
I
870.1300
Acute
Inhalation
(
rat)
256961
LC50
<
0.163
mg/
L
(<
7
mg/
kg)
I
870.2400
Primary
Eye
Irritation
(
rabbit)
256966,
40542602
Irritation
clear
by
7
days
III
870.2500
Primary
Skin
Irritation
256962
Max.
score
=
2.0;
72
h
=
0.5
IV
870.2600
Dermal
Sensitization
256963
Negative
NA
870.6100
Acute
Neurotoxicity
Delayed
Hen
41606801
Negative
NA
A
28
day
dermal
toxicity
study
was
selected
for
this
risk
assessment
because
it
is
of
an
appropriate
duration
and
route
of
exposure,
and
the
effects
of
concern
(
ChEI,
hematological
effects,
and
neuropathology)
were
assessed.
Based
on
the
effects
seen
in
this
study
(
MRID#
45481601),
the
LOAEL
was
0.3
mg/
kg/
day
(
based
on
ChEI
in
RBC
and
brain
on
day
28),
with
no
NOAEL
determined.
In
addition
to
the
standard
application
of
a
UF
of
100
to
account
for
inter­
species
variation
(
10x)
and
for
intra­
species
extrapolation
(
10x),
a
UF
of
3
was
applied,
to
extrapolate
from
a
LOAEL
to
a
NOAEL
(
total
UF=
300).
The
choice
of
this
study
and
UF
are
supported
by
the
NOAEL
of
0.11
from
a
chronic
dietary
neurotoxicity
study
with
methyl
parathion,
based
on
brain,
plasma,
and
erythrocyte
ChEI
and
neuropathology
at
the
LOAEL
of
0.53
mg/
kg/
day,
previously
selected
(
March
29,
1999)
for
this
endpoint,
with
a
dermal
absorption
factor
of
100%.

This
chronic
dietary
neurotoxicity
study
in
rats
(
MRID#
41853801,
44204501)
was
selected
for
the
short­
and
intermediate­
term
inhalation
endpoints.
The
dose
and
endpoint
for
risk
assessment
purposes
is
the
NOAEL
=
0.11
mg/
kg
based
on
plasma,
brain
and
RBC
ChEI,
and
neuropathology
at
0.53
mg/
kg
(
LOAEL).
This
study
for
risk
assessment
does
not
underestimate
the
risk
for
both
short­
(
1­
30
days)
and
intermediate­
term
(
1­
6
months)
exposure,
due
to
the
longer
duration
of
the
selected
study
(
one
year)
and
the
evaluation
of
the
critical
effects
(
ChEI
and
neuropathology).
A
UF
of
100
was
applied
to
account
for
inter­
species
variation
(
10x)
and
for
intraspecies
extrapolation
(
10x).
Due
to
the
high
toxicity
seen
in
the
submitted
acute
inhalation
study,
100%
absorption
was
used.
Page
25
of
120
Table
9:
Methyl
Parathion
Endpoints.

Exposure
Scenario
Dose
(
mg/
kg/
day)
Effect
Study
Short­
(
1­
30
days)
&
Intermediate­
(
1­
6
months)
term
Dermal
LOAEL
=
0.3
UF
=
300
Inhibition
of
brain
and
RBC
ChE.
No
NOAEL
identified.
28­
Day
dermal
toxicity
study
in
rats.
MRID#
45481601
Dermal
LOC
for
occupational
MOE
=
300
Short
­
&
Intermediateterm
Inhalation
NOAEL
=
0.11
UF
=
100
Neuropathology
and
inhibition
of
brain,
plasma,
and
RBC
ChE.
Inhalation
absorption
rate
estimated
to
be
100%.
One
year
dietary
neurotoxicity
study
in
rats.
MRID#
41853801,
44204501
Inhalation
LOC
for
occupational
MOE
=
100
Cancer
Classification:
Group
E
or
"
Not
Likely"

The
overall
LOC
for
occupational
MOE
is
100
since
for
the
dermal
study,
the
LOAEL
of
0.3
mg/
kg/
day
is
divided
by
3
to
determine
an
adjusted
LOAEL
of
0.1
mg/
kg/
day
for
use
in
the
risk
calculations.
In
other
words,
the
dermal
and
inhalation
risks
were
normalized
by
applying
the
3x
factor
to
the
dose.
Biomonitoring
exposures
may
occur
by
both
dermal
and
inhalation
routes
and,
given
the
available
data,
cannot
be
separated
into
components
for
risk
assessment.

c.
Exposure
The
duration
of
exposure
for
handlers
of
methyl
parathion
is
assumed
to
be
short­
and
intermediate­
term
(
1­
30
days;
1­
6
months).
Since
methyl
parathion
is
applied
to
several
large
acreage
crops,
it
is
assumed
that
a
professional
pesticide
applicator
could
apply
methyl
parathion
for
over
one
month,
therefore;
intermediate
term
handler
exposure
was
assessed;
however,
endpoints
and
doses
are
the
same
as
for
the
short
term
handler
exposures.

Handler
exposure
assessments
were
completed
using
a
baseline
exposure
scenario
and,
if
required,
increasing
levels
of
risk
mitigation
(
PPE
and
engineering
controls)
in
an
attempt
to
achieve
an
appropriate
margin
of
exposure.
The
baseline
scenario
generally
represents
a
handler
wearing
long
pants,
a
long­
sleeved
shirt,
no
respirator,
and
no
chemical­
resistant
gloves.
Scenarios
were
assessed
with
PHED
and
with
chemical
specific
data
at
the
median
and
90th
percentile
study
unit
exposure.
For
simplicity,
scenarios
with
median
values,
chemical
specific
data
and
engineering
controls
are
presented
here.
For
a
complete
scenario
listing
see
the
"
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Methyl
Parathion.
By
Renee
Sandvig.
May
29,
2002".
Page
26
of
120
Scenarios
included
in
this
document
are:

2a)
Mixing/
Loading
Liquids
(
EC
formulations)
for
Aerial
Application
2c)
Mixing/
Loading
Liquids
(
EC
formulations)
for
Groundboom
Application
3a)
Mixing/
Loading
Liquids
(
ME
formulation)
for
Aerial/
Chemigation
Application
3c)
Mixing/
Loading
Liquids
(
ME
formulation)
for
Groundboom
Application
3e)
Mixing/
Loading
Liquids
(
ME
formulation)
for
Airblast
Sprayer
4)
Applying
Liquids
with
Aerial
Equipment
(
EC
and
ME
formulations)
5)
Applying
Liquids
with
a
Groundboom
Sprayer
(
EC
formulation)
6a)
Applying
Liquids
with
a
Groundboom
Sprayer
(
ME
formulation)
7)
Applying
Sprays
with
an
Airblast
Sprayer
(
ME
formulation)

i.
Chemical
Specific
Data
Chemical
specific
handler
data
were
submitted
by
Cheminova
and
Cerexagri
according
to
the
requirements
stated
in
the
1999
MOA.
Cheminova
submitted
one
biomonitoring
mixer/
loader
study
in
support
of
the
EC
formulation
(
MRID#
455276­
01).
Cerexagri
submitted
two
biomonitoring
mixer/
loader
studies
(
MRID#
455130­
01
&
453271­
01)
and
two
biomonitoring
groundboom
application
studies
(
MRID#
454490­
01
&
455024­
01)
in
support
of
the
ME
formulation.
These
studies
have
been
reviewed
by
the
Agency
for
compliance
with
OPPTS
Series
875:
Occupational
and
Residential
Exposure
Test
Guidelines.
All
workers
who
participated
in
the
biomonitoring
studies
read
and
signed
Informed
Consent
forms,
which
explained
the
purpose
of
the
study,
the
procedures,
and
a
statement
of
their
rights.

Unit
exposure
values
were
calculated
from
the
five
submitted
chemical
specific
handler
studies.
The
amount
of
methyl
parathion
that
a
worker
was
exposed
to
was
determined
by
the
amount
of
the
methyl
parathion
metabolite,
4­
(
or
para)
nitrophenol
(
4NP)
found
in
the
workers'
urine.
The
raw
data
(
which
consisted
of
the
amount
of
4NP
found
in
a
24­
hour
urine
sample)
were
corrected
for
four
parameters:
1)
field
recovery
data,
2)
creatinine
content,
3)
molecular
weight,
and
4)
metabolism
of
methyl
parathion
to
4NP
in
the
body.
The
corrections
for
these
parameters
are
explained
in
Revised
"
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Methyl
Parathion.
Renee
Sandvig.
May
29,
2002.

Both
inhalation
and
dermal
exposure
may
result
from
the
handling
of
methyl
parathion.
Biomonitoring
data
measures
in
total
exposure
(
dermal
+
inhalation),
therefore
it
is
difficult
to
determine
from
which
route
this
exposure
occurred.
Since
the
dermal
and
inhalation
endpoints
are
very
similar
(
0.11
mg/
kg/
day
for
inhalation
and
0.1
mg/
kg/
day
for
dermal),
there
was
no
need
to
determine
from
which
route
the
exposure
occurred.
Page
27
of
120
ii.
Surrogate
Data
Chemical
specific
handler
data
does
not
exist
for
several
of
the
identified
handler
scenarios,
including
application
of
sprays
with
aerial
equipment,
an
airblast
sprayer
(
ME
formulation
only)
and
a
groundboom
sprayer
(
EC
formulation
only).
It
is
the
EPA
policy
to
use
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1
to
assess
handler
exposures
for
regulatory
actions
when
chemical­
specific
monitoring
data
are
not
available.
The
exposure
and
risk
values
were
also
calculated
using
PHED
unit
exposure
values
for
the
scenarios
that
have
chemical
specific
handler
unit
exposure
data
(
mixing/
loading
the
EC
and
ME
formulations
and
applying
the
ME
formulation
with
a
groundboom
sprayer)
as
a
comparison,
since
the
PHED
data
have
more
replicates.

PHED
was
designed
by
a
task
force
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
Regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
PHED
is
a
software
system
consisting
of
two
parts
­­
a
database
of
measured
exposure
values
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(
i.
e.,
replicates).
Users
select
criteria
to
subset
the
PHED
database
to
reflect
the
exposure
scenario
being
evaluated.
The
subsetting
algorithms
in
PHED
are
based
on
the
central
assumption
that
the
magnitude
of
handler
exposures
to
pesticides
are
primarily
a
function
of
activity
(
e.
g.,
mixing/
loading,
applying),
formulation
type
(
e.
g.,
wettable
powders,
granulars),
application
method
(
e.
g.,
aerial,
groundboom),
and
clothing
scenarios
(
e.
g.,
gloves,
double
layer
clothing).

iii.
Data
Comparison
Table
10
below,
shows
a
comparison
of
the
PHED
unit
exposure
values
and
the
unit
exposure
values
determined
from
the
submitted
biomonitoring
studies.
After
the
unit
exposure
values
were
obtained
from
the
study
data,
the
doses
were
calculated
using
the
standard
handler
exposure
equations.

Table
10.
Comparison
of
PHED
and
Study
Unit
Exposure
Values.

Mixer/
Loader
ME
Open
System
(
mg/
lb
ai)
Mixer/
Loader
EC
Closed
System
(
mg/
lb
ai)
Open
Groundboom
Tractor
Applicator
ME
(
mg/
lb
ai)

PHED
unit
exposure
(
dermal/
inhalation)
0.017/
0.00024
(
liquid
surrogate
data)
0.0086/
0.000083
0.011/
0.00015
(
liquid
surrogate
data)

PPE
worn
double
layer
of
clothes,
gloves,
dust/
mist
respirator
single
layer
of
clothes,
gloves
double
layer
of
clothes,
gloves,
dust/
mist
respirator
#
of
PHED
Replicates
75
to
122
dermal,
53
hand,
85
inhalation
16
to
22
dermal,
31
hand,
27
inhalation
23
to
42
dermal,
21
hand,
22
inhalation
Page
28
of
120
Biomonitoring
Study
Unit
Exposure
(
total)
0.000201
0.000030
0.000468
PPE
worn
double
layer
of
clothing,
gloves,
plastic
goggles,
and
dust/
mist
filtering
respirator.
Some
workers
also
wore
a
face
shield,
instead
of
goggles,
chemical
resistant
apron,
and
Tyvek
®
rain
type
hat.
Double
layer
of
clothing,
gloves,
protective
eye
wear,
chemical­
resistant
apron;
and
dust/
mist
filtering
respirator.
double
layer
of
clothes,
gloves,
protective
eyewear,
chemical­
headgear;
and
dust/
mist
respirator
#
of
Study
Replicates
26
16
15
Study
Distribution/
Average
Used
neither
lognormal
or
normal/
median
neither
lognormal
or
normal/
median
lognormal/
geometric
mean
90th
Percentile
Study
Unit
Exposure
Value
(
total)
0.000882
0.000151
0.00186
The
following
factors
should
be
considered
when
comparing
the
differences
in
the
unit
exposure
values
calculated
from
the
study
and
the
PHED
unit
exposure
values.
The
PHED
data
unit
exposure
values
for
mixing/
loading
of
the
ME
formulation
were
conducted
using
liquids,
not
an
ME
formulation;
therefore,
the
study
unit
exposure
values
for
this
formulation
should
be
considered
more
representative
for
the
mixing/
loading
scenario
than
the
PHED
values.
The
lower
ME
unit
exposure
values
may
indicate
that
the
ME
formulation
is
not
as
readily
absorbed
into
the
skin
as
a
standard
liquid,
since
it
is
encased
in
the
microcapsules.
Also,
as
required
by
the
1999
MOA,
the
workers
in
the
chemical
specific
studies
were
wearing
more
PPE
than
the
workers
did
in
the
PHED
studies.
In
the
groundboom
study,
in
addition
to
the
double
layer
of
clothing,
gloves
and
dust/
mist
respirator,
the
workers
wore
plastic
eyewear
and
headgear.
In
the
mixer/
loader
studies,
some
workers
wore
eyewear
or
face
shields,
rain
hats
and
aprons,
in
addition
to
the
double
layer
of
clothing,
gloves
and
dust/
mist
respirator.
In
the
closed
mixing/
loading
study
for
the
EC
formulation,
the
workers
wore
double
layer
of
clothing
and
a
dust/
mist
respirator,
which
are
not
normally
worn
by
workers
operating
closed
systems,
but
which
were
required
for
the
methyl
parathion
EC
by
the
1999
MOA.
This
extra
PPE
may
have
lowered
the
study
unit
exposure
values
in
comparison
to
the
PHED
data.

d.
Summary
of
Risk
Concerns
for
Handlers
Dermal
and
inhalation
risks
for
handlers
were
combined
into
a
total
MOE
since
the
effects
seen
at
the
LOAEL
were
the
same
(
ChEI).
Handler
exposures
to
methyl
parathion
are
expected
to
be
shortand
intermediate­
term
(
1­
30
days,
1­
6
months,
respectively).
Since
short­
and
intermediate­
term
exposures
have
the
same
endpoints,
the
following
risks
are
for
both
durations
of
exposure.
The
target
MOE
for
occupational
exposures
is
100
(
3x
assigned
to
the
short
and
intermediate
term
dermal
endpoint
was
already
accounted
for
by
dividing
the
LOAEL
of
0.3
mg/
kg/
day
by
3
to
determine
an
adjusted
LOAEL
of
0.1
mg/
kg/
day
for
use
in
the
risk
calculations).
Page
29
of
120
Chemical
specific
data
do
not
presently
exist
for
the
following
scenarios
and
may
further
refine
exposure
and
risk
calculations:
applying
the
EC
formulation
with
aerial
equipment
and
groundboom
equipment,
and
applying
the
ME
formulation
with
aerial
equipment
and
airblast
sprayers.
Additionally,
no
data
exists
for
flagging
aerial
spray
operations
for
both
formulations,
but
the
registrants
have
asked
to
prohibit
the
use
of
human
flaggers
for
methyl
parathion
applications.

°
For
mixing/
loading
the
EC
formulation,
all
of
the
assessed
scenarios
have
a
risk
of
concern
using
PHED
data.
Using
the
chemical
specific
data,
no
scenarios
are
of
concern
at
the
50th
percentile.

°
For
mixing/
loading
the
ME
formulation,
all
of
the
assessed
scenarios
have
a
risk
of
concern
using
PHED
data.
Using
the
chemical
specific
data,
one
out
of
the
four
scenarios
assessed
mixing/
loading
for
aerial
applications
has
a
risk
of
concern
at
the
additional
PPE
level
of
exposure;
at
the
50th
percentile.

°
For
applying
the
EC
formulation,
no
chemical
specific
data
were
available
and
all
scenarios
assessed
using
PHED
surrogate
data
have
a
risk
of
concern.

°
For
applying
the
ME
formulation,
all
of
the
assessed
scenarios
have
a
risk
of
concern
using
PHED
data.
Using
the
chemical
specific
data
for
applying
ME
with
a
groundboom,
there
is
a
risk
of
concern
at
an
application
rate
of
1
lb
ai/
acre
and
200
acres
per
day.

The
PHED
data
are
considered
at
the
50th
percentile
and
for
regulatory
purposes,
the
50th
percentile
(
or
median)
of
the
biomonitoring
studies
are
presented
here.
Risks
of
concern
do
exist
using
the
study
data,
at
the
90th
percentile
for
mixing/
loading
the
EC
formulation
for
aerial
applications,
mixing/
loading
the
ME
formulation
for
groundboom,
airblast,
and
aerial
applications.
The
PHED
surrogate
data
do
have
more
replicates
(
53
to
122)
compared
with
the
study
data
(
26)
for
mixing/
loading
and
39
to
47
PHED
replicates
compared
to
15
study
replicates
for
applying
sprays
with
a
groundboom.

The
risks
from
mixing/
loading
the
EC
formulation
in
the
closed
micromatic
"
DV"
liquid
transfer
system
are
lower
than
those
assessed
using
closed
mixing/
loading
PHED
liquid
data.
This
may
indicate
that
the
closed
system
used
in
this
study
is
effective
at
reducing
the
risks
from
mixing/
loading
the
ECs.
However,
the
study
conducted
on
closed
mixing/
loading
using
the
micromatic
"
DV"
transfer
system
had
workers
wearing
more
PPE
than
would
normally
be
used
with
an
engineering
control,
such
as
double
layer
of
clothing
and
a
dust/
mist
respirator.
Risks
of
concern
still
exist
using
the
study
data
at
the
higher
usage
amounts
(
1200
acres
per
day)
and
the
90th
percentile.
The
PHED
data
do
have
more
replicates
(
16
to
32)
compared
with
the
study
data
(
16)
for
mixing/
loading.

Table
11
summarizes
the
MOEs
calculated
for
each
mitigation
level.
The
short
and
Page
30
of
120
intermediate­
term
MOEs
are
identical
since
they
have
the
same
endpoint
(
dermal
endpoint
adjusted).
Page
31
of
120
Table
11.
Summary
of
Occupational
Short­
and
Intermediate­
Term
Total
Inhalation
and
Dermal
MOEs
for
Methyl
Parathion.

Exposure
Scenario
(
Scenario
#)
Unit
Exposure
Data
Sourcea
Maximum
Application
Rate
(
lb
ai/
acre)
b
Cropc
Daily
Acres
Treatedd
Total
MOEe
Baselinef
Additional
PPEg
Engineering
Controlsh
Mixer/
Loader
Exposure
and
Dose
Levels
Mixing/
Loading
Liquids
(
EC
formulations)
for
Aerial
Application
(
2a)
Study
(
45527601)
median
0.375
sugar
beets
350
ND
ND
1800
1.5
Potatoc
440
0.5
Corn
1200
390
1.0
Alfalfa
190
Mixing/
Loading
Liquids
(
EC
formulations)
for
Groundboom
Application
(
2c)
Study
(
45527601)
median
0.375
sugar
beets
80
ND
ND
7800
1.5
potato
1900
0.5
Corn
200
2300
1.0
Alfalfa
1200
Mixing/
Loading
Liquids
(
ME
formulation)
for
Aerial/
Chemigation
Application
(
3a)
Study
(
45327101,
45513001)
Median
0.5
Onion
350
ND
200
ND
1.0
corn
100
2.0
Walnut
50
1
corn
1200
29
Mixing/
Loading
Liquids
(
ME
formulation)
for
Groundboom
Application
(
3c)
Study
(
45327101,
45513001)
Median
0.5
Onion
80
ND
870
ND
1.5
Potato
290
1
corn
200
170
Mixing/
Loading
Liquids
(
ME
formulation)
for
Airblast
Sprayer
(
3e)
Study
(
45327101,
45513001)
Median
2
walnuts
40
ND
440
ND
Applicator
Exposure
Applying
Liquids
with
Aerial
Equipment
(
EC
and
ME
formulations)
(
4)
PHED
0.375
sugar
beets
350
See
Eng.
Controls
See
Eng.
Controls
11
1.0
Alfalfa
4
2.0
Walnut
2
0.5
Corn
1200
2
1.0
Alfalfa
1
Table
11.
Summary
of
Occupational
Short­
and
Intermediate­
Term
Total
Inhalation
and
Dermal
MOEs
for
Methyl
Parathion.

