Document ID: EPA-HQ-OPP-2002-0266-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-03-17T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
April
7,
2002
CERTIFIED
MAIL
Dear
Registrant:

This
is
to
inform
you
that
the
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
review
of
the
available
data
and
public
comments
received
related
to
the
preliminary
and
revised
risk
assessments
for
the
organophosphate
pesticide
methamidophos.
The
public
comment
period
on
the
revised
risk
assessment
phase
of
the
reregistration
process
is
closed.
Based
on
comments
received
during
the
public
comment
period
and
additional
data
received
from
the
registrant,
the
Agency
revised
the
human
health
and
environmental
effects
risk
assessments
and
made
them
available
to
the
public
on
February
3,
2000.
Additionally,
the
Agency
held
a
Technical
Briefing
on
February
3,
2000,
where
the
results
of
the
revised
human
health
and
environmental
effects
risk
assessments
were
presented
to
the
general
public.
This
Technical
Briefing
concluded
Phase
4
of
the
OP
Public
Participation
Pilot
Process
developed
by
the
Tolerance
Reassessment
Advisory
Committee,
and
initiated
Phase
5
of
that
process.
During
Phase
5,
all
interested
parties
were
invited
to
participate
and
provide
comments
and
suggestions
on
ways
the
Agency
might
mitigate
the
estimated
risks
presented
in
the
revised
risk
assessments.
This
public
participation
and
comment
period
commenced
on
February
22,
2000
,
and
closed
on
April
22,
2000.

Based
on
its
review,
EPA
has
identified
risk
mitigation
measures
that
the
Agency
believes
mitigation
measures
are
necessary
to
address
the
human
health
and
environmental
risks
associated
with
the
current
use
of
methamidophos.
The
EPA
is
now
publishing
its
interim
decision
on
the
reregistration
eligibility
of
and
risk
management
decision
for
the
current
uses
of
methamidophos
and
its
associated
human
health
and
environmental
risks.
The
reregistration
eligibility
and
tolerance
reassessment
decisions
for
methamidophos
will
be
finalized
once
the
cumulative
risks
for
all
of
the
organophosphate
pesticides
are
considered.
The
enclosed
"
Interim
Reregistration
Eligibility
Decision
for
methamidophos,"
which
was
approved
on
April
5,
2002,
contains
the
Agency's
decision
on
the
individual
chemical
methamidophos.

A
Notice
of
Availability
for
this
Interim
Reregistration
Eligibility
Decision
for
methamidophos
is
being
published
in
the
Federal
Register.
To
obtain
a
copy
of
the
interim
RED
document,
please
contact
the
OPP
Public
Regulatory
Docket
(
7502C),
US
EPA,
Ariel
Rios
Building,
1200
Pennsylvania
Avenue
NW,
Washington,
DC
20460,
telephone
(
703)
305­
5805.
Electronic
copies
of
the
interim
RED
and
all
supporting
documents
are
available
on
the
Internet.
See
http:
www.
epa.
gov/
pesticides/
op.
The
interim
RED
is
based
on
the
updated
technical
information
found
in
the
methamidophos
public
docket.
The
docket
not
only
includes
background
information
and
comments
on
the
Agency's
preliminary
risk
assessments,
it
also
now
includes
the
Agency's
revised
risk
assessments
for
methamidophos
(
Revised
Dietary
Exposure
and
Risk
Analyses
for
the
HED
Revised
Human
Health
Risk
Assessment,
July
19,
2000,
Methamidophos:
Addendum
to
the
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document,
September
15,
2000,
Recalculated
Tier
II
Drinking
Water
EECs
for
Methamidophos
Incorporating
the
Index
Reservoir
and
Percent
Cropped
Area,
October
17,
2000.),
and
a
document
summarizing
the
Agency's
Response
to
Comments.
The
Response
to
Comments
document
addresses
corrections
to
the
preliminary
risk
assessments
submitted
by
chemical
registrants,
as
well
as
responds
to
comments
submitted
by
the
general
public
and
stakeholders
during
the
comment
period
on
the
risk
assessment.
The
docket
will
also
include
comments
on
the
revised
risk
assessment,
and
any
risk
mitigation
proposals
submitted
during
Phase
5.
For
methamidophos,
no
proposal
was
submitted
by
Bayer,
the
technical
registrant.

This
document
and
the
process
used
to
develop
it
are
the
result
of
a
pilot
process
to
facilitate
greater
public
involvement
and
participation
in
the
reregistration
and/
or
tolerance
reassessment
decisions
for
these
pesticides.
As
part
of
the
Agency's
effort
to
involve
the
public
in
the
implementation
of
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
the
Agency
is
undertaking
a
special
effort
to
maintain
open
public
dockets
on
the
organophosphate
pesticides
and
to
engage
the
public
in
the
reregistration
and
tolerance
reassessment
processes
for
these
chemicals.
This
open
process
follows
the
guidance
developed
by
the
Tolerance
Reassessment
Advisory
Committee
(
TRAC),
a
large
multistakeholder
advisory
body
that
advised
the
Agency
on
implementing
the
new
provisions
of
the
FQPA.
The
reregistration
and
tolerance
reassessment
reviews
for
the
organophosphate
pesticides
are
following
this
new
process.

Please
note
that
the
methamidophos
risk
assessment
and
the
attached
interim
RED
concern
only
this
particular
organophosphate.
This
interim
RED
presents
the
Agency's
conclusions
on
the
dietary
risks
posed
by
exposure
to
methamidophos
alone.
The
Agency
has
also
concluded
its
assessment
of
the
ecological
and
worker
risks
associated
with
the
use
of
methamidophos.
Because
the
FQPA
directs
the
Agency
to
consider
available
information
on
the
basis
of
cumulative
risk
from
substances
sharing
a
common
mechanism
of
toxicity,
such
as
the
toxicity
expressed
by
the
organophosphates
through
a
common
biochemical
interaction
with
cholinesterase
enzyme,
the
Agency
will
evaluate
the
cumulative
risk
posed
by
the
entire
organophosphate
class
of
chemicals
after
considering
the
risks
for
the
individual
organophosphates.
The
Agency
is
working
towards
completion
of
a
methodology
to
assess
cumulative
risk
and
the
individual
risk
assessments
for
each
organophosphate
are
likely
to
be
necessary
elements
of
any
cumulative
assessment.
The
Agency
has
decided
to
move
forward
with
individual
assessments
and
to
identify
mitigation
measures
necessary
to
address
those
human
health
and
environmental
risks
associated
with
the
current
uses
of
methamidophos.
The
Agency
will
issue
the
final
tolerance
reassessment
decision
for
methamidophos
and
finalize
decisions
on
reregistration
eligibility
once
the
cumulative
risks
for
all
of
the
organophophates
are
considered.
This
document
contains
a
generic
and/
or
a
product­
specific
Data
Call­
In(
s)
(
DCI)
that
outline(
s)
further
data
requirements
for
this
chemical.
Note
that
a
complete
DCI,
with
all
pertinent
instructions,
is
being
sent
to
registrants
under
separate
cover.
Additionally,
for
product­
specific
DCIs,
the
first
set
of
required
responses
to
is
due
90
days
from
the
receipt
of
the
DCI
letter.
The
second
set
of
required
responses
is
due
eight
months
from
the
date
of
the
DCI.

In
this
interim
RED,
the
Agency
has
determined
that
methamidophos
will
be
eligible
for
reregistration
provided
that
all
the
conditions
identified
in
this
document
are
satisfied,
including
implementation
of
the
risk
mitigation
measures
outlined
in
Section
IV
of
the
document.
The
Agency
believes
that
current
uses
of
methamidophos
may
pose
unreasonable
adverse
effects
to
human
health
and
the
environment,
and
that
such
effects
can
be
mitigated
with
the
risk
mitigation
measures
identified
in
this
interim
RED.
Accordingly,
the
Agency
recommends
that
registrants
implement
these
risk
mitigation
measures
immediately.
Sections
IV
and
V
of
this
interim
RED
describe
labeling
amendments
for
end­
use
products
and
data
requirements
necessary
to
implement
these
mitigation
measures.
Instructions
for
registrants
on
submitting
the
revised
labeling
can
be
found
in
the
set
of
instructions
for
product­
specific
data
that
accompanies
this
interim
RED.

Should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
outlined
in
this
document,
the
Agency
will
continue
to
have
concerns
about
the
risks
posed
by
methamidophos.
Where
the
Agency
has
identified
any
unreasonable
adverse
effect
to
human
health
and
the
environment,
the
Agency
may
at
any
time
initiate
appropriate
regulatory
action
to
address
this
concern.
At
that
time,
any
affected
person(
s)
may
challenge
the
Agency's
action.

If
you
have
questions
on
this
document
or
the
label
changes
necessary
for
reregistration,
please
contact
the
Special
Review
and
Reregistration
Division
representative,
Mark
A.
Hartman,
at
(
703)
308­
0734.
For
questions
about
product
reregistration
and/
or
the
Product
DCI
that
accompanies
this
document,
please
contact
Bonnie
Adler
at
(
703)
308­
8523.

Sincerely,

Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Attachment
Interim
Reregistration
Eligibility
Decision
for
Methamidophos
Case
No.
0043
TABLE
OF
CONTENTS
Executive
Summary
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1
I.
Introduction
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6
II.
Chemical
Overview
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8
A.
Regulatory
History
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8
B.
Chemical
Identification
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8
C.
Use
Profile
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9
D.
Estimated
Usage
of
Pesticide
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10
III.
Summary
of
Methamidophos
Risk
Assessment
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11
A.
Human
Health
Risk
Assessment
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11
1.
Dietary
Risk
from
Food
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12
a.
Toxicity
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13
b.
FQPA
Safety
Factor
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13
c.
Population
Adjusted
Dose
(
PAD)
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13
d.
Exposure
Assumptions
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14
e.
Food
Risk
Characterization
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15
2.
Dietary
Risk
from
Drinking
Water
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15
a.
Surface
Water
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16
b.
Ground
Water
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17
c.
Drinking
Water
Levels
of
Comparison
(
DWLOCs)
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18
3.
Aggregate
Risk
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20
4.
Occupational
and
Residential
Risk
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20
a.
Toxicity
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21
b.
Exposure
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22
c.
Occupational
Handler
Risk
Summary
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24
1)
Agricultural
Handler
Risk
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24
2)
Post­
Application
Occupational
Risk
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.
.
.
.
.
.
.
.
25
B.
Environmental
Risk
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
26
1.
Environmental
Fate
and
Transport
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
27
2.
Ecological
Risk
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
27
a.
Ecological
Hazard
Profile
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
28
b.
Risk
to
Birds
and
Mammals
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
29
c.
Risk
to
Aquatic
Animals
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
30
d.
Incidents
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
31
e.
Endangered
Species
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
31
C.
Benefits
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
31
IV.
Interim
Risk
Management
and
Reregistration
Decision
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
35
A.
Determination
of
Interim
Reregistration
Eligibility
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
35
B.
Summary
of
Phase
5
Comments
and
Responses
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
36
C.
Regulatory
Position
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
1.
FQPA
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
a.
"
Risk
Cup"
Determination
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
b.
Tolerance
Summary
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
41
2.
Endocrine
Disruptor
Effects
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
47
3.
Labels
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
47
a.
Agricultural
Use
Exposure
Reduction
Measures
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
47
b.
Homeowner
Use
Exposure
Reduction
Measures
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
D.
Regulatory
Rationale
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
1.
Human
Health
Risk
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
a.
Dietary
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
1)
Acute
Dietary
(
Food)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
2)
Chronic
Dietary
(
Food)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
48
3)
Drinking
Water
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
49
b.
Homeowner
Risk
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
50
c.
Aggregate
Risk
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
51
d.
Occupational
Risk
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
52
1)
Agricultural
Uses
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
52
2.
Environmental
Risk
Mitigation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
57
E.
Other
Labeling
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
57
1.
Endangered
Species
Statement
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
58
2.
Spray
Drift
Management
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
58
F.
Methamidophos
Risk
Mitigation
Summary
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
60
1.
Dietary
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
60
2.
Occupational
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
60
3.
Ecological
Risks
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
61
V.
What
Registrants
Need
to
Do
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
62
A.
Data
Call­
In
Responses
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
62
B.
Manufacturing
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
63
1.
Additional
Generic
Data
Requirements
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
63
2.
Labeling
for
Manufacturing
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
64
C.
End­
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
64
1.
Additional
Product­
Specific
Data
Requirements
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
64
2.
Labeling
for
End­
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
64
D.
Existing
Stocks
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
64
E.
Labeling
Changes
Summary
Table
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
66
VI.
Related
Documents
and
How
to
Access
Them
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
76
A.
Availability
at
OPP
Docket
Room
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
76
B.
Availability
on
the
Internet
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
76
VII:
Appendices
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
77
Appendix
A.
Use
Patterns
Eligible
for
Reregistration
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
77
Appendix
B:
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methamidophos
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
82
Appendix
C:
Technical
Support
Documents
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
92
Appendix
D:
Bibliography
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
94
Appendix
E:
Generic
Data
Call
In
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
115
Appendix
F:
Product
Specific
Data
Call
In
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
116
Appendix
G:
EPA'S
Batching
of
Methamidophos
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
117
Appendix
H:
List
of
Registrants
Sent
DCIs
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
119
Appendix
I:
List
of
Available
Related
Documents
and
Electronically
Available
Forms
.
.
.
.
120
Methamidophos
TEAM
Office
of
Pesticide
Programs:

Health
Effects
Risk
Assessment
Felecia
Fort
Susan
Hanley
Nancy
McCarroll
Environmental
Fate
Risk
Assessment
Michael
Davy
Ian
Kennedy
Stephanie
Syslo
Use
and
Usage
Analysis
Timothy
Kiely
Angel
Chiri
Donald
Atwood
Registration
Support
Marilyn
Mautz
Risk
Management
Mark
Hartman
Elizabeth
Vizard­
Knee
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
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.
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
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.
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
1
Executive
Summary
EPA
has
completed
its
review
of
public
comments
on
the
revised
risk
assessments
and
is
issuing
its
risk
management
decisions
for
methamidophos.
The
decisions
outlined
in
this
document
do
not
include
the
final
tolerance
reassessment
decision
for
methamidophos;
however,
some
tolerance
actions
will
be
undertaken
prior
to
completion
of
the
final
tolerance
reassessment.
Seven
tolerances
will
be
revoked
now,
because
there
are
no
currently
registered
uses;
three
tolerances
will
be
modified,
and
several
other
commodity
definitions
will
be
corrected.
The
final
tolerance
reassessment
decision
for
this
chemical
will
be
issued
once
the
cumulative
risks
for
all
of
the
organophosphates
are
considered.
The
Agency
may
need
to
pursue
further
risk
management
measures
for
methamidophos
once
cumulative
risks
are
considered.

The
revised
risk
assessments
are
based
on
review
of
the
required
target
data
base
supporting
the
use
patterns
of
currently
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
methamidophos.
After
considering
the
revised
risks
and
comments
and
mitigation
suggestions
from
the
technical
registrant,
Bayer,
and
other
interested
parties
EPA
developed
its
risk
management
decision
for
uses
of
methamidophos
that
pose
risks
of
concern.
This
decision
is
discussed
fully
in
this
document.

Methamidophos
is
an
organophosphate
insecticide
used
on
a
variety
of
insects,
first
registered
in
1972
for
cotton,
potatoes
and
numerous
other
crops.
Use
data
from
1999
and
2000
indicate
an
average
annual
domestic
use
of
approximately
640,000
pounds
of
active
ingredient
(
lbs
ai)
of
methamidophos.

The
methamidophos
risk
assessments
are
different
than
those
for
most
organophosphate
pesticides
because
methamidophos
is
a
metabolite
of
the
organophosphate
pesticide
acephate.
Consequently,
the
dietary
(
food)
assessments,
and
to
some
extent
the
drinking
water
assessment,
encompass
the
risk
of
methamidophos
from
applications
of
methamidophos
only,
and
from
"
all
sources"
which
includes
applications
of
acephate.
Methamidophos
is
not
registered
for
use
in
residential
settings.
Previously,
acephate
had
numerous
residential,
recreational
and
institutional
uses
which
were
evaluated
in
the
acephate
IRED.
To
mitigate
risks
of
concern,
acephate
use
in
these
settings
have
been
limited
to
indoor
use
in
institutional
settings
such
as
schools
and
hospitals,
use
on
ornamentals
in
the
residential
settings,
spot
or
mound
treatments
for
fire
ant
control,
and
use
on
golf
course
turf.
The
risks
associated
with
the
degradation
of
acephate
to
methamidophos
for
these
uses
were
evaluated
in
the
acephate
IRED
and
were
found
to
be
negligible.

Overall
Risk
Summary
EPA's
human
health
risk
assessment
for
methamidophos
indicates
some
risk
concerns.
Food
risk,
both
acute
and
chronic,
is
below
the
Agency's
level
of
concern.
Drinking
water
risk
estimates
2
based
on
screening
models,
from
surface
water
for
acute
and
chronic
exposures,
is
of
concern
for
all
populations.
Conversely,
drinking
water
risk
estimates
based
on
screening
models,
from
ground
water
for
acute
and
chronic
exposures,
is
not
of
concern
for
all
populations.
There
are
concerns
for
workers
who
mix,
load,
and
apply
methamidophos
to
agricultural
sites
and
to
workers
who
re­
enter
treated
areas.
Also,
EPA
has
identified
acute
and
chronic
risk
to
birds
and
mammals
that
are
of
concern,
and
some
risk
to
freshwater
invertebrates.

To
mitigate
risks
of
concern
posed
by
the
uses
of
methamidophos
the
Agency
has
decided
on
a
number
of
label
amendments
to
address
the
worker,
drinking
water
and
ecological
concerns.
Results
of
the
risk
assessments,
and
the
necessary
label
amendments
to
mitigate
those
risks,
are
presented
in
this
interim
RED.

Dietary
Risk
(
food)

Acute
and
chronic
dietary
risk
assessments
for
food
do
not
exceed
the
Agency's
level
of
concern;
therefore,
no
mitigation
is
warranted
at
this
time
for
dietary
(
food)
exposure
to
methamidophos
from
food.

Dietary
(
drinking
water)

Surface
water
estimated
concentrations
were
derived
from
the
PRZM­
EXAMS
model
with
the
Standard
Index
Reservoir
and
percent
crop
area
(
PCA)
and
the
GEENEC
model
(
for
methamidophos
derived
from
application
of
acephate).
Ground
water
estimated
concentrations
were
derived
from
the
SCI­
GROW
Model.
These
are
screening
level
estimates
designed
to
provide
high­
end
estimates
of
potential
pesticide
exposure.
Such
predictions
provide
a
screen
to
eliminate
those
chemicals
that
are
not
likely
to
cause
concerns
in
drinking
water.
Exceedances
in
drinking
water
risk
assessments
using
the
screening
model
estimates
do
not
necessarily
mean
a
risk
of
concern
actually
exists,
but
may
indicate
the
need
for
better
data
(
e.
g.,
monitoring
studies
specific
to
use
patterns
and
drinking
water
sources)
on
which
to
confirm
decisions.

Based
on
model
predictions
of
currently
registered
uses,
the
EECs
for
methamidophos
from
the
application
of
methamidophos
in
surface
water
range
from
28.6
to
61.8
ppb
for
acute
exposure,
and
from
1.5
to
3.8
ppb
for
chronic
exposure.
The
only
surface
water
EEC
calculated
for
methamidophos
from
the
application
of
acephate,
using
the
Tier
I
GEENEC
model
is
22
ppb.
The
acute
and
chronic
EEC
for
methamidophos
in
groundwater
is
0.028
ppb.
The
SCI­
GROW
model
was
also
used
to
estimate
ground
water
concentrations
for
methamidophos
resulting
from
the
application
of
acephate.
The
modeled
EEC
for
methamidophos
in
ground
water
from
the
application
of
acephate
to
cotton
is
0.005
ppb.
Table
3
summarizes
the
modeled
EECs
for
the
respective
crop
scenarios.
The
DWLOCs
for
methamidophos
from
all
sources
are
2.9
for
acute
exposure
and
0.6
for
chronic
exposure.
The
Agency
is
therefore
concerned
with
possible
exposure
to
methamidophos
residues
in
surface
water
sources
of
drinking
water
and
is
requiring
confirmatory
monitoring
data
to
evaluate
actual
acute
and
3
chronic
concentrations
of
methamidophos.
The
Agency
does
not
have
risk
concerns
for
exposure
to
drinking
water
from
ground
water
sources.

Aggregate
Risk
The
acute
aggregate
risk
assessment
for
methamidophos
from
all
sources
combines
exposure
from
food
and
drinking
water
sources
only.
Acute
dietary
(
food)
risk
estimates
are
below
100%
of
the
aPAD
for
the
US
population
and
all
population
subgroups.
Infants
is
the
most
highly
exposed
population
subgroup
and
has
an
acute
drinking
water
level
of
comparison
(
DWLOC)
of
2.9
ppb.
Based
on
screening­
level
model
predictions
of
the
remaining
supported
uses,
the
acute
(
peak)
drinking
water
estimated
concentration
in
surface
water
is
61.8
ppb
which
is
of
risk
concern
to
the
Agency.
The
screening­
level
model
predictions
of
acute
concentrations
in
ground
water
is
0.033
ppb
for
methamidophos,
which
is
less
than
the
DWLOC
and
not
of
risk
concern
to
the
Agency.

However,
due
to
the
uncertainties
and
limitations
of
the
model
predictions,
the
Agency
believes
that
actual
acute
concentration
of
methamidophos
in
surface
water
is
likely
to
be
less
than
the
DWLOC.
To
demonstrate
this,
confirmatory
surface
water
monitoring
data
is
to
be
generated
to
address
this
risk
concern.

Similarly,
the
chronic
aggregate
risk
assessment
for
methamidophos
combines
exposure
from
food
and
drinking
water
sources
only.
Chronic
dietary
(
food)
risk
estimates
are
well
below
100%
of
the
cPAD
for
the
US
population
and
all
population
subgroups.
Children
1­
6
years
old
is
the
most
highly
exposed
population
subgroup
and
result
in
a
chronic
DWLOC
of
0.9
ppb.
Based
on
screening­
level
model
predictions
of
the
remaining
supported
uses,
the
average
(
chronic)
estimated
concentration
in
surface
water
is
3.8
ppb,
which
is
of
risk
concern
to
the
Agency.
Similarly,
due
to
the
same
uncertainties
and
limitations
of
the
model
predictions
for
acute
exposure,
the
Agency
also
believes
that
actual
chronic
concentrations
of
methamidophos
in
surface
water
is
likely
to
be
less
than
the
DWLOC.
To
demonstrate
this
confirmatory
surface
water
monitoring
data
is
to
be
generated
to
address
the
risk
concern.

The
screening­
level
model
predictions
of
acute
concentrations
in
ground
water
is
0.033
ppb
for
methamidophos,
which
is
less
than
the
DWLOC
and
not
of
risk
concern
to
the
Agency.

Occupational
Risk
Occupational
exposure
to
methamidophos
is
of
concern
to
the
Agency,
and
it
has
been
determined
that
a
number
of
mitigation
measures
are
necessary
at
this
time.
For
the
agricultural
uses
of
methamidophos,
several
mixer/
loader/
applicator
risk
scenarios
currently
exceed
the
Agency's
level
of
concern
(
i.
e.,
MOEs
are
less
than
100).
EPA
believes
that
most
of
these
risks
can
be
mitigated
to
an
acceptable
level
by
phasing
out
use
on
cotton
and
with
the
following
label
restrictions:
use
of
closed
cabs
by
applicators;
use
of
enclosed
vehicles
for
flaggers
or
the
use
of
ground
positioning
system
(
GPS)
4
equipment
that
negates
the
need
for
flaggers
for
aerial
application.;
and
increased
Restricted
Entry
Intervals
(
REIs).

Ecological
Risk
Ecological
risks
are
also
of
concern
to
the
Agency.
The
Agency's
assessment
suggests
the
potential
for
the
liquid
formulation
to
cause
acute
effects
to
birds
for
broadcast
applications.
The
avian
acute
RQs
range
from
0.38
to
6.63.
The
highest
avian
acute
RQ
is
from
nine
1
lb
ai/
A
ground
or
aerial
applications
to
tomatoes.
For
the
same
use
patterns,
mammalian
acute
RQs
range
from
0.2
to
20.3.
Regarding
chronic
risk
to
birds,
the
RQs
range
from
2.49
to
32.87.
Again
the
same
use
patterns
resulted
in
chronic
RQs
for
mammals
ranging
from
0.75
to
9.86.
All
use
patterns
are
of
concern
to
the
Agency
for
acute
and
chronic
effects
to
birds
and
mammals.

Acute
risk
to
freshwater
fish
and
estuarine
fish
is
not
of
concern
for
any
use
patterns,
with
RQs
ranging
from
<
0.05
to
0.07.
The
acute
high
risk,
restricted
use
risk
and
endangered
species
risk
is
of
concern
for
freshwater
invertebrates
at
the
maximum
application
rate
of
1.0
lb
ai/
A
with
RQs
ranging
from
1.1
to
3.0
and
may
be
of
concern
for
estuarine
invertebrates.
No
chronic
risk
assessment
was
conducted
since
there
are
no
chronic
data
for
aquatic
species.

Because
of
the
toxicity
of
methamidophos,
to
help
protect
terrestrial
birds,
mammals
and
freshwater
invertebrates,
it
is
very
important
to
reduce
their
potential
exposure
to
methamidophos
products
that
have
been
applied.
In
additional
to
the
phase
out
of
the
cotton
use
to
mitigate
occupational
risks
of
concern
which
will
also
serve
to
reduce
risk
to
birds
and
mammals,
reductions
in
the
maximum
number
of
applications
allowed
per
season
are
needed
to
reduce
risks
to
birds,
mammals
and
fresh
water
invertebrates.

The
Agency
has
determined
that,
with
the
phase­
out
of
the
cotton
use
and
the
addition
of
the
label
restrictions
and
amendments
detailed
in
this
document,
until
the
outcome
of
cumulative
risks
for
all
of
the
organophosphates
has
been
considered,
other
currently
registered
uses
of
methamidophos
may
continue.

The
Agency
is
issuing
this
Interim
Reregistration
Eligibility
Document
(
IRED)
for
methamidophos,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
This
interim
RED
document
includes
guidance
and
time
frames
for
complying
with
any
necessary
label
changes
for
products
containing
methamidophos.
Note
that
there
is
no
comment
period
for
this
document,
and
that
the
time
frames
for
compliance
with
the
label
changes
outlined
in
this
document
are
shorter
than
those
given
in
previous
REDs.
As
part
of
the
process
discussed
by
the
TRAC,
which
sought
to
open
up
the
process
to
interested
parties,
the
Agency's
risk
assessments
for
methamidophos
have
already
been
subject
to
numerous
public
comment
periods,
and
a
further
comment
period
for
methamidophos
was
deemed
unnecessary.
Phase
6
of
the
pilot
process
did
not
include
a
public
comment
period;
however,
for
some
chemicals,
the
Agency
may
provide
for
another
comment
period,
5
depending
on
the
content
of
the
risk
management
decision.
With
regard
to
complying
with
the
risk
mitigation
measures
outlined
in
this
document,
the
Agency
has
shortened
this
time
period
so
that
the
risks
identified
herein
are
mitigated
as
quickly
as
possible.
Neither
the
tolerance
reassessment
nor
the
reregistration
eligibility
decision
for
methamidophos
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
methamidophos.
6
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.
FQPA
also
amends
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
an
assessment
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.
Methamidophos
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
methamidophos.
It
is
intended
to
be
only
the
first
phase
in
the
reregistration
process
for
methamidophos.
The
Agency
will
eventually
proceed
with
its
assessment
of
the
cumulative
risk
of
the
OP
pesticides
and
issue
a
final
reregistration
eligibility
decision
for
methamidophos.

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.

In
addition
to
the
policy
issues
that
resulted
from
the
TRAC
process,
the
Agency
issued,
on
Sept.
29,
2000,
a
Pesticide
Registration
Notice
(
PR
2000­
9)
that
presents
EPA's
approach
for
managing
risks
from
organophosphate
pesticides
to
occupational
users.
The
Worker
Risk
Mitigation
7
for
Organophosphate
Pesticides
PR
Notice
describes
the
Agency's
baseline
approach
to
managing
risks
to
handlers
and
workers
who
may
be
exposed
to
organophosphate
pesticides,
and
the
Agency
expects
that
other
types
of
chemicals
will
be
handled
similarly.
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
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
the
Worker
Risk
PR
Notice.

This
document
consists
of
six
sections.
Section
I
contains
the
regulatory
framework
for
reregistration/
tolerance
reassessment.
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.
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
lists
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
www.
epa.
gov/
pesticides/
op,
and
in
the
Public
Docket.
8
S
P
NH
2
O
C
H
3
OCH
3
II.
Chemical
Overview
A.
Regulatory
History
Methamidophos
was
first
registered
in
the
United
States
in
1972
under
the
trade
name
Monitor.
It
was
used
principally
on
potatoes,
cotton,
and
cole
crops
to
control
a
broad
spectrum
of
insects
through
contact,
and
systemic
action
inhibiting
cholinesterase.
A
Registration
Standard,
which
describes
the
terms
and
conditions
for
the
continued
registration
of
methamidophos,
was
issued
for
methamidophos
in
1982.

In
1997,
the
technical
registrant,
Bayer
Corporation,
voluntarily
cancelled
all
uses
of
methamidophos
except
for
use
on
cotton,
potatoes,
and
tomatoes
(
special
local
need
only).
In
1998,
a
special
local
needs
registration
was
issued
for
use
on
alfalfa
grown
for
seed
in
California.
By
December
1999,
the
registrant
had
also
voluntarily
phased­
in
closed
mixing
and
loading
systems
for
all
remaining
uses
to
address
potential
worker
exposures.

B.
Chemical
Identification
Methamidophos:

!
Common
Name:
Methamidophos
!
Chemical
Name:
O,
S­
dimethyl
phosphoramidothioate
!
Chemical
family:
Organophosphate
!
Case
number:
0043
!
CAS
registry
number:
10265­
92­
6
!
OPP
chemical
code:
101201
!
Empirical
formula:
C2H8NO2PS
!
Molecular
weight:
141.1
!
Trade
and
other
names:
Monitor
9
!
Basic
manufacturer:
Bayer
Corporation,
Valent
U.
S.
A.

Methamidophos
is
a
colorless
to
white
crystalline
solid
with
a
strong
mercaptan­
like
odor,
and
a
melting
point
of
46.1oC.
It
is
readily
soluble
(>
200
g/
L)
in
water,
acetone,
dimethylfomamide,
dichloromethane,
and
2­
propanol,
and
is
soluble
in
n­
octanol
at
50­
100
g/
L,
toluene
at
2­
5
g/
L,
and
nhexane
at
<
1
g/
L.
The
vapor
pressure
of
methamidophos
is
approximately
1.725
x
10­
5
mm
Hg.

C.
Use
Profile
The
following
information
is
based
on
the
currently
registered
uses
of
methamidophos:

Type
of
Pesticide:
Insecticide/
acaricide.

Summary
of
Use
Sites:

Food/
Feed
Crop:
Cotton,
potato,
and
tomato.

Other
Agricultural
Sites:
None.

Residential:
None.

Public
Health:
None.

Nonfood
Crop:
Alfalfa
grown
for
seed
Target
Pests:
Broad
spectrum
of
insects
including:
aphid,
Colorado
potato
beetle,
green
peach
aphid,
leafhopper,
leafminer,
lygus
bug,
stink
bug,
tomato
pinworm,
and
whitefly.

Formulation
Types
Registered:

Technical
Grade/
Manufacturer­
Use
Product
(
MUP):
liquid
60­
72%
ai.

End­
Use
Product:
emulsifiable
concentrate
(
EC)
40%
ai.

Method
and
Rates
of
Application:

Equipment:
Aircraft,
ground
sprayer,
and
sprinkler
irrigation.

Method
and
Rate:
Chemigation
(
potatoes
only),
high
volume
spray
(
dilute),
and
low
volume
spray
(
concentrate).
Maximum
use
rate
for
all
crops
is
1.0
lb
10
ai/
A.
The
label
allows
four
applications
per
season
on
cotton
and
potatoes,
and
up
to
nine
applications
per
season
on
tomatoes.

Timing:
Methamidophos
end­
use
products
are
applied
at
various
times
including
atplant
and
foliar
timings.

Use
Classification:
Restricted
Use
D.
Estimated
Usage
of
Pesticide
Table
1
summarizes
the
best
available
estimates
for
the
pesticide
uses
of
methamidophos.
These
estimates
are
derived
from
a
variety
of
published
and
proprietary
sources
available
to
the
Agency
for
1999
and
2000.
A
full
listing
of
all
uses
of
methamidophos,
with
the
corresponding
use
and
usage
data
for
each
site,
has
been
completed
and
is
in
the
"
Quantitative
Use
Assessment,"
dated
5­
9­
2000
and
the
"
Use
and
Usage
Analysis
for
Methamidophos,"
dated
November
20,
2001,
which
are
available
in
the
public
docket.
Approximately
640,000
pounds
of
active
ingredient
(
lbs
ai)
of
methamidophos
are
used
annually,
according
to
Agency
estimates.
Methamidophos
use
is
highest
on
potatoes
(
87%
of
total
methamidophos
pounds
applied),
followed
by
tomato
(
8%
of
total
methamidophos
pounds
applied),
and
cotton
(
5%
of
total
methamidophos
pounds
applied).

Table
1.
Methamidophos
Usage
Summary
in
the
United
States1
Crop
Percent
Crop
Treated
Base
Acres
Treated
(
1000
acres)
2
Average
Number
of
Applications
Per
Year
Average
Application
Rate
(
lbs
ai/
A)
Pounds
Active
Ingredient
Applied
(
1000
lbs.)

Alfalfa
for
Seed
(
CA
only)
50%
33*
1.0
0.8
36
Cotton
2%
288*
1.0
0.3
84
Potatoes
29%
322*
1.7
0.9
520
Tomatoes
(
Fresh)
15%
18*
2.5
0.6
28
Tomatoes
(
Processed)
3%
9*
1.0
0.9
8
11
1Source:
USDA
1999
and
2000
Agricultural
Chemical
Use
(
May,
2000,
May
2001,
July,
2001)
and
California
Department
of
Pesticide
Regulation,
Pesticide
Use
Report
(
2000)..
2Base
acres
treated
derived
from
estimate
of
acres
grown
in
USDA
1999
and
2000
Agricultural
Chemical
Use
(
May
2000,
May
2001,
July,
2001).
*
Base
acres
treated
for
California
derived
from
harvested
acreage;
other
states
based
on
USDA
2000
Agricultural
Chemical
Use.

III.
Summary
of
Methamidophos
Risk
Assessment
The
purpose
of
this
summary
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
these
risk
assessments,
and
to
better
understand
the
conclusions
reached
in
the
assessments.
Following
is
a
list
of
EPA's
revised
human
health
and
ecological
risk
assessments
and
supporting
information
that
were
used
to
formulate
the
findings
and
conclusions
for
the
organophosphate
pesticide
methamidophos.
The
listed
documents
may
also
be
found
on
the
Agency's
web
page
at
www.
epa.
gov/
pesticides/
op
and
in
the
public
docket.

These
risk
assessments
for
methamidophos
were
presented
at
a
February
3,
2000
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
risk
management
decision
for
methamidophos
only;
the
Agency
must
consider
a
cumulative
assessment
of
the
risks
of
all
the
OP
pesticides
before
any
final
decisions
can
be
made.

Human
Health
Risks
°
Human
Health
Risk
Assessment­
Methamidophos
Revised
Risk
Assessment,
February
3,
2000.
°
Revised
Dietary
Exposure
and
Risk
Analyses
for
the
HED
Revised
Human
Health
Risk
Assessment,
July
19,
2000.
°
Methamidophos:
Addendum
to
the
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document,
September
15,
2000.
°
Recalculated
Tier
II
Drinking
Water
EECs
for
Methamidophos
Incorporating
the
Index
Reservoir
and
Percent
Cropped
Area,
October
17,
2000.

Environmental
Fate
and
Ecological
Effects
°
Amended
EFED
Methamidophos
RED
Chapter,
September
15,
1999.