Exposure
Scenario
(
Scenario
#)
Unit
Exposure
Data
Sourcea
Maximum
Application
Rate
(
lb
ai/
acre)
b
Cropc
Daily
Acres
Treatedd
Total
MOEe
Baselinef
Additional
PPEg
Engineering
Controlsh
Page
32
of
120
Applying
Liquids
with
a
Groundboom
Sprayer
(
EC
formulation)
(
5)
PHED
0.375
sugar
beets
80
16
21
46
1.5
Potato
4
5
12
0.5
Corn
200
5
6
14
1.0
Alfalfa
2
3
7
Applying
Liquids
with
a
Groundboom
Sprayer
(
ME
formulation)
(
6a)
Study
(
45449001,
45502401)
geometric
mean
0.5
Onions
80
ND
370
ND
1.5
Potato
130
1.0
Corn
200
75
Applying
Sprays
with
an
Airblast
Sprayer
(
ME
formulation)
(
7)
PHED
2.0
Walnut
40
0.24
0.40
5
Footnotes
EC
=
emulsifiable
concentrate
formulation.
ME
=
microencapsulate
formulation.
ND
=
No
data
for
this
scenario
for
this
data
source.

a
Unit
exposure
data
source:
PHED
unit
exposure
data
shown
for
all
scenarios,
either
as
the
sole
unit
exposure
data
source
or
as
a
comparison
to
the
unit
exposure
data
determined
from
the
studies.
Unit
exposure
data
from
the
studies
shown
for
the
average
unit
exposure
value.
See
above
study
summaries
and
description
of
unit
exposure
calculations
shown
previously
in
this
document
for
more
information.
b
Application
rates
are
a
range
of
maximum
application
rates
proposed
by
the
registrant
and
on
the
labels.
See
list
of
crop
specific
application
rates
in
the
use
section
of
this
assessment
for
more
information.
c
Crops
named
are
index
crops
which
are
chosen
to
represent
all
other
crops
at
or
near
that
application
rate
for
that
use.
See
the
application
rates
listing
in
the
use
summary
section
of
this
document
for
further
information
on
application
rates
used
in
this
assessment.
The
assessment
of
the
range
of
application
rates
that
exists
for
a
scenario
is
what
is
assessed,
index
crops
are
only
for
clarification.
Note:
the
rate
for
use
of
the
EC
on
white
potatoes
is
0.75
lb
ai.
d
Daily
amount
treated
are
based
on
Science
Advisory
Council
for
Exposure
Policy
#
9.1.11
e
Total
Short
and
Intermediate
Term
MOE
=
1/((
1/
dermal
MOE)+(
1/
inhalation
MOE)).
See
Appendix
Tables
E,
F,
and
G
for
individual
dermal
and
inhalation
values.
f
Baseline
exposure
represents
long
pants,
long
sleeved
shirt,
no
gloves,
no
respirator,
open
mixing/
loading,
open
cab
tractor.
Baseline
data
are
not
available
for
aerial
equipment.
g
Additional
PPE
represents
long
pants,
long
sleeved
shirt,
coveralls,
gloves,
dust/
mist
respirator,
open
mixing/
loading,
open
cab
tractor.
h
Engineering
controls
represent
long
pants,
long
sleeved
shirt,
no
gloves
or
respirator
with
the
following
equipment:
Scenario
Number
2
Micromatic
"
DV"
liquid
transfer
system,
gloves,
double
layer
clothing,
and
dust/
mist
respirator
3
Closed
mixing
/
loading,
single
layer
clothing,
chemical
resistant
gloves.
4,
5,
6,
7
Enclosed
cab,
single
layer
clothing,
no
gloves.
Page
33
of
120
6.
Post­
Application
Occupational
Risk
The
postapplication
occupational
risk
assessment
considered
exposures
to
workers
entering
treated
agricultural
sites.
All
of
the
postapplication
risk
calculations
for
handlers
completed
in
this
assessment
are
included
in
the
HED
chapter.
Calculations
were
done
for
activities
such
as
scouting
and
irrigation,
sweet
corn
and
walnut
harvesting,
hand
weeding,
and
thinning.

In
the
Worker
Protection
Standard
(
WPS),
a
restricted
entry
interval
(
REI)
is
defined
as
the
duration
of
time
which
must
elapse
before
residues
decline
to
a
level
so
entry
into
a
previously
treated
area
and
engaging
in
any
task
or
activity
would
not
result
in
exposures
which
are
of
concern.
Typically,
the
activity
with
the
highest
risk
will
drive
the
selection
of
the
appropriate
REI
for
the
crop.
The
REIs
on
currently
registered
methyl
parathion
labels
were
set
according
to
the
requirements
stated
in
the
1999
MOA.
The
REIs
set
in
the
agreement
were
considered
interim
until
methyl
parathion
dislodgeable
foliar
residue
(
DFR)
data
were
reviewed
and
analyzed
in
order
to
determine
the
final
requirements
for
the
REIs.
These
interim
REIs
are
4
days,
except
for
areas
receiving
less
than
25
inches
of
average
rainfall
per
year.
In
these
low
rainfall
areas
the
REI
is
5
days.

a.
Chemical
Specific
Data
The
Agency
has
determined
that
there
are
potential
postapplication
exposures
to
individuals
entering
treated
fields.
Chemical
specific
handler
data
were
submitted
by
the
Cheminova
and
Cerexagri
according
to
the
requirements
stated
in
the
MOA
between
the
primary
methyl
parathion
registrants
and
the
Agency,
dated
August
2,
1999.
Cheminova
submitted
three
DFR
studies
on
corn,
cabbage
and
cotton
in
support
of
the
EC
formulation
(
MRID#
452837­
01,
453174­
01,
&
452925­
01).
Cerexagri
submitted
four
DFR
studies
on
corn
(
2),
walnuts,
and
cotton
(
MRID#
452750­
1,
452697­
01,
453592­
01,
&
452697­
02)
and
three
postapplication
biomonitoring
studies
on
walnut
harvesting,
sweet
corn
hand
harvesting,
and
cotton
scouting
(
MRID#
453677­
01
&
453915­
01
amended,
452001­
01,
&
452047­
01),
in
support
of
the
ME
formulation.
The
postapplication
ME
studies
were
done
concurrently
with
the
DFR
studies
in
order
to
determine
the
transferability
of
the
ME
for
the
activity
conducted
in
the
studies.
These
studies
have
been
reviewed
by
the
Agency
for
compliance
with
OPPTS
Series
875:
Occupational
and
Residential
Exposure
Test
Guidelines.
All
workers
who
participated
in
the
biomonitoring
studies
read
and
signed
Informed
Consent
forms,
which
explained
the
purpose
of
the
study,
the
procedures,
and
a
statement
of
their
rights.
Summaries
of
the
studies
can
be
found
in
Revised
"
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Methyl
Parathion.
Renee
Sandvig.
May
29,
2002.
The
level
of
DFR
of
methyl
paraoxon,
a
degradate
of
methyl
parathion,
was
also
determined
in
the
DFR
studies.
No
toxicity
data
exist
for
methyl
paraoxon,
so
it
is
assumed
to
have
the
same
toxicity
as
methyl
parathion.
Therefore,
the
DFR
values
for
methyl
paraoxon
were
combined
with
the
methyl
parathion
DFR
values
found
on
that
day.
Page
34
of
120
b.
Exposure
and
Risk
Calculations
Chemical
specific
DFR
data
exist
for
the
EC
formulation
on
cotton,
corn
and
cabbage.
Chemical
specific
DFR
data
exist
for
the
ME
formulation
on
cotton,
corn
and
walnuts.
The
DFR
data
were
extrapolated
to
all
remaining
crops.
DFR
data
were
taken
at
three
sites
for
each
crop
tested,
for
both
formulations.
Regression
analyses
were
run
on
each
data
set,
to
determine
half
lives
and
correlation
coefficients
(
R
value)
in
order
to
predict
residues
between
sampling
days
or
after
the
study
was
completed,
if
necessary.
For
each
formulation,
there
was
no
apparent
trend
in
the
half
lives
of
the
DFR
values
between
sites
for
a
single
crop,
such
as
half
lives
being
longer
in
arid
regions.
Therefore,
for
brevity,
the
Agency
chose
one
site
per
crop
per
formulation
to
use
in
the
calculation
of
REIs.
To
be
protective,
the
site
with
the
longest
half
life
was
chosen.
The
half
lives
of
the
ME
formulation
are
longer
than
the
EC
formulation.
This
most
likely
occurred
because
the
polymeric­
type
microcapsules
are
designed
to
slowly
release
the
active
ingredient
over
time.

Transfer
coefficients
were
calculated
from
the
three
submitted
chemical
specific
postapplication
biomonitoring
studies
and
four
microencapsulate
DFR
studies.
The
amount
of
methyl
parathion
that
a
worker
was
exposed
to
was
determined
by
the
amount
of
the
methyl
parathion
metabolite,
4NP
found
in
the
workers'
urine.
The
raw
data
(
which
consisted
of
the
amount
of
4NP
found
in
a
24
hour
urine
sample)
were
corrected
for
four
parameters:
1)
field
recovery
data,
2)
creatinine
content,
3)
molecular
weight,
and
4)
metabolism
of
methyl
parathion
to
4NP
in
the
body.

A
dose
and
an
MOE
were
determined
from
the
declining
predicted
DFR
values
until
the
target
MOE
of
100
was
reached
for
every
crop
for
both
formulations.
Re­
entry
workers
are
expected
to
have
both
short
term
and
intermediate
exposures,
but,
since
the
short­
and
intermediate­
term
dermal
endpoints
are
the
same,
the
calculated
REIs
are
for
both
short­
and
intermediate­
term
exposures.
The
adjusted
dermal
LOAEL
used
in
the
short­
and
intermediate­
term
assessment
is
0.1
mg/
kg/
day
and
the
target
MOE
is
100.

c.
Occupational
Postapplication
Worker
Summary
Occupational
postapplication
risks
from
dermal
exposure
are
of
concern.
For
short­
and
intermediate­
term
exposure
to
the
EC
formulation,
the
day
after
treatment
when
the
calculated
MOE
equals
or
exceeds
the
target
MOE
of
100
(
REI)
ranges
from
4
to
27
days.
For
short­
and
intermediate­
term
exposures
to
the
ME
formulation,
the
day
after
treatment
when
the
calculated
MOE
equals
or
exceeds
the
target
MOE
of
100
(
REI)
ranges
from
8
to
52
days.
See
Table
9
for
a
summary.
The
half
lives
and
subsequent
REI
calculations
of
the
ME
formulation
are
longer
than
those
for
the
EC
formulation.
As
mentioned
above,
this
most
likely
occurred
because
the
polymeric­
type
microcapsules
are
designed
to
slowly
release
the
active
ingredient
over
time.

Worker
exposure
from
entering
the
treated
fields
in
the
three
biomonitoring
postapplication
ME
studies
results
in
a
risk
of
concern
for
hand
harvesting
sweet
corn
when
exposures
were
extrapolated
to
an
eight
hour
work
day.
Page
35
of
120
Table
12.
Summary
of
Calculated
Short­
and
Intermediate­
term
Days
Until
MOEs
Are
100.

Application
Rate
(
lb
ai/
acre)
Activity
Transfer
Coefficienta
(
cm2/
hr)
Day
after
treatment
when
MOE
=
100
Emulsifiable
Concentrate
alfalfa
1
irrigating
and
scouting
1,500
4
barley
0.75
irrigating
and
scouting
1,500
4
beans,
dried
1.5
Hand
harvest
2,500
27
irrigating
and
scouting
1,500
19
cabbage
1.5
Hand
harvesting,
irrigating,
pruning,
and
thinning
5,000
13
hand
weeding
and
scouting
2,000
11
corn
0.5
Hand
harvesting
and
detasseling
17,000
5
irrigating
and
scouting
1,000
3
cotton
0.75
irrigating
and
scouting
1,500
6
hops
1
hand
and
mechanical
harvesting,
training,
hand
weeding,
and
stripping
2,000
16
scouting
1,300
9
oats
0.75
irrigating
and
scouting
1,500
4
onions
0.5
Hand
harvesting
and
thinning
2,500
10
irrigating,
scouting,
hand
weeding,
and
pruning
300
7
peas,
dried
1
hand
harvest
2,500
20
irrigating
and
scouting
1,500
11
canola
0.5
irrigating
and
scouting
1,500
4
rice
0.75
irrigating
and
scouting
1,500
4
rye
0.75
irrigating
and
scouting
1,500
4
soybeans
0.5
irrigating
and
scouting
1,500
4
sugar
beets
0.375
irrigating
and
scouting
1,500
9
100
4
sunflower
1
irrigating
and
scouting
1,500
4
wheat
1.5
irrigating
and
scouting
1,500
4
white
potato
0.75
irrigating
and
scouting
1,500
6
hand
weeding
300
4
Crop
Microencapsulate
Application
Rate
(
lb
ai/
acre)
Activity
Transfer
Coefficienta
(
cm2/
hr)
Day
after
treatment
when
MOE
=
100
Page
36
of
120
almonds,
pecans,
walnuts
2
hand
harvest
(
exposure
to
foliage)
shaking
trees,
hand
raking
nuts,
mechanically
blowing
and
sweeping
nuts
into
windrows
49b
25
hand
harvest
(
exposure
to
soil)
shaking
trees,
hand
raking
nuts,
mechanically
blowing
and
sweeping
nuts
into
windrows
3c
(
g
dry
soil/
hour)
14
(
soil)

barley,
oats,
rice
and
wheat
0.75
Irrigating
and
scouting
640c
31
beans,
dried
1
hand
harvesting
2,500
14
irrigating
and
scouting
640c
11
corn
1
hand
harvesting
and
de­
tasseling
12,000d
52
irrigating
and
scouting
640c
31
sweet
corn
1
hand
harvesting
and
de­
tasseling
Florida
half­
life
data
12,000d
9
cotton
1
scouting
640c
11
lentils
and
dried
peas
0.5
Hand
harvesting
1,500
13
irrigating
and
scouting
640c
10
onions
0.5
Hand
harvesting
1,500
13
irrigating
and
scouting
300
8
soybeans
0.75
Irrigating
and
scouting
640c
11
sweet
potato
0.75
Hand
harvesting
2,500
14
irrigating
and
scouting
640c
11
white
potato
1.5
Irrigating
and
scouting
640c
12
hand
weeding
300
10
Footnotes:

a
Transfer
Coefficients
from
chemical
specific
studies,
when
noted,
otherwise
are
from
Science
Advisory
Council
on
Exposure
Policy
3.1.16
b
Transfer
coefficient
from
microencapsulate
walnut
harvesting
study
MRID
#
45391501.
c
Transfer
coefficient
from
microencapsulate
cotton
scouting
study
MRID
#
45204701.
d
Transfer
coefficient
form
microencapsulate
sweet
corn
hand
harvesting
study
MRID
#
45800101.

7.
Human
Incident
Summary
The
Agency
has
reviewed
the
Incident
Data
System,
the
Poison
Control
Center,
the
California
Department
of
Food
and
Agriculture
(
Department
of
Pesticide
Regulation),
and
the
National
Pesticide
Page
37
of
120
Telecommunications
Network
databases
for
reported
incident
information
for
methyl
parathion
(
Review
of
Methyl
Parathion
Incident
Reports.
Jerome
Blondell
&
Monica
Spann.
February
5,
1998).
A
number
of
accidental
human
poisonings
from
exposure
to
methyl
parathion
in
both
occupational
and
residential
settings
have
been
reported.
The
data
from
these
sources
often
lacked
specific
information
on
the
extent
of
exposure
and
the
circumstances
of
exposure.
Collectively,
however,
the
incidence
information
indicate
definite
poisoning
risks
from
misuse
of
products
that
contain
methyl
parathion,
or
from
not
wearing
personal
protective
equipment,
or
from
spray
drift.

Exposure
to
methyl
parathion
can
lead
to
systemic
illness.
In
outdoor
agricultural
situations,
the
primary
activities
associated
with
poisoning
are
application
and
spray
drift.
Compared
to
other
OP
and
carbamate
insecticides,
methyl
parathion
is
associated
with
less
poisoning
when
adjusted
for
amount
of
use.
To
some
extent
the
similarity
between
the
methyl
parathion
and
the
far
more
toxic
ethyl
parathion
(
in
terms
of
poisonings
and
deaths
even
after
adjusting
for
use),
may
have
resulted
in
workers
handling
any
product
with
the
'
parathion'
name
with
greater
care.
More
recently,
ethyl
parathion
uses
have
been
cancelled.

Interior
home
misuse
of
methyl
parathion
has
resulted
in
deaths
in
two
separate
incidents
in
Mississippi.
Food
or
water
contamination
and
an
unusually
high
concentration
used
in
the
application
probably
contributed
to
these
deaths
which
occurred
in
the
1970s
and
early
1980s.
The
more
recent
cases
exposed
primarily
in
Ohio,
Mississippi,
and
Louisiana
have
been
summarized
in
Environmental
Health
Perspectives
and
the
articles
can
be
found
at:
"
http://
ehpnet1.
niehs.
nih.
gov/
docs/
2002/
suppl­
6/
toc.
html".

B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
is
presented
below.
For
detailed
discussions
of
all
aspects
of
the
environmental
risk
assessment,
see
the
revised
Environmental
Fate
and
Effects
Division
chapter,
dated
July
30,
1999,
available
in
the
public
docket.
This
document
was
revised
to
account
for
use
reductions
in
the
number
of
applications
and
maximum
application
rate.

In
general,
ecological
risk
assessment
indicates
that
methyl
parathion
may
pose
an
acute
and
chronic
risk
of
adverse
effects
to
birds.
Toxicity
studies
indicate
that
a
series
of
effects
occur
with
short
exposure
to
methyl
parathion.
These
effects
include
direct
mortality,
as
well
as
sub­
lethal
effects
such
as
reproduction
effects,
changes
in
maternal
care
and
viability
of
young
birds,
anorexia,
increased
susceptibility
to
predation,
and
greater
sensitivity
to
environmental
stress.
Estimated
environmental
concentrations
suggest
that
levels
of
concern
for
acute
risk
to
freshwater
fish
are
exceeded
only
at
the
highest
use
rate,
although
there
is
high
uncertainty
in
this
analysis.
Other
data
suggest
the
potential
for
indirect
effects
to
freshwater
fish
from
methyl
parathion
exposure.
Methyl
parathion
use
appears
to
pose
acute
risk
to
estuarine
and
marine
fish,
although
there
is
uncertainty
associated
with
the
exposure
component
of
this
analysis
(
e.
g.,
use
of
a
static
pond
to
represent
water
bodies
that
may
be
influenced
by
tides).

Extensive
field
incident
data
over
20
years
indicate
that
methyl
parathion
poses
risks
to
honey
bees,
and
that
bee
kill
incidents
continue
to
occur.
Currently,
warning
language
is
on
labels
for
the
ME
Page
38
of
120
formulation,
because
the
microencapsules
are
inadvertently
collected
by
honey
bees
along
with
pollen.
Studies
suggest
that
the
emulsifiable
concentrate
formulation
of
methyl
parathion
is
also
hazardous
to
bees.

Further,
evidence
exists
in
the
open
literature
that
methyl
parathion
may
hinder
successful
reproduction
and
sexual
development
in
non­
target
organisms,
such
as
birds,
mammals,
and
fish.

1.
Environmental
Fate
and
Transport
The
major
routes
of
dissipation
for
methyl
parathion
are
microbial
degradation,
aqueous
photolysis,
hydrolysis,
and
incorporation
into
soil
organic
matter.
Methyl
parathion
degrades
rapidly
(
t
½
<
5
days)
in
soil
and
water.
It
also
is
expected
to
photodegrade
(
t
½
=
49
hours)
in
aquatic
environments.
Other
degradation
processes
appear
to
be
less
important
routes
of
methyl
parathion
dissipation.
Methyl
parathion
slowly
hydrolyzed
(
t
½
=
68
days
at
pH
5,
t
½
=
40
days
at
pH
7,
t
½
=
33
days
at
pH
9)
in
sterile
buffer
solutions
and
slowly
photodegraded
(
t
½
=
61
days)
on
soil
surfaces.

The
major
(>
10%
of
applied)
degradation
product
of
methyl
parathion
is
4­
nitrophenol
which
is
formed
by
the
cleavage
of
the
P­
O
bond
in
methyl
parathion.
Several
minor
degradates
(<
10%
of
applied)
that
have
been
found
in
laboratory
studies
including
methyl
paraoxon,
which
is
the
only
degradate
included
in
the
dietary
risk
assessment
and
tolerance
expression
for
methyl
parathion.
Methyl
paraoxon
is
formed
through
desulfonation
(
P=
S
to
P=
O)
of
methyl
parathion.

Methyl
parathion
is
mobile
to
relatively
mobile
in
soil
and
thus
runoff
and
leaching
could
be
potential
routes
of
dissipation.
However,
the
low
persistence
of
methyl
parathion
is
expected
to
limit
the
extent
of
off­
site
movement.
Another
route
of
dissipation
is
the
secondary
movement
through
volatilization
of
methyl
parathion
from
soil
and
leaf
surfaces.
Although
laboratory
studies
indicate
that
methyl
parathion
volatilization
is
not
a
major
route
of
dissipation,
methyl
parathion
has
been
detected
in
air
and
rain
samples
across
the
United
States.
These
detections
appear
to
be
correlated
to
use
on
cotton,
soybeans,
and
wheat.

2.
Toxicity
(
Hazard)
Assessment
a.
Avian/
Mammalian
Toxicity
Methyl
parathion
is
highly
toxic
to
very
highly
toxic
to
birds
on
a
acute
basis
from
single
oral
doses,
dermal
exposures
and
from
short
term
dietary
exposure.
Toxicity
values
are
given
in
Table
13.
Page
39
of
120
Table
13.
Acute
Toxicity
to
Birds
Species
LD50
(
mg/
kg)
Toxicity
Category
Acute
Oral
(
Single
dose
by
gavage)

Mallard
duck
(
MRID
00160000)
6.6
Very
highly
toxic
Northern
bobwhite
quail
(
MRID
00160000)
7.6
Very
highly
toxic
Acute
Dermal
Northern
bobwhite
quail
Emulsifiable
concentrate
(
MRID
71200)
Micro­
encapsulate
(
MRID
83103)
2.9
9.1
Very
highly
toxic
Subacute
dietary1
(
five
days
of
treated
feed)

Northern
bobwhite
quail
(
MRID
102329)
28
Very
highly
toxic
1
Test
organisms
observed
an
additional
three
days
while
on
untreated
feed.