A.
Human
Health
Risk
Assessment
The
methamidophos
risk
assessments
are
different
than
those
for
most
organophosphate
pesticides
because
methamidophos
is
a
metabolite
of
the
organophosphate
pesticide
acephate.
12
Consequently,
the
assessments
encompass
the
risk
of
methamidophos
from
applications
of
methamidophos
only,
and
from
"
all
sources"
which
includes
applications
of
acephate.
Acute
probabilistic
and
chronic
dietary
(
food)
risk
assessments
were
conducted
as
well
as
a
qualitative
assessment
of
the
potential
exposure
to
all
methamidophos
sources
through
drinking
water.
EPA
issued
its
preliminary
risk
assessments
for
methamidophos
on
October
30,
1998
(
Phase
3
of
the
TRAC
process).
In
response
to
comments
and
studies
submitted
during
Phase
3
and
Phase
5,
the
risk
assessments
were
updated
and
refined.
Major
revisions
to
the
human
health
risk
assessment
are
listed
below:

°
Refinement
of
the
acute
dietary
(
food)
risk
assessment
to
use
probabilistic
(
Monte
Carlo)
techniques;

°
Incorporation
of
data
from
USDA's
Pesticide
Data
Program
(
PDP)
into
the
dietary
(
food)
risk
assessment;

°
Adjustment
to
percent
crop
treated
estimates;

°
Incorporating
washing
and
cooking
factors
into
the
dietary
(
food)
assessment;

°
Revised
anticipated
residues
were
calculated
for
use
in
the
dietary
risk
assessment;

°
Use
of
residue
data
from
a
potato
processing
study
was
incorporated
into
the
dietary
risk
assessment;

°
Information
concerning
a
submitted
import
tolerance
petition
for
peppers,
squash,
and
strawberries
was
incorporated.

°
1999
PDP
monitoring
data
on
canned
tomatoes
was
incorporated
in
the
dietary
assessment.

°
Use
of
new
toxicological
endpoints
for
dermal
risk
assessment.
These
data
affect
the
lowest
observed
effect
level,
and
no
observed
effect
level
in
the
dermal
risk
assessments.

°
Use
of
three
dislodgeable
foliar
residue
studies
submitted
by
Bayer
to
assess
postapplication
exposure
to
agricultural
workers,
and
set
restricted
entry
intervals.

°
Recalculated
Tier
II
drinking
water
EECs
incorporating
the
Index
Reservoir
and
Percent
Cropped
Area.

1.
Dietary
Risk
from
Food
13
a.
Toxicity
The
Agency
has
reviewed
all
toxicity
studies
submitted
and
has
determined
that
the
toxicity
database
is
complete,
and
that
it
supports
an
interim
RED
for
all
currently
registered
uses.
Further
details
on
the
toxicity
of
methamidophos
can
be
found
in
the
February
3,
2000
"
Human
Health
Risk
Assessment"
and
subsequent
addenda.
A
brief
overview
of
the
studies
and
safety
factors
used
for
the
dietary
(
food)
risk
assessment
is
outlined
in
Table
2
in
this
document.

b.
FQPA
Safety
Factor
The
FQPA
Safety
Factor
(
SF)
was
reduced
from
10x
to
3x.
A
weight­
of­
the­
evidence
approach
indicated
neuropathology
in
hens
and
humans
reported
in
the
open
scientific
literature.
This
led
the
Agency
to
conclude
that
an
FQPA
safety
factor
is
appropriate.
In
studies
from
the
open
scientific
literature,
ingestion
of
methamidophos
has
been
shown
to
result
in
delayed
peripheral
neuropathy
in
humans.
Similarly,
adult
hens
developed
poly
neuropathy.
The
Agency
determined
that
the
10x
factor
can
be
reduced
to
3x
primarily
because:
1)
there
was
no
increased
susceptibility
of
the
offspring
of
rats
or
rabbits
to
pre­
and/
or
post­
natal
exposure
2)
a
two­
generation
reproductive
toxicity
study
in
rats
showed
no
increased
sensitivity
in
pups
when
compared
to
adults
3)
the
toxicology
database
is
complete;
and
4)
the
dietary
food
exposure
assessment
does
not
underestimate
the
potential
exposure
for
infants
and
children
from
residues
in
food.
However,
based
on
this
evidence,
the
requirement
of
a
developmental
neurotoxicity
study
has
been
triggered.
This
study
will
in
turn
provide
additional
data
(
e.
g.,
potential
increased
susceptibility,
and
effects
on
the
development
of
the
fetal
nervous
system,
etc.).
More
information
can
be
found
in
the
document
"
FQPA
Safety
Factor
Recommendations
for
the
Organophosphates,"
dated
August
6,
1998.

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).
The
RfD
is
calculated
by
taking
the
no
observed
adverse
effect
level
(
NOAEL)
from
an
appropriate
study
and
dividing
it
by
an
uncertainty
factor
(
i.
e.,
NOAEL/
UF).
A
risk
estimate
that
is
less
than
100%
of
the
acute
PAD
(
aPAD)
or
chronic
PAD
(
cPAD)
does
not
exceed
the
Agency's
risk
concern.
In
the
case
of
methamidophos,
the
FQPA
safety
factor
is
3x;
therefore
the
acute
and
chronic
PADs
are
equivalent
to
the
acute
and
chronic
RfDs
divided
by
3,
respectively.
The
aPAD
for
methamidophos
is
0.001
mg/
kg/
day.
The
cPAD
for
methamidophos
is
0.0001
mg/
kg/
day.
The
basis
for
the
aPAD
and
the
cPAD
are
summarized
in
Table
2
below.

Table
2.
Summary
of
Toxicological
Endpoints
Used
in
the
Dietary
Risk
Assessment
14
Exposure
Scenario
Dose
Endpoint
Toxicology
Study
UF
FQPA
Safety
Factor
PAD
(
mg/
kg/
day)

Acute
dietary
NOAEL
=
0.3
mg/
kg/
day
LOAEL
=
0.7
mg/
kg/
day
Plasma,
erythrocyte
and
brain
cholinesterase
inhibition.
Acute
neurotoxicity
study
in
rats
(
MRIDs
43025001,
43345801)
100
3
0.001
Chronic
dietary
NOAEL
=
0.03
mg/
kg/
day
LOAEL
=
0.06
mg/
kg/
day
Brain
cholinesterase
inhibition.
8­
week
subchronic
oral
toxicity
cholinesterase
study
in
rat
(
MRID
41867201)
100
3
0.0001
d.
Exposure
Assumptions
The
Agency
conducts
dietary
(
food)
risk
assessments
using
the
dietary
exposure
evaluation
model
(
DEEM
 
)
,
which
incorporates
consumption
data
generated
in
USDA's
continuing
survey
of
food
intakes
by
individuals,
1989­
1992.
For
the
assessment
of
dietary
(
food)
exposure
to
residues
of
methamidophos
resulting
from
the
use
of
methamidophos,
monitoring
data
generated
through
the
USDA
Pesticide
Data
Program
(
PDP)
for
potatoes
and
tomatoes,
and
through
the
Food
and
Drug
Administration
(
FDA)
Surveillance
Monitoring
Program
for
peppers,
squash,
and
strawberries
were
used.
Anticipated
residue
values
from
crop
residue
field
trial
studies,
and
percent
crop­
treated
data
were
used
for
cotton.
For
the
assessment
of
dietary
(
food)
exposure
to
residues
of
methamidophos
resulting
from
the
use
of
acephate,
PDP
or
FDA
monitoring
data
were
used
for
succulent
beans,
cauliflower,
celery,
lettuce
and
peppers.
Anticipated
residue
values
from
crop
residue
field
trial
studies,
and
percent
crop­
treated
data
were
used
for
dry
beans,
Brussels
sprouts,
cotton,
cranberries,
macadamia
nuts,
mint,
peanuts
and
soybeans.

For
acute
probabilistic
dietary
risk
assessments,
the
entire
distribution
of
single­
day
food
consumption
events
is
combined
with
a
distribution
of
residues
to
obtain
a
distribution
of
exposure
in
mg/
kg/
day.
Chronic
dietary
(
food)
risk
assessments
use
the
three­
day
average
of
consumption
for
each
subpopulation
combined
with
residues
in
commodities
to
determine
average
exposure
in
mg/
kg/
day.
For
probabilistic
assessments,
the
Agency
regulates
at
the
99.9th
percentile
of
exposure.
Both
assessments
included
the
dietary
(
food)
risk
from
methamidophos
exposure
from
use
of
methamidophos
and
from
the
use
of
acephate.

Valent
U.
S.
A.
Corporation
has
submitted
an
import
tolerance
petition
in
support
of
uses
of
methamidophos
on
squash,
strawberries
and
peppers.
There
is
an
existing
tolerance
for
methamidophos
on
peppers,
but
none
has
been
established
for
the
latter
two
commodities.
The
dietary
15
risk
assessment
includes
these
proposed
uses.
Otherwise,
these
proposed
tolerances
are
not
addressed
in
this
IRED.

e.
Food
Risk
Characterization
Generally,
a
dietary
(
food)
risk
estimate
that
is
less
than
100%
of
the
acute
or
chronic
Population
Adjusted
Dose
does
not
exceed
EPA's
risk
concerns.
Acute
dietary
(
food)
exposure
to
methamidophos
from
applications
of
methamidophos
alone,
and
from
"
all
sources"
(
applications
of
methamidophos
and
acephate)
result
in
risk
estimates
that
are
below
the
Agency's
level
of
concern
 
that
is,
less
than
100%
of
the
acute
PAD
is
used.
For
example,
for
exposure
resulting
from
applications
of
methamidophos
alone,
for
the
most
exposed
subpopulation,
children
7­
12
years
old,
the
percent
acute
PAD
value
is
33%
at
the
99.9th
percentile
of
exposure
from
consumption
of
food
alone.
For
exposure
resulting
from
applications
of
methamidophos
from
"
all
sources",
for
the
most
exposed
subpopulation,
all
infants,
the
percent
acute
PAD
value
is
76%
at
the
99.9th
percentile
of
exposure
from
consumption
of
food
alone.

Chronic
dietary
(
food)
exposure
estimates
are
also
below
the
Agency's
level
of
concern
for
all
subpopulations.
For
the
most
highly
exposed
subpopulation,
children
1­
6
years
old,
the
percent
chronic
PAD
values
are
15%
for
methamidophos
alone
and
37%
when
including
methamidophos
residues
from
the
application
of
acephate,
from
consumption
of
food
alone.

2.
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
actual
monitoring
data,
if
available,
to
estimate
those
risks.
Modeling
is
considered
to
be
an
unrefined
assessment
and
provides
a
high­
end
estimate
of
risk.
Very
limited
monitoring
data
is
available
for
methamidophos
therefore,
modeling
was
used
to
estimate
drinking
water
risks
from
these
sources.

The
GENEEC
and
PRZM­
EXAMS
models
were
used
to
estimate
surface
water
concentrations,
and
SCI­
GROW
was
used
to
estimate
groundwater
concentrations.
All
of
these
are
considered
to
be
screening
models,
with
the
PRZM­
EXAMS
model
being
somewhat
more
refined
than
the
other
two.

As
in
the
dietary
risk
assessment
for
food,
separate
drinking
water
risk
assessments
were
conducted
for
both
exposure
to
methamidophos
as
a
result
of
the
application
of
methamidophos
and
exposure
to
methamidophos
from
all
sources
including
the
application
of
acephate.

Although
the
environmental
fate
data
base
for
methamidophos
is
not
complete,
supplemental
information
from
ungradable
laboratory
studies
indicate
that
methamidophos
is
not
persistent
in
aerobic
16
environments
but
may
be
persistent
in
anaerobic
aquatic
environments
where
it
will
be
associated
with
the
aqueous
phase.
No
acceptable
data
are
available
on
the
behavior
of
methamidophos
under
field
conditions,
but
information
from
acceptable
terrestrial
field
dissipation
studies
for
acephate
indicated
that
methamidophos
is
not
persistent.

a.
Surface
Water
The
Tier
II
PRZM­
EXAMS
screening
model
is
used
to
estimate
upper­
bound
environmental
concentrations
(
EECs)
in
drinking
water
derived
from
surface
water.
This
model,
in
general,
is
based
on
more
refined,
less
conservative
assumptions
than
the
Tier
I
GENEEC
screening
model.
Acute
modeled
EECs
for
methamidophos
in
surface
water
from
the
application
of
methamidophos
alone
range
from
29
ppb
to
48
ppb,
depending
on
the
crop
site.
Chronic
modeled
EECs
for
methamidophos
in
surface
water
from
the
application
of
methamidophos
alone
range
from
3.9
ppb
to
6.9
ppb,
depending
on
the
crop
site.

The
Agency
also
used
the
recently
implemented
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
to
the
Tier
II
PRZM­
EXAMS
model
to
calculate
upper­
bound
EECs
for
methamidophos
in
drinking
water
derived
from
surface
water.
Applying
the
IR
and
PCA
modifications,
acute
modeled
EECs
for
methamidophos
in
surface
water
from
the
application
of
methamidophos
alone
range
from
28.6
ppb
to
61.8
ppb
depending
on
the
crop
site.
Chronic
modeled
EECs
for
methamidophos
in
surface
water
from
the
application
of
methamidophos
alone
range
from
1.5
ppb
to
3.8
ppb,
depending
on
the
crop
site.

The
surface
water
model
assumes
methamidophos
applications
are
made
at
the
maximum
rate
for
each
crop
on
the
current
label,
using
the
labeled
methods
of
application.
The
model
results
are
also
based
on
four
applications
per
season
with
a
seven
day
retreatment
interval.
The
lack
of
acceptable
aerobic
aquatic
metabolism
data
increase
the
uncertainty
of
the
chronic
estimated
environmental
concentrations
(
EECs).

To
estimate
the
potential
exposure
to
methamidophos
from
the
application
of
acephate,
the
Agency
relied
upon
the
Tier
I
GENEEC
screening
model.
A
higher­
tiered
model
was
not
used
in
this
case
due
to
the
high
level
of
uncertainty
surrounding
any
estimate
of
the
decay
rate
for
acephate
and
the
transformation
rate
of
acephate
to
methamidophos
which
are
needed
to
use
the
PRZM­
EXAMS
model.
The
acute
modeled
EEC
for
methamidophos
in
surface
water
from
the
application
of
acephate
to
cotton
is
22
ppb.
The
chronic
modeled
EEC
for
methamidophos
in
surface
water
from
the
application
of
acephate
to
cotton
is
12
ppb.
This
analysis
assumes
a
25%
conversion
efficiency
from
acephate
to
methamidophos
at
time
of
application
resulting
in
the
equivalent
of
six
applications
at
0.25
lb
methamidophos/
ai./
A
on
cotton.
EECs
for
other
crops
were
not
developed.

For
the
purposes
of
assessing
drinking
water
risks
from
exposure
to
methamidophos
from
all
sources
(
i.
e.
including
both
methamidophos
and
acephate
applications)
the
Agency
will
rely
upon
the
17
model
estimates
generated
using
the
PRZM­
EXAMS
model
with
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
described
above
which
are
based
upon
the
application
of
methamidophos
alone.
The
Agency
believes
that
the
conservative
default
PCA
used
for
the
scenario
with
the
highest
EEC
(
potatoes
in
ME)
would
most
likely
account
for
methamidophos
residues
from
both
methamidophos
and
acephate
applications
in
a
given
watershed.
For
this
scenario,
the
default
PCA
value
of
0.87
was
used
to
calculate
the
EEC.
This
assumes
that
87%
of
the
watershed
being
evaluated
is
cropped
in
potatoes
and/
or
other
crops
that
methamidophos
can
be
applied
to.
In
this
particular
case,
it
is
estimated
that
65,000
acres
of
potatoes
are
grown
in
the
state
of
Maine
each
year.
Cotton
is
not
grown
in
Maine
and
there
is
not
a
SLN
for
tomatoes
there
so
all
methamidophos
use
in
that
state
would
be
on
potatoes.
If
it
was
assumed
that
all
that
acreage
fell
into
any
one
of
the
nine
watersheds
in
Maine
as
a
worst­
case
scenario,
the
range
of
PCA
values
would
likely
be
0.04
to
0.16
or
4%
to
16%,
significantly
lower
than
the
87%
assumption.
The
effect
of
the
PCA
value
on
EECs
has
a
linear
relationship.
Consequently,
using
these
values
would
reduce
EECs
by
a
factor
of
5
to
20.
Further,
the
main
crop
uses
of
acephate
(
beans,
cotton,
lettuce
and
tobacco)
are
either
not
grown
in
Maine
or
are
not
likely
to
have
significant
acreage.
Therefore,
additional
contribution
of
methamidophos
residue
from
the
application
of
acephate
in
this
scenario
is
very
unlikely.
Even
though
this
analysis
has
not
been
deemed
to
be
sufficient
to
change
the
PCA
quantitatively,
it
does
support
the
belief
that
this
EEC
likely
provides
a
sufficiently
protective
estimate
of
exposure
to
methamidophos
from
all
sources
in
drinking
water.
Further,
the
information
is
not
currently
available
to
enable
the
Agency
to
use
a
Tier
II
model
to
estimate
concentrations
of
methamidophos
from
the
application
of
acephate,
as
described
above,
and
it
is
not
considered
appropriate
to
combine
the
results
of
a
Tier
II
assessment
(
methamidophos
applications)
with
the
results
of
a
Tier
I
assessment
(
acephate
applications).

Monitoring
for
methamidophos
in
surface
water
is
limited.
No
residues
were
detected
in
the
available
samples
(
328
samples
primarily
from
Florida
and
Mississippi)
but
the
limits
of
detection
for
this
sampling
are
uncertain
and
it
is
unclear
if
these
samples
were
taken
in
areas
where
methamidophos
was
being
used.
Given
these
limitations,
the
existing
surface
water
monitoring
database
cannot
be
used
to
estimate
concentrations
of
methamidophos
in
surface
water.
The
U.
S.
Geological
Survey
(
USGS)
in
its
National
Water
Quality
Assessment
(
NAWQA)
program
is
not
currently
analyzing
for
methamidophos.

b.
Ground
Water
The
Tier
I
screening
model,
SCI­
GROW,
was
used
to
estimate
drinking
water
concentrations
derived
from
groundwater.
The
acute
and
chronic
EEC
for
methamidophos
in
groundwater
is
0.028
ppb.
The
ground
water
modeling
assumes
the
maximum
yearly
total
application
of
methamidophos
(
nine
applications
at
1.0
lb/
a.
i./
A
on
tomatoes
in
Florida)
per
the
current
labels.
Methamidophos
is
not
expected
to
leach
significantly
to
groundwater
given
that
it
is
not
persistent
under
aerobic
conditions.
This
expectation
is
reflected
in
the
results
of
the
model.
Further,
a
majority
of
use
areas
will
have
ground
water
that
is
less
vulnerable
to
contamination
than
that
in
areas
used
to
derive
the
SCI­
GROW
18
estimate.
Very
limited
ground
water
monitoring
data
for
methamidophos
is
available.
Four
detections
were
recorded
in
these
data
which
were
collected
between
1984
and
1993.