Chronic
effects
to
birds
measured
by
avian
reproduction
studies
show
reproductive
effects
at
low
levels
as
seen
in
Table
14.

Table
14.
Reproductive
Toxicity
to
Birds
Species/
Study
Duration
NOEC
(
ppm
ai)
LOEC
(
ppm
ai)
LOEC
Endpoints
Northern
bobwhite
(
MRID
41179302)
6.27
15.5
Egg
production,
egg
set
per
hen
and
adult
female
bodyweight
Mammalian
toxicity
Wild
mammal
testing
is
not
available
for
methyl
parathion;
therefore,
rat
toxicity
values
obtained
from
the
Agency's
Health
Effects
Division
(
HED)
substitute
for
wild
mammal
testing.
Acute
and
chronic
rat
toxicity
data
relevant
to
ecological
effects
show
that
methyl
parathion
is
very
highly
toxic
to
small
mammals
on
an
acute
oral
basis.
Methyl
parathion
affects
mammalian
reproduction
at
dietary
concentrations
above
5
ppm
and
causes
significant
decreased
pup
survival
and
reduced
maternal
bodyweight
during
lactation.

Non­
target
Insect
toxicity:
Honey
bee
toxicity
tests
show
that
methyl
parathion
is
very
highly
toxic
to
honey
bees.

Table
15.
Nontarget
Insect
Toxicity
Species
Results
MRID
No.
Author/
Year
Study
Classification
Honey
bee
(
Apis
mellifera)
LD50
0.111
µ
g/
bee
44038201
Atkins,
1981
Core
Species
Results
MRID
No.
Author/
Year
Study
Classification
Page
40
of
120
Honey
bee
(
Apis
mellifera)
Penncap­
M
LD50
0.214
µ
g/
bee
44038201
Atkins,
1981
Core
b.
Toxicity
to
Aquatic
Animals
Freshwater
Fish
and
Amphibians:
Methyl
parathion
has
been
shown
to
be
moderately
to
highly
toxic
to
freshwater
fish
and
amphibians;
toxicity
values
are
listed
in
the
table
below.
Methyl
parathion
is
also
moderately
toxic
to
larval
stages
of
developing
frogs
and
possibly
other
amphibian
species.

Table
16:
Freshwater
Fish
and
Amphibian
Acute
Toxicity
Species/
%
ai
96­
hour
LC50
(
ppm)
(
95%
CI)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Bluegill
sunfish
(
Lepomis
macrochirus)
77
1.0(
0.6­
1.6)
highly
toxic
40098001
Mayer/
1986
Core
Chorus
frog
(
Pseudacris
triseriata)
90
3.7(
N.
R.)
moderately
toxic
40098001
Mayer/
1986
Supplemental
Freshwater
Fish,
Chronic
Methyl
parathion
causes
chronic
effects
in
fish
at
concentrations
less
than
80
ppb.
The
endpoints
measured
are
based
on
growth.

Table
17.
Freshwater
Fish
Early
Life­
Stage
Toxicity
Under
Flow­
through
Conditions
Species/
Study
Duration
%
ai
NOEC/
LOEC
(
ppm)
(
95%
CI)
Endpoints
Affected
MRID
No.
Author/
Year
Study
Classification
Fathead
Minnow
(
Pimephales
promelas)
80
0.31/
0.38
Weight
233438
Jarvinen/
1988
Core
Rainbow
trout
(
Oncorhynchus
mykiss)
Technical
75.1
<
0.08
Length
and
weight
250628
Bailey/
1983
Supplemental
Freshwater
Invertebrates,
Acute
A
freshwater
aquatic
invertebrate
toxicity
test
showed
methyl
parathion
to
be
very
highly
toxic
to
aquatic
invertebrates.
Page
41
of
120
Table
18:
Freshwater
Invertebrate
Acute
Toxicity
Species
%
ai
48­
hour
LC50/
EC50
(
ppb)
(
95%
CI)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Waterflea
(
Daphnia
magna)
90
0.14(
0.09­
0.2)
very
highly
toxic
40094602
Johnson/
1980
Core
Freshwater
Invertebrate,
Chronic
A
freshwater
aquatic
invertebrate
life­
cycle
test
shows
that
methyl
parathion
affects
aquatic
invertebrates
at
less
than
0.25
ppb.
From
other
studies,
endpoints
affected
are
number
of
young
produced
and
survival
and
growth.

Table
19.
Freshwater
Aquatic
Invertebrate
Life­
Cycle
Toxicity
Species/
Flow­
through)
%
ai
21­
day
NOEC/
LOEC
(
ppb)
Endpoints
Affected
MRID
No.
Author/
Year
Study
Classification
Waterflea
(
Daphnia
magna)
80%
0.02/
0.25
Neonates
produced,
survival,
growth
(
length)
44371716
Fernandez­
Casalderrey
Supplemental
Estuarine
and
Marine
Fish,
Acute
Acute
toxicity
testing
with
estuarine/
marine
fish
shows
that
methyl
parathion
is
very
highly
toxic
to
estuarine
fish.

Table
20:
Estuarine/
Marine
Fish
Acute
Toxicity
Species
%
ai
96­
hour
LC50
ppm
(
95%
CI)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Spot
(
Leiostmous
xanthurus)
99
0.059
(
0.045­
0.074)
"
very
highly
toxic"
40228401
Mayer/
1986
Supplemental
No
data
are
available
to
assess
the
chronic
affect
of
methyl
parathion
on
estuarine
and
marine
fish.

Estuarine
and
Marine
Invertebrates,
Acute
and
Chronic
Methyl
parathion
was
shown
to
be
very
highly
toxic
to
estuarine/
marine
invertebrates
on
acute
basis
and
to
cause
chronic
effects
at
low
concentrations.
Page
42
of
120
Table
21(
a):
Estuarine/
Marine
Invertebrate
Acute
Toxicity
Species/
Static
or
Flow­
through
%
ai.
96­
hour
LC50/
EC50
(
ppb)
(
measured)
(
95%
CI)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Mysid
(
Americamysis
bahia)
43.2
0.35
(
0.31­
0.39)
a.
i.,
not
product
very
highly
toxic
40932104
Core
Table
21(
b).
Estuarine/
Marine
Invertebrate
Life­
Cycle
Toxicity
Species/(
Static
Renewal
or
Flowthrough
21­
day
NOEC/
LOEC
(
ppb)
MATC
(
ppm)
Endpoints
Affected
MRID
No.
Author/
Year
Study
Classification
Mysid
(
Americamysis
bahia)
0.11/
0.37
0.20
Survival
and
Number
of
offspring/
&
66341
Lowe/
1981
Core
c.
Toxicity
to
Plants
Environmental
Health
Criteria
145
from
the
World
Health
Organization
(
WHO)
1993
reports
that
phytotoxic
effects
of
methyl
parathion
have
been
observed
in
cotton
and
lettuce
and
that
methyl
parathion
has
been
shown
to
cause
a
reduction
of
growth
in
sorghum.
No
terrestrial
plant
data
have
been
reviewed
for
this
assessment.

Aquatic
plant
testing
shows
that
methyl
parathion
is
``
moderately
toxic"
to
marine
diatoms.

Table
22:
Nontarget
Aquatic
Plant
Toxicity
(
Tier
II)

Species
Nonvascular
Plants
%
ai
EC50/
(
ppm)
(
95%
CI)
MRID
No.
Author/
Year
Study
Classification
Marine
diatom
(
Skeletonema
costatum)
99
5.3
(
4.3­
5.7)
Lowe
66341/
1981
Supplemental
3.
Exposure
and
Risk
Calculations
a.
Levels
of
Concern
Risk
characterization
integrates
the
results
of
the
exposure
and
ecotoxicity
data
to
evaluate
the
likelihood
of
adverse
ecological
effects.
The
Agency
calculates
risk
quotients
(
RQs)
by
dividing
exposure
estimates
by
acute
and
chronic
ecotoxicity
values:
Page
43
of
120
RQ
=
EXPOSURE/
TOXICITY
RQs
are
then
compared
to
OPP's
levels
of
concern
(
LOCs).
These
LOCs
are
criteria
used
by
OPP
to
indicate
potential
risk
to
nontarget
organisms
and
the
need
to
consider
regulatory
action.
The
criteria
indicate
that
a
pesticide
used
as
directed
has
the
potential
to
cause
adverse
effects
on
nontarget
organisms.
Risk
presumptions,
along
with
the
corresponding
LOCs,
are
given
in
the
table
below:

Table
23.
Risk
Presumptions
for
Terrestrial
and
Aquatic
Animals
Risk
Presumption
LOC
terrestrial
animals
LOC
aquatic
animals
Acute
High
Risk
there
is
potential
for
acute
risk;
regulatory
action
may
be
warranted
in
addition
to
restricted
use
classification,
0.5
0.5
Acute
Restricted
Use
­
there
is
potential
for
acute
risk,
but
may
be
mitigated
through
restricted
use
classification,
0.2
0.1
Acute
Endangered
Species
­
endangered
species
may
be
adversely
affected;
regulatory
action
may
be
warranted,
0.1
0.05
Chronic
Risk
­
there
is
potential
for
chronic
risk;
regulatory
action
may
be
warranted.
1
1
b.
Exposure
and
Risk
to
Nontarget
Terrestrial
Animals
For
pesticides
applied
as
liquids,
the
estimated
environmental
concentrations
(
EECs)
on
food
items
following
product
application
are
compared
to
LC50
values
to
assess
risk
with
a
Risk
Quotient
(
RQ)
method.
Estimates
of
maximum
and
average
residue
levels
of
methyl
parathion
on
wildlife
food
was
based
on
the
model
of
Hoerger
and
Kenega
(
1972),
as
modified
by
Fletcher
et
al.
(
1994).
EECs
resulting
from
multiple
applications
are
calculated
from
the
maximum
number
of
applications,
minimum
application
interval,
and
foliar
half­
life
data.
Willis
and
McDowell
(
1987)
reported
a
number
of
methyl
parathion
foliar
half­
lives
ranging
from
0.1
to
13.5
days,
with
most
values
being
<
2
days.
This
assessment
uses
a
foliar
half­
life
of
2.4
days
which
is
the
upper
90th
percentile
confidence
limit
of
the
mean
value.
The
foliar
half­
life
adjustment
does
not
account
for
the
formation
of
toxic
degradates.
Methyl
paraoxon,
which
is
highly
toxic,
may
form
on
plant
foliage
after
the
parent
degrades
which
would
cause
this
analysis
to
underestimate
avian
risk
because
it
does
not
consider
potential
avian
exposure
to
methyl
paraoxon.

Avian:
The
table
below
lists
the
avian
acute
and
chronic
risk
quotients
for
several
major
crops
for
methyl
parathion
use.
Short
grass
represents
the
food
items
with
the
highest
residue
concentration
and
therefore,
the
highest
RQ,
conversely,
seeds
represent
the
foodstuffs
with
the
lowest
RQs.
Other
food
items
fall
within
this
range.
For
birds,
RQs
greatly
exceed
all
levels
of
concern
even
for
single
applications.
Page
44
of
120
Table
24:
Avian
Acute
and
Reproduction
Risk
Quotients
for
Single
and
Multiple
Applications
Based
on
Maximum
Residues
(
LC50
=
28.2
ppm,
Reproduction
NOEC
=
6.27
ppm)

Crop
(
#
Apps,
App.
Interval
in
days)
Rate
(
lbs
ai/
A)
Food
Items
Single
Application
Multiple
Applications
Acute
RQ*
Reproduction*
*
RQ
Acute
RQ*
Reproduction
RQ**

Cotton
(
5,7)
1.5
Short
grass
12.77
57.42
14.71
66.18
Seeds
0.80
3.59
0.92
4.14
Corn
(
3,5)
1.0
Short
grass
8.51
38.28
10.99
49.44
Seeds
0.53
2.39
0.69
3.09
Alfalfa
(
6,4)
1.0
Short
grass
8.51
38.28
12.41
55.82
Seeds
0.53
2.39
0.78
3.49
Pecan
(
8,14)
2.0
Short
grass
17.02
76.56
17.33
77.92
Seeds
1.06
4.78
1.08
4.87
Potato
(
4,7)
1.5
Short
grass
12.77
57.42
14.71
66.16
Seeds
0.80
3.59
0.92
4.14
*
acute
RQ
(
EEC/
LC50)

**
Reproduction**
RQ
(
EEC/
NOEC)

For
mammals,
risk
quotients
are
calculated
on
a
body
weight
basis
based
on
an
LD50
on
a
body
weight
basis.
Even
though
risk
quotients
are
provided
on
a
single
application
only,
most
single
application
uses
exceed
LOC
criteria.
Multiple
applications
will
result
in
quantitatively
higher
exceedances
of
the
LOC
criteria.
Page
45
of
120
Table
25:
Mammalian
Acute
and
Chronic
Risk
Quotients
for
a
Single
Application
Based
on
Average
Residues
(
LD50
=
3.6
ppm,
Reproduction
NOEC
=
5
ppm)

Crop
(
#
Apps,
App.
Interval
in
days)
App.
Rate
(
lbs
ai/
A)
Food
Items
15
g
mammal
Acute
RQ
35
g
mammal
Acute
RQ
1000
g
mammal
Acute
RQ
Rat
Chronic
Dietary
RQ
Cotton
(
5,7)

Potato
(
4,7)
1.5
Short
grass
95.00
66.00
15.00
72.00
Seeds
1.31
0.94
0.19
4.50
Corn
(
3,5)

Alfalfa
(
6,4)
1.0
Short
grass
63.33
44.00
10.00
48.00
Seeds
0.88
0.63
0.13
3.00
Pecan
(
8,14)
2.0
Short
grass
126.67
88.00
20.00
96.00
Seeds
1.75
1.25
0.25
6.00
Risk
quotients
are
generally
not
calculated
for
non­
target
insects.
Tests
with
Penn­
cap
M
showed
that
the
average
mortality
of
the
adult
honey
bees
was
from
29
to
72
times
higher
than
normal
the
first
48
hours
after
pollen
containing
Penncap
­
M,
stored
13.5
and
14.5
months
in
the
cells
of
wax
combs,
was
introduced
into
nucleus
colonies.
After
1
week
adult
mortality
was
still
4
to
10
times
higher
than
normal.
After
4
weeks,
mortality
was
nearly
normal.
Chemical
analysis
of
the
stored
pollen
showed
26
ppm
methyl
parathion.
(
MRID
160948).
Methyl
parathion
is
very
highly
toxic
to
bees
on
an
acute
contact
basis
and
suggest
strongly
that
mortality
will
occur
under
fields
conditions.
Additional
evidence
from
the
open
literature
is
cited
in
the
risk
assessment.
Field
reports
of
bee
kills
are
provided
Appendix
2.
Also,
several
studies
have
shown
that
methyl
parathion
is
toxic
to
bees
exposed
to
foliar
residues
(
Atkins
and
Kellum,
1980,
MRID
00074486,
Waller,
1983
MRID
138663).
Atkins
and
Kellum
(
1980)
reported
that
residues
of
methyl
parathion
on
alfalfa
foliage
were
highly
toxic
to
honeybees
at
application
rates
ranging
from
0.03125
to
0.5
lb
ai/
acre.
At
the
higher
rates
(
0.25
and
0.5
lb
ai/
acre),
the
toxicity
persisted
from
4
to
6
days.

c.
Exposure
and
Risk
to
Nontarget
Aquatic
Animals
i.
Surface
water
resource
assessment
PRZM­
EXAMS
water
modeling
was
conducted
to
determine
potential
exposure
to
aquatic
animals
in
surface
water.
The
modeling
results
are
summarized
here.
Refer
to
the
EFED
chapter
for
an
in­
depth
discussion
of
the
water
models.

Non­
targeted
monitoring
data
for
methyl
parathion
in
surface
waters
is
fairly
robust
and
the
drinking
water
assessment
is
based
on
monitoring
data.
However,
most
of
the
monitoring
information
gathered
is
from
large
water
bodies
and
ecological
impacts
are
often
greatest
in
low
order
streams,
Page
46
of
120
ponds
and
potholes.
PRZM­
EXAMS
is
an
edge
of
field
model
and
is
appropriate
to
estimate
concentrations
for
exposures
to
fish
and
aquatic
invertebrates.

The
tables
below
cite
a
variety
of
estimated
concentrations
from
particular
modeling
scenarios
and
provides
risk
quotients
for
aquatic
animals.
Generally,
freshwater
fish
are
not
likely
to
be
at
direct
risk
from
uses
of
methyl
parathion,
but
estuarine/
marine
fish
may
potentially
be
at
risk
from
some
uses
of
methyl
parathion
(
e.
g.,
cotton
and
pecans
uses
near
these
environments).
Freshwater
and
estuarine/
marine
invertebrates
may
potentially
be
at
risk
based
on
exceedance
of
acute
and
chronic
LOCs
from
all
uses
of
methyl
parathion.

ii.
Risk
Quotients
for
Aquatic
Animals
Table
26:
Risk
Quotients
for
Freshwater
fish
and
Amphibians
(
LC50
=
1.0
ppm
and
NOEC
<
80
ppb)

Crop/
Site
Rate
(
lbs.
ai/
A)
No.
of
applications
/
interval
EEC
(
Peak)
ppb
EEC
(
60
day)
ppb
Acute
RQ
(
EEC/
LC50)
Chronic
RQ
(
EEC/
NOEC)

MS
Cotton
1.5
5,7
106.76
12.33
0.11
0.15
IL
Corn
1.0
3,5
19.26
3.82
0.02
0.05
PA
Alfalfa
1.0
6,4
22.01
5.96
0.02
0.08
GA
Pecan
2.0
8,14
123.5
15.83
0.12
0.20
ID
Potato
1.5
4,7
41.70
6.75
0.04
0.08
Table
27:
Risk
Quotients
for
Freshwater
Invertebrates
(
EC50
=
0.14
ppb
and
NOEC
=
0.02
ppb)

Crop/
Site
Rate(
lbs.
ai/
A)
No.
of
applications
/
interval
EEC
(
Peak)
ppb
EEC
(
21
day)
ppb
Acute
RQ
(
EEC/
EC50)
Chronic
RQ
(
EEC/
NOEC)

MS
Cotton
1.5
5,7
106.76
29.51
762.6
1475.5
IL
Corn
1.0
3,5
19.26
8.60
137.6
430
PA
Alfalfa
1.0
6,4
22.01
11.55
157.2
577.5
GA
Pecan
2.0
8,14
123.5
35.39
882.1
1769.5
ID
Potato
1.5
4,7
41.70
15.81
297.9
790.5
Page
47
of
120
Table
28:
Risk
Quotients
for
Estuarine/
Marine
Fish
(
EC50
=
59
ppb)

Crop/
Site
Rate(
lbs.
ai/
A)
No.
of
applications
/
interval
EEC
(
Peak)
ppb
EEC
(
60
day)
ppb
Acute
RQ
(
EEC/
EC50)

MS
Cotton
1.5
5,7
106.76
12.33
1.81
IL
Corn
1.0
3,5
19.26
3.82
0.33
PA
Alfalfa
1.0
6,4
22.01
5.96
0.37
GA
Pecan
2.0
8,14
123.5
15.83
2.09
ID
Potato
1.5
4,7
41.70
6.75
0.71
No
acceptable
fish
early­
life
stage
study
is
available
for
estuarine
/
marine
fish.
Therefore,
chronic
risk
to
estuarine/
marine
fish
cannot
be
evaluated
at
this
time.

Table
29:
Risk
Quotients
for
Estuarine/
Marine
Invertebrates
(
EC50
=
0.35
ppb
and
NOEC
=
0.11
ppb).

Crop/
Site
Rate(
lbs.
ai/
A)
No.
of
applications
/
interval
EEC
(
Peak)
ppb
EEC
(
21
day)
ppb
Acute
RQ
(
EEC/
EC50)
Chronic
RQ
(
EEC/
NOEC)

MS
Cotton
(
New)
1.5
5,7
106.76
29.51
305.03
268.27
IL
Corn
(
New)
1.0
3,5
19.26
8.60
55.03
78.18
PA
Alfalfa
(
New)
1.0
6,4
22.01
11.55
62.89
105.0
GA
Pecan
(
New)
2.0
8,14
123.5
35.39
352.86
321.73
ID
Potato
(
New)
1.5
4,7
41.70
15.81
119.14
143.73
d.
Exposure
and
Risk
to
Nontarget
Plants
Exposure
to
terrestrial
plants
will
occur
through
foliar
sprays.
Risk
to
terrestrial
plants
cannot
be
assessed
due
to
lack
of
phytotoxicity
data.
Exposure
to
nontarget
aquatic
plants
may
occur
through
runoff
or
spray
drift
from
adjacent
treated
sites.
Since
methyl
parathion
was
shown
to
be
of
moderate
toxicity
to
Skeletonema
costatum,
there
are
no
major
concerns
to
highlighted
at
this
time.
However,
data
are
lacking
on
other
aquatic
plants.

4.
Ecological
Incidents
The
majority
of
methyl
parathion
ecological
incidents
are
honey
bee
kills.
The
risk
to
honeybees
is
well
illustrated
by
over
two
decades
of
bee
kills
since
Penncap­
M
was
first
marketed
in
the
1970'
s.
Both
formulations
can
cause
bee
kills,
but
the
microencapsulated
formulation
extends
the
life
of
the
product
in
the
hive.
A
detailed
summary
of
bee
kills
is
included
in
the
July,
1999
EFED
risk
assessment.
It
is
significant
that
the
great
majority
of
the
incidents
included
in
the
table
are
related
to
Page
48
of
120
orchard
uses
of
methyl
parathion.
The
removal
of
tree
fruit
uses
should
significantly
reduce
the
number
of
bee
kills
caused
by
methyl
parathion.