The
SCI­
GROW
model
was
also
used
to
estimate
ground
water
concentrations
for
methamidophos
resulting
from
the
application
of
acephate.
The
modeled
EEC
for
methamidophos
in
ground
water
from
the
application
of
acephate
to
cotton
is
0.005
ppb.
This
analysis
assumes
a
25%
conversion
efficiency
from
acephate
to
methamidophos
at
time
of
application
resulting
in
the
equivalent
of
six
applications
at
0.25
lb
methamidophos/
ai./
A
on
cotton.
EECs
for
other
crops
were
not
developed.

Since
the
same
model
was
used
to
develop
both
the
EECs
from
methamidophos
applications
and
methamidophos
resulting
from
applications
of
acephate,
the
Agency
has
decided
to
combine
the
estimates
for
the
purposes
of
assessing
drinking
water
risks
from
exposure
to
methamidophos
from
all
sources.

c.
Drinking
Water
Levels
of
Comparison
(
DWLOCs)

To
determine
the
maximum
allowable
contribution
of
water
containing
pesticide
residues
permitted
in
the
diet,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food
(
and
if
appropriate,
residential
uses)
then
determines
a
"
drinking
water
level
of
comparison"(
DWLOC)
to
determine
whether
modeled
or
monitoring
levels
exceed
this
level.
The
Agency
uses
the
DWLOC
as
a
surrogate
to
capture
risk
associated
with
exposure
from
pesticides
in
drinking
water.
The
DWLOC
is
the
maximum
concentration
in
drinking
water
which,
when
considered
together
with
dietary
(
food)
exposure,
does
not
exceed
a
level
of
concern.

The
results
of
the
Agency's
drinking
water
analysis
are
summarized
here.
Details
of
this
analysis,
which
used
screening
models,
are
found
in
the
HED
Human
Health
Risk
Assessment
dated
February
3,
1999,
the
EFED
Environmental
Risk
Assessment
dated
September
15,
1999,
and
the
Recalculated
Tier
II
Drinking
Water
EECs
for
Methamidophos
Incorporating
the
Index
Reservoir
and
Percent
Cropped
Area,
October
17,
2000.

For
acute
risk,
surface
water
EECs
exceed
the
acute
DWLOCs
for
all
subpopulations
(
Table
3).
Even
if
it
is
assumed
that
there
are
no
food
exposures
to
methamidophos,
drinking
water
alone,
based
on
model
estimates,
would
result
in
exceedences
of
the
risk
cup,
particularly
for
infants
and
children.
Ground
water
EECs
do
not
exceed
the
acute
DWLOCs
for
any
subpopulations.
Therefore,
the
Agency
does
not
have
a
risk
concern
for
ground
water
sources
of
dietary
exposure
for
the
general
U.
S.
population
or
the
most
highly
exposed
subpopulation.
The
table
below
presents
the
calculations
for
the
acute
drinking
water
assessment.

Table
3.
Summary
of
DWLOC
Calculations
for
Acute
Risk
19
Population
Subgroup
aPAD
(
mg/
kg/
day)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
DWLOC
(
ppb)
Maximum
Surface
Water
EECs
(
ppb)
Maximum
Groundwater
EECs
(
ppb)

Methamidophos
U.
S.
Population
0.001
0.000269
0.000731
25.6
61.8
0.028
Children
7­
12
years
old
0.001
0.000334
0.000684
6.8
61.8
0.028
Methamidophos
from
all
Sources
U.
S.
Population
0.001
0.000429
0.000571
20
61.8
0.033
All
Infants
0.001
0.000762
0.000238
2.4
61.8
0.033
For
chronic
risk,
surface
water
EECs
slightly
exceed
the
chronic
DWLOCs
for
all
subpopulations
(
Table
4).
Ground
water
EECs
do
not
exceed
the
chronic
DWLOCs
for
any
subpopulations.
Therefore,
the
Agency
does
not
have
a
risk
concern
for
ground
water
sources
of
dietary
exposure
for
the
general
U.
S.
population
or
the
most
highly
exposed
subpopulation.
The
table
below
presents
the
calculations
for
the
chronic
drinking
water
assessment.

Table
4.
Summary
of
DWLOC
Calculations
for
Chronic
Risk
Population
Subgroup
cPAD
(
mg/
kg/
day)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
DWLOC
(
ppb)
Maximum
Surface
Water
EECs
(
ppb)
Maximum
Groundwater
EECs
(
ppb)

Methamidophos
U.
S.
Population
0.0001
0.000007
0.000093
3.3
3.8
0.028
Children
1­
6
years
old
0.0001
0.000015
0.000085
0.9
3.8
0.028
Methamidophos
from
all
Sources
U.
S.
Population
0.0001
0.000023
0.000077
3
3.8
0.033
Children
1­
6
years
old
0.0001
0.000037
0.000063
0.6
3.8
0.033
The
acute
and
chronic
dietary
risks
from
drinking
water
exposure
are
above
the
Agency's
level
20
of
concern
for
most
subpopulations.

3.
Aggregate
Risk
An
aggregate
risk
assessment
looks
at
the
combined
risk
from
dietary
exposure
(
food
and
drinking
water
routes)
and
any
non­
occupational
exposures
(
residential
use).
Acute
and
chronic
aggregate
risk
assessments
were
conducted
for
methamidophos.
Methamidophos
is
not
registered
for
use
in
residential
settings.
Previously,
acephate
had
numerous
residential,
recreational
and
institutional
uses
which
were
evaluated
in
the
acephate
IRED.
To
mitigate
risks
of
concern,
acephate
use
in
these
settings
have
been
limited
to
indoor
use
in
institutional
settings
such
as
schools
and
hospitals,
use
on
ornamentals
in
the
residential
settings,
spot
or
mound
treatments
for
fire
ant
control,
and
use
on
golf
course
turf.
The
risks
associated
with
the
degradation
of
acephate
to
methamidophos
for
these
uses
were
evaluated
in
the
acephate
IRED
and
were
found
to
be
negligible.
Therefore,
aggregate
short­
term
exposures
were
not
estimated.
Results
of
the
aggregate
risk
assessment
are
summarized
here,
and
are
discussed
in
the
methamidophos
human
health
risk
assessment.

The
Agency
was
only
able
to
quantify
food
sources
of
dietary
exposure
to
methamidophos
because
dietary
exposures
through
drinking
water
have
only
been
estimated
using
models.
Neither
adequate
groundwater
or
surface
water
monitoring
data
were
available
to
estimate
potential
drinking
water
exposures
to
methamidophos.

Acute
Aggregate
Risk
Assessment:
Potential
acute
dietary
risks
from
food
sources
alone
do
not
exceed
the
Agency's
level
of
concern.
The
most
exposed
subpopulation,
all
infants,
consume
76%
of
the
acute
PAD
at
the
99.9th
percentile
of
exposure,
based
on
highly
refined
exposure
estimates.
Further,
potential
drinking
water
risks
from
exposure
to
water
from
ground
water
sources
does
not
exceed
the
acute
DWLOCs
and,
therefore,
do
not
exceed
the
Agency's
level
of
concern.
However,
when
drinking
water
exposure
concentrations,
derived
from
surface
water
models,
are
added
to
the
acute
dietary
risk
assessment,
the
potential
exists
for
acute
dietary
exposures
through
drinking
water
that
exceed
the
acute
DWLOCs,
resulting
in
acute
aggregate
risks
of
concern.

Chronic
Aggregate
Risk
Assessment:
In
the
case
of
the
food
component
of
the
chronic
aggregate
risk
assessment,
risks
are
well
below
the
Agency's
level
of
concern.
No
more
than
37%
of
chronic
PAD
is
consumed
for
children
1­
6.
Further,
potential
drinking
water
risks
from
exposure
to
water
from
ground
water
sources
does
not
exceed
the
chronic
DWLOCs
and,
therefore,
do
not
exceed
the
Agency's
level
of
concern.
However,
based
on
modeled
estimates
of
methamidophos
concentrations
in
surface
water,
the
potential
exists
for
chronic
dietary
exposures
through
drinking
water
that
exceed
the
chronic
DWLOCs,
resulting
in
chronic
aggregate
risks
of
concern.

4.
Occupational
and
Residential
Risk
Occupational
workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
21
pesticide,
or
re­
entering
treated
sites.
Methamidophos
is
a
restricted
use
pesticide
and
has
no
uses
in
residential
areas.
However,
methamidophos
is
a
degradant
of
the
pesticide
acephate
which
does
have
residential
uses.
Methamidophos
residential
exposure
risk
resulting
from
acephate
applications
in
residential
areas
was
evaluated
in
the
Interim
Reregistration
Eligibility
Decision
for
Acephate
dated
September
30,
2001.
Occupational
handlers
of
methamidophos
include:
individual
farmers
or
growers
who
mix,
load,
and/
or
apply
pesticides,
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.

a.
Toxicity
The
toxicity
of
methamidophos
is
integral
to
assessing
the
occupational
risk.
All
risk
calculations
are
based
on
the
most
current
toxicity
information
available
for
methamidophos,
including
a
21­
day
dermal
toxicity
study.
The
toxicological
endpoints,
and
other
factors
used
in
the
occupational
and
residential
risk
assessments
for
methamidophos
are
listed
below.
Due
to
the
use
patterns
of
methamidophos,
long­
term
exposure
is
considered
highly
unlikely.

Table
5.
Summary
of
Toxicological
Endpoints
and
Other
Factors
Used
in
the
Human
Occupational
Risk
Assessments
for
Methamidophos
Route
and
Duration
of
Exposure
Toxicological
Endpoint
and
Dose
Study
Absorption
Factor
Short­
Term
Dermal
NOAEL
=
0.745
mg/
kg/
day,
LOAEL
=
11.2,
mg/
kg/
day,
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
21­
day
dermal
toxicity
in
rats
NA
Intermediate­
Term
Dermal
NOAEL
=
0.745
mg/
kg/
day,
LOAEL
=
11.2,
mg/
kg/
day,
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
21­
day
dermal
toxicity
in
rats
NA
Short­
Term
Inhalation
NOAEL
=
0.001
mg/
l,
LOAEL
=
0.005
mg/
l,
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
90­
day
inhalation
toxicity
study­
rats
NA
22
Intermediate­
Term
Inhalation
NOAEL
=
0.001
mg/
l,
LOAEL
=
0.005
mg/
l,
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
90­
day
inhalation
toxicity
study­
rats
NA
Methamidophos
is
acutely
toxic,
causing
death
to
laboratory
animals
shortly
after
exposure
to
relatively
low
oral,
dermal,
or
inhalation
doses.
Methamidophos
is
only
moderately
irritating
to
the
eyes
and
mildly
irritating
to
the
skin.
Death
and
other
signs
of
systemic
toxicity
occurred
shortly
after
dermal
or
ocular
application.
These
findings
suggest
that
methamidophos
is
rapidly
absorbed
via
these
routes.

Table
6.
Acute
Toxicity
Profile
for
Occupational
Exposure
for
Methamidophos
Study
Type
(
MRID)
Results
Toxicity
Category
Acute
Oral­
Rat
(
00014044)
LD50=
15.6
mg/
kg
%
LD50=
13.0
mg/
kg
&
I
Acute
Dermal­
Rabbit
(
00014049)
LD50=
118
mg/
kg
%
I
Acute
Inhalation­
Rat
(
00148449)
LC50=
0.052­
0.079
mg/
l
%
LC50=
0.062­
0.128
mg/
l
&
I
Primary
Eye
Irritation­
Rabbit
(
00014221)
Corneal
opacity
and
pannus
present
in
2/
6
rabbits
for
10
days
post­
treatment.
One
death.
I
Primary
skin
irritation­
Rabbit
(
00014220)
PIS=
0.6.
Test
material
was
lethal
to
5/
9
animals
within
24
hrs.
of
treatment.
I
Dermal
Sensitization­
Guinea
Pig
(
00147929)
Not
a
skin
sensitizer.
NA
b.
Exposure
Three
chemical­
specific
dislodgeable
foliar
residue
studies
that
were
submitted
to
the
Agency
by
the
technical
registrant
were
used
to
evaluate
post­
application
exposures.
Chemical­
specific
exposure
data
for
handlers
were
not
available
for
methamidophos,
so
risks
to
pesticide
handlers
were
assessed
using
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED).
In
addition,
standard
assumptions
about
average
body
weight,
work
day,
area
treated
daily
and
volume
of
pesticide
handled
were
used
to
calculate
risk
estimates.
The
quality
of
the
data
and
exposure
factors
represents
the
best
23
sources
of
data
currently
available
to
the
Agency
for
completing
these
kinds
of
assessments.
The
application
rates
are
derived
directly
from
methamidophos
labels.
The
exposure
factors
(
e.
g.,
body
weight,
amount
treated
per
day,
protection
factors,
etc.)
are
all
standard
values
that
have
been
used
by
the
Agency
over
several
years,
and
the
PHED
unit
exposure
values
are
the
best
available
estimates
of
exposure.
Some
PHED
unit
exposure
values
are
high
quality
while
others
represent
low
quality,
but
are
the
best
available
data.
The
quality
of
the
data
used
for
each
scenario
assessed
is
discussed
in
the
Human
Health
Assessment
document
for
methamidophos,
which
is
available
in
the
public
docket.

Anticipated
use
patterns
and
application
methods,
range
of
application
rates,
and
daily
amount
treated
were
derived
from
current
labeling.
Application
rates
specified
on
methamidophos
labels
range
to
a
maximum
of
1.0
pounds
of
active
ingredient
per
acre
in
agricultural
settings.
The
Agency
typically
uses
acres
treated
per
day
values
that
are
thought
to
represent
eight
hours
of
application
work
for
specific
types
of
application
equipment.

Occupational
handler
exposure
assessments
are
conducted
by
the
Agency
using
different
levels
of
personal
protection.
The
Agency
typically
evaluates
all
exposures
with
minimal
protection
and
then
adds
additional
protective
measures
using
a
tiered
approach
to
obtain
an
appropriate
MOE
(
i.
e.,
going
from
minimal
to
maximum
levels
of
protection).
The
lowest
suite
of
personal
protective
equipment
(
PPE)
is
baseline
PPE.
If
required
(
i.
e.,
MOEs
are
less
than
100),
increasing
levels
of
risk
mitigation
PPE
are
applied.
If
MOEs
are
still
less
than
100,
engineering
controls
(
EC)
are
applied.
The
levels
of
protection
that
formed
the
basis
for
calculations
of
exposure
from
methamidophos
activities
include:

°
Baseline:
Long­
sleeved
shirt
and
long
pants,
shoes
and
socks.
°
Minimum
PPE:
Baseline
+
chemical
resistant
gloves
and
a
respirator
if
risk
is
driven
by
inhalation.
°
Maximum
PPE:
Coveralls
over
long­
sleeved
shirt
and
long
pants,
chemical
resistant
gloves,
chemical
footwear
plus
socks,
chemical
resistant
headgear
for
overhead
exposures,
and
a
respirator
if
risk
is
driven
by
inhalation.
°
Engineering
controls:
Engineering
controls
such
as
a
closed
cab
tractor
for
application
scenarios,
or
a
closed
mixing/
loading
system
such
as
a
closed
mechanical
transfer
system
for
liquids.
Some
engineering
controls
are
not
applicable
for
certain
scenarios
(
e.
g.,
for
handheld
application
methods
there
are
no
known
devices
that
can
be
used
to
routinely
lower
the
exposures).

For
methamidophos,
since
the
same
toxicological
endpoint
and
uncertainty
factors
are
being
used
for
both
short­
term
and
intermediate­
term
(
1­
30
days
to
several
months)
exposure
durations,
both
risk
estimates
are
identical.
Although
information
is
not
available
to
determine
what
percentage
of
applicators
apply
methamidophos
continuously
for
more
than
30
days,
it
is
believed
to
be
a
very
small
segment
of
commercial
applicators.
24
c.
Occupational
Handler
Risk
Summary
Inhalation
and
dermal
exposure
to
methamidophos
can
result
from
occupational
use.
The
Agency
assessed
dermal
and
inhalation
risks
(
MOEs)
for
each
crop
currently
registered
for
methamidophos.
Since
the
toxicological
endpoints
used
for
dermal
and
inhalation
exposures
are
the
same;
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition,
the
MOEs
for
each
route
of
exposure
were
combined
to
create
a
single
MOE
for
each
scenario.
For
methamidophos,
occupational
MOEs
greater
than
100
are
not
of
risk
concern
to
the
Agency.
1)
Agricultural
Handler
Risk
EPA
has
determined
that
there
are
potential
exposures
to
mixers,
loaders,
applicators,
or
other
handlers
during
typical
use­
patterns
associated
with
methamidophos.
All
the
MOEs
in
the
tables
below
are
based
on
combined
dermal
and
inhalation
MOEs.
The
scenario
numbers
correspond
to
the
scenario
numbers
detailed
and
discussed
in
Appendix
A
of
the
Occupational
and
Residential
Exposure
Chapter.
The
current
labels
require
use
of
a
dry­
coupling
mixing/
loading
system.
Based
on
the
use
patterns,
five
major
exposure
scenarios
(
each
assessed
at
the
same
maximum
application
rate
of
1.0
lb
ai/
A)
were
identified
for
methamidophos:

°
(
1a)
mixing/
loading
of
liquid
formulation
for
aerial
application
and
chemigation
(
potato
only);
°
(
1b)
mixing/
loading
of
liquid
formulation
for
groundboom
application;
°
(
2)
applying
sprays
with
an
aircraft;
°
(
3)
applying
sprays
with
groundboom
equipment;
and
°
(
4)
flagging
aerial
spray
applications.