There
are
relatively
few
bird
and
fish
kill
incidents
which
are
strongly
linked
to
methyl
parathion
use.
The
absence
of
additional
documented
incidents
involving
non­
targeted
terrestrial
organisms
does
not
necessarily
mean
that
such
incidents
do
not
exist.
Mortality
incidents
must
be
seen,
reported,
investigated,
and
submitted
to
the
Agency
in
order
to
be
recorded
in
the
database.
Incidents
may
not
be
noted
because
the
carcasses
decayed
in
the
field,
were
removed
by
scavengers,
or
were
in
out­
ofthe
way
or
hard­
to­
see
locations.
Poisoned
birds
may
fly
off­
site
to
less
conspicuous
areas
before
dying.
An
incident
also
may
not
be
reported
to
appropriate
authorities
capable
of
investigating
it.

5.
Endangered
Species
Endangered
species
LOCs
are
exceeded
for
acute
and
chronic
risks
to
birds,
mammals
and
freshwater
and
estuarine/
marine
invertebrates,
fish,
amphibians,
reptiles
and
terrestrial
invertebrates
(
including
insects).
At
this
time
there
are
no
federally
listed
estuarine
invertebrates.

When
the
regulatory
changes
recommended
in
this
IRED
are
implemented
and
the
ecological
effects
and
environmental
fate
data
are
submitted
and
accepted
by
the
Agency,
the
Reasonable
and
Prudent
Alternatives
and
Reasonable
and
Prudent
Measures
in
the
Biological
Opinion(
s)
may
need
to
be
reassessed
and
modified
based
on
the
new
information.

The
Agency
is
currently
engaged
in
a
Proactive
Conservation
Review
with
FWS
and
the
National
Marine
Fisheries
Service
under
section
7(
a)(
1)
of
the
Endangered
Species
Act.
The
objective
of
this
review
is
to
clarify
and
develop
consistent
processes
for
endangered
species
risk
assessments
and
consultations.
Subsequent
to
the
completion
of
this
process,
the
Agency
will
reassess
the
potential
effects
of
methyl
parathion
use
to
federally
listed
threatened
and
endangered
species.
At
that
time
the
Agency
will
also
consider
any
regulatory
changes
recommended
in
the
IRED
that
are
being
implemented.
Until
such
time
as
this
analysis
is
completed,
the
overall
environmental
effects
mitigation
strategy
articulated
in
this
document
and
any
County
Specific
Pamphlets
described
in
Section
IV
which
address
methyl
parathion,
will
serve
as
interim
protection
measures
to
reduce
the
likelihood
that
endangered
and
threatened
species
may
be
exposed
to
methyl
parathion
at
levels
of
concern.

6.
Risk
Characterization
a.
Terrestrial
Organisms
i.
Avian
Risk
EPA
concludes
that
methyl
parathion
may
pose
significant
acute
and
chronic
risk
to
birds
in
the
wild
based
on
the
exceedance
of
the
levels
of
concern.

Pen
studies
using
northern
bobwhite
quail
and
incident
reports
document
methyl
parathion's
acute
toxicity
to
birds
(
see
table
below).
Shellenberger
(
1970)
reported
40%
mortality
(
8
birds)
of
Page
49
of
120
caged,
12­
week­
old
northern
bobwhite
quail
exposed
to
eight
weekly
sprays
of
1
lb
ai/
A
methyl
parathion
EC.
Another
study
reported
mortality
rates
of
8
to
67%
and
increases
in
stress
in
bobwhite
quail
exposed
to
microencapsulated
(
Penncap­
M)
and
EC
formulations
of
methyl
parathion
(
Pennwalt
1980;
MRID
00061213).
Edwards
(
1968;
MRID
00090488)
observed
mortality
rates
of
5
and
20%
for
caged
quail
and
pheasants,
respectively,
in
an
alfalfa
hayfield
treated
with
0.5
lb/
acre
methyl
parathion.
Another
study
of
42
penned
pheasants
reported
11
deaths
and
sickness
in
half
of
birds
treated
with
three
applications
of
methyl
parathion
at
3
lb
ai/
A
(
Smith,
1987).
Another
study
with
caged
bobwhites
showed
potentially
lethal
levels
of
acetylcholinesterase
(
AChE)
inhibition
(
55.3%
and
59.9%),
respectively
for
both
Penncap­
M
and
Technical
methyl
parathion
when
sprayed
at
1
lb
ai/
A
(
Knittle,
1973;
MRID
093632).
ACHE
inhibition
of
$
50%
may
cause
death
(
Ludke
et
al.
1975).
The
relevance
of
pen
studies
is
supported
by
White,
et
al.
(
1990;
MRID
44357806)
who
reported
that
free
bobwhites
spent
60%
of
the
time
they
were
observed
in
or
within
100
m
of
a
Georgia
sorghum
and
cotton
fields
treated
with
methyl
parathion.

Additionally
studies
indicate
that
a
suite
of
effects
occur
with
short
exposure
to
methyl
parathion.
These
effects
include
direct
mortality,
as
well
as
acute
sublethal
and
chronic
effects
such
as:
reproduction
effects,
changes
in
maternal
care
and
viability
of
young
birds,
anorexia,
increased
susceptibility
to
predation,
and
greater
sensitivity
to
environmental
stress.

For
several
reasons,
most
of
the
uncertainty
in
this
risk
analysis
is
associated
with
the
terrestrial
exposure
component.
First,
there
were
no
direct
field
measurements
of
methyl
parathion
residues
used
in
the
avian
risk
assessment.
Furthermore,
while
the
application
method
and
timing
are
such
that
one
can
reasonably
assume
exposure
of
birds
each
time
methyl
parathion
is
applied,
there
are
little
direct
data
(
e.
g.
incidents)
showing
avian
adverse
effects.

Finally,
the
uncertainty
in
the
environmental
fate
database
for
the
highly
toxic
metabolite,
methyl
paraoxon,
may
lead
to
an
underestimation
of
avian
and
mammalian
exposure
to
biologically
active
methyl
parathion
residues.
The
quantities
of
methyl
paraoxon
produced
from
parent
on
animal
food
items
are
not
known.
This
point
is
particularly
important
because
degradation
of
parent
to
methyl
paraoxon
in
leaves
and
avian
food
items
may
result
in
a
prolonged
exposure
to
toxic
residues
which
can
result
in
acute
and/
or
chronic
effects
to
birds,
mammals,
and
reptiles.

The
use
of
methyl
parathion
is
expected
to
coincide
with
the
timing
of
waterfowl
breeding.
The
major
breeding
grounds
for
waterfowl
are
in
the
prairie­
pothole
region
of
North
America,
where
important
crops
include
spring
wheat,
barley
and
sunflowers;
methyl
parathion
is
used
on
each
of
these
crops.

Cotton
and
rice
use
in
Mississippi
River
watersheds
and
in
California
are
expected
to
affect
resident
bird
populations
(
non­
migratory
birds)
with
nests
near
treated
fields.
In
addition
to
waterfowl,
a
large
number
of
shorebirds
such
as
gulls,
cranes,
herons,
plovers,
sandpipers,
egrets,
stilts,
terns
and
others
are
found
in
and
around
aquatic
resources
that
could
be
contaminated
with
methyl
parathion.

Further
avian
exposure
to
methyl
parathion
is
likely
in
the
80
million
acres
in
the
United
States
planted
to
corn
which
accounts
for
more
than
19%
of
methyl
parathion
applied
annually.
At
least
200
Page
50
of
120
bird
species
are
found
in
and
around
corn,
the
majority
of
which
is
produced
in
three
regions
(
the
Corn
Belt
­
Iowa,
Missouri,
Illinois,
Indiana,
Ohio;
the
Great
Lakes
states
­
Minnesota,
Michigan,
Wisconsin;
and
the
northern
plain
states
­
North
and
South
Dakota,
Nebraska,
Kansas,
and
Colorado).
Methyl
parathion
applied
to
corn
planted
near
prairie­
potholes
in
the
Great
Lakes
and
northern
plains
regions
would
be
expected
to
affect
waterfowl
using
these
areas.
Application
of
methyl
parathion
to
corn
in
states
that
border
the
Gulf
of
Mexico
and
the
Atlantic
and
Pacific
Oceans
is
also
expected
to
result
in
exposure
to
waterfowl
and
water
birds.

Mortality
and
reproductive
impairment
of
survivors
pose
important
risk
to
the
maintenance
of
viable
populations
of
avian
species.
The
potential
for
adverse
population
impacts
to
many
avian
species
from
methyl
parathion
exposure
is
greatest
with
the
cotton,
grain
and
sunflower
uses.
Data
showing
population
effects
do
not
establish
causality
for
these
population
declines
since
a
variety
of
factors
are
likely
to
contribute
to
population
decline.
However,
the
data
do
suggest
that
local
populations
of
many
bird
species
could
be
sensitive
to
the
subacute
or
reproductive
effects
from
exposure
to
methyl
parathion
detailed
in
the
risk
assessment.

ii.
Risks
to
Mammals
Acute
and
chronic
toxicity
studies
indicate
that
methyl
parathion
is
very
highly
toxic
to
mammals.
Mammals
are
expected
to
be
adversely
affected
by
methyl
parathion
through
oral,
dermal,
and
inhalation
exposure
pathways.

Herbivores
and
insectivores
are
more
likely
than
granivores
to
be
adversely
affected
by
oral
methyl
parathion
exposure,
because
they
must
consume
a
greater
amount
of
food
in
proportion
to
their
body
weight
each
day.
Estimates
show
that
mammals
may
experience
adverse
effects
at
a
single
application
of
the
lowest
use
rate
for
any
crop.
And
the
risk
posed
by
exposure
to
methyl
parathion
is
expected
to
increase
with
the
number
of
applications.
The
minimum
number
of
applications
agreed
upon
for
this
assessment
is
2
and
the
maximum
is
8.

Dermal
exposure
to
methyl
parathion
is
also
highly
likely
for
mammals.
Small
mammals,
such
as
meadow
voles
or
field
mice,
live
in
and
around
the
treated
fields
and
find
it
difficult
to
impossible
to
escape
the
treated
area.

Young
mammals
are
expected
to
be
at
greater
risk
than
adults.
The
young
of
almost
any
species
eat
more
than
adults
per
kilogram
of
body
weight.
In
addition,
very
young
mammals
are
hairless
and
may
be
susceptible
to
dermal
exposure
from
a
variety
of
sources
including
residue
on
the
fur
of
the
mother.

iii.
Risk
to
Insects
Currently
the
Agency
does
not
conduct
quantitative
risk
assessments
for
nontarget
insects.
However,
acute
toxicity
testing
shows
that
methyl
parathion
is
highly
toxic
to
honeybees
(
LD50=
0.11­
0.21
µ
g/
bee,
MRID
44038201).
Additionally,
Penncap­
M
capsules
are
small
and
durable
enough
to
be
carried
to
the
beehive
with
pollen
grains
and
may
adversely
affect
honeybees
in
the
hive.
The
Page
51
of
120
cancellation
of
methyl
parathion
fruit
and
vegetable
crops
should
reduce
the
effect
on
honeybees.
b.
Aquatic
Organisms
i.
Risk
to
Fish
The
uncertainty
in
the
assessment
of
potential
concentrations
of
methyl
parathion
in
surface
water
(
see
above)
has
ramifications
for
risk
assessments
for
aquatic
organisms.

For
freshwater
fish,
modeled
concentrations
indicate
that
only
use
at
the
highest
label
rates
may
result
in
exceedance
of
risk
presumption
categories
for
freshwater
fish.
Published
literature
indicates
that
methyl
parathion
exposure
has
detrimental
effects
on
freshwater
fish,
including
behavioral
changes,
growth
reduction
from
damage
to
the
food
supply,
and
indirect
mortality.
Given
that
the
cotton
use
area
extends
in
the
southern
United
States
from
California
to
Virginia,
a
large
number
of
freshwater
species
could
be
affected
by
methyl
parathion
exposure.
Therefore,
although
there
is
uncertainty
in
the
magnitude
of
the
exposure
calculated
using
simulation
models
for
the
large
diversity
of
water
body
types
throughout
the
methyl
parathion
use
area,
sublethal
or
indirect
effects
from
exposure
in
the
cotton
use
area
seem
likely.

ii.
Risk
to
Aquatic
Invertebrates
For
freshwater
aquatic
invertebrates,
laboratory
studies
submitted
to
EPA
indicate
that
methyl
parathion
is
likely
to
cause
adverse
effects
in
freshwater
invertebrates
under
all
labeled
methyl
parathion
use
scenarios.

Impacts
to
populations
of
freshwater
aquatic
invertebrates
may
cause
additional
indirect
effects
to
the
ecosystem,
as
discussed
above.
For
instance,
large
decreases
in
populations
due
to
toxic
effects
to
freshwater
invertebrates
can
lead
to
algae
blooms
and
subsequently
may
cause
fish
kills
by
depleting
dissolved
oxygen
in
treated
ponds
as
both
invertebrates
and
algae
decay.

For
estuarine
and
marine
fish,
EPA
concludes
that
methyl
parathion
poses
acute
risk.
This
assessment
is
founded
on
consistent
toxicological
data
submitted
by
the
registrants
and
in
the
open
literature
and
the
widespread
use
of
the
compound
on
many
crops
that
may
result
in
transport
of
methyl
parathion
to
estuarine/
marine
surface­
water
bodies.

Open
literature
studies
report
adverse
affects
of
methyl
parathion
exposure
to
estuarine
and
marine
fish.
Published
studies
have
also
reported
acute
sublethal
effects
on
estuarine
and
marine
fish,
such
as
behavioral
changes,
cholinesterase
inhibition,
and
ovarian
damage.
Chronic
effects
of
methyl
parathion
use
on
estuarine
species
cannot
be
assessed
due
to
lack
of
chronic
estuarine
data.

For
estuarine
and
marine
invertebrates,
as
reported
in
the
toxicity
portion
of
this
document,
estuarine/
marine
invertebrates
are
extremely
sensitive
to
methyl
parathion.
Open
literature
studies
show
that
use
of
methyl
parathion
under
normal
use
conditions
has
contaminated
the
estuarine/
marine
environment
and
had
an
effect
on
estuarine
invertebrate
species.
However,
the
California
EPA
Department
of
Pesticide
Regulation
has
performed
Ceriodaphnia
dubia
bioassays
concurrently
with
Page
52
of
120
their
surface
water
sampling,
and
reported
no
observable
effects
connected
with
methyl
parathion
concentrations
since
mitigation
measures
were
instituted
in
response
to
a
decline
in
striped
bass
populations.
In
light
of
supporting
open
literature
data,
and
the
evidence
of
adverse
effects
in
California
before
mitigation
was
instituted,
the
certainty
in
the
overall
risk
to
estuarine/
marine
invertebrates
is
high.

In
addition
to
California,
where
effects
on
estuarine
species
has
been
observed
in
connection
with
methyl
parathion
use
on
rice,
the
coastal
areas
of
the
Gulf
States
include
a
vast
areas
of
tidal
flats,
salt
and
freshwater
marshes
which
provide
habitat
for
estuarine
species.
Therefore,
runoff
of
methyl
parathion
into
shallow
aquatic
areas
is
likely
to
cause
exposure
to
many
important
estuarine
species.

IV.
Interim
Risk
Management
and
Reregistration
Decision
A.
Determination
of
Interim
Reregistration
Eligibility
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submissions
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.,
an
active
ingredient
specific)
data
required
to
support
reregistration
of
products
containing
methyl
parathion
active
ingredients.

The
Agency
has
completed
its
assessment
of
the
occupational
and
ecological
risks
associated
with
the
use
of
pesticides
containing
the
active
ingredient
methyl
parathion,
as
well
as
a
methyl
parathion­
specific
dietary
risk
assessment
that
has
not
considered
the
cumulative
effects
of
organophosphates
as
a
class.
Based
on
a
review
of
these
data
and
public
comments
on
the
Agency's
assessments
for
the
active
ingredient
methyl
parathion,
EPA
has
sufficient
information
on
the
human
health
and
ecological
effects
of
methyl
parathion
to
make
interim
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
certain
uses
of
methyl
parathion
are
eligible
for
reregistration
provided
that:
(
i)
current
data
gaps
and
additional
data
needs
are
addressed;
(
ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
label
amendments
are
made
to
reflect
these
measures;
and
(
iii)
the
cumulative
risk
assessment
for
the
organophosphates
support
a
final
reregistration
eligibility
decision.
Label
changes
are
described
in
Section
IV.
Appendix
B
identifies
the
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
interim
determination
of
reregistration
eligibility
of
methyl
parathion,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

Although
the
Agency
has
not
yet
considered
cumulative
risks
for
the
organophosphates,
the
Agency
is
issuing
this
interim
assessment
now
in
order
to
identify
risk
reduction
measures
that
are
necessary
to
support
the
continued
use
of
methyl
parathion.
Based
on
its
current
evaluation
of
methyl
parathion
alone,
the
Agency
has
determined
that
methyl
parathion
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA.
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
use
of
methyl
parathion.

At
the
time
that
cumulative
risks
are
considered,
the
Agency
will
address
any
outstanding
risk
Page
53
of
120
concerns.
For
methyl
parathion,
if
all
changes
outlined
in
this
document
are
incorporated
into
the
labels,
then
pesticides
containing
methyl
parathion
generally
will
not
cause
unreasonable
risk
to
humans
and
the
environment.
But,
because
this
is
an
interim
RED,
the
Agency
may
take
further
actions,
if
warranted,
to
finalize
the
reregistration
eligibility
decision
for
methyl
parathion
after
considering
the
cumulative
risk
of
the
organophosphate
class.
Such
an
incremental
approach
to
the
reregistration
process
is
consistent
with
the
Agency's
goal
of
improving
the
transparency
of
the
reregistration
and
tolerance
reassessment
processes.
By
evaluating
each
organophosphate
in
turn
and
identifying
appropriate
risk
reduction
measures,
the
Agency
is
addressing
the
risks
from
the
organophosphates
in
as
timely
a
manner
as
possible.

Because
the
Agency
has
not
yet
considered
the
cumulative
risks
for
the
organophosphates,
this
reregistration
eligibility
decision
does
not
fully
satisfy
the
reassessment
of
the
existing
methyl
parathion
food
residue
tolerances
as
called
for
by
the
Food
Quality
Protection
Act
(
FQPA).
When
the
Agency
has
completed
the
cumulative
assessment,
methyl
parathion
tolerances
will
be
reassessed
in
that
light.
At
that
time,
the
Agency
will
reassess
methyl
parathion
along
with
the
other
organophosphate
pesticides
to
complete
the
FQPA
requirements
and
make
a
final
reregistration
eligibility
determination.
By
publishing
this
interim
decision
on
reregistration
eligibility
and
requesting
mitigation
measures
now
for
the
individual
chemical
methyl
parathion,
the
Agency
is
not
deferring
or
postponing
FQPA
requirements;
rather,
EPA
is
taking
steps
to
assure
that
uses
which
exceed
FIFRA's
unreasonable
risk
standard
do
not
remain
on
the
label
indefinitely,
pending
consideration
of
the
cumulative
risks.
This
decision
does
not
preclude
the
Agency
from
making
further
FQPA
determinations
and
tolerance­
related
rulemakings
that
may
be
required
on
this
pesticide
or
any
other
in
the
future.

If
the
Agency
determines,
before
finalization
of
the
RED,
that
any
of
the
determinations
described
in
this
interim
RED
are
no
longer
appropriate,
the
Agency
will
pursue
appropriate
action,
including
but
not
limited
to,
reconsideration
of
any
portion
of
this
interim
RED.

B.
Summary
of
Phase
5
Comments
and
Responses
When
making
its
interim
reregistration
decision,
the
Agency
planned
to
take
into
account
all
comments
received
during
Phase
5
of
the
OP
Pilot
Process;
however,
no
comments
were
received
which
impacted
the
regulatory
decision.

C.
Regulatory
Position
1.
FQPA
Assessment
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
this
organophosphate.
The
assessment
was
for
this
individual
organophosphate,
and
does
not
attempt
to
fully
reassess
these
tolerances
as
required
under
FQPA.
FQPA
requires
the
Agency
to
evaluate
food
tolerances
on
the
basis
of
cumulative
risk
from
substances
sharing
a
common
mechanism
of
toxicity,
such
as
the
toxicity
expressed
by
the
organophosphates,
i.
e.,
cholinesterase
inhibition.
The
Page
54
of
120
Agency
will
evaluate
the
cumulative
risk
posed
by
the
entire
class
of
organophosphates
once
the
policy
concerning
cumulative
assessments
is
resolved.

EPA
has
determined
that
after
the
use
cancellations
in
the
1999
MOA,
dietary
risk
(
food
plus
water)
from
exposure
to
methyl
parathion
will
be
within
its
own
"
risk
cup"
with
the
mitigation
measure
of
reducing
the
application
rate
and
total
number
of
allowable
applications.
In
other
words,
if
methyl
parathion
did
not
share
a
common
mechanism
of
toxicity
with
other
chemicals,
EPA
would
be
able
to
conclude
today
that
the
tolerances
for
methyl
parathion
meet
the
FQPA
safety
standards.
In
reaching
this
determination
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
the
chronic
and
acute
food
exposure.
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
drinking
water.
Results
of
this
aggregate
assessment
indicate
that
the
human
health
risks
from
these
combined
exposures
are
considered
to
be
within
acceptable
levels;
that
is,
combined
risks
from
all
exposures
to
methyl
parathion
"
fit"
within
the
individual
risk
cup.
Therefore,
the
methyl
parathion
tolerances
remain
in
effect
and
unchanged
until
a
full
reassessment
of
the
cumulative
risk
from
all
organophosphates
is
completed.

b.
Interim
Tolerance
Reassessment
Summary
In
the
individual
assessment,
tolerances
for
residues
of
methyl
parathion
in/
on
plant
commodities
[
40
CFR
§
180.241]
are
presently
expressed
in
terms
of
ethyl
parathion
and/
or
methyl
parathion.
Since
there
were
use
cancellations
which
were
brought
about
by
FQPA
safety
findings,
according
to
FFDCA
408
(
l)(
2)
the
tolerances
from
the
canceled
uses
are
to
be
revoked
within
180
days
after
the
last
lawful
use.
There
was
a
Federal
Register
notice
published
June
2,
2000
which
listed
the
tolerances
which
are
being
proposed
for
revocation.
The
comment
period
for
this
proposal
closed
on
August
2,
2000.
The
following
tolerances
were
revoked
upon
publication
of
the
final
rule
on
January
5,
2001:
apples,
artichokes,
beets
(
greens
alone),
beets
(
with
or
without
tops),
birdsfoot
trefoil
forage,
birdsfoot
trefoil
hay,
broccoli,
Brussels
sprouts,
carrots,
cauliflower,
celery,
cherries,
collards,
grapes,
kale,
kohlrabi,
lettuce,
mustard
green,
nectarines,
peaches,
pears,
plums
(
fresh
prunes),
rutabagas
(
with
or
without
tops),
rutabaga
tops,
spinach,
tomatoes,
turnips
(
with
or
without
tops),
turnips
greens,
vegetables
leafy
Brassica
(
cole),
and
vetch.
Methyl
parathion
applications
are
allowed
for
lentils,
but
the
tolerance
for
lentils
is
removed
since
lentils
are
included
under
the
dried
peas
tolerance.
Residues
resulting
from
legal
applications
of
methyl
parathion
may
be
found
in
frozen
commodities
after
the
tolerances
were
revoked.
The
FDA
developed
a
"
channels
of
trade"
guidance
policy
which
specifies
types
of
documentation
necessary
to
prove
legal
applications
of
methyl
parathion.

At
this
time
no
changes
are
being
made
to
the
tolerance
residue
levels
for
the
remaining
methyl
parathion
tolerances.
The
residue
chemistry
portion
of
the
HED
risk
assessment
provided
a
complete
listing
of
recommended
tolerance
level
changes
which
will
be
considered
during
the
cumulative
assessment
for
all
the
organophosphates.

Until
September
3,
2002,
the
tolerances
for
methyl
parathion
and
ethyl
parathion
were
combined
under
40
CFR
§
180.121.
A
final
rule
was
published
in
the
Federal
Register
on
June
5,
2002
to
separate
the
tolerances
into
ethyl
parathion
tolerances
in
§
180.121
and
the
methyl
parathion
tolerances
under
§
180.122.
This
notice
also
revokes
the
tolerances
for
which
there
are
no
domestic
Page
55
of
120
uses
and
provides
dates
for
expiration
for
all
ethyl
parathion
tolerances.

Table
30.
Summary
of
Methyl
Parathion
Tolerances
Listed
Under
40
CFR
§
180.122
Commodity
Current
Tolerance,
(
ppm)

Alfalfa
(
fresh)
1.25
Alfalfa
(
hay)
5
Almonds,
sugar
Beets,
sugar
Beet
(
tops),
Filberts,
Pecans,
Potatoes,
Safflower
Seed,
Sorghum,
Soybeans,
Sweet
potatoes,
Walnuts
0.1
Almond
hulls
3
Barley,
Beans
(
dried),
Cabbage,
Clover,
Corn,
Corn
(
forage),
Grass
(
forage),
Hops,
Oats,
Onions,
Peanuts,
Peas
(
dried),
Peas
(
forage),
Rice,
Soybean
hay,
Wheat,
1
Cotton
(
seed),
0.75
Guar
beans,
Mustard
Seed,
Rapeseed,
Sunflower
seed,
0.2
The
tolerances
associated
with
cabbage,
dried
beans,
dried
peas,
hops,
lentils,
pecans,
and
sugar
beets
will
be
proposed
for
revocation.

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

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
methyl
parathion
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

3.
Labels
Label
amendments,
in
addition
to
the
existing
label
requirements,
are
necessary
in
order
for
methyl
parathion
products
to
be
eligible
for
reregistration.
Page
56
of
120
Provided
the
following
risk
mitigation
measures
are
incorporated
in
their
entirety
into
labels
for
methyl
parathion­
containing
products,
the
Agency
finds
that
some
of
the
currently
registered
uses
of
methyl
parathion
would
be
eligible
for
reregistration,
pending
a
cumulative
assessment
of
the
organophosphates.
The
regulatory
rationale
for
each
of
the
mitigation
measures
outlined
below
is
discussed
immediately
after
this
list
of
required
mitigation
measures.

The
following
uses
are
eligible
for
reregistration:
Alfalfa,
barley,
corn,
cotton,
grass
forage/
fodder/
hay,
oats,
onion,
pastures,
rangeland,
rape
seed
(
canola),
rice,
rye,
soybeans,
sunflower,
sweet
corn,
sweet
potatoes,
walnuts,
wheat,
white
potatoes,
and
yams.

4.
Mitigation
for
Agricultural
Uses
°
Deletion
of
use
on
cabbage,
dried
beans,
dried
peas,
hops,
lentils,
pecans,
and
sugar
beets.
°
Label
changes
to
include
reduction
of
application
rates
and
numbers
of
applications
as
proposed
by
registrants
(
see
Table
1).

°
To
lower
potential
exposures
to
aquatic
organisms:
methyl
parathion
may
not
be
mixed/
loaded
or
otherwise
handled
in
areas
prone
to
runoff
or
movement
into
aquatic
environments
or
wetlands.
This
does
not
apply
to
aquatic
applications
to
rice.

°
Closed
delivery
(
mixing/
loading/
handling)
systems
are
required
for
aerial
applications
of
the
microencapsulated
formulation.

°
Engineering
controls
such
as
a
closed
cab
and
closed
cockpit
are
required
for
applications
of
both
the
microencapsulated
formulation
and
the
EC
formulation.

°
Use
on
sweet
corn
is
limited
to
control
of
silk
fly
only.
This
restricts
use
to
the
southern
US.

°
Use
of
human
flaggers
is
prohibited.

°
REIs
for
EC
applications
are
as
follows:

Table
31:
Re­
entry
intervals
for
various
crops
following
application
of
emulsifiable
concentrate
methyl
parathion.

Use
site
REI
(
days)

alfalfa,
barley,
cottona,
oats,
canola,
rice,
rye,
soybeans,
sunflowers,
wheat,
white
potatoes
4
sweet
cornb
(
for
use
against
silk
fly),
field
corn
3
onionsc*
6
a
For
cotton,
a
MOE
of
90
was
used
at
request
of
growers
who
needed
to
get
into
fields
earlier
than
a
6
day
REI
which
was
necessary
for
a
MOE
of
100.
b
For
sweet
corn,
the
REI
was
recalculated
using
the
DFR
data
from
Florida
since
silk
fly
is
a
pest
that
primarily
occurs
in
Florida.
c
For
onions,
the
REI
is
based
on
the
activities
of
hand­
weeding
and
pruning
with
an
MOE
of
92.
Page
57
of
120
°
REIs
for
microencapsulated
formulation
applications
are
as
follows:

Table
32:
Re­
entry
intervals
for
various
crops
following
application
of
microencapsulated
methyl
parathion.

Use
site
REI
(
days)

barley,
field
corn,
oats,
rice,
wheat
31
sweet
corn**
(
for
use
against
silk
fly)
9
walnuts
25
onions
13
white
potatoes
12
sweet
potatoes,
cotton,
soybeans
11
**
For
sweet
corn,
the
REI
was
recalculated
using
the
DFR
data
from
Florida
since
silk
fly
is
a
pest
that
primarily
occurs
in
Florida.

D.
Benefits
Assessment
Summary
Benefit
assessments
were
conducted
for
methyl
parathion
use
on:
field
and
sweet
corn,
walnuts,
cotton,
soybeans,
sweet
potatoes,
sunflowers,
and
rice.
For
these
crops,
clear
high
benefits
were
shown
for
soybeans,
sweet
potatoes
and
rice;
moderate
benefits
were
shown
for
sunflowers,
but
this
benefit
may
increase
when
ethyl
parathion
may
no
longer
be
used
on
sunflowers.
For
sweet
corn,
high
benefits
were
shown
in
control
of
silk
fly,
and
therefore,
use
is
retained
for
this
pest
only.
For
field
corn,
walnuts,
and
cotton
benefits
are
considered
to
be
low
because
several
alternative
pesticides
remain
for
these
crops
including
the
organophosphates:
azinphos
methyl,
acephate,
dicrotophos
and
terbufos.
However,
for
the
most
part,
these
organophosphate
alternatives
have
different,
but
still
serious
ecological
risks
and
little
if
any
risk
reduction
would
be
attained
by
promoting
a
shift
to
these
alternative
pesticides.

Benefit
assessments
are
available
on
the
EPA
website
and
in
the
docket
for
methyl
parathion.

Reported
methyl
parathion
use
was
very
low
for
alfalfa,
barley,
cabbage,
dried
beans,
dried
peas,
grass,
hops,
lentils,
oats,
onions,
pecans,
rape
seed
(
canola),
rye,
sugar
beets,
and
white
potatoes.
Therefore,
benefits
for
these
crops
were
assumed
to
be
low
and
formal
benefits
assessments
were
not
conducted.
Consultations
with
USDA
indicated
benefit
for
use
on
alfalfa,
barley,
grass,
oats,
onions,
rape
seed,
rye,
and
potatoes.
These
crops
have
very
low
amounts
of
use
primarily
focused
on
certain
pests
in
isolated
areas
of
the
country,
but
could
be
considered
to
be
high
benefit
for
those
areas
and
therefore
use
is
retained.

Several
growers
expressed
desire
to
retain
use
on
pecans
to
control
stink
bug
even
though
there
are
alternative
pyrethroid
compounds
which
control
stink
bugs.
There
is
an
issue
of
resistance
management
with
the
use
of
pyrethroids,
but
EPA
believes
that
resistance
management
of
stink
bugs
can
be
managed
in
the
crops
surrounding
the
pecan
groves.
Based
on
what
would
Page
58
of
120
be
the
required
re­
entry
interval,
spray
drift
issues
and
ecological
risk,
the
benefits
for
use
on
pecans
does
not
outweigh
the
risks
for
this
use.

E.
Regulatory
Rationale
1.
Human
Health
Risk
Mitigation
a.
Dietary
Mitigation
i.
Dietary
(
Food)

Based
on
recent
use
changes
and
thus
current
labels,
at
the
99.9th
percentile,
the
dietary
risk,
food
only,
is
below
levels
of
concern
for
all
population
subgroups,
including
the
most
exposed
population
subgroups,
children
1­
6
and
children
6­
12,
at
75%
and
77%
of
the
aPAD,
respectively.
No
additional
mitigation
for
acute
dietary
food
risks
is
required.

The
chronic
dietary
risk
estimate
is
below
the
Agency's
level
of
concern
and
is
estimated
to
be
less
than
8%
of
the
cPAD
for
all
population
subgroups
including
the
most
exposed
population
subgroups,
infants
and
children
(
1­
6
years).
No
additional
mitigation
for
chronic
dietary
food
risks
is
required.

There
are
some
residue
and
feeding
studies
which
have
not
been
submitted
and
a
DNT
study
which
is
currently
in
review;
these
studies
may
affect
the
dietary
risk
assessment
and
the
FQPA
safety
factor.
The
full
10x
FQPA
safety
factor
has
been
applied
to
the
current
assessment
and
this
decision
will
be
revisited
when
the
DNT
study
review
is
complete.
The
DNT
study
has
been
screened
and
is
considered
unlikely
to
change
the
dietary
endpoint.
The
screened
study
was
considered
in
the
safety
factor
decision
for
the
organophosphate
cumulative
assessment.
The
dietary
assessment
for
methyl
parathion
will
be
revised
when
these
studies
are
submitted
and
the
review
is
complete.

ii.
Drinking
Water
Though
acute
exposure
to
methyl
parathion
from
food
sources
alone
does
not
exceed
the
Agency's
level
of
concern
(<
100%
acute
PAD),
limited
targeted
ground­
and
surface
water
monitoring
data
indicate
potential
exposures
at
unacceptable
levels.
Based
on
this
uncertainty,
and
on
the
risks
posed
to
aquatic
organisms
from
methyl
parathion,
the
registrants
have
proposed
reducing
the
application
rate
and
number
of
applications
for
several
crops.
Additionally,
the
Agency
is
requiring
that
methyl
parathion
not
be
mixed/
loaded
or
otherwise
handled
in
areas
prone
to
runoff
to
aquatic
areas.

As
stated
in
the
dietary
(
food)
section,
the
dietary
assessment
will
be
revised
when
the
dietary
review
is
completed.
The
drinking
water
assessment
will
be
updated
at
that
time
including
a
review
of
any
additional
monitoring
which
may
reflect
mitigation
from
the
1999
MOA
and
this
reregistration
eligibility
review.
While
the
Agency
presumes
that
the
risk
from
combined
food
and
drinking
water
will
be
acceptable
in
the
revised
dietary
assessment,
the
Agency
reserves
the
option
of
requiring
targeted
water
monitoring
studies
pending
the
results
of
this
dietary
(
food
and
water)
revised
assessment.
Page
59
of
120
b.
Occupational
Risk
Mitigation
i.
Handler
Risk
The
highest
occupational
risk
assessed
from
biomonitoring
data
is
to
mixer
and
loaders
handling
the
microencapsulated
formulation.
The
biomonitoring
study
was
conducted
using
2.5
gallon
containers
to
handle
all
applications
including
those
for
large
acreage.
In
reality,
bulk
containers
are
used
when
mixing
and
loading
for
large
acreages.
The
use
of
bulk
tanks
with
closed
couplings
should
reduce
the
exposure
below
the
amount
measured
in
the
biomonitoring
study.
Based
on
the
biomonitoring
MOEs
for
mixer
and
loaders,
closed
delivery
systems
are
required
for
aerial
applications
of
the
microencapsulated
formulation.

Biomonitoring
data
for
groundboom
applicators
using
the
microencapsulated
formulation
show
risk
from
applications
of
200
acres
at
the
median
and
at
applications
at
rates
above
0.5
lb
ai/
A
for
80
acres.
No
biomonitoring
was
conducted
for
other
application
methods
or
for
any
applications
with
the
EC
formulation.
Engineering
controls
such
as
a
closed
cab
and
cockpit
are
required
for
applications
of
both
the
microencapsulated
formulation
and
the
EC
formulation.

ii.
Post­
Application
Risk
EPA
has
determined
that
post
application
exposures
of
methyl
parathion
can
occur
in
occupational
settings.
Current
REIs
required
by
the
1999
MOA
are
4
and
5
days.
In
order
to
reduce
re­
entry
worker
risk,
REIs
are
as
noted
in
Tables
31
and
32.
Please
note
that
longer
REIs
were
assessed
for
some
uses,
but
those
uses
are
proposed
for
cancellation.

Additionally
in
order
to
manage
such
long
REIs,
EPA
notes
that
some
activities
may
occur
during
the
REI
as
long
as
certain
conditions
are
met,
including
protective
clothing,
no
reentry
during
first
4
hours
after
application,
8
hour
per
day
maximum,
notification
of
reliance
on
exception,
etc.,
as
set
forth
for
the
exception
for
limited­
contact
activities
and
irrigation
published
in
the
Federal
Register
on
May
3,
1995
(
65
FR
21955).

These
activities
may
include
the
following:

Work
performed
by
workers
driving
or
riding
on
tractors
or
other
power
equipment
(
e.
g.,
selfpropelled
harvesters)
affording
substantial
protection
against
contact
with
treated
soil
or
foliage.
Examples
of
this
kind
of
in­
field
work
would
include
cultivation
and
ground
application
of
fertilizer
products.

Emergency
repairs
of
tractors
or
implements.

Irrigation
operations
and
work
on
irrigation
equipment,
including
needed
repairs
or
adjustments
of
equipment.

Hand
labor
activities,
including
but
not
limited
hand
cultivation
or
hand
harvesting,
specifically
would
be
allowed
during
the
REI.
Page
60
of
120
2.
Environmental
Risk
Mitigation
To
address
the
high
potential
ecological
risk
to
aquatic
invertebrates
from
methyl
parathion,
and
the
general
uncertainty
related
to
methyl
parathion
effects
on
aquatic
organisms,
EPA
is
requiring
the
following
mitigation
measures:

Cancellation
of
uses
which
do
not
have
high
benefits
including:
cabbage,
dried
beans,
dried
peas,
hops,
lentils,
pecans,
and
sugar
beets.

Label
changes
to
include
reduction
of
application
rate
and
numbers
of
applications
as
proposed
by
registrants
(
see
Table
1).

To
lower
potential
exposures
to
aquatic
organisms,
methyl
parathion
may
not
be
mixed/
loaded
or
otherwise
handled
in
areas
prone
to
runoff
to
water
bodies,
aquatic
areas
or
wetlands.
This
restriction
does
not
apply
to
aquatic
applications
to
rice.
Aquatic
applications
are
allowed
based
on
high
benefits.

Although
risks
are
expected
to
still
exist
for
birds,
small
mammals,
aquatic
invertebrates
and
nontarget
insects,
no
additional
mitigation
options
are
recommended
at
this
time.
The
use
changes
as
captured
in
the
Methyl
Parathion
MOA,
specifically
the
deletion
of
the
orchard
uses
of
methyl
parathion,
are
expected
to
significantly
reduce
ecological
risks
posed
by
methyl
parathion
to
honey
bees
and
birds.

F.
Other
Labeling
The
Agency
is
also
requiring
other
use
and
safety
information
to
be
placed
on
the
labeling
of
all
end­
use
products
containing
methyl
parathion.
For
the
specific
labeling
statements,
refer
to
Section
V
of
this
document.

1.
Endangered
Species
Statement
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
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
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
REDs
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
This
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
that
are
being
implemented
at
this
time.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.

The
Endangered
Species
Protection
Program
as
described
in
a
Federal
Register
notice
Page
61
of
120
(
54
FR
27984­
28008,
July
3,
1989)
is
currently
being
implemented
on
an
interim
basis.
As
part
of
the
interim
program,
the
Agency
has
developed
County
Specific
Pamphlets
that
articulate
many
of
the
specific
measures
outlined
in
the
Biological
Opinions
issued
to
date.
The
Pamphlets
are
available
for
voluntary
use
by
pesticide
applicators
on
EPA's
website
at
www.
epa.
gov/
espp.
A
final
Endangered
Species
Protection
Program,
which
may
be
altered
from
the
interim
program,
has
been
proposed
for
public
comment
in
the
Federal
Register
(
reference??).

2.
Spray
Drift
Management
The
Agency
is
currently
working
with
stakeholders
to
develop
appropriate
generic
label
statements
to
address
spray
drift
risk.
Once
this
process
has
been
completed,
methyl
parathion
product
labels
will
need
to
be
revised
to
include
this
additional
language.

V.
What
Registrants
Need
to
Do
In
order
to
be
eligible
for
reregistration,
registrants
need
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV
and
V,
which
include,
among
other
things,
submission
of
the
following:

A.
For
methyl
parathion
technical
grade
active
ingredient
products,
registrants
need
to
submit
the
following
items.

Within
90
days
from
receipt
of
the
generic
data
call­
in
(
DCI):

(
1)
completed
response
forms
to
the
generic
DCI
(
i.
e.,
DCI
response
form
and
requirements
status
and
registrant's
response
form);
and
(
2)
submit
any
time
extension
and/
or
waiver
requests
with
a
full
written
justification.

Within
the
time
limit
specified
in
the
generic
DCI:

(
1)
cite
any
existing
generic
data
which
address
data
requirements
or
submit
new
generic
data
responding
to
the
DCI.

Please
contact
Laura
Parsons
at
703­
305­
5776
with
questions
regarding
generic
reregistration
and/
or
the
DCI.
All
materials
submitted
in
response
to
the
generic
DCI
should
be
addressed:

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
DCI/
SRRD)
Document
Processing
Desk
(
DCI/
SRRD)
Laura
Parsons
Laura
Parsons,
US
EPA
(
7508C)
Office
of
Pesticide
Programs
(
7508C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
Page
62
of
120
B.
For
products
containing
the
active
ingredient
methyl
parathion,
registrants
need
to
submit
the
following
items
for
each
product.

Within
90
days
from
the
receipt
of
the
product­
specific
data
call­
in
(
PDCI):

(
1)
completed
response
forms
to
the
PDCI
(
i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
(
2)
submit
any
time
extension
or
waiver
requests
with
a
full
written
justification.

Within
eight
months
from
the
receipt
of
the
PDCI:

(
1)
two
copies
of
the
confidential
statement
of
formula
(
EPA
Form
8570­
4);

(
2)
a
completed
original
application
for
reregistration
(
EPA
Form
8570­
1).
Indicate
on
the
form
that
it
is
an
"
application
for
reregistration";

(
3)
five
copies
of
the
draft
label
incorporating
all
label
amendments
outlined
in
Table
[
insert
table
number]
of
this
document;

(
4)
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);

(
5)
if
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(
EPA
Form
8570­
32);
and
(
6)
the
product­
specific
data
responding
to
the
PDCI.