As
summarized
in
Table
7,
occupational
risks
are
of
concern
(
i.
e.,
MOEs
<
100)
for
most
scenarios,
even
when
maximum
PPE
are
utilized.
Handler
risks
are
also
of
concern
for
many
scenarios
with
engineering
controls.
Engineering
controls
are
considered
to
be
the
maximum
feasible
mitigation.
It
is
notable
that
dermal
exposures
are
driving
the
Agency's
risk
concern
for
the
occupational
scenarios
in
question
rather
than
inhalation
exposures
especially
in
the
case
of
applicators
and
flaggers.
For
example,
the
MOE
of
51
for
groundboom
applicators
for
cotton
using
enclosed
cabs
is
composed
of
an
MOE
of
53
for
the
dermal
component
and
an
MOE
of
2198
for
the
inhalation
component.

Table
7.
Agricultural
Uses:
Remaining
Risk
Concerns
(
combined
dermal
&
inhalation
MOEs)

Total
MOEs
for
Short­
and
Intermediate­
Term
Risks
Exposure
Scenario
Crop
Area
Treated
(
A/
day)
Baseline
Min.
PPE
Max.
PPE
Engineering
Controls
25
Mixer/
Loader
(
1a)
Mixing/
loading
liquid
formulation
for
aerial
application
or
chemigation
Cotton/
Alfalfa
1200
0.015
1.8
2.5
5
Potato/
Tomato
350
0.052
6.3
8.7
17
(
1b)
Mixing/
loading
liquid
formulation
for
groundboom
application
Cotton/
Alfalfa
200
0.090
11
15
30
Potato/
Tomato
80
0.23
28
38
74
Applicator
(
2)
Applying
sprays
with
an
aircraft
Cotton/
Alfalfa
1200
NA
NA
NA
8.4
Potato/
Tomato
350
NA
NA
NA
29
(
3)
Applying
sprays
with
groundboom
equipment
Cotton/
Alfalfa
200
16
18
23
51
Potato/
Tomato
80
41
46
59
128
Flagger
(
4)
Flagging
aerial
spray
applications
Cotton/
Alfalfa
1200
3.7
3.6
3.9
183
Potato/
Tomato
350
13
12
14
626
2)
Post­
Application
Occupational
Risk
The
Agency
also
assessed
post­
application
risks
to
workers
who
may
be
exposed
to
methamidophos
when
they
enter
previously
treated
fields,
because
their
skin
may
contact
treated
surfaces.
Exposures
are
directly
related
to
the
kind
of
tasks
performed.
EPA
examines
the
amount
of
pesticide
residue
found
on
the
workers
over
time
from
various
studies.
The
Agency
evaluates
this
information
to
determine
the
number
of
days
following
application
that
must
elapse
before
the
pesticide
residues
dissipate
to
a
level
where
worker
MOEs
equal
or
exceed
100
while
wearing
baseline
attire.
Baseline
attire
is
defined
as
long­
sleeved
shirt,
long
pants,
coveralls,
shoes
and
socks.
Based
on
the
results
of
the
post­
application
worker
assessment,
the
Agency
establishes
restricted
entry
intervals
(
REIs)
before
workers
may
enter
treated
areas.
At
present,
the
Worker
Protection
Standard
designates
the
REI
to
be
48
hours,
or
72
hours
in
regions
where
the
annual
rainfall
is
less
than
25
inches.

The
Agency
completed
a
post­
application
exposure
assessment
for
methamidophos
for
the
following
scenarios:
irrigating,
scouting,
thinning,
and
weeding
immature
plants
for
cotton,
potatoes
and
tomatoes;
irrigating,
scouting,
and
weeding
mature
plants
for
potatoes
and
tomatoes;
and
pruning,
staking,
tying
and
hand
harvesting
for
tomatoes.
The
dermal
NOAEL
of
0.745
mg/
kg/
day
based
on
a
21­
day
dermal
toxicity
study
in
rats
(
Table
5)
was
used
to
assess
potential
dermal
exposure
to
workers
26
re­
entering
treated
fields.
The
post­
application
assessment
is
also
based
on
8
hours
of
worker
daily
exposure
and
the
default
transfer
coefficients
(
Tcs)
shown
in
Table
8.
Also,
three
chemical­
specific
dislodgeable
foliar
residue
(
DFR)
studies
were
conducted
for
methamidophos
which
were
used
to
determine
the
DFR
values
used
in
conducting
the
post­
application
risk
assessment.

For
post­
application
risks
to
methamidophos,
an
MOE
of
100
or
greater
is
not
of
concern
to
the
Agency.
Table
8
summarizes
the
occupational
post­
application
risks
following
foliar
applications
of
methamidophos.
In
summary,
except
for
methamidophos
use
on
cotton,
which
resulted
in
a
MOE
>
100
within
one
day
after
being
treated,
all
crops
are
of
post­
application
risk
concern
with
REIs
as
high
as
18
days
after
being
treated,
such
as
foliar
use
of
methamidophos
on
tomatoes
in
Florida.

Table
8.
Occupational
Post­
application
Risks
from
Foliar
Applications
of
Methamidophos
Crop
Task
Transfer
Coefficient
(
cm2/
hr)
DAT*
where
MOE
>
100
Cotton
Irrigating,
scouting,
thinning,
and
weeding
immature
plants
100
DAT
0
Potato
Irrigating,
scouting,
thinning,
and
weeding
immature
plants
300
DAT
4
(
KA)
DAT
1
(
MO)
DAT
2
(
WA)

Irrigating
and
scouting
mature
plants
1500
DAT
11
(
KA)
DAT
4
(
MO)
DAT
7
(
WA)

Tomato
Irrigating,
scouting,
thinning,
and
weeding
immature
plants
500
DAT
12
(
FL)
DAT
4
(
CA)
DAT
6
(
GA)

Irrigating
and
scouting
mature
plants
700
DAT
15
(
FL)
DAT
5
(
CA)
DAT
8
(
GA)

Hand
harvesting,
pruning,
staking,
tying
1000
DAT
18
(
FL)
DAT
7
(
CA)
DAT
9
(
GA)

*
DAT
=
Day
after
treatment
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
Amended
EFED
Methamidophos
RED
Chapter,
September
15,
1999,
available
in
the
public
docket.
The
only
revision
to
this
publicly
available
document
is
a
revised
drinking
water
assessment
discussed
in
the
dietary
risk
section
above.
27
1.
Environmental
Fate
and
Transport
Although
the
environmental
fate
database
for
methamidophos
is
not
complete,
supplemental
information
from
upgradable
laboratory
studies
indicate
that
methamidophos
is
not
persistent
in
aerobic
environments
but
may
be
persistent
in
anaerobic
aquatic
environments
where
it
will
be
associated
with
the
aqueous
phase.
No
acceptable
data
are
available
on
the
behavior
of
methamidophos
under
field
conditions,
but
information
from
acceptable
terrestrial
field
dissipation
studies
for
acephate
indicate
that
methamidophos
is
not
persistent.

Aerobic
soil
metabolism
is
the
main
degradative
process
for
methamidophos.
Methamidophos
degraded
with
a
calculated
half­
life
of
14
hours
in
a
sandy
loam
soil
at
exaggerated
applications
rates.
Its
major
degradates
also
rapidly
degrade
in
soil
(
half­
life
<
four
days).
Methamidophos
photodegrades
rapidly
on
soil
(
half­
life
of
63
hours)
but
photodegrades
very
slowly
in
sterile
aqueous
solutions
(
half­
life
of
>
200
days)
and
is
stable
against
hydrolysis
under
acidic
conditions.

Laboratory
studies
show
that
methamidophos
is
very
soluble
and
very
mobile.
The
methamidophos
degradate
DMPT
is
also
expected
to
be
very
mobile.
Because
methamidophos
and
its
degradate
are
not
persistent
under
aerobic
conditions,
little
methamidophos
residue
could
be
expected
to
leach
to
groundwater.
Volatilization
from
soil
water
is
not
expected
to
be
a
major
route
of
dissipation
for
methamidophos
because
of
its
rapid
metabolism
in
soil
and
its
calculated
Henry's
constant
of
1.6
x
10­
11
mole/
m3.

2.
Ecological
Risk
Assessment
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
studies
to
estimated
environmental
concentrations
(
EECs)
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
nontarget
organisms
from
the
use
of
methamidophos
products,
the
Agency
calculates
a
Risk
Quotient
(
RQ),
which
is
the
ratio
of
the
EEC
to
the
toxicity
endpoint
values,
such
as
the
median
lethal
dose
(
LD50)
or
the
median
lethal
concentration
(
LC50).
These
RQ
values
are
then
compared
to
the
Agency's
levels
of
concern
(
LOCs)
which
indicates
whether
a
chemical,
when
used
as
directed,
has
the
potential
to
cause
undesirable
effects
on
nontarget
organisms.
In
general,
the
higher
the
RQ
the
greater
the
concern.
When
the
RQ
exceeds
the
LOC
for
a
particular
category
(
e.
g.
endangered
species),
the
Agency
presumes
a
risk
of
concern
to
that
category.
The
LOCs
and
the
corresponding
risk
presumptions
are
presented
in
Table
9.

Table
9.
LOCs
and
Associated
Risk
Presumptions
IF...
THEN
the
Agency
presumes...

Mammals
and
Birds
The
acute
RQ
>
LOC
of
0.5,
Acute
risk
The
acute
RQ
>
LOC
of
0.2,
Risk
that
may
be
mitigated
through
restricted
use
The
acute
RQ
>
LOC
of
0.1,
Acute
effects
may
occur
in
Endangered
species
IF...
THEN
the
Agency
presumes...

28
The
chronic
RQ
>
LOC
of
1
Chronic
risk
and
Chronic
effects
may
occur
in
Endangered
species
Fish
and
Aquatic
Invertebrates
The
acute
RQ
>
LOC
of
0.5
Acute
risk
The
acute
RQ
>
LOC
of
0.1
Risk
that
may
be
mitigated
through
restricted
use
The
acute
RQ
>
LOC
of
0.05
Acute
effects
may
occur
in
Endangered
species
The
chronic
RQ
>
LOC
of
1
Chronic
risk
and
Chronic
effects
may
occur
in
Endangered
species
Plants
The
RQ
>
LOC
of
1
Acute
risk
The
RQ
>
LOC
of
1
Acute
risk
and
endangered
plants
may
be
affected
a.
Ecological
Hazard
Profile
Avaian/
Mammaliam
Based
on
a
review
of
the
available
toxicity
database,
data
for
birds
showed
methamidophos
to
be
highly
to
very
highly
toxic
for
acute
oral
exposure
and
slightly
to
very
highly
toxic
for
subacute
dietary
exposure.
Table
10
summarizes
selected
acute
toxicity
information
for
birds.

Table
10.
Acute
Oral
Toxicity
to
Birds
Species
LD
50
(
mg/
kg)
Toxicity
Category
Acute
Oral
(
Single
dose
by
gavage)

Mallard
Duck
8.48
Very
highly
toxic
Northern
Bobwhite
Quail
8
Very
highly
toxic
Common
Grackle
6.7
Very
highly
toxic
Dark
eyed
Junco
8
Very
highly
toxic
Subacute
dietary1
(
five
days
of
treated
feed)

Mallard
Duck
847.7
Moderately
toxic
Northern
Bobwhite
Quail
42
Very
highly
toxic
The
effects
in
avian
reproduction
testing
included
reduced
egg
thickness.
Table
11
summarizes
the
results
of
the
chronic
toxicity
tests
for
avian
species.
29
Table
11.
Avian
Reproductive
Toxicity
Species/
Study
Duration
NOEC
(
ppm
ai)
LOEC
(
ppm
ai)
LOEC
Endpoints
Northern
bobwhite
3
5
Egg
thickness
Mallard
duck
>
15
>
15
No
Effect
Wild
mammal
testing
is
not
required
for
methamidophos.
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
methamidophos
is
highly
toxic
to
small
mammals
on
an
acute
oral
and
dermal
basis
and
is
considered
highly
toxic
to
bees.

Aquatic
Data
for
freshwater
fish
showed
methamidophos
to
be
slightly
toxic
for
acute
exposure.
For
freshwater
aquatic
invertebrates,
data
indicated
that
methamidophos
is
very
highly
toxic
for
acute
exposure.
Data
for
estuarine
and
marine
fish
showed
methamidophos
to
be
moderately
toxic
for
acute
exposure.
For
estuarine
and
marine
aquatic
invertebrates,
data
indicated
that
methamidophos
is
slightly
to
very
highly
toxic
for
acute
exposure.
Data
was
either
not
required
(
fish)
or
unavailable
(
invertebrates)
to
assess
the
chronic
effects
of
methamidophos.
Table
12
summarizes
invertebrate
toxicity.

Table
12.
Acute
Toxicity
to
Aquatic
Invertebrates
Species,
Study
Type
EC
50
(
ppb
ai)
Toxicity
Category
48­
hr
96­
hr
Freshwater
Waterflea
0.026
­
Very
highly
toxic
Estuarine/
Marine
Oyster
­
39
Slightly
toxic
Blue
Shrimp
­
0.00016
Very
highly
toxic
Mysid
Shrimp
­
5.6
Moderately
toxic
b.
Risk
to
Birds
and
Mammals
EPA
uses
models
to
estimate
exposure
of
nontarget
plants
and
animals
to
methamidophos.
For
terrestrial
birds
and
mammals,
the
Agency
first
estimates
initial
levels
of
pesticide
residues
on
various
wildlife
food
items.
Acute
and
chronic
risks
to
birds
and
mammals
were
predicted
for
the
liquid
30
formulations
of
methamidophos.

The
Agency's
assessment
suggests
the
potential
for
the
liquid
formulation
to
cause
acute
effects
to
birds
for
broadcast
applications.
The
avian
acute
RQs
range
from
0.38
to
6.63.
The
highest
avian
acute
RQ
is
from
nine
1
lb
ai/
A
ground
or
aerial
applications
to
tomatoes.
Regarding
chronic
risk
to
birds,
the
RQs
range
from
2.49
to
32.87.
Table
13
summarizes
the
risk
quotients
for
birds.

Table
13.
Avian
Acute
and
Chronic
Risk
Quotients
Based
on
Bobwhite
Quail
#
of
Applications
Diet
EEC
(
ppm)
Risk
Quotient
Max.
Mean
Acute
Chronic
Tomatoes
at
5
app
at
1.0
lb
ai
Short
grass
256
91
6.10
30.22
Tall
grass
117
38
2.79
12.80
Broad
Leaf
144
48
3.43
16.00
Seed
Fruit
16
7
0.38
2.49
Tomatoes
at
9
app
at
1.0
lb
ai
Short
grass
278
99
6.63
32.87
Tall
grass
128
42
3.04
13.92
Broad
Leaf
157
52
3.73
17.40
Seed
Fruit
17
8
0.41
2.71
Potatoes/
Cotton
at
4
app
at
1.0
lb
ai
Short
grass
256
91
6.10
30.22
Tall
grass
117
38
2.79
12.80
Broad
Leaf
144
48
3.43
16.00
Seed
Fruit
16
7
0.38
2.49
For
the
same
use
patterns,
mammalian
acute
RQs
range
from
0.2
to
20.3
and
in
chronic
RQs
for
mammals
ranging
from
0.75
to
9.86.
All
use
patterns
are
of
concern
to
the
Agency
for
acute
and
chronic
effects
to
birds
and
mammals.

c.
Risk
to
Aquatic
Animals
To
assess
potential
risk
to
aquatic
animals,
the
Agency
uses
a
computer
model
to
generate
EECs
of
methamidophos
in
surface
water.
However,
unlike
the
drinking
water
assessment
described
in
the
human
health
risk
assessment
section
of
this
document,
the
ecological
water
resource
assessment
does
not
include
the
index
reservoir
and
percent
crop
area
factor.
These
refinements
are
solely
used
to
assess
pesticide
exposure
to
humans
from
drinking
water
sources.
Hence,
the
EECs
used
to
assess
exposure
to
aquatic
animals
are
not
the
same
as
the
EEC
values
used
to
assess
human
dietary
exposure
from
drinking
water
sources.
31
Acute
risk
to
freshwater
fish
and
estuarine
fish
is
not
of
concern
for
any
use
patterns,
with
RQs
ranging
from
<
0.05
to
0.07.
The
acute
high
risk,
restricted
use
risk
and
endangered
species
risk
is
of
concern
for
freshwater
invertebrates
at
the
maximum
application
rate
of
1.0
lb
ai/
A
with
RQs
ranging
from
1.1
to
3.0.
Risk
may
be
of
concern
for
some
estuarine
invertebrates
based
on
supplemental
data
on
blue
shrimp.
No
chronic
risk
assessment
was
conducted
since
there
are
no
chronic
data
for
aquatic
species.

d.
Incidents
Approximately
six
wildlife
mortality
incidents
likely
not
to
be
associated
with
misuse
have
been
reported
to
the
Agency
since
1980.
Four
of
these
incidents
involved
crops
which
are
no
longer
registered.
Three
of
these
incidents
involved
adverse
impacts
on
bee
colonies
including
two
from
use
on
potatoes.

e.
Endangered
Species
Endangered
species
LOCs
are
exceeded
for
acute
and
chronic
risks
to
birds
and
mammals
and
acute
risks
to
freshwater
invertebrates
for
all
currently
registered
uses
of
methamidophos.

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
methamidophos
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
of
the
IRED
which
address
methamidophos,
will
serve
as
interim
protection
measures
to
reduce
the
likelihood
that
endangered
and
threatened
species
may
be
exposed
to
methamidophos
at
levels
of
concern.

C.
Benefits
The
Agency
has
assessed
the
benefits
of
all
registered
uses
of
methamidophos.
A
summary
of
the
Agency's
benefits
findings
is
presented
below;
for
more
information,
see
the
following
documents:
Use
and
Usage
Analysis
for
Methamidophos,
dated
November
20,
2001,
and
Methamidophos
Use
on
Cotton,
Tomatoes
and
Potatoes,
dated
December
6,
2001.
All
of
these
documents
are
available
in
the
public
docket
and
on
the
internet.