Please
contact
Jane
Mitchell
at
703­
3087­
8061
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed:

By
US
mail:
By
express
or
courier
service
only:
Document
Processing
Desk
(
PDCI/
PRB)
Document
Processing
Desk
(
PDCI/
PRB)
Jane
Mitchell
Jane
Mitchell
US
EPA
(
7508C)
Office
of
Pesticide
Programs
(
7508C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
Page
63
of
120
A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
methyl
parathion
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
Based
on
a
need
to
further
refine
the
human
health
and
the
ecological
risk,
the
following
additional
data
are
necessary.

Applicator
Biomonitoring
Studies
for
EC
and
Microencapsulated
Formulation
for
each
Application
Method.
(
Guideline
OPPTS
875.1500)

Residue
Analytical
Method
(
Guideline
OPPTS
860.1340)

Magnitude
of
Residues
Crop
Field
Trial
Data
for
the
EC
Formulation
­­
wheat
forage,
wheat
hay
(
Guideline
OPPTS
860.1500)

Magnitude
of
Residues
Crop
Field
Trial
Data
for
the
Microencapsulated
Formulation
 
rice
straw
(
Guideline
OPPTS
860.1500)

Magnitude
of
Residues,
meat/
milk/
poultry/
eggs
(
Guideline
OPPTS
860.1480)

Anaerobic
Aquatic
Metabolism.
(
Guideline
OPPTS
835.4400)

Field
Volatility
(
Guideline
OPPTS
835.8100)

Terrestrial
Field
Dissipation
for
the
Microencapsulated
Formulation
(
Guideline
OPPTS
835.6100)

Estuarine
and
Marine
Fish
Early
Life
Stage
Test
(
Guideline
OPPTS
850.1400)

Vegetative
Vigor
(
Guideline
OPPTS
850.4150)

Seedling
Emergence
(
Guideline
OPPTS
850.4100)

Also,
one
study
Aquatic
Plant
Growth
(
Guideline
OPPTS
850.4400)
is
reserved
pending
the
results
of
the
terrestrial
plant
test
studies.

The
above
studies
will
be
used
as
confirmatory
data.
If
the
Agency
finds
that
new
studies
identify
additional
risks
of
concern,
the
Agency
will
reconsider
the
measures
established
in
this
Interim
RED.

Also,
a
Data
Call­
In
Notice
(
DCI)
was
recently
sent
to
registrants
of
organophosphate
pesticides
currently
registered
under
FIFRA
(
August
6,
1999
64FR42945­
42947,
August
18,
1999
64FR44922­
44923).
DCI
requirements
included
acute,
subchronic,
and
developmental
neurotoxicity
studies.
The
methyl
parathion
developmental
neurotoxicity
study
has
been
submitted
and
is
currently
in
Page
64
of
120
review.

2.
Labeling
for
Manufacturing
Use
Products
To
remain
in
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
20
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
product­
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
Registrants
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.

A
product­
specific
data
call­
in,
outlining
specific
data
requirements,
accompanies
this
interim
RED.

2.
Labeling
for
End­
Use
Products
Labeling
changes
are
necessary
to
implement
the
mitigation
measures
outlined
in
Section
IV
above.
Specific
language
to
incorporate
these
changes
is
specified
in
the
Table
20
at
the
end
of
this
section.

C.
Existing
Stocks
Registrants
may
generally
distribute
and
sell
products
bearing
old
labels/
labeling
for
26
months
from
the
date
of
the
issuance
of
this
Interim
Reregistration
Eligibility
Decision
document.
Persons
other
than
the
registrant
may
generally
distribute
or
sell
such
products
for
50
months
from
the
date
of
the
issuance
of
this
interim
RED.
However,
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.
Refer
to
"
Existing
Stocks
of
Pesticide
Products;
Statement
of
Policy";
Federal
Register,
Volume
56,
No.
123,
June
26,
1991.

The
Agency
has
determined
that
registrant
may
distribute
and
sell
methyl
parathion
products
bearing
old
labels/
labeling
for
26
months
from
the
date
of
issuance
of
this
interim
RED.
Persons
other
than
the
registrant
may
distribute
or
sell
such
products
for
50
months
from
the
date
of
the
issuance
of
this
interim
RED.
Registrants
and
persons
other
than
the
registrant
remain
obligated
to
meet
pre­
existing
label
requirements
and
existing
stocks
requirements
applicable
to
products
they
sell
or
distribute.
Page
65
of
120
D.
Labeling
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.
The
following
table
describes
how
language
on
the
labels
should
be
amended.

Table
20:
Summary
of
Required
Labeling
Changes
for
Methyl
parathion
Description
Required
Labeling
Placement
on
Label
Manufacturing
Use
Products
Formulation
Instructions
required
on
all
MUP's
"
Only
for
formulation
into
an
insecticide
for
use
on
(
registrant
inserts
correct
use
site(
s))."
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
MUP
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
Description
Required
Labeling
Placement
on
Label
Page
66
of
120
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
"
Environmental
Hazards"

"
This
chemical
is
highly
toxic
to
aquatic
invertebrates
and
wildlife
and
toxic
to
fish.
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,
estuaries,
oceans
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
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
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance
contact
your
state
Water
Board
or
Regional
Office
of
the
EPA"
Directions
for
Use
End
Use
Products
Restricted
Use
Pesticide
"
RESTRICTED
USE
PESTICIDE"

The
Emulsifiable
Concentrate
Formulation
"
Due
to
very
high
toxicity
to
humans
and
birds."
The
Microencapsulated
Formulation
"
Due
to
residual
effects
to
avian
species
and
bees."

"
For
retail
sale
to,
and
use
only
by
Certified
Applicators
or
persons
under
the
direct
supervision
of
a
Certified
Applicator,
and
only
for
those
uses
covered
by
the
Certified
Applicator's
certification."
Top
of
front
panel
Handler
PPE
considerations
Note
the
following
information
when
preparing
labeling
for
all
end
use
products:

For
sole­
active­
ingredient
end­
use
products
that
contain
methyl
parathion
the
product
label
must
be
revised
to
adopt
the
handler
personal
protective
equipment
(
PPE)/
engineering
control
requirements
set
forth
in
this
section.
Any
conflicting
PPE
requirements
on
the
current
label
must
be
removed.

PPE
that
is
established
on
the
basis
of
Acute
Toxicity
testing
with
the
end­
use
products
must
be
compared
with
the
active
ingredient
PPE
specified
below
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.
Precautionary
Statements
Under
PPE
Requirements
Description
Required
Labeling
Placement
on
Label
Page
67
of
120
Handler
PPE
requirements
(
all
formulations)
"
Personal
Protective
Equipment
(
PPE)

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
applicators
using
engineering
controls
must
wear:
Long­
sleeved
shirt
and
long
pants
Shoes
plus
socks
In
addition,
mixers
and
loaders
must
wear
chemical­
resistant
gloves
and
a
chemical
resistant
apron."

"
See
engineering
controls
for
additional
requirements.

Handlers
performing
tasks,
such
as
spill
clean­
up,
for
which
engineering
controls
are
not
feasible
must
wear:

"
Coveralls
over
long­
sleeved
shirt
and
long
pants,
Chemical­
resistant
gloves,
Chemical
resistant
shoes
footwear
plus
socks,
Chemical­
resistant
headgear
if
overhead
exposure,
Chemical­
resistant
apron
if
exposed
to
the
concentrate
"
A
respirator
with
an
organic­
vapor
removing
cartridge
with
a
prefilter
approved
for
pesticides
(
MSHA/
NIOSH
approval
number
prefix
TC­
23C),
or
a
canister
approved
for
pesticides
(
MSHA/
NIOSH
approval
number
prefix
TC­
14G),
or
a
NIOSH­
approved
respirator
with
an
organic
vapor
(
OV)
cartridge
or
canister
with
any
R
or
P
or
HE
prefilter."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
User
Safety
Requirements
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry."

"
Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
Description
Required
Labeling
Placement
on
Label
Page
68
of
120
Engineering
controls
for
Mixers
and
Loaders
using
the
Emulsifiable
Concentrate
Formulation
for
all
applications
and
for
aerial
applications
of
the
Microencapsulated
Formulation.
Products
for
these
uses
are
marketed
in
a
closed
loading
system
that
meets
the
specifications
of
the
WPS
"
Engineering
Controls"

"
Mixers
and
loaders
must
use
a
closed
system
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240(
d)(
4)],
for
dermal
protection
and
must:
­­
wear
the
personal
protective
equipment
required
above
for
mixers/
loaders,
­­
wear
protective
eyewear
if
the
system
operates
under
pressure,
and
­­
be
provided
and
have
immediately
available
for
use
in
an
emergency,
such
as
a
broken
package,
spill,
or
equipment
breakdown
the
following:
coveralls
and
chemical­
resistant
footwear
and
a
respirator
specified
in
the
PPE
section
above)."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
User
Safety
Requirements
Engineering
controls
for
all
applicators.
"
Engineering
Controls"

"
Use
of
human
flaggers
is
prohibited."

"
Applicators
must
use
an
enclosed
cab
that
meets
the
definition
in
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[
40
CFR
170.240(
d)(
5)]
for
dermal
protection.
In
addition,
such
applicators
must:
­­
wear
the
personal
protective
equipment
required
above,
­­
either
wear
the
type
of
respirator
specified
in
the
PPE
section
of
this
labeling
or
use
an
enclosed
cab
that
is
declared
in
writing
by
the
manufacturer
or
by
a
government
agency
to
provide
at
least
as
much
respiratory
protection
as
the
type
of
respirator
specified
in
the
PPE
section
of
this
labeling,
­­
be
provided
and
must
have
immediately
available
for
use
in
an
emergency
when
they
must
exit
the
cab
in
the
treated
area:
coveralls,
chemical­
resistant
gloves,
chemical­
resistant
footwear,
a
respirator
specified
in
the
PPE
section
above,
and
chemical­
resistant
headgear,
if
overhead
exposure,
­­
take
off
any
PPE
that
was
worn
in
the
treated
area
before
reentering
the
cab,
and
­­
store
all
such
PPE
in
a
chemical­
resistant
container,
such
as
a
plastic
bag,
to
prevent
contamination
of
the
inside
of
the
cab."

"
Pilots
must
use
an
enclosed
cockpit
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[
40
CFR
170.240(
d)(
6)]."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
User
Safety
Requirements
Description
Required
Labeling
Placement
on
Label
Page
69
of
120
User
Safety
Recommendations
"
User
Safety
Recommendations"

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

Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.
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"

"
This
pesticide
is
highly
toxic
to
birds
and
mammals.
Runoff
may
be
hazardous
to
aquatic
organisms
in
neighboring
areas.
Do
not
mix,
load
or
otherwise
handle
in
areas
prone
to
runoff
or
movement
into
aquatic
environments.
For
terrestrial
uses,
do
not
apply
directly
to
water
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high­
water
mark.
Keep
out
of
lakes,
ponds,
and
streams.
Do
not
contaminate
water
when
disposing
of
equipment
wastewater
or
rinsate".

"
This
product
is
highly
toxic
to
bees
exposed
to
direct
treatment
or
residues
on
blooming
crops
or
weeds.
Do
not
apply
this
product
or
allow
it
to
drift
to
blooming
crops
or
weeds
if
bees
are
visiting
the
treatment
area."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Description
Required
Labeling
Placement
on
Label
Page
70
of
120
Restricted­
Entry
Interval
fpr
the
Emulsifiable
Concentrate
Formulation.
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI).

The
Directions
for
Use
must
be
amended
to
reflect
the
following
REI:

The
REI
for
the
following
crops
is
3
days:

sweet
corn.
field
corn
The
REI
for
the
following
crops
is
4
days:

alfalfa,
barley,
cotton,
oats,
canola,
rice,
rye,
soybeans,
sunflowers,
wheat,
white
potatoes,
grass
The
REI
for
the
following
crops
is
6
days:

onions
Directions
for
Use,
Agricultural
Use
Requirements
Box
or
Next
to
the
Crop
or
Use
for
which
it
applies.
Description
Required
Labeling
Placement
on
Label
Page
71
of
120
Restricted­
Entry
Interval
fpr
the
Microencapsulated
Formulation.
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI).

The
Directions
for
Use
must
be
amended
to
reflect
the
following
REI:

The
REI
for
the
following
crop
is
9
days:

sweet
corn
The
REI
for
the
following
crops
is11
days:

sweet
potatoes,
cotton,
soybeans
The
REI
for
the
following
crops
is
12
days:

white
potatoes
The
REI
for
the
following
crop
is
13
days:

onions
The
REI
for
use
of
the
microencapsulated
formulation
on
the
following
crop
is
25
days:

walnuts
The
REI
for
use
of
the
microencapsulated
formulation
on
the
following
crops
is
31
days:

barley,
field
corn,
oats,
rice,
wheat
Directions
for
Use,
Agricultural
Use
Requirements
Box
or
Next
to
the
Crop
or
Use
for
which
it
applies.

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
worn
over
long­
sleeve
shirt
and
long
pants,

­
chemical­
resistant
gloves
made
of
any
waterproof
material,

­
chemical­
resistant
footwear
plus
socks,
and
­
chemical­
resistant
headgear
for
overhead
exposures."
Directions
for
Use,
Agricultural
Use
Requirements
Box
Notification
Statement
"
Notify
workers
of
the
application
by
warning
them
orally
and
by
posting
warning
signs
at
entrances
to
treated
areas."
Directions
for
Use,
Agricultural
Use
Requirements
Box
Description
Required
Labeling
Placement
on
Label
Page
72
of
120
General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application.
For
any
requirements
specific
to
your
State
or
tribe,
consult
the
agency
responsible
for
pesticide
regulation."
Place
in
the
Direction
for
Use
directly
above
the
Agricultural
Use
Box.

Application
Restrictions
The
following
risk
mitigation
measures
must
be
reflected
in
the
directions
for
use:

New
maximum
application
rates
for
the
Emulsifiable
Concentrate
formulation:

Alfalfa:

1.0
lbs
ai/
A/
application
6.0
lbs
ai/
A/
year
Do
not
make
more
than
2
applications
per
cutting
or
6
applications
per
year.

Barley,
oats,
rice,
rye,
wheat:

0.75
lbs
ai/
A/
application
1.5
lbs
ai/
A/
year
Do
not
make
more
than
2
applications
per
year.

Field
corn,
sweet
corn,
onions,
rapeseed
(
canola),
soybeans:

0.5
lbs
ai/
A/
application
1.0
lbs
ai/
A/
year
Do
not
make
more
than
2
applications
per
year.

Cotton:

0.75
lbs
ai/
A/
application
3.75
lbs
ai/
A/
year
Do
not
make
more
than
5
applications
per
year.

Grass:

0.75
lbs
ai/
A/
application
3.0
lbs
ai/
A/
year
Do
not
make
more
than
2
applications
per
cutting
or
4
applications
per
year.

Sunflower:

1.0
lbs
ai/
A/
application
2.0
lbs
ai/
A/
year
Place
in
the
Direction
for
Use
under
Application
Instructions
for
Each
Crop
Description
Required
Labeling
Placement
on
Label
Page
73
of
120
Do
not
make
more
than
2
applications
per
year
White
potatoes:

0.75
lbs
ai/
A/
application
2.25
lbs
ai/
A/
year
Do
not
make
more
than
3
applications
per
year
Application
Restrictions
The
following
risk
mitigation
measures
must
be
reflected
in
the
directions
for
use:

New
maximum
application
rates
for
the
Microencapsulated
formulation:

Barley,
oats,
rice,
soybeans,
wheat:

0.75
lbs
ai/
A/
application
1.5
lbs
ai/
A/
year
Do
not
make
more
than
2
applications
per
year.

Field
Corn:

1.0
lbs
ai/
A/
application
3.0
lbs
ai/
A/
year
Do
not
make
more
than
3
applications
per
year.

Sweet
corn:

0.75
lbs
ai/
A/
application
3.0
lbs
ai/
A/
year
Do
not
make
more
than
4
applications
per
year.

Cotton:

1.0
lbs
ai/
A/
application
4.0
lbs
ai/
A/
year
Do
not
make
more
than
4
applications
per
year.

Onions:

0.5
lbs
ai/
A/
application
2.0
lbs
ai/
A/
year
Do
not
make
more
than
4
applications
per
year.

Sweet
potatoes
and
yams:

0.75
lbs
ai/
A/
application
Place
in
the
Direction
for
Use
under
Application
Instructions
for
Each
Crop
Description
Required
Labeling
Placement
on
Label
Page
74
of
120
6.0
lbs
ai/
A/
year
Do
not
make
more
than
8
applications
per
year.

Walnuts:

2.0
lbs
ai/
A/
application
8.0
lbs
ai/
A/
year
Do
not
make
more
than
4
applications
per
year
White
potatoes:

1.5
lbs
ai/
A/
application
6.0
lbs
ai/
A/
year
Do
not
make
more
than
4
applications
per
year
Application
Restrictions
Sweet
Corn:

"
For
use
to
control
silk
fly
only".
Remove
references
to
all
other
pests.
Place
in
the
Direction
for
Use
under
Application
Instructions
for
Each
Crop
Application
Restrictions
Delete
the
following
uses
from
all
labels:

cabbage,
dried
beans,
dried
peas,
hops,
lentils,
pecans,
sugar
beets
Place
in
the
Direction
for
Use
under
Application
Instructions
for
Each
Crop
Spray
Drift
Requirements
The
Agency
is
currently
working
with
stakeholders
to
develop
appropriate
generic
label
statements
to
address
spray
drift
risk.
Once
this
process
has
been
completed,
methyl
parathion
product
labels
will
need
to
be
revised
to
include
this
additional
language.
Place
in
the
Direction
for
Use
where
appropriate
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.
Page
75
of
120
Page
76
of
120
Site
1
Formula
tion2
Max
Single
App
Rate
(
lb
ai/
acre)
Max
Seasonal
Rate
(
lb
ai/
acre)
Minimum
Retreatment
interval
Preharvest
Interval
(
Days)
Use
Limitations
Alfalfa
EC
1.00
6.00
NS
15
Maximum
of
2
applications
per
cutting.

Barley
EC
0.75
1.50
7
15
ME
0.75
1.50
7
14
Canola
EC
0.50
1.00
7
28
Oilseed
crop
only.
Not
for
use
on
rapeseed.

Do
not
graze
treated
fields
or
feed
treated
forage
or
threshings
to
livestock.

Corn
EC
0.50
1.00
7
12
ME
1.00
3.00
14
12
Cotton
EC
0.75
3.75
3
7
ME
1.00
4.00
5
14
Grass
EC
0.75
3.00
NS
15
Maximum
of
2
applications
per
cutting.

Apply
in
a
minimum
of
3
gal/
A
of
water
using
ground
equipment
or
1
gal/
A
using
aerial
equipment.

Oats
EC
0.75
1.50
7
15
ME
0.75
1.50
7
14
Onions
EC
0.50
1.00
7
15
ME
0.50
2.00
7
15
Site
1
Formula
tion2
Max
Single
App
Rate
(
lb
ai/
acre)
Max
Seasonal
Rate
(
lb
ai/
acre)
Minimum
Retreatment
interval
Preharvest
Interval
(
Days)
Use
Limitations
Page
77
of
120
Rice
EC
0.75
1.50
7
15
Aerial
applications
only.

Do
not
use
in
rice
fields
where
shellfish
farming
occurs.
Treated
rice
water
should
be
impounded
for
24
days
after
the
last
application
before
release
into
potable
water
sources.
[
Note:
The
24­
day
impoundment
of
treated
rice
water
is
consistent
with
CA
restrictions.]
ME
0.75
1.50
21
15
Rye
EC
0.75
1.50
7
15
Soybeans
EC
0.75
1.50
5
14
Do
not
feed
green
immature
growing
plants
to
livestock.
Do
not
harvest
for
livestock
feed.

ME
0.75
1.50
7
30
Sunflower
EC
1.00
2.00
7
30
Sweet
Corn
EC
0.50
1.00
3
3
For
use
to
control
silk
fly.
Do
not
use
for
other
pests.

ME
0.75
3.00
14
12
Sweet
Potatoes
ME
0.75
6.00
7
5
Walnuts
ME
2.00
8.00
21
14
Wheat
EC
0.75
1.50
7
15
ME
0.75
1.50
7
14
White
Potatoes
EC
1.50
4.50
7
5
ME
1.50
6.00
7
5
1.
Page
78
of
120
Page
79
of
120
APPENDIX
B
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
All
830.1600
61­
2A
Start.
Mat.
&
Mnfg.
Process
All
40406601
830.1670
61­
2B
Formation
of
Impurities
All
00055859
830.1700
62­
1
Preliminary
Analysis
All
40482401
830.1750
62­
2
Certification
of
limits
All
830.1800
62­
3
Analytical
Method
All
830.6302
63­
2
Color
ALL
40406601
830.6303
63­
3
Physical
State
ALL
40406601
830.6304
63­
4
Odor
ALL
40406601
830.7050
None
UV/
Visable
Absorption
830.7200
63­
5
Melting
Point
ALL
40406601
830.7220
63­
6
Boiling
Point
ALL
40406601
830.7300
63­
7
Density
All
40406601
830.7840
830.7860
63­
8
Solubility
All
40406601
830.7950
63­
9
Vapor
Pressure
All
40406601
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
80
of
120
830.7370
63­
10
Dissociation
Constant
All
40406601
830.7550
63­
11
Octanol/
Water
Partition
Coefficient
All
40406601
830.7000
63­
12
pH
All
40406601
830.6313
63­
13
Stability
All
40406601
830.6314
63­
14
Oxidizing/
Reducing
Action
All
830.6315
63­
15
Flammability
All
830.6316
63­
16
Explodability
All
830.6317
63­
17
Storage
Stability
All
830.7100
63­
18
Viscosity
All
830.6319
63­
19
Miscibility
All
830.6320
63­
20
Corrosion
characteristics
All
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
ABCD
00160000,
00061213,
00090488,
093632,
44357806
850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
ABCD
71200,
83103,
102329,00160000
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
ABCD
00160000,
00022923*

850.2400
71­
3
Wild
Mammal
Toxicity
850.2300
71­
4A
Avian
Reproduction
­
Quail
41179302
850.2300
71­
4B
Avian
Reproduction
­
Duck
41179301
850.1075
72­
1A
Fish
Toxicity
Bluegill
40098001,
40094602
850.1075
72­
1C
Fish
Toxicity
Rainbow
Trout
40932101,
40094602
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
81
of
120
850.1010
72­
2A
Invertebrate
Toxicity
40098001
850.1010
72­
2B
Invertebrate
Toxicity
­
TEP
40094602,
40098001*

None
72­
3A
Estuarine/
Marine
Toxicity
­
Fish
40932103,
05000819,
40228401
None
72­
3B
Estuarine/
Marine
Toxicity
­
Mollusk
40228401
None
72­
3C
Estuarine/
Marine
Toxicity
­
Shrimp
40932104
None
72­
4A
Fish­
Early
Life
Stage
233438,
250628*,
41083101
None
72­
4B
Estuarine/
Marine
Invertebrate
Life
Cycle
(
41506801
Guideline
not
acceptable
in
CRMS),
44371716,
250628,
66341
850.1500
72­
5
Life
Cycle
Fish
122­
2
Aquatic
Plant
Growth
4828401*,
66341
??????
123­
1
Non­
target
Terrestrial
Plant
Phytotoxicity
850.4400
123­
2
Aquatic
Plant
Growth
44371714,
44371712,
44378601,
44371715,
44371713
DG
141­
1
Honey
Bee
Acute
Contact
00074486*,
138663,
44038201*,
160948
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity­
Rat
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit/
Rat
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
25696*
1
40364105
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
256966,
40542602
870.2500
81­
5
Primary
Skin
Irritation
256962
870.2600
81­
6
Dermal
Sensitization
256963
870.6100
81­
7
Acute
Delayed
Neurotoxicity
­
Hen
41606801
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
82
of
120
870.6200
81­
8A
Acute
Neurotoxicity
Screening
Battery­
Rat
41853801,
44204501
870.3100
82­
1A
90­
Day
Feeding
­
Rodent
870.3150
82­
1B
90­
Day
Feeding
­
Non­
rodent
870.3200
82­
2
21­
Day
Dermal
­
Rabbit/
Rat
45481601
870.3465
82­
4
90­
Day
Inhalation­
Rat
870.4100
83­
1A
Chronic
Feeding
Toxicity
­
Rodent
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Non­
Rodent
74299
870.4200
83­
2A
Oncogenicity
­
Rat
2525010­
2525030,
00132949,

870.4200
83­
2B
Oncogenicity
­
Mouse
42216401,
00127239,
00124901
870.3700
83­
3A
Developmental
Toxicity
­
Rat
41853801,
44204501
(
Reserved
in
CRMS
Report)

870.3700
83­
3B
Developmental
Toxicity
­
Rabbit
870.3800
83­
4
2­
Generation
Reproduction
­
Rat
00119087
870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity
870.5140
84­
2A
Gene
Mutation
(
Ames
Test)

870.5375
84­
2B
Structural
Chromosomal
Aberration
None
84­
4
Other
Genotoxic
Effects
870.7485
85­
1
General
Metabolism
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2100
132­
1A
Foliar
Residue
Dissipation
45275001,
45269701,45292501,(
45317401
No
Decision)
,45269702,
(
45283701
in
Review)
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
83
of
120
875.2200
132­
1B
Soil
Residue
Dissipation
45359201
875.2400
133­
3
Dermal
Passive
Dosimetry
Exposure
875.2500
133­
4
Inhalation
Passive
Dosimetry
Exposure
None
231
Estimation
of
Dermal
Exposure
at
Outdoor
Sites
None
232
Estimation
of
Inhalation
Exposure
at
Outdoor
Sites
Special
Studies
45527601,
45513001,
45327101,
45449001,

45502401,455130001,45367701,45391501,
45200101,

45204701
ENVIRONMENTAL
FATE
None
160­
5
Chemical
Identity
835.2120
161­
1
Hydrolysis
0013275*,

40784501
835.2240
161­
2
Photodegradation
­
Water
40809701
835.2410
161­
3
Photodegradation
­
Soil
00061200,
00072377,
40809702
835.2370
161­
4
Photodegradation
­
Air
43803501
835.4100
162­
1
Aerobic
Soil
Metabolism
41735901
835.4200
162­
2
Anaerobic
Soil
Metabolism
(
40809701
Reserved
in
CRMS)

835.4400
162­
3
Anaerobic
Aquatic
Metabolism
41768901,
40809702
DG
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
84
of
120
835.4300
162­
4
Aerobic
Aquatic
Metabolism
42069601
835.1240
163­
1
Leaching/
Adsorption/
Desorption
40999001
835.1410
163­
2
Laboratory
Volatilization
42264201,
41194011*

835.6100
164­
1
Terrestrial
Field
Dissipation
41481001,
41752501,
41481002,
41752502
DG
164­
2
Aquatic
Sediment
Dissipation
41481003,
41752503
None
165­
4
Bioaccumulation
in
Fish
41001901
Field
Bird
Studies
44357804,
44371608,
00061213,
44271604,
00090488,
093632,
44371601,
44357806,
44357080,44378603,
443571604,
44371606,
44371601,
44371701,
44413601,
44371602,
44342007
Field
Mesocosm
Special
Studies
44371714,
44371712,
44378601,
44371715,
44371713
Special
Studies
44378602,
44371714,
44378611,
44572901,
66341
RESIDUE
CHEMISTRY
None
171­
2
Chemical
Identity
860.1300
171­
4A
Nature
of
Residue
­
Plants
41001401,
41001404,
41001403,
42914601,
44669501
860.1300
171­
4B
Nature
of
Residue
­
Livestock
00128039*,
41001406,
41001405
860.1340
171­
4C
Residue
Analytical
Method
­
Plants
00003724,
00035330,
00073196,
00080018,
00085260,00085261,
00085262,
00101100,
00101122,
00101124,
00101213,
00102312,
00102367,
00102376,
00102414,
00113173,
05004211*,
4241601*,
42281001,
42307901,
42307902,
42690001,
42717601,
4217602*,
42844601,42844602,
42844603,
42844604
DG
860.1340
171­
4D
Residue
Analytical
Method
­
Animals
(
00047726,
00105217
No
Decision)
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
85
of
120
860.1380
171­
4E
Storage
Stability
00102314,
42230901,
42291901,
42307001,
43685601,43758801,
44159702,
44632602,
44643602,
44413301,
44413403
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry
/
Egg
(
43127609
Not
Sastified)
DG
860.1500
171­
4K
Crop
Field
Trials
(
Bulb
Vegetables)
00102356,
41395104,
41596203
860.1500
171­
4K
Crop
Field
Trials
(
Leafy
Vegetables)
00061199,
41379304,
42844602
860.1500
171­
4K
Crop
Field
Trials
(
Pecans)
(
43760901,
43760910
Not
Satisfied)
DG
860.1500
171­
4K
Crop
Field
Trials
(
Potato)
00101095,
00102356,
41438102
860.1500
171­
4K
Crop
Field
Trials
(
Sugar
Beets)
0010195,
00102418,
41379306
860.1500
171­
4K
Crop
Field
Trials
(
Turnips)
41717806
860.1500
171­
4K
Crop
Field
Trials
(
Lettuce
Head)
44669501
860.1500
171­
4K
Crop
Field
Trials
(
Cabbage)
00061199,
42844602,
41379304
860.1500
171­
4K
Crop
Field
Trials
(
Peas,
succulent
or
dried)
00102417,
42241601,
41596207
860.1500
171­
4K
Crop
Field
Trials
(
Peas,
vine,
hay)
41596207,
42241601
860.1500
171­
4K
Crop
Field
Trials
(
Walnuts)
44159701
860.1500
171­
4K
Crop
Field
Trials
(
Corn,
field,
forage,
and
stover)
00051649,
41717803,
42307901,
00085261,
41717805,
44398301
860.1500
171­
4K
Crop
Field
Trials
(
Almonds)
00102418,
44632601
(
Time
extension
in
CRMS
Report)

860.1500
171­
4K
Crop
Field
Trials
(
Corn,
sweet,
forage,
&
stover)
00051649
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
86
of
120
860.1500
171­
4K
Crop
Field
Trials
(
Alfalfa)
00102356,
00104198,
41517101,
44811901,
00035330,
00035332,
00072376,
00035890,
0047726,
00101221
860.1500
171­
4K
Crop
Field
Trials
(
Cotton,
seed
&
gin
byproducts)
45296201,
44501201,
44813201
860.1500
171­
4K
Crop
Field
Trials
(
Sunflower)
00031669,
41359904,
00102312
860.1500
171­
4K
Crop
Field
Trials
(
Soybeans
forge
&
hay)
00101100,
00102367,
00102356,
4156003
860.1500
171­
4K
Crop
Field
Trials
(
Barley)
00051649,
00086695,
00072376
860.1500
171­
4K
Crop
Field
Trials
(
Corn)
0051649,
00085260,
00085259,
00085261,
41560002,
41717803,
41717804,
41717805,
44398301
860.1500
171­
4K
Crop
Field
Trials
(
Oats)
(
00051649,
00072376,
00086695
Not
satisfied)

860.1500
171­
4K
Crop
Field
Trials
(
Rice)
00051649,
41379307,
4156004*,
44643601
860.1500
171­
4K
Crop
Field
Trials
(
Rye)
00101096
(
Not
satisfied)

860.1500
171­
4K
Crop
Field
Trials
(
Wheat)
0051649,
00072376,
00086695,
41560001,
41596209,
45299301,
44848501,
4484505*,
44794501,
41818502
860.1500
171­
4K
Crop
Field
Trials
(
Rice
Straw)
41379307
DG
860.1500
171­
4K
Crop
Field
Trials
(
Wheat
forge,
hay,
&
straw)
00051649,
00072376,
41596209,
41818502
DG
860.1500
171­
4K
Crop
Field
Trials
(
Grass
forge
&
hay)
00102417,
41359902,
41359903,
41359905,
43479501,
44811902
860.1500
171­
4K
Crop
Field
Trials
(
Alfalfa
hay)
00035330,
00035332,
00035890,
00047726,
00072376,
00101221,
00102356,
00104198,
41517101,
44811901
860.1500
171­
4K
Crop
Field
Trials
(
Cottonseed)
00080018,
0008516,
00086695,
00099011,
00101100,
00101122,
00101226,
00101489,
00102291,
00102314,
00102362,
00102376,
00105217,
00113173,
41395103,
41457904,
44430601,
45296201
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methyl­
Parathion
REQUIREMENT
USE
PATTERN
CITATION(
S)

Page
87
of
120
860.1500
171­
4K
Crop
Field
Trials
(
Rape
seed)
00003724,
42717601
860.1500
171­
4K
Crop
Field
Trials
(
Hops)
44501201
860.1500
171­
4K
Crop
Field
Trials
(
Snap
bean)
44812901
860.1500
171­
4K
Crop
Field
Trials
(
Soybean
&
wheat
aspirated
grain
fractions0
45289901,
45289902
860.1500
171­
4K
Crop
Field
Trials
(
Sweet
potatoes)
00031669
(
Not
Satisfied)

OTHER
830.7050
None
UV/
Visible
Absorption
850.4400
122­
2
Aquatic
Plant
Growth
860.1520
171­
4L
Processed
Food
(
Potato)
41438102
860.1520
171­
4L
Processed
Food
(
Rapeseed)
42717602
(
Not
satisfied)

860.1520
171­
4L
Processed
Food
(
Rice)
00051649,
41596205
(
Not
satisfied)

860.1520
171­
4L
Processed
Food
(
Soybeans)
41517104,
42690001
(
Not
satisfied)

860.1520
171­
4L
Processed
Food
(
Wheat)
415596209*

860.1360
171­
4M
Multiresidue
Method
810.1000
90­
1
Use/
Usage
Data
850.3020
141­
1
Honey
Bee
Acute
Contact
Page
88
of
120
APPENDIX
C:
BIBLIOGRAPHY
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________

Page
89
of
120
3724
Winterlin,
W.
(
1968)
Residues
Found
on
Mustard
and
Rape
Seed.
Includes
undated
method.
(
Unpublished
study
received
Aug
11,
1972
under
3E1300;
prepared
by
Univ.
of
California­­
Davis,
Dept.
of
Environmental
Toxicology
8516E.
I.
du
Pont
de
Nemours
and
Company
(
1976)
Data
Supporting
Use
of
Lannate(
R)
I
Methomyl
Insecticide
and
Lannate(
R)
I
L
Methomyl
Insecticide
Plus
Methyl
Parathion
on
Cotton.
Summary
of
studies
227339­
B
through
227339­
M.
(
Unpublished
study
received
Jul
13,
1976
under
352­
342;
CDL:
227339­
A)

31669
Penwalt
Corporation
(
1977)
Residue
Data:
Introduction:
Penncap­
M.
(
Unpublished
study
received
Feb
12,
1980
under
4581­
EX­
16;
CDL:
241841­
A)

35330
Orloski,
E.
J.;
Devine,
J.
M.;
Pass,
B.
C.;
et
al.
(
1969)
Malathion
and
Methyl
parathion
Residues
in
Alfalfa:
Report
No.
C­
217.
Includes
undated
method
entitled:
Gas
chromatographic
determination
of
Malathion
and
Methyl
parathion
residues
in
alfalfa
(
green
foliage
and
dry
hay).
(
Unpublished
study
received
Feb
19,
1970
under
241­
219;
prepared
in
cooperation
with
Syracuse
Univ.
Research
Corp.,
submitted
by
American
Cyanamid
Co.,
Princeton,
N.
J.;
CDL:
002059­
C)

35332
Roberts,
W.
W.;
Waldron,
A.
C.;
Goleman,
L.;
et
al.
(
1967)
Alfalfa
Residues:
Methal
and
Ethul
parathion.
(
Unpublished
study
re­
ceived
Apr
1,
1969
under
241­
219;
prepared
in
cooperation
with
Ohio
State
Univ.
and
Univ.
of
Nevada,
Cooperative
Extension
Service,
Div.
of
Agricultural
Biochemistry
and
Pest
Control,
submitted
by
American
Cyanamid
Co.,
Princeton,
N.
J.;
CDL:
002059­
G)

35890
Dorough,
H.
W.;
Randolph,
N.
M.
(
1967)
Comparative
Residual
Nature
of
certain
Insecticides
Applied
as
Low
Volume
Concentrate
and
Water
Emulsion
Sprays.
Bulletin
of
Environmental
Contamination
&
Toxicology
2(
6):
340­
342.
(
Also~
In~
unpublished
submission
received
Apr
1,
1969
under
241­
219;
submitted
by
American
Cyanamid
Co.,
Princeton,
N.
J.;
CDL:
002059­
F)

47726
Fahey,
J.
E.
(
1961)
The
Results
of
Tests
on
the
Amount
of
Residue
Remaining,
Including
a
Description
of
the
Analytical
Method
Used:
Methyl
parathion|.
(
Unpublished
study
received
May
4,
1962
under
524­
128;
prepared
in
cooperation
with
U.
S.
Dept.
of
Agriculture,
submitted
by
Monsanto
Co.,
Washington,
D.
C.;
CDL:
101429­
B)

51649
Culver,
W.
H.
(
1975)
Introduction
and
Summary:
Penncap­
M.
(
Un­
published
study
received
Dec
24,
1975
under
6E1724;
prepared
in
cooperation
with
GHT
Laboratories,
submitted
by
Pennwalt
Corp.,
Philadelphia,
Pa.;
CDL:
095194­
A)
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________

Page
90
of
120
55859
A/
S
Cheminova
(
19??)
?
Chemical
Analysis
of
Methyl
parathion:
Pr­
Ch­
mp­
3.
(
Unpublished
study
received
Sep
22,
1980
under
4787­
4;
CDL:
243416­
A)

61199
Pennwalt
Corporation
(
1972)
Disappearance
of
Methyl
and
Ethyl
parathion
on
Foliage
from
Applications
of
Penncaps
and
E.
C.
Formulations.
(
Unpublished
study
received
Sep
29,
1980
under
4581­
292;
CDL:
243398­
A)

61200
Pennwalt
Corporation
(
1972)
Degradation
of
Methyl
parathion
E.
C.
versus
Pencap
M
in
Soil.
(
Unpublished
study
received
Sep
29,
1980
under
4581­
292;
CDL:
243398­
B)

61213
Pennwalt
Corporation
(
1980)
Penncap­
M(
R)
I
Insecticide­­
Simulated
Avian
Field
Study:
Project
No.
WT­
12­
79.
(
Unpublished
study
received
Sep
29,
1980
under
4581­
292;
CDL:
243398­
P)

66341
U.
S.
Environmental
Protection
Agency,
Environmental
Research
Laboratory
(
1981)
Acephate,
Aldicarb,
Carbophenothion,
DEF,
EPN,
Ethoprop,
Methyl
Parathion,
and
Phorate:
Their
Acute
and
Chronic
Toxicity,
Bioconcentration
Potential,
and
Persistence
as
Related
to
Marine
Environments:
EPA­
600/
4­
81­
023.
(
Unpublished
study)

71200
Fink,
R.;
Beavers,
J.
B.;
Brown,
R.;
et
al.
(
1980)
Final
Report:
Acute
Dermal
LD50­­
Bobwhite
Quail:
Project
No.
110­
124.
(
Unpublished
study
received
Dec
4,
1980
under
4581­
292;
prepared
by
Wildlife
International
Ltd.
and
Washington
College,
submitted
by
Pennwalt
Corp.,
Philadelphia,
Pa.;
CDL:
244308­
O)

72376
Pennwalt
Corporation
(
1972)
Disappearance
of
Methyl
and
Ethyl
Parathion
on
Foliage
from
Applications
of
Penncaps
and
E.
C.
Formulations.
(
Compilation;
unpublished
study
received
Dec
4,
1980
under
4581­
292;
CDL:
244308­
A)

72377
Pennwalt
Corporation
(
1971)
Methyl
Parathion
Residues
in
or
on
Grape
Leaves|.
(
Compilation;
unpublished
study
received
Dec
4,
1980
under
4581­
292;
CDL:
244308­
D)

73196
FMC
Corporation
(
1964)
(
Residues
on
Grain
Sorghum).
(
Compilation;
unpublished
study
received
Jan
7,
1967
under
7F0519;
CDL:
090614­
F)

74299
Daly,
I.
W.;
Rinehart,
W.
E.
(
1980)
A
Three
Month
Feeding
Study
of
Methyl
Parathion
in
Rats:
Project
No.
77­
2059.
(
Unpublished
study,
including
letter,
submitter
summary,
dated
Mar
7,
1980
from
T.
W.
Fuhremann
to
W.
D.
Carpenter
and
letter
dated
Aug
5,
1980
from
T.
W.
Fuhremann
to
W.
D.
Carpenter,
received
May
4,
1981
under
524­
68;
prepared
by
Bio/
dynamics,
Inc.
in
cooperation
with
Experimental
Pathology
Laboratories,
Inc.,
submitted
by
Monsanto
Co.,
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________

Page
91
of
120
Washington,
D.
C.;
CDL:
244993­
A;
244994)

80018
Monsanto
Company
(
1981)
Residues
of
Methyl
Parathion
in
Ginned
Cottonseed
following
Postemergent
Application
of
Methyl
Para­
thion/
Permethrin
Tank
Mixes
to
Cotton
Fields:
MSL­
1669.
Includes
undated
method
entitled:
Analytical
residue
method
for
methyl
parathion
in
cottonseed
and
method
Ran
0018
dated
Jan
16,
1981.
(
Unpublished
study
received
Aug
31,
1981
under
524­
128;
CDL:
245821­
A)

83103
Fink,
R.;
Beavers,
J.
B.;
Brown,
R.;
et
al.
(
1980)
Final
Report:
Acute
Dermal
LD50­­
Bobwhite
Quail:
Project
No.
110­
123.
(
Unpublished
study
received
Dec
4,
1980
under
4581­
292;
prepared
by
Wildlife
International
Ltd.
and
Washington
College,
submitted
by
Pennwalt
Corp.,
Philadelphia,
Pa.;
CDL:
244308­
N)

85259
Hercules,
Incorporated
(
1976)
Data
Summary:
Toxaphene
and
Methyl
Parathion
on
Sweet
Corn|.
(
Compilation;
unpublished
study
received
Apr
15,
1976
under
891­
23;
CDL:
223962­
A)

85260
University
of
Florida
(
1974)
Analysis
of
Toxaphene
and
Methyl
Parathion
Residues
on
Sweet
Corn.
(
Unpublished
study
received
Apr
15,
1976
under
891­
23;
prepared
by
Institute
of
Food
and
Agricultural
Sciences,
Dept.
of
Food
Science,
Pesticide
Research
Laboratory,
submitted
by
Hercules,
Inc.,
Agricultural
Chemicals,
Wilmington,
Del.;
CDL:
233962­
C)

85261
Weischedel,
B.
C.
(
1976)
Toxaphene
and
Methyl
Parathion
Residues
on
Sweet
Corn
from
Florida:
Anal/
8109.
(
Unpublished
study
received
Apr
15,
1976
under
891­
23;
submitted
by
Hercules,
Inc.,
Agricultural
Chemicals,
Wilmington,
Del.;
CDL:
233962­
D)