Alfalfa
for
Seed
In
2000,
more
than
50%
of
the
alfalfa
seed
acreage
in
California
was
treated
with
32
methamidophos.
The
primary
target
pest
of
methamidophos
applications
is
lygus
bug,
which
is
a
key
pest
in
alfalfa
seed.
Lygus
bug
can
cause
significant
economic
damage
to
alfalfa
grown
for
seed
throughout
the
growing
season.
Methamidophos
is
an
important
element
of
a
resistance
management
program
for
this
pest
early
in
the
season,
before
introducing
pollinators
into
the
fields.
It
is
the
most
effective
chemical
for
lygus
bug
control
at
this
time
of
the
season.
The
alternatives
to
methamidophos
include
methidathion,
which
is
less
effective;
and
synthetic
pyrethroids,
which
have
limited
use
due
to
problems
with
resistance.
Methamidophos
is
applied
once
per
season
at
an
average
rate
of
one
pound
per
acre.

Cotton
In
2000,
an
estimated
2%
of
the
U.
S.
cotton
acreage
was
treated
with
methamidophos.
Arkansas
and
Louisiana
reported
4%
of
state
cotton
acreage
treated
in
that
year,
while
California
reported
2%.
The
average
number
of
applications
made
to
cotton
per
year
is
one
at
an
average
application
rate
of
0.3
pounds
of
active
ingredient
per
acre.
In
California,
methamidophos
use
is
targeted
primarily
for
the
control
of
lygus
bugs.
State
cotton
specialists
have
indicated
that
methamidophos
is
an
important
part
of
their
IPM
programs
in
California
and
also
noted
that
lygus
bugs
are
developing
resistance
to
some
alternatives
to
methamidophos.
The
alternatives
to
methamidophos
for
lygus
bug
control
include
acephate,
aldicarb,
bifenthrin,
cyfluthrin,
cypermethrin,
dimethoate,
oxamyl,
and
zetamethrin.

In
Louisiana
and
Arkansas
methamidophos
applications
are
targeted
primarily
for
control
of
whiteflies
and
thrips.
State
experts
in
Louisiana
have
indicated
that
a
shifting
thrip
species
population
in
that
state
has
increased
the
importance
of
methamidophos
use
there.
For
thrip
control,
the
alternatives
to
methamidophos
include
acephate,
aldicarb,
dicrotophos,
imidacloprid
and
phorate.
For
the
control
of
whiteflies
the
alternatives
include
acephate,
buprofezin,
chlorpyrifos,
fenpropathrin,
profenofos,
and
pyriproxifen.

Potatoes
In
2000,
an
estimated
29%
of
the
U.
S.
potato
acreage
was
treated
with
methamidophos.
Washington
reported
80%
of
state
acreage
treated
in
that
year,
while
Idaho,
Oregon
and
Pennsylvania
all
reported
greater
than
28%
of
state
acreage
treated.
The
average
number
of
applications
made
to
potatoes
per
year
ranged
from
1
to
3.2
at
an
average
application
rate
of
between
0.6
and
1.0
pound
of
active
ingredient
per
acre.
Methamidophos
application
in
potatoes
is
generally
a
7
­
10
day
preventative
program
and
cannot
be
applied
within
14
days
of
harvest.

The
three
primary
target
pests
for
use
of
methamidophos
on
potatoes
are
green
peach
aphid,
Colorado
potato
beetle
and
leafhoppers.
Pre­
and
post­
emergence
control
of
the
green
peach
aphid,
a
vector
for
the
potato
leafroll
virus,
is
the
critical
methamidophos
use
in
most
areas
of
the
country.
Alternatives
for
pre­
emergence
control
include
aldicarb,
imidacloprid
and
phorate.
Only
imidacloprid
is
a
potential
alternative
for
post­
emergence
control
but
it
is
significantly
more
costly
and
does
not
have
33
the
period
of
residual
effectiveness
that
methamidophos
has
that
is
necessary
in
some
potato
growing
regions.
There
is
also
concern
for
potential
resistance
in
some
regions
for
imidacloprid.
Aldicarb's
use
for
pre­
emergence
control
is
limited
due
to
a
150
day
pre­
harvest
interval
(
PHI).
These
circumstances
make
methamidophos
critical
to
potato
production,
especially
in
the
production
of
potatoes
for
seed,
where
there
is
zero
tolerance
for
aphids
or
the
viruses
they
carry.

For
Colorado
potato
beetle
control,
alternatives
to
methamidophos
include
carbofuran,
esfenvalerate,
endosulfan,
imidacloprid
and
phosmet.
The
effectiveness
of
the
alternatives
vary
by
region.
In
the
major
production
areas,
carbofuran
and
methamidophos
are
the
most
efficacious
pesticides
for
controlling
this
pest.
For
the
control
of
leafhoppers
in
potatoes,
there
are
a
number
of
registered
alternatives
to
methamidophos,
however,
only
carbaryl
may
provide
acceptable
efficacy.

Tomato
(
Fresh)

In
2000,
an
estimated
15%
of
the
U.
S.
fresh
market
tomato
acreage
was
treated
with
methamidophos.
This
is
down
from
an
estimated
60%
of
the
U.
S.
fresh
tomato
crop
treated
with
methamidophos
in
1994.
In
Florida,
which
accounts
for
more
than
40%
of
U.
S.
fresh
market
tomato
production,
14%
of
the
fresh
tomato
acreage
was
treated
with
methamidophos
in
2000.
In
California,
which
accounts
for
30%
of
U.
S.
fresh
market
tomato
production,
8%
of
the
fresh
tomato
acreage
was
treated
with
methamidophos
in
2000.
In
Georgia,
North
Carolina,
South
Carolina
and
Tennessee,
which
account
for
a
combined
10%
of
U.
S.
fresh
market
tomato
production,
86%,
58%,
46%
and
22%
of
the
tomato
acreage
in
each
state
was
treated
with
methamidophos
in
2000,
respectively.
The
average
number
of
applications
made
with
methamidophos
to
fresh
market
tomatoes
per
year
ranged
from
1.2
to
3.3,
with
average
application
rates
ranging
from
0.5
and
1.0
pound
of
active
ingredient
per
acre.

Methamidophos
is
used
primarily
to
control
Western
flower
thrips
in
fresh
tomatoes
in
the
Southeastern
U.
S.
This
pest
a
primary
vector
of
Tomato
Spotted
Wilt
Virus,
which
can
reduce
the
marketable
yields
on
fresh
tomatoes
by
up
to
50%.
Methamidophos
applications
are
critical
for
the
control
of
this
pest
because
growers
target
as
many
as
5­
6
insecticide
applications
per
season
for
this
pest,
and
the
only
effective
alternative
to
methamidophos,
spinosad,
is
limited
to
two
applications
per
season.
Without
methamidophos,
growers
would
not
achieve
sufficient
control
of
the
pest,
and
would
likely
face
significant
yield
losses
from
the
virus.

Methamidophos
is
also
used
to
control
silverleaf
whitefly
in
the
Southeastern
U.
S.
This
is
a
difficult
pest
to
manage
and
it
transmits
Tomato
Mottle
Virus
and
Tomato
Yellow
Leaf
Curl
Virus,
which
can
cause
significant
tomato
damage.
Methamidophos
is
considered
to
be
important
as
a
costeffective
synergist
mixed
with
a
synthetic
pyrethroid
insecticide
to
control
this
pest.
The
alternatives
to
methamidophos
to
control
silverleaf
whitefly
include
endosulfan,
esfenvalerate,
fenpropathrin,
imidacloprid,
permethrin,
pymetrozine,
pyriproxifen
and
thiamethoxam.

In
California,
the
primary
target
pest
for
methamidophos
on
fresh
tomatoes
is
stink
bug.
34
Methamidophos
is
the
only
effective
insecticide
available
for
controlling
this
economically
important
pest.
The
primary
alternatives
to
methamidophos
for
the
control
of
this
pest
are
limited
in
their
effectiveness.
Imidacloprid
is
only
effective
against
low
populations,
dimethoate
is
a
severe
hazard
to
bees,
and
endosulfan
has
waterway
restrictions
which
limit
its
use.
Without
methamidophos,
growers
would
not
achieve
sufficient
control
of
the
pest,
and
would
likely
face
significant
yield
losses.

Methamidophos
is
applied
to
fresh
tomatoes
late
in
the
growing
season
in
California.
Therefore,
many
cultural
activities
such
as
weeding,
pruning,
staking
and
tying
are
completed
well
in
advance
of
application
of
this
material.
By
contrast,
in
the
Southeastern
U.
S.,
methamidophos
is
applied
throughout
the
season,
resulting
in
applications
before
or
soon
after
these
activities
occur
in
the
field.
Current
labels
require
a
7
day
PHI.

Tomato
(
Processed)

California
accounts
for
more
than
95%
of
the
U.
S.
production
of
processed
tomatoes.
In
2000,
an
estimated
3%
of
the
California
processed
tomato
acreage
was
treated
with
methamidophos.
Methamidophos
usage
on
processed
tomatoes
has
seen
a
steady
decline
since
the
mid­
1990'
s.
An
average
of
one
application
is
made
with
methamidophos
to
California
processed
tomatoes
per
year,
and
slightly
less
than
one
pound
of
active
ingredient
is
applied
on
average
per
acre
per
application.

As
in
the
case
of
fresh
tomatoes
in
California,
the
primary
target
pest
of
methamidophos
application
to
processing
tomatoes
is
stink
bug.
The
limitations
mentioned
earlier
on
the
primary
alternatives
to
methamidophos
for
control
of
this
pest,
make
methamidophos
an
important
tool
in
processed
tomato
production.

Methamidophos
is
applied
to
processed
tomatoes
late
in
the
growing
season
in
CA.
Therefore,
many
cultural
activities
such
as
weeding,
pruning,
staking
and
tying
are
completed
well
in
advance
of
application
of
this
material.
Current
labels
require
a
14
day
PHI
in
CA.
35
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
methamidophos
active
ingredient.

The
Agency
has
completed
its
assessment
of
the
occupational
and
ecological
risks
associated
with
the
use
of
pesticides
containing
the
active
ingredient
methamidophos
,
as
well
as
a
methamidophos­
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
methamidophos,
EPA
has
sufficient
information
on
the
human
health
and
ecological
effects
of
methamidophos
to
make
an
interim
decision
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
methamidophos
products
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
including
the
phase
out
of
the
cotton
use,
and
label
amendments
are
made
to
reflect
these
measures;
and
(
iii)
cumulative
risks
considered
for
the
organophosphates
support
a
final
reregistration
eligibility
decision.

As
part
of
the
Agency's
ongoing
process
to
review
and
take
the
necessary
risk
reduction
measures
as
required
by
FQPA,
on
December
4,
2001,
EPA
released
the
preliminary
cumulative
risk
assessment
for
organophosphate
pesticides
for
public
comment.
That
assessment
is
based
on
evaluation
of
the
potential
exposure
of
31
total
organophosphate
pesticides
from
eating
food,
drinking
water,
and
residential
sources.
The
assessment
also
takes
into
account
EPA's
past
regulatory
actions
on
various
pesticides,
such
as
eliminating
uses.
Continuing
the
effort
to
ensure
transparency
of
decision
processes,
EPA
conducted
a
technical
briefing
and
presented
the
assessment
to
the
Scientific
Advisory
Panel
for
peer
review
and
comment.
The
Agency
intends
to
release
a
revised
cumulative
risk
assessment
during
summer
2002.

Although
the
Agency
has
not
yet
considered
its
final
cumulative
risk
assessment
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
methamidophos.
Based
on
its
current
evaluation
of
methamidophos
alone,
the
Agency
has
determined
that
methamidophos
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
methamidophos.
36
At
the
time
that
the
cumulative
assessment
is
finalized,
the
Agency
will
address
any
outstanding
risk
concerns.
For
methamidophos,
if
all
changes
outlined
in
this
document
are
incorporated
into
the
labels,
then
all
currently
recognized
risks
will
be
adequately
managed.
But,
because
this
is
an
interim
RED,
the
Agency
may
take
further
actions,
if
warranted,
to
finalize
the
reregistration
eligibility
decision
for
methamidophos
after
assessing
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
mitigation
measures,
the
Agency
is
addressing
the
risks
from
the
organophosphates
in
as
timely
a
manner
as
possible.

Because
the
Agency
has
not
yet
concluded
its
cumulative
risk
assessment
for
the
organophosphates,
this
interim
reregistration
eligibility
decision
does
not
fully
satisfy
the
reassessment
of
the
existing
methamidophos
food
residue
tolerances
as
called
for
by
the
Food
Quality
Protection
Act
(
FQPA).
When
the
Agency
has
concluded
its
cumulative
risk
assessment,
methamidophos
tolerances
will
be
reassessed
in
that
light.
At
that
time,
the
Agency
will
reassess
methamidophos
along
with
the
other
organophosphate
pesticides
to
complete
the
FQPA
requirements
and
make
a
final
reregistration
determination.
By
publishing
this
interim
decision
on
reregistration
eligibility
and
requesting
mitigation
now
for
the
individual
chemical
methamidophos,
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
completion
of
assessment
required
under
the
FQPA.
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.

Label
changes
for
methamidophos
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
methamidophos,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

B.
Summary
of
Phase
5
Comments
and
Responses
When
making
its
interim
reregistration
decision,
the
Agency
took
into
account
all
comments
received
during
Phase
5
of
the
OP
Public
Participation
Process.
These
comments
in
their
entirety
are
available
in
the
docket.
The
Agency
received
comments
from
the
technical
registrant,
Bayer
Corporation.
Comments
were
also
received
from
the
National
Potato
Council,
the
California
Tomato
Research
Institute,
the
National
Agricultural
Aviation
Association,
Florida
Fruit
and
Vegetable
Association,
Washington
State
University,
California
Tomato
Commission
and
Environmental
Focus.
The
Agency
also
received
approximately
10
comments
from
various
agri­
business
companies
and
associations,
commodity
groups,
farm
bureaus,
universities,
extension,
and
state
agencies,
as
well
as
private
citizens,
supporting
the
use
of
methamidophos.
A
brief
summary
of
the
comments
and
the
37
Agency
response
is
noted
here.

Registrant
Comments
Comment:
Bayer
noted
differences
between
dietary
assessment
conducted
by
EPA
versus
the
Bayer
assessment.
The
three
main
differences
noted
were
(
1)
processing
factors
used,
particularly
in
tomato
residue
assessment,
(
2)
percent
crop
treated
data
used
and
(
3)
imputation
of
composite
residue
data
appears
to
be
inappropriate
and
exaggerates
high­
end
predictions
for
residues.

Response:
The
dietary
assessment
was
conducted
with
the
best
available
data
and
in
accordance
with
Agency
policy.
The
most
recent
dietary
assessment
reflects
some
of
the
concerns
noted
by
the
registrant.
These
include
changes
to
the
%
crop
treated
and
the
use
of
processed
tomato
data.

Comment:
Some
assumptions
used
by
the
Agency
in
the
assessment
appear
not
to
be
reflective
of
assumptions
supported
by
data
the
Agency
has
on
hand.
The
risk
assessment
uses
transfer
coefficients
ranging
from
2500
to
10000
whereas
recent
studies
have
shown
that
more
realistic
values
range
from
100
to
650
for
activities
such
as
scouting
and
harvesting.

Response:
The
risk
assessment
has
been
revised
to
incorporate
updated
TC's
which
were
generated
as
a
result
of
the
ARTF
data.
The
range
of
TC's
used
is
300
to
1500
depending
on
the
crop
involved
and
the
activity
being
evaluated.

Comment:
The
assessment
also
appears
to
have
inadequately
considered
the
personal
protective
equipment
requirements
specified
on
the
product
label.
The
revised
assessment
failed
to
use
NIOSH
exposure
reduction
factors
for
the
label
specified
respiratory
protection.
The
revised
assessment
also
used
dermal
exposure
reduction
factors
that
are
not
consistent
with
exposure
reduction
factors
used
by
other
regulatory
agencies
or
with
exposure
reduction
factors
derived
from
PHED
data.

Response:
Where
possible,
the
labeled
PPE
was
accounted
for
in
the
various
PPE
scenarios
evaluated
in
the
risk
assessment.
There
are
some
PPE,
such
as
chemical­
resistant
aprons,
that
the
Agency
views
as
qualitative
measures
because
there
are
no
recognized
protection
factors
(
PF)
to
assess
their
effectiveness.
The
Agency
has
no
protection
factors
to
assess
headgear.
Face
and
neck
wipe
monitoring
data
constitutes
dermal
head
exposure
values.
All
occupational
handlers
were
assessed
as
wearing
footwear
(
socks
plus
shoes
or
boots),
foot
exposure
is
not
traditionally
monitored,
and
therefore,
a
100
percent
protection
factor
is
implied.
Finally,
inhalation
exposures
were
not
the
most
significant
risk
factor,
(
if
protection
factors
were
increased,
little
change
in
combined
MOEs
would
result).
38
Comment:
The
uncertainty
attributed
to
interspecies
variability
for
the
selected
endpoint
is
not
supported
by
available
human
and
animal
data.
Therefore
Bayer
believes
that
an
MOE
of
10
provides
an
adequate
margin
of
safety
for
the
product
and
should
be
used
for
the
methamidophos
occupational
exposure
and
risk
assessment.

Response.
Consistent
with
the
Agency's
policy
announced
on
December
14,
2001,
this
assessment
does
not
consider
or
rely
on
any
third­
party
studies
which
intentionally
dose
human
subjects
with
toxicants
to
identify
or
quantify
their
effects.
Therefore,
the
Agency
continues
to
employ
the
uncertainty
of
100.

Washington
State
University
Comment:
Comments
that
EPA
rejected
a
human
exposure
study
and
indicated
that
if
these
results
were
used,
the
100­
fold
uncertainty
factor
applied
to
the
chronic
RfD
could
be
confidently
reduced.

Response:
Consistent
with
the
Agency's
policy
announced
on
December
14,
2001,
this
assessment
does
not
consider
or
rely
on
any
third­
party
studies
which
intentionally
dose
human
subjects
with
toxicants
to
identify
or
quantify
their
effects.
Therefore,
the
Agency
continues
to
employ
the
100­
fold
uncertainty
factor.

Comment:
The
potato
processing
study,
although
submitted
by
the
manufacturer,
has
some
serious
methodological
flaws
as
pointed
out
by
the
Agency.
Consequently,
the
10X
concentration
factor
for
potato
chips
is
completely
unrealistic.
The
DEEM
analysis
for
tomato
puree
has
an
ambiguous
entry.
The
stated
processing
factor
for
tomato
puree
is
0.7,
yet
the
acute
DEEM
analysis
shows
that
there
are
several
puree
types
with
factors
of
3.3.

Response:
Although
some
irregularities
were
noted
in
the
potato
processing
study,
the
Agency
concluded
that
these
actions
did
not
likely
affect
the
overall
conclusions
of
the
study.
Unless
additional
information
is
provided,
the
10X
concentration
factor
will
continue
to
be
used
in
the
dietary
assessment.
With
respect
to
tomatoes,
a
revised
dietary
assessment
has
been
conducted
which
incorporates
monitoring
data
for
processed
tomatoes.
Since
actual
processed
commodity
data
was
used,
a
processing
factor
was
not
applied.
Consequently,
the
concerns
about
the
tomato
processing
factor
is
no
longer
applicable.

Comment:
The
post
application
exposure
scenario
included
hand
harvesting
of
potatoes.
This
is
a
situation
that
is
a
remote
exception
rather
than
the
rule.
Further,
a
question
was
raised
as
to
the
use
of
different
transfer
coefficients
for
different
compounds
having
the
same
post
occupational
activity.
39
Response:
The
current
policy
on
transfer
coefficients
lists
potatoes
under
Vegetables,
"
root".
Within
the
root
vegetable
category,
mechanical
potato
harvesting
exposure
was
assigned
a
value
of
0.
Hand
harvesting
was
listed
as
out
of
scope
of
the
transfer
coefficient
table.
Therefore,
hand
harvesting
is
no
longer
a
scenario
for
which
risk
estimates
are
developed.

California
Tomato
Research
Institute
Comment:
The
commentor
states
that
the
PDP
data
are
not
representative
of
California's
95%
portion
of
the
US
processed
crop
and
that
using
the
PDP
data
coupled
with
a
processing
factor
does
not
deliver
a
relevant
or
accurate
processed
methamidophos
exposure.
Use
information
and
residue
data
collected
by
California
Department
of
Pesticide
Regulation
was
provided.

Response:
As
discussed
earlier,
a
revised
dietary
assessment
which
includes
USDA
monitoring
data
for
processed
tomatoes
and
percent
crop
treated
information
which
separates
processed
and
fresh
tomato
has
been
conducted.

Environmental
Focus
Comment:
Environmental
Focus
has
concerns
pertaining
to
assigning
a
15%
default
value
for
drift
when
applying
methamidophos
next
to
surface
water.
The
AgDRIFT
model
does
not
specify
a
drift
default
value
associated
with
aerial
application.

Response:
The
15%
value
is
the
result
of
the
adoption
of
the
AgDRIFT
model,
which
when
used
with
default
values
for
droplet
size,
pond
size
and
wind
speed
gives
that
result.
The
modeling
conducted
by
the
Agency
is
intended
to
be
a
conservative
screening
assessment.
The
assumptions
made
are
not
considered
unreasonable
and
fall
within
the
range
of
allowed
use
of
the
chemical.

Comment:
Environmental
Focus
has
concerns
that
the
Agency
uses
a
scenario
in
its
assessment
that
assumes
an
aerial
applicator
will
apply
next
to
a
drinking
water
supply
when
wind
speed
is
10
mph.

Response:
The
models
are
used
as
a
screening
tool
and,
as
such,
are
intended
to
simulate
situations
that
could
occur
in
the
field.
The
modeling
is
done
according
to
the
label,
and
in
conditions
that
are
not
intended
to
be
typical
but
are
realistic.

National
Agricultural
Aviation
Association
40
Comment:
NAAA
is
concerned
that
the
data
the
EPA
uses
to
determine
the
occupational
risk
associated
with
the
aerial
application
are
outdated
and
overly
conservative.
Specifically,
PHED
does
not
include
data
on
worker
exposure
subsequent
to
1992­
which
is
before
the
Worker
Protection
Standards
went
into
effect
at
a
time
when
many
techniques
and
equipment
to
protect
workers
became
commonplace.
NAAA
believes
that
if
more
current
data
that
takes
into
account
technological
advancements
that
enhance
worker
protection,
any
exposure
assessment
would
demonstrate
an
adequate
margin
of
safety
for
those
involved
aerial
application
including
new
technological
advances.

Response:
The
Agency
considered
this
comment
during
the
risk
mitigation
process.
The
Agency
would
consider
any
data
that
the
NAAA
would
submit.

Comment:
NAAA
has
concerns
pertaining
to
assigning
a
15%
default
value
for
drift
when
applying
methamidophos
next
to
surface
water.
The
AgDRIFT
model
does
not
specify
a
drift
default
value
associated
with
aerial
application.

Response:
See
earlier
response
to
similar
question.

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
is
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
through
a
common
biochemical
interaction
with
the
cholinesterase
enzyme.
The
Agency
will
evaluate
the
cumulative
risk
posed
by
the
entire
class
of
organophosphates
once
the
methodology
is
fully
developed
and
the
policy
concerning
cumulative
assessments
is
resolved.

EPA
has
determined
that
risk
from
exposure
to
methamidophos
is
within
its
own
"
risk
cup."
In
other
words,
if
methamidophos
did
not
share
a
common
mechanism
of
toxicity
with
other
chemicals,
EPA
would
be
able
to
conclude
today
that
the
tolerances
for
methamidophos
meet
the
FQPA
safety
standards,
provided
the
risk
mitigation
measures
outlined
in
this
document
are
implemented
and
additional
data
needs
are
addressed.
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,
residential
uses,
and
41
drinking
water.
Results
of
this
aggregate
assessment
indicate
that
the
human
health
risks
from
these
combined
exposures
are
considered
to
be
within
acceptable
levels.
While
the
combined
risks
from
all
exposures
to
methamidophos
"
fill"
the
aggregate
risk
cup,
the
water
exposures
are
based
on
screeninglevel
modeling
estimates.
The
Agency
has
determined
that
actual
drinking
water
exposures
are
likely
to
be
lower
than
predicted
by
these
models
and
has
made
a
regulatory
determination
that
combined
risks
from
all
exposures
to
methamidophos
"
fit"
within
the
individual
risk
cup.
Except
for
those
tolerances
that
are
to
be
lowered
or
revoked,
the
current
methamidophos
tolerances
remain
in
effect
and
unchanged
until
a
full
reassessment
of
the
cumulative
risk
from
all
organophosphates
is
considered
later
this
year.

b.
Tolerance
Summary
Tolerances
for
residues
of
methamidophos
in/
on
plant
commodities
[
40
CFR
§
180.315
(
a)
and
(
b)]
are
currently
expressed
in
terms
of
residues
of
methamidophos
per
se.

The
available
plant
and
animal
metabolism
studies
indicate
that
the
residue
of
concern
is
the
parent
methamidophos.
Methamidophos
is
also
a
metabolite
of
acephate.
It
is
recommended
that
residues
of
methamidophos
resulting
from
the
metabolism
of
acephate
be
included
under
the
tolerance
regulations
for
methamidophos
as
a
pesticide
[
40
CFR
§
180.315(
c)].
This
change
is
needed
to
achieve
compatibility
with
the
MRLs
of
the
Codex
Alimentarius
Commission,
if
only
in
terms
of
residue
definition.
Such
a
change
in
the
residue
definition
requires
deletion
of
paragraph
(
d)
(
8)
of
40
CFR
§
180.3
which
states
that
methamidophos
residues
may
not
exceed
the
higher
of
the
two
tolerances
established
for
the
use
of
acephate
or
methamidophos
as
a
pesticide.

The
listing
of
methamidophos
tolerances
under
40
CFR
§
180.315
should
be
subdivided
into
parts
(
a),
(
b),
and
(
c).
Part
(
a)
should
be
reserved
for
permanent
tolerances,
part
(
b)
for
tolerances
with
regional
registration,
and
part
(
c)
for
tolerances
reflecting
use
of
acephate
formulations
alone
(
i.
e.,
no
methamidophos
formulations
are
registered
for
use
on
these
commodities).

The
Agency
will
commence
proceedings
to
revoke
and
modify
existing
tolerances,
and
correct
commodity
definitions.
The
establishment
of
a
new
tolerance
or
raising
tolerances
will
be
deferred,
pending
consideration
of
cumulative
risk
for
the
organophosphates.
"
Reassessed"
does
not
imply
that
all
of
the
tolerances
have
been
reassessed
as
required
by
FQPA,
since
these
tolerances
may
only
be
reassessed
once
the
cumulative
risk
assessment
of
all
organophosphate
pesticides
is
considered,
as
required
by
the
statute.
Rather,
this
IRED
provides
reassessed
tolerances
for
methamidophos
in/
on
various
commodities,
supported
by
all
the
submitted
residue
data,
only
for
the
single
organophosphate
chemical
methamidophos.
EPA
will
finalize
these
tolerances
after
considering
the
cumulative
risks
for
all
organophosphate
pesticides.
The
Agency's
tolerance
summary
is
provided
in
Table
14.
This
table
lists
several
tolerances
associated
with
uses
that
are
no
longer
registered,
as
announced
in
FIFRA
6(
f)(
1)
Notices
of
Receipt
of
Requests
from
the
registrant
for
cancellation
and/
or
use
deletion,
which
EPA
approved.
Therefore,
the
associated
tolerances
should
be
revoked.
42
Table
14.
Tolerance
Summary
for
Methamidophos
Commodity
Tolerance
Listed
Under
40
CFR
§
180.315
Reassessed
Tolerance
Tolerance
Listed
Under
40
CFR
§
180.108
Comment
[
Correct
Commodity
Definition]

Tolerances
Listed
Under
40
CFR
§
180.315
(
a)

Beets,
sugar,
roots
0.02
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
sugar
beets
and
there
are
no
registered
acephate
uses.
Beets,
sugar,
tops
0.50
Revoke
­­

Broccoli
1.0
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
broccoli
and
there
are
no
registered
acephate
uses.

Brussels
sprouts
1.0
1.0
0.5
This
tolerance
must
be
moved
to
§
180.315(
c).

Cabbage
1.0
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
cabbage
and
there
are
no
registered
acephate
uses.

Cauliflower
1.0
0.5
0.5
This
tolerance
must
be
moved
to
§
180.315(
c).

Cottonseed
0.1
(
N)
0.2
­­
[
Cotton,
undelinted
seed]

Cucumbers
1.0
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
cucumbers
and
there
are
no
registered
acephate
uses.

Eggplant
1.0
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
eggplant
and
there
are
no
registered
acephate
uses.

Lettuce,
head
1.0
1.0
1
This
tolerance
must
be
moved
to
§
180.315(
c).

Melons
0.5
Revoke
­­
The
registrants
are
not
supporting
methamidophos
use
on
melons
and
there
are
no
registered
acephate
uses.
Commodity
Tolerance
Listed
Under
40
CFR
§
180.315
Reassessed
Tolerance
Tolerance
Listed
Under
40
CFR
§
180.108
Comment
[
Correct
Commodity
Definition]

43
Peppers
1.0
1.0
1
This
tolerance
must
be
moved
to
§
180.315(
c).
[
Pepper,
bell
and
non­
bell]

Potatoes
0.1(
N)
0.1
­­

Tomatoes
1.0
2.0
­­

Tolerance
To
Be
Proposed
Under
40
CFR
§
180.315
(
a)

Cotton,
gin
byproducts
­­
10
­­

Tolerance
Listed
Under
40
CFR
§
180.315
(
b)

Celery
1
1.0
1
This
tolerance
must
be
moved
to
§
180.315(
c).

Tolerances
to
be
Listed
Under
40
CFR
§
180.315(
c)

Beans
(
succulent
and
dry
form)
­­
1.0
1
[
Beans,
dry
and
succulent]

Brussels
sprouts
1.0
1.0
0.5
Cauliflower
1.0
1.0
0.5
Celery
1
1.0
1
Cranberries
­­
0.1
0.1
Lettuce
1.0
1.0
1
[
Lettuce,
head]

Mint
hay
­­
2
1
[
Mint,
tops
(
leaves
and
stem)]

Peppers
1.0
1.0
1
[
Peppers,
bell
and
nonbell

Soybeans
­­
 
1
Tolerances
Listed
Under
40
CFR
§
180.315
(
a)

Pending
label
amendments
for
some
crops,
adequate
field
trial
data
are
available
to
reassess
the
established
tolerances
for
cottonseed,
potatoes,
and
tomatoes.
The
available
data
suggest
that
the
tolerance
levels
for
cottonseed
and
tomato
should
be
raised
to
0.2
ppm
and
2.0
ppm,
respectively.

The
use
of
methamidophos
on
Brussels
sprouts,
cauliflower,
lettuce,
and
peppers
was
cancelled
in
1997.
Because
there
are
registered
acephate
uses
on
these
crops,
methamidophos
tolerances
for
these
crops
should
be
moved
to
40
CFR
§
180.315(
c).

The
following
tolerances
should
be
revoked
as
the
registrants
are
not
supporting
methamidophos
44
uses
and
there
are
no
registered
acephate
uses
on
these
commodities:
beets,
sugar,
roots;
beets,
sugar,
tops;
broccoli;
cabbage;
cucumbers;
eggplant;
and
melons.

Tolerance
to
be
Proposed
Under
40
CFR
§
180.315
(
a)

A
tolerance
for
residues
of
methamidophos
in/
on
cotton
gin
byproducts
must
be
proposed.
The
available
data
support
a
tolerance
level
of
10
ppm.

Tolerance
Listed
Under
40
CFR
§
180.315
(
b)

The
use
of
methamidophos
on
celery
was
cancelled
in
1997.
Because
there
are
registered
acephate
uses
on
this
crop,
the
methamidophos
tolerance
for
this
crop
should
be
moved
to
40
CFR
§
180.315(
c).

Tolerances
to
be
Listed
Under
40
CFR
§
180.315(
c)

The
basic
producer
of
acephate
(
Valent
U.
S.
A.
Corporation)
intends
to
support
use
of
acephate
on
the
following
food/
feed
crops:
beans
(
snap,
dry,
and
lima);
Brussels
sprouts;
cauliflower;
celery;
cotton;
cranberries;
lettuce,
head;
peanut;
pepper,
non­
bell;
pepper,
bell;
peppermint/
spearmint;
soybean;
and
tobacco.
Therefore,
tolerances
for
residues
of
methamidophos
in/
on
these
commodities
(
except
tobacco)
resulting
from
use
of
acephate
should
be
established
under
40
CFR
§
180.315(
c).
The
tolerance
expression
in
this
section
should
read:
"
Tolerances
are
established
for
residues
of
methamidophos
in
or
on
the
following
raw
agricultural
commodities
as
a
result
of
the
application
of
acephate:".

Tolerances
for
combined
residues
of
acephate
and
methamidophos
in
cottonseed
meal
and
hulls
have
been
established
(
40
CFR
§
180.108).
However,
based
on
a
cottonseed
processing
study
submitted
to
satisfy
methamidophos
reregistration
requirements,
methamidophos
residues
do
not
concentrate
in
cottonseed
processed
commodities.
Therefore,
tolerances
for
methamidophos
residues
in
cottonseed
processed
commodities
are
not
required
under
40
CFR
§
180.315(
c).

A
tolerance
for
the
combined
residues
of
acephate
and
methamidophos
in
soybean
meal
has
been
established
(
40
CFR
§
180.108).
Data
for
soybean
processed
commodities
were
reviewed
in
the
Acephate
Reregistration
Standard
Update
(
dated
1/
29/
92).
In
one
study
conducted
in
1978,
soybeans
were
treated
with
three
applications
of
a
75%
SC/
S
formulation
at
1
or
2
lb
ai/
A/
application
(
2x
or
4x
the
maximum
seasonal
rate
Valent
wishes
to
support).
Methamidophos
residues
were
found
to
concentrate
slightly
in
soybean
meal
(
average
concentration
of
1.2x)
and
hulls
(
average
concentration
of
1.9x)
but
not
in
crude
oil.
In
a
second
study
conducted
in
1987,
soybeans
were
treated
with
11
applications
of
a
75%
SC/
S
formulation
at
2
lb
ai/
A/
application
(
-
15x
the
maximum
seasonal
rate
Valent
wishes
to
support).
Methamidophos
residues
were
0.01­
0.02
ppm
in/
on
soybeans,
0.02
ppm
in
meal,
0.02
ppm
in
hulls
and
<
0.01
ppm
in
refined
oil.
Based
on
the
exaggerated
application
rates
used
in
the
studies
and
the
resulting
residues
in
processed
commodities,
the
Agency
concludes
that
no
45
tolerances
are
required
for
methamidophos
residues
in
soybean
processed
commodities.

For
mint
hay,
data
submitted
by
the
registrant
since
the
tolerance
was
set
support
an
increase
in
the
tolerance.

Tolerances
Listed
Under
40
CFR
§
180.315(
a)
and
(
b)

Tolerances
have
been
established
for
residues
of
methamidophos
in/
on
various
raw
agricultural
commodities
[
40
CFR
§
180.315(
a)
and
(
b)].
In
addition,
tolerances
have
been
established
for
combined
residues
of
acephate
and
its
metabolite
methamidophos
in/
on
various
plant
and
animal
commodities
[
40
CFR
§
180.108(
a)
and
(
b)].
Tolerances
established
for
acephate
in/
on
several
commodities
(
beans,
Brussels
sprouts,
cauliflower,
celery,
cranberries,
lettuce,
mint
hay,
and
peppers)
include
limits
on
residues
of
methamidophos.

Residue
Analytical
Methods
Adequate
methods
are
available
for
data
collection
and
tolerance
enforcement
for
plant
commodities.
For
tolerance
enforcement,
the
Pesticide
Analytical
Manual
(
PAM)
Vol.
II
lists
a
GLC
method
(
designated
as
Method
I)
with
thermionic
detection
for
the
determination
of
methamidophos
(
LOD
=
0.01
ppm)
residues
in/
on
plant
commodities.
PAM
Vol.
II
also
lists
a
TLC
method
(
designated
as
Method
A)
as
a
confirmatory
method.
Adequate
radiovalidation
data
for
the
enforcement
method
using
samples
from
the
plant
metabolism
studies
have
been
submitted
and
evaluated.