85262
Martin,
B.
W.
(
1975)
Determination
of
Residues
of
Methyl
Parathion
and
Toxaphene.
Undated
method.
(
Unpublished
study
received
Apr
15,
1976
under
891­
23;
prepared
by
Everglades
Laboratoratories,
Inc.,
submitted
by
Hercules,
Inc.,
Agricultural
Chemicals,
Wilmington,
Del.;
CDL:
233962­
E)

86695
Pennwalt
Corporation
(
1968)
Residue
Chemistry:
Introduction:
?
Penn­
cap­
M^(
R)
I|.
(
Unpublished
study
received
Oct
28,
1981
under
4581­
292;
CDL:
246182­
A)

90488
Edwards,
W.
R.;
Graber,
R.
R.
(
1967)
Responses
of
Avians
to
Methyl
Parathion
in
a
Hayfield.
(
Unpublished
study
received
on
unknown
date
under
unknown
admin.
no.;
submitted
by
;
CDL:
130204­
A)
BIBLIOGRAPHY
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Page
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of
120
99011
Nor­
Am
Agricultural
Products,
Inc.
(
1975)
Summary:
Residue
Data
for
Tank
Mix
Applications
of
Chlordimeform
Fundal/
Galecron
plus
Azodrin,
Methyl
Parathion/
Toxaphene
or
Methyl
Parathion
When
Applied
to
Cotton.
(
Compilation;
unpublished
study
received
Aug
15,
1975
under
2139­
98;
CDL:
223839­
A)

101095
National
Agricultural
Chemicals
Assoc.
(
1970)
Parathion/
Methyl
Parathion
Pesticide
Petition:
Results
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Analysis
of
Root
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(
Compilation;
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CDL:
090847­
C)

101096
National
Agricultural
Chemicals
Assoc.
(
1970)
Parathion/
Methyl
Parathion
Pesticide
Petition:
Results
of
Analysis
of
Rye­­
0.5
ppm.
(
Compilation;
unpublished
study
received
Dec
12,
1970
under
1F1091;
CDL:
090847­
D)

101100
National
Agricultural
Chemicals
Assoc.
(
1969)
Parathion/
Methyl
Parathion
Pesticide
Petition.
(
Compilation;
unpublished
study
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Sep
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1969
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090885­
A)

101122
National
Agricultural
Chemicals
Assoc.
(
1970)
Results
of
Analyses
of
Field
Treated
Cottonseed
and
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unpublishd
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May
6,
1969
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0F0878;
CDL:
093175­
A)

101124
Univ.
of
Nevada
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1969)
?
Residues
of
Ethyl
and
Methyl
Parathion
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Alfalfa|.
(
Compilation;
unpublished
study
received
Mar
3,
1969,
Dec
31,
1970
under
9E0823;
CDL:
093524­
A)

101213
Monsanto
Co.
(
1964)
?
Residue
Studies
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Parathion
on
Sorghum|.
(
Unpublished
study
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Sep
11,
1964
under
unknown
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no.;
CDL:
122516­
A)

101221
Union
Carbide
Corp.
(
1967)
Sevithion
Residues
in
Alfalfa
Hay­­
a
Summary.
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unpublished
study
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1,
1968
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1016­
EX­
28;
CDL:
126503­
D)

101226
Agchem
(
1978)
Residue
Data
Introduction:
Penncap­
E.
(
Unpublished
study
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Nov
16,
1978
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4581­
EX­
23;
CDL:
235971­
A)

101489
Pennwalt
Corporation
(
1978?)
?
Residue
Data
on
Penncap­
M^(
R)
I
Insecticide
and
Permethrin,
Including
Method
Determining
Cis
and
Trans
Isomers
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Permethrin|.
(
Compilation;
unpublished
study
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5,
1982
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4581­
292;
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247267­
A)

102291
Walker,
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Yeomans,
A.;
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J.;
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Comparative
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Low­
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Sprays
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(
U.
S.
Agricultural
Research
Service,
Entomology
Research
Div.,
Analytical
Investigations,
Aerosol
Investiga­
tions,
Biological
Investigations
and
Plant
Pest
Control
Div.;
unpublished
study;
CDL:
005066­
B)

102312
Dorough,
H.
(
1968)
Letter
sent
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C.
Compton
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Apr
19,
1968
(
Methyl
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Residues
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Apr
22,
1968
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8E0718;
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Texas
A
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M
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New
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A)

102314
Pennwalt
Corp.
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1972)
Introduction:
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M
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known
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093631­
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Pennwalt
Corp.
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1972)
Pencap
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LC50
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102356
Pennwalt
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1973)
Residues
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Methyl
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14,
1977
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292;
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A)

102362
Bouchard,
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(
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Cotton:
?
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1971
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876­
125;
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IL;
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102367
Stranz,
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1963)
Methyl
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Stalks
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Hay)­­
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102376
Peterson,
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Pasarela,
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49;
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123158­
G)

102414
Waldron,
A.;
Coleman,
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1967)
Ethyl
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Project
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unknown
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Extension
Service,
Pesticide
Chemicals
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Princeton,
NJ;
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102417
Keckemet,
O.
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1977)
Residue
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Penncap­
M.
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3,
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94
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1977
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4581­
292;
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A)

102418
Keckemet,
O.
(
1977)
Residue
Data:
Penncap­
M.
(
Unpublished
study
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Mar
29,
1977
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4581­
EX­
24;
submitted
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Pennwalt
Corp.,
Philadelphia,
PA;
CDL:
228782­
A)

104198
Velsicol
Chemical
Corp.
(
1964)
Residues
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Various
Insecticides
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Alfalfa,
Red
Clover,
Milk
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Jan
27,
1961;
Aug
30,
1963;
Dec
24,
1963;
Jan
20,
1964
under
unknown
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no.;
CDL:
122412­
B)

105217
Ciba­
Geigy
Corp.
(
1978)
The
Results
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Tests
on
the
Amount
of
Residues
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Including
a
Description
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the
Analytical
Methods
Used:
Curacron.
(
Compilation;
unpublished
study
received
Mar
3,
1978
under
100­
598;
CDL:
096851­
A;
096852;
096853;
096854;
096855)

113173
Mitchell,
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Russell;
Cleveland,
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1971)
Cygard
630:
Malathion,
Methyl
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Methyl
Paraoxon
Residues
in
Undelinted
Cottonseed:
Report
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C­
261.
(
Unpublished
study
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8,
1971
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unknown
admin.
no.;
prepared
in
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with
Syracuse
Univ.
Research
Corp.,
submitted
by
American
Cyanamid
Co.,
Princeton,
NJ;
CDL:
120007­
A)

119087
Daly,
I.;
Hogan,
G.
(
1982)
A
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Generation
Reproduction
Study
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Methyl
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Project
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80­
2456;
BD­
80­
139.
Final
rept.
(
Unpublished
study
received
Dec
9,
1982
under
524­
68;
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dynamics,
Inc.,
submitted
by
Monsanto
Co.,
Washington,
DC;
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124901
Simmon,
V.;
Mitchell,
A.;
Jorgenson,
T.
(
1977)
Evaluation
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Selected
Pesticides
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Chemical
Mutagens:
In
vitro
and
in
vivo
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EPA­
600/
1­
77­
028:
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(
Un­
published
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Sep
14,
1977
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1471­
35;
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Stanford
Research
Institute,
Environmental
Toxicology
Div.,
Health
Effects
Research
Laboratory,
and
U.
S.
Environmental
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Agency,
Office
of
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and
Development,
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Elanco
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Div.
of
Eli
Lilly
and
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Indianapolis,
IN;
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127239
Ulland,
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National
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National
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Div.
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Bethesda,
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USNIH.
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NIH)
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ed
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Page
95
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1982
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unknown
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by
Stauffer
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CA;
CDL:
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132949
Mortelmans,
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Riccio,
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Shepherd,
G.
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1980)
In
vitro
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Mitotic
Crossing­
Over,
Mitotic
Gene
Conversion
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Reverse
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S.
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D7
for
Seven
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SRI
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7558­
20;
Contract
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68­
02­
2947.
Final
rept.
(
Unpublished
study
received
Dec
5,
1983
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239­
2471;
prepared
by
SRI
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submitted
by
Chevron
Chemical
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Richmond,
CA;
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138663
Waller,
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Hanny,
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Harvey;
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(
1983)
A
Comparison
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Methyl
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Unpublished
study
received
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11,
1984
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4581­
292;
submitted
by
Agchem
Div.,
Pennwalt
Corp.,
Philadel­
phia,
PA;
CDL:
252448­
C)

160948
Rhodes,
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Wilson,
W.;
Sonnet,
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al.
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1980)
Honey
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M.
American
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577­
580,588.

40364105
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Miyamoto,
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1980)
Comparison
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various
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neurotoxic
esterase
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hens
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40406601
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S
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17
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40482401
A/
S
Cheminova
(
1987)
Product
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Methyl
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Technical
...
Supplementary
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...:
Study
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MVF/
01.12.87­
MP­
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Unpublished
study
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A/
S
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association
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the
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42
p.

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Cuthbert,
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Carr,
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1986)
Methyl
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60
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40784501
Wilmes,
R.
(
1987)
Parathion­
methyl:
Hydrolysis
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Report
#
PF
2883:
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M
1110168­
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Unpublished
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AG.
34
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40809701
Wilmes,
R.
(
1987)
Parathion­
methyl:
Photodegradation
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Laboratory
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ID
M
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0:
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ID
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2884.
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Bayer
AG.
47
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40809702
Wilmes,
R.
(
1988)
Parathion­
methyl:
Photodegradation
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Laboratory
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M
1130170­
3:
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ID
PF
2885.
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AG.
46
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40932101
Surprenant,
D.
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1988)
Acute
Toxicity
of
Methyl
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TEP
(
Methyl
Parathion
Typical
End­
Use
Product)
to
Rainbow
Trout
(
Salmo
gairdneri)
Under
Flow­
through
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SLS
Report
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88­
7­
2772;
SLS
Study
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11704.0388.6113.108.
Unpublished
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Life
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39
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40932103
Surprenant,
D.
(
1988)
Acute
Toxicity
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Methyl
Parathion
TEP
(
Methyl
Parathion
Typical
End­
Use
Product)
to
Sheephead
Minnow
(
Cyprinodon
variegatus)
Under
Flow­
through
Conditions:
Project
ID:
SLS
Report
No.
88­
8­
2783;
SLS
Study
No.
11704.0388.6114.505.
Unpublished
study
prepared
by
Springborn
Life
Sciences,
Inc.
39
p.

40932104
Surprenant,
D.
(
1988)
Acute
Toxicity
of
Methyl
Parathion
TEP
(
Methyl
Parathion
Typical
End­
Use
Product)
to
Mysid
Shrimp
(
Mysidopsis
bahia)
Under
Flow­
through
Conditions:
Project
ID:
SLS
Report
No.
88­
8­
2781;
SLS
Study
No.
11704.0388.6114.515.
Unpublished
study
prepared
by
Springborn
Life
Sciences,
Inc.
37
p.

40999001
Daly,
D.
(
1989)
Soil
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Desorption
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Carbon
14­
methyl
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ABC
Final
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Unpublished
study
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Analytical
Bio­
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Inc.
346
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41001401
Linke,
P.;
Bornatsch,
W.;
Brauner,
A.;
et
al.
(
1988)
Metabolism
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phenyl­
UL­?
Carbon
14||
Parathion­
methyl
in
Cotton
Seeds
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Leaves:
PF­
Report
No.
3037.
Unpublished
study
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by
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77
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41001403
Linke,
P.;
Brauner,
A.
(
1988)
Parathion­
methyl:
Metabolism
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Laboratory
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ID:
M
173
0
193­
4.
Unpublished
study
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Bayer
Ag.
62
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41001404
Ritter,
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(
1988)
?
Carbon
14|­
Parathion­
methyl:
Plant
Metabolism
Study
with
Lettuce
in
the
Greenhouse
in
Accordance
with
the
EPA
...
Residue
Chemistry
...:
RCC
Project
092114.
Unpublished
study
prepared
by
RCC
Umweltchemie
Ag.
75
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41001405
Van
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A.
(
1988)
(
Carbon
14)­
Parathion­
methyl:
Metabolism,
Absorption,
Distribution
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Excretion
after
Repeated
Oral
Administration
to
a
Lactating
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RCC
Project
091585.
Unpublished
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by
R
C
C
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152
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41001406
Van
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A.
(
1988)
?
Carbon
14|­
Parathion­
methyl:
Metabolism,
Ab­
sorption,
Distribution
and
Excretion
after
Repeated
Oral
Administration
to
Laying
Hens:
RCC
Project
091798.
Unpublished
study
prepared
by
R
C
C
Umweltchemie
Ag.
145
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41001901
Grau,
R.;
Ecker,
W.;
Klein,
O.
(
1988)
Methyl
Parathion:
Bioaccumulation
in
Fish:
Laboratory
Project
ID:
E­
2860059­
0
and
M­
2880192­
0.
Unpublished
study
prepared
by
Bayer
Ag.
64
p.

41083101
Surprenant,
D.
(
1989)
The
Toxicity
of
Methyl
Parathion
Technical
to
Sheepshead
Minnow
(
Cyprindon
variegatus)
Embryos
and
Larvae:
Project
ID
88­
12­
2877.
Unpublished
study
prepared
by
Springborn
Life
Sciences,
Inc.
65
p.

41179301
Beavers,
J.;
Corbitt,
A.;
Jaber,
M.
(
1988)
Methyl
Parathion:
A
One­
generation
Reproduction
Study
with
the
Mallard
(
Anas
platyrhyn­
chos):
Laboratory
Project
No.
232­
109.
Unpublished
study
pre­
pared
by
Wildlife
International
Ltd.
91
p.

41179302
Beavers,
J.;
Corbitt,
A.;
Jaber,
M.
(
1988)
Methyl
Parathion:
A
One­
generation
Reproduction
Study
with
the
Bobwhite
(
Colinus
vir
ginianus):
Laboratory
Project
No.
232­
108.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
96
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41359902
Canez,
V.
(
1989)
The
Magnitude
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Methyl
Parathion
Residues
of
Bermuda
Grass:
Lab
Project
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PAL/
MP/
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Unpublished
study
prepared
by
Analytical
Development
Corp.
216
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41359903
Canez,
V.
(
1989)
The
Magnitude
of
Methyl
Parathion
Residues
on
Bluegrass:
Lab
Project
Number:
PAL/
MP/
BL.
Unpublished
study
prepared
by
Analytical
Development
Corp.
210
p.

41359904
Canez,
V.
(
1989)
The
Magnitude
of
Methyl
Parathion
Residues
on
Sunflower:
Lab
Project
Number:
PAL/
MP/
SS.
Unpublished
study
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The
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41379304
Canez,
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The
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41379306
Canez,
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The
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41379307
Cooley,
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The
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PAL­
MP­
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41395103
Canez,
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The
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Cot­
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252
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41395104
Canez,
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The
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426
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41438102
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The
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02H.
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41457904
Pitt,
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Methyl
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Methyl
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41481001
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Terrestrial
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41481003
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Canez,
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Canez,
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41596207
LeRoy,
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41596209
LeRoy,
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The
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LeRoy,
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Canez,
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Patterson,
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Magnitude
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Methyl
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Research
Services,
Inc.,
Research
Options,
Inc.,
and
Morse
Laboratories,
Inc.
297
p.
{
OPPTS
875.1500}

45481601
Beyrouty,
P.
(
2001)
A
4­
Week
Dermal
Toxicity
Study
of
Methyl
Parathion
in
Rats:
Lab
Project
Number:
97533.
Unpublished
study
prepared
by
ClinTrials
BioResearch
Ltd.
1260
p.

45502401
Belcher,
T.
(
2001)
Biomonitoring
Assessment
of
Worker
Exposure
to
Methyl
Parathion
During
Application
to
Potatoes
Using
Penncap­
M
Microencapsulated
Insecticide:
Final
Study
Report:
Lab
Project
Number:
KP­
2001­
02:
ERS21007.
Unpublished
study
prepared
by
Excel
Research
Services,
Inc.
703
p.
{
OPPTS
875.1500}

45513001
Willard,
T.
(
2001)
Occupational
Exposure
Monitoring
of
Mixing/
Loading
Activities
for
Aerial
Application
of
Penncap­
M
Microencapsulated
Insecticide
Utilizing
Biological
Monitoring:
Final
Study
Report:
Lab
Project
Number:
KP­
2001­
03.
Unpublished
study
prepared
by
American
Agricultural
Services,
Inc.
764
p.
{
OPPTS
875.2600}

45527601
Merricks,
D.
(
2001)
Biological
Monitoring
of
Workers
Mixing
and
Loading
a
4lb/
gallon
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________

Page
110
of
120
Emulsifiable
Concentrate
Formulation
of
Methyl
Parathion
for
Aerial
Application
(
Using
a
MICRO
MATIC:
DV:
Liquid
Transfer
Valve
System):
Lab
Project
Number:
2904.
Unpublished
study
prepared
by
Agrisearch
Incorporated.
596
p.
Page
111
of
120
APPENDIX
D:
GENERIC
DATA
CALL­
IN
APPENDIX
E:
PRODUCT
SPECIFIC
DATA
CALL­
IN
APPENDIX
F:
LIST
OF
COMPANIES
RECEIVING
DCIs
placeholder
for
these
three
appendices
Page
112
of
120
APPENDIX
G:
BATCHING
EPA'S
BATCHING
OF
Methyl
Parathion
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
Methyl
Parathion
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.
Notwith­
standing
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
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
Page
113
of
120
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.

Fifteen
products
were
found
which
contain
Methyl
Parathion
as
the
active
ingredient.
These
products
have
been
placed
into
three
batches
and
a
"
No
Batch"
category
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.
Furthermore,
the
following
bridging
strategies
are
deemed
acceptable
for
this
chemical:

°
Batch
1:
EPA
Reg.
No.
4787­
33
may
not
cite
studies
conducted
with
EPA
Reg.
No.
1812­
431
°
Batch
2:
EPA
Reg.
No.
67760­
39
may
not
cite
studies
conducted
with
EPA
Reg.
No.
19713­
322.

°
No
Batch:
Each
product
in
this
Batch
should
generate
their
own
data.

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
1812­
431
80.0
4787­
33
80.0
Batch
2
EPA
Reg.
No.
%
Active
Ingredient
19713­
322
Methyl
parathion:
28.67
Parathion:
57.69
19713­
324
Methyl
parathion:
28.67
Parathion:
57.69
67760­
39
Methyl
parathion:
29.04
Parathion:
58.01
Page
114
of
120
Batch
3
EPA
Reg.
No.
%
Active
Ingredient
1812­
432
45.11
5905­
533
45.11
19713­
511
44.80
19713­
512
44.80
34704­
819
45.50
51036­
321
45.50
67760­
43
45.50
No
Batch
EPA
Reg.
No.
%
Active
Ingredient
4581­
393
22.00
5905­
534
Methyl­
parathion:
39.94
Malathion:
39.94
34704­
818
54.70
Page
115
of
120
APPENDIX
H:
LIST
OF
TECHNICAL
SUPPORT
DOCUMENTS
HED
DOCUMENTS:

°
METHYL
PARATHION.
The
2nd
Revised
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED).
PC
Code:
053501,
Case
#
0153.
Locke,
Diana.

°
Revised
"
Occupational
and
Residential
Exposure
and
Risk
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Methyl
Parathion"
Renee
Sandvig.

°
Methyl
Parathion:
HED
Response
to
Cheminova
Comments
on
Risk
Assessment.
Jeff
Dawson
EFED
DOCUMENTS
°
Revised
Tier2
PRZM/
EXAMS
Modeling
for
Methyl
Parathion
(
Includes
Terrestrial
Values).
Amer
Al­
Mudallal.

°

BEAD
DOCUMENTS
°
BEAD
Assessment
for
the
Impacts
of
Cancellation
of
Methyl
Parathion
Use
on
Sunflowers.
David
Brassard
and
Jihad
Alsadek
°
Benefits
Assessment
for
Methyl
Parathion
Use
in
Cotton.
Bill
Gross;
Nicole
Mosz,
and
Timothy
Kiely
°
BEAD
Impact
Assessment
for
the
Use
of
Methyl
Parathion
on
Field
Corn.
David
Brassard
and
Jihad
Alsadek
°
BEAD
Benefits
Assessment
for
Methyl
Parathion
Use
on
Sweet
corn.
Donald
Atwood
and
Timothy
Kiely.

°
Biological
and
Economic
Impact
Analysis
of
Methyl
Parathion
on
Sweet
Potatoes.
Nikhil
Mallampalli
and
Timothy
Kiely.

°
BEAD
Benefits
Assessment
for
Methyl
Parathion
Use
on
Walnuts.
Donald
Atwood
and
Jihad
Alsadek.

°
Benefits
Assessment
for
Methyl
Parathion
Use
on
Soybeans.
Bill
Gross
and
Timothy
Kiely.
Page
116
of
120
°
Benefits
Assessment
for
Methyl
Parathion
Use
on
Rice:
Impacts
of
Cancellation.
Colwell
Cook
and
Timothy
Kiely.

°
BEAD
Preliminary
Assessment
of
the
Impacts
of
Extending
Restricted
Entry
Intervals
for
Methyl
Parathion
Use
on
Cotton,
Field
Corn,
Rice,
Soybean,
Sunflower,
Sweet
Corn,
Sweet
Potato,
and
Walnuts.
David
Brassard.
Page
117
of
120
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/
8570­
1.
pdf
8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570­
5.
pdf
8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570­
17.
pdf
8570­
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf
8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570­
27.
pdf
8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570­
28.
pdf
8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570­
30.
pdf
8570­
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
Page
118
of
120
8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
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
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
Page
119
of
120
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.

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:

1.
Date
of
receipt;
2.
EPA
identifying
number;
and
3.
Product
Manager
assignment.
Page
120
of
120
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.