Because
no
tolerances
are
required
for
animal
commodities,
no
enforcement
method
for
animal
commodities
is
required.

CODEX
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
methamidophos
in/
on
various
plant
and
animal
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
methamidophos
per
se.
The
expression
of
residues
for
Codex
MRLs
and
U.
S.
tolerances
is
harmonized.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
15.
Further
harmonization
of
U.
S.
tolerances
and
Codex
MRLs
are
not
feasible
at
this
time
because
of
differences
in
agricultural
practices.

Table
15.
Codex
MRLs
and
Applicable
U.
S.
Tolerances
for
Methamidophos.

Codex
Reassessed
U.
S.

Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
(
mg/
kg)

Alfalfa
forage
(
green)
2
1
­­
No
U.
S.
registrations.

Brussels
sprouts
1
1.0
Cabbages,
Head
0.5
2
­­
U.
S.
registrants
not
supporting
use.
Codex
Reassessed
U.
S.

Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
(
mg/
kg)

46
Cattle
fat
0.01
(*)
3
­­

Cattle
meat
0.01
(*)
­­

Cauliflower
0.5
2
0.5
Celery
1
1.0
Cotton
seed
0.1
4
0.2
Cucumber
1
­­
U.
S.
registrants
not
supporting
use.

Goat
fat
0.01
(*)
­­

Goat
meat
0.01
(*)
­­

Hops,
dry
5
­­
No
U.
S.
registrations.

Lettuce,
Head
1
1.0
Melons,
except
Watermelon
0.5
­­
U.
S.
registrants
not
supporting
use.

Milks
0.01
(*)
­­

Peach
1
2
­­
No
U.
S.
registrations.

Peppers,
Chili
2
1.0
Peppers,
Sweet
1
1.0
Pome
fruits
0.5
­­
No
U.
S.
registrations
Potato
0.05
4
0.1
Rape
seed
0.1
­­
No
U.
S.
registrations
Sheep
fat
0.01
(*)
­­

Sheep
meat
0.01
(*)
­­

Soya
bean
(
dry)
0.05
1
0.01
Sugar
beet
0.05
­­
U.
S.
registrants
not
supporting
use.

Sugar
beet
leaves
or
tops
1
­­
U.
S.
registrants
not
supporting
use.

Tomato
1
2
2
Tree
tomato
0.01
(*)
1
­­
No
U.
S.
registrations.

Watermelon
0.5
­­
U.
S.
registrants
not
supporting
use.

1
Based
on
treatment
with
acephate.

2
The
MRL
is
based
on
residues
from
the
use
of
methamidophos,
not
acephate
(
1996
JMPR).

3
(*)
=
At
or
about
the
limit
of
detection.

4
Including
residues
resulting
from
the
use
of
acephate.
47
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,
methamidophos
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

3.
Labels
A
number
of
label
amendments,
in
addition
to
the
existing
label
requirements,
are
necessary
in
order
for
methamidophos
products
to
be
eligible
for
reregistration.
The
Agency
has
determined
that
these
measures,
in
addition
to
the
existing
label
requirements,
will
adequately
reduce
risks
to
handlers.

Provided
the
following
risk
management
measures
are
incorporated
in
their
entirety
into
labels
for
methamidophos­
containing
products,
the
Agency
finds
that
all
currently
registered
uses
of
methamidophos
are
eligible
for
interim
reregistration,
pending
consideration
of
cumulative
risks
of
the
organophosphates.
While
all
uses
are
eligible
at
this
time,
the
cotton
use
will
be
phased
out
over
five
years.
The
regulatory
rationale
for
each
of
the
risk
management
measures
outlined
below
is
discussed
immediately
after
this
list
of
required
risk
management
measures.

a.
Agricultural
Use
Exposure
Reduction
Measures
For
agricultural
use,
the
following
measures
are
required,
in
addition
to
the
existing
labeling
requirements
to
address
drinking
water,
occupational
handler
and
ecological
risks
of
concern.
The
registrant
has
not
yet
agreed
to
these
measures.

°
Require
all
labels
be
amended
to
indicate
that
applications
must
be
made
using
enclosed
cab
tractors
or
enclosed
cockpits.
°
Require
all
labels
be
amended
to
indicate
that
flaggers
must
be
in
enclosed
vehicles
or
mechanical
flaggers
be
used;
or
the
use
of
ground
positioning
system
(
GPS)
equipment
that
negates
the
need
for
flaggers
for
aerial
application.
°
Require
all
labels
to
reduce
maximum
#
of
applications
to
2
per
season
during
phase
out
period
48
for
cotton.
°
Require
all
labels
to
reduce
maximum
#
of
applications
to
4
or
less
per
season
for
tomatoes
(
current
SLNs
that
have
maximum
#
of
applications
less
than
3
would
retain
that
number
of
applications).
°
Require
all
labels
to
increase
REIs
for
all
activities
to
4
days
for
potatoes.
°
Require
Section
24(
c)
labels
to
increase
REIs
for
all
activities
to
4
days
for
tomatoes
except
in
CA
where
the
REI
will
remain
at
3
days.

b.
Homeowner
Use
Exposure
Reduction
Measures
There
are
no
residential
uses
for
methamidophos.

D.
Regulatory
Rationale
The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
methamidophos.
Where
labeling
revisions
are
imposed,
specific
language
is
set
forth
in
the
summary
tables
of
Section
V
of
this
document.

1.
Human
Health
Risk
Mitigation
a.
Dietary
Mitigation
Dietary
risk
from
food
sources
alone
are
not
of
concern.
Screening
level
modeling
estimates
indicate
that
aggregate
methamidophos
exposure
from
food
and
drinking
water
may
fill
the
risk
cup:
however,
the
Agency
has
determined
that
drinking
water
exposures
are
likely
lower
than
predicted.
Therefore,
the
Agency
has
made
an
interim
determination
that
no
additional
mitigation
is
necessary
at
this
time.
EPA
will
require
additional
data
to
refine
the
drinking
water
modeling
values
and
confirm
this
interim
conclusion.

1)
Acute
Dietary
(
Food)

Acute
dietary
(
food)
exposure
to
methamidophos
from
applications
of
methamidophos
alone,
and
from
"
all
sources"
(
applications
of
methamidophos
and
acephate)
result
in
risk
estimates
that
are
below
the
Agency's
level
of
concern
 
that
is,
less
than
100%
of
the
acute
PAD
is
used.
For
example,
for
exposure
resulting
from
applications
of
methamidophos
alone,
for
the
most
exposed
subpopulation,
children
7­
12
years
old,
the
percent
acute
PAD
value
is
33%
at
the
99.9th
percentile
of
exposure
from
consumption
of
food
alone..
For
exposure
resulting
from
applications
of
methamidophos
alone
and
methamidophos
residues
from
the
application
of
acephate,
for
the
most
exposed
subpopulation,
all
infants,
the
percent
acute
PAD
value
is
76%
at
the
99.9th
percentile
of
exposure
from
consumption
of
food
alone.
No
mitigation
measures
are
necessary
at
this
time
to
address
acute
dietary
risk
from
food.

2)
Chronic
Dietary
(
Food)

Chronic
dietary
(
food)
exposure
estimates
are
below
the
Agency's
level
of
concern
for
all
subpopulations.
For
the
most
highly
exposed
subpopulation,
children
1­
6
years
old,
the
percent
49
chronic
PAD
values
are
15%
for
methamidophos
alone
and
37%
when
including
methamidophos
residues
from
the
application
of
acephate,
from
consumption
of
food
alone.
No
mitigation
measures
are
necessary
at
this
time
to
address
chronic
dietary
risk
from
food.

3)
Drinking
Water
Surface
water
drinking
water
estimated
concentrations
were
derived
from
the
PRZM­
EXAMS
model
with
the
Standard
Index
Reservoir
and
percent
crop
area
(
PCA)
and
the
GEENEC
model
(
for
methamidophos
derived
from
application
of
acephate).
Ground
water
estimated
concentrations
were
derived
from
the
SCI­
GROW
Model.
These
are
screening
level
estimates
designed
to
provide
highend
estimates
of
potential
pesticide
exposure.
Such
predictions
provide
a
screen
to
eliminate
those
chemicals
that
are
not
likely
to
cause
concerns
in
drinking
water.
Exceedances
in
drinking
water
risk
assessments
using
the
screening
model
estimates
do
not
necessarily
mean
a
risk
of
concern
actually
exists,
but
may
indicate
the
need
for
better
data
(
e.
g.,
monitoring
studies
specific
to
use
patterns
and
drinking
water
sources)
on
which
to
confirm
decisions.

Based
on
model
predictions
of
currently
registered
uses,
the
EECs
for
methamidophos
from
the
application
of
methamidophos
in
surface
water
range
from
28.6
to
61.8
ppb
for
acute
exposure,
and
from
1.5
to
3.8
ppb
for
chronic
exposure.
The
only
surface
water
EEC
calculated
for
methamidophos
from
the
application
of
acephate,
using
the
Tier
I
GEENEC
model
is
22
ppb.
The
acute
and
chronic
EEC
for
methamidophos
from
all
sources
in
groundwater
is
0.033
ppb.
Table
3
summarizes
the
modeled
EECs
for
the
respective
crop
scenarios.

The
acute
and
chronic
dietary
risks
from
drinking
water
exposure
from
ground
water
sources
are
not
of
concern
because
the
groundwater
EECs
are
well
below
the
DWLOCs.
The
acute
and
chronic
dietary
risks
from
drinking
water
exposure
from
surface
water
sources
are
above
the
Agency's
level
of
concern
for
all
subpopulations.
However,
there
are
uncertainties
which
lead
the
Agency
to
expect
that
actual
exposure
from
drinking
water
is
unlikely
to
be
as
high
as
the
levels
used
in
the
development
of
the
risk
assessment
which
are
based
on
screening
models.
Based
on
these
uncertainties
and
the
anticipated
reduction
in
water
contamination
implementing
the
risk
reduction
measures
contained
in
this
document,
the
Agency
believes
that
the
risks
from
drinking
water
are
not
of
concern.

The
drinking
water
risk
assessments
are
based
on
screening
level
models
that
are
conservative
in
their
estimates
of
drinking
water
exposure.
Actual
exposure
is
expected
to
be
lower
than
the
EEC's
reported
in
the
IRED.
An
example
of
the
type
of
assumptions
used
in
the
model
that
can
contribute
to
conservative
estimates
involves
rainfall
levels.
To
determine
what
rainfall
level
to
use
in
the
model,
the
Agency
identifies
a
peak
rainfall
level
for
each
of
36
years
of
daily
rainfall
data.
The
model
then
assumes
that
rainfall
will
equal
the
90th
percentile
of
these
36
annual
peak
values
when
estimating
concentrations,
a
conservative
assumption.
Also,
the
percent
cropped
area
(
PCA)
assumption
for
potatoes
used
in
the
model
is
0.87,
the
default
assumption.
This
means
the
model
assumes
that
87%
of
a
watershed
is
planted
with
one
of
these
crops
and
that
100%
of
this
crop
is
treated
with
methamidophos,
which
appears
unlikely
to
occur
especially
considering
that
the
PCA
calculated
for
major
crops
like
corn
and
cotton
using
data
submitted
to
the
Agency
are
0.46
and
0.20
respectively.
For
example,
with
respect
to
the
scenario
with
the
highest
calculated
EEC,
potatoes
in
Maine,
it
is
estimated
that
65,000
acres
of
potatoes
are
grown
in
the
state
of
Maine
each
year.
If
it
was
assumed
that
all
that
acreage
fell
into
any
one
of
the
nine
watersheds
in
Maine
as
a
worst­
case
scenario,
the
range
of
PCA
values
would
likely
be
0.04
to
0.16
or
4%
to
16%,
significantly
lower
than
the
87%
50
assumption.
The
effect
of
the
PCA
value
on
EECs
has
a
linear
relationship.
Consequently,
using
these
values
would
reduce
EECs
by
a
factor
of
5
to
20.
Even
though
this
analysis
has
not
been
deemed
to
be
sufficient
to
change
the
PCA
quantitatively,
it
does
provide
a
sense
of
the
potential
uncertainty
of
the
modeled
water
concentrations
in
this
case.

With
regard
to
the
potential
risks
associated
with
acephate
application,
the
model
used
to
estimate
water
concentrations
is
a
tier
I
model
and,
as
such,
is
not
as
refined
as
the
tier
II
PRZMEXAMS
model.
A
higher­
tiered
model
was
not
used
in
this
case
due
to
the
high
level
of
uncertainty
surrounding
any
estimate
of
the
decay
rate
for
acephate
and
the
transformation
rate
of
acephate
to
methamidophos
which
are
needed
to
use
the
PRZM­
EXAMS
model.
This
increases
the
level
of
uncertainty
associated
with
these
estimates.
For
the
purposes
of
assessing
drinking
water
risks
from
exposure
to
methamidophos
from
all
sources
(
i.
e.
including
both
methamidophos
and
acephate
applications)
the
Agency
will
rely
upon
the
model
estimates
generated
using
the
PRZM­
EXAMS
model
with
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
described
above
which
are
based
upon
the
application
of
methamidophos
alone.
The
Agency
believes
that
the
conservative
default
PCA
used
for
the
scenario
with
the
highest
EEC
(
potatoes
in
ME)
discussed
above
would
most
likely
account
for
methamidophos
residues
from
both
methamidophos
and
acephate
applications
in
a
given
watershed.
As
mentioned
above,
these
estimates
may
be
as
much
as
a
factor
of
5
to
20
times
greater
than
actual
water
concentrations.
Further,
the
main
crop
uses
of
acephate
(
beans,
cotton,
lettuce
and
tobacco)
are
either
not
grown
in
Maine
or
are
not
likely
to
have
significant
acreage.
Therefore,
additional
contribution
of
methamidophos
residue
from
the
application
of
acephate
in
this
scenario
is
very
unlikely.
These
considerations
support
the
belief
that
this
modeled
EEC
likely
provides
a
sufficiently
protective
estimate
of
exposure
to
methamidophos
from
all
sources
in
drinking
water.
Further,
the
information
is
not
currently
available
to
enable
the
Agency
to
use
a
Tier
II
model
to
estimate
concentrations
of
methamidophos
from
the
application
of
acephate,
as
described
above,
and
it
is
not
considered
appropriate
to
combine
the
results
of
a
Tier
II
assessment
(
methamidophos
applications)
with
the
results
of
a
Tier
I
assessment
(
acephate
applications).

The
risk
reduction
measures
contained
in
this
IRED,
including
a
phase
out
of
the
cotton
use
and
the
reduction
in
the
maximum
number
of
applications
allowed
per
season
for
all
crops,
are
expected
to
reduce
the
amount
of
methamidophos
available
to
reach
surface
waters.
This
supports
the
Agency's
belief
that
drinking
water
risks
will
be
reduced
to
a
level
at
which
the
risk
cup
is
not
exceeded.

Furthermore,
for
many
chemicals
where
there
are
uncertainties
in
the
modeling
estimates,
the
Agency
also
relies
on
actual
monitoring
data
to
confirm
resultant
expectations.
Thus,
for
methamidophos,
the
Agency
is
also
requiring
confirmatory
surface
water
monitoring
data
to
evaluate
actual
acute
and
chronic
concentrations
of
methamidophos
in
the
drinking
water
sources.
This
monitoring
data
is
to
be
generated
from
a
multi­
year
sampling
program
involving
community
water
systems
from
surface
water
sources
in
multiple
locations
in
different
regions
of
the
country
to
represent
different
use
sites,
crops,
soil
types,
and
rainfall
regimes.
Water
samples
are
to
be
analyzed
to
determine
the
concentrations
of
methamidophos.
Also,
prior
to
initiating
this
sampling
program,
the
registrant
is
required
to
submit
a
study
protocol
to
the
Agency
to
ensure
that
the
sampling
locations
and
procedures
are
adequate
to
address
the
drinking
water
risk
concerns.

b.
Homeowner
Risk
Mitigation
Methamidophos
is
not
registered
for
use
in
residential
settings.
Previously,
acephate
had
51
numerous
residential,
recreational
and
institutional
uses
which
were
evaluated
in
the
acephate
IRED.
To
mitigate
risks
of
concern,
acephate
use
in
these
settings
have
been
limited
to
indoor
use
in
nonresidential
institutional
settings
such
as
schools
and
hospitals,
use
on
ornamentals
in
the
residential
settings,
spot
or
mound
treatments
for
fire
ant
and
harvester
ant
control,
and
use
on
golf
course
turf.
The
risks
associated
with
the
degradation
of
acephate
to
methamidophos
for
these
uses
were
evaluated
in
the
acephate
IRED
and
were
found
to
be
negligible.
Therefore,
no
further
risk
mitigation
is
needed
with
respect
to
the
residential
uses
of
acephate
to
address
risks
associated
with
methamidophos
exposure.

c.
Aggregate
Risk
Mitigation
The
Agency's
aggregate
risk
assessment
for
methamidophos
is
based
on
exposure
estimates
for
food
and
residential
uses,
and
uses
a
screening­
level
assessment
of
modeled
estimates
for
drinking
water
contamination.
Dietary
(
food)
risk
estimates
are
based
on
a
refined
assessment
that
incorporates
percent
crop
treated
data,
monitoring
data,
and
processing
data.

Acute
Exposure
The
acute
aggregate
risk
assessment
for
methamidophos
from
all
sources
combines
exposure
from
food
and
drinking
water
sources
only.
Acute
dietary
(
food)
exposure
estimates
are
below
100%
of
the
aPAD
for
the
US
population
and
all
population
subgroups.
Infants
are
the
most
highly
exposed
population
subgroup
and
result
in
an
acute
drinking
water
level
of
comparison
(
DWLOC)
of
2.9
ppb.
Based
on
screening­
level
model
predictions
of
the
remaining
supported
uses,
the
acute
(
peak)
drinking
water
estimated
concentration
in
surface
water
is
61.8
ppb
which
is
of
risk
concern
to
the
Agency.
The
screening­
level
model
predictions
of
acute
concentrations
in
ground
water
is
0.033
ppb
for
methamidophos,
which
is
less
than
the
DWLOC
and
not
of
risk
concern
to
the
Agency.

However,
due
to
the
uncertainties
and
limitations
of
the
model
predictions,
the
Agency
believes
that
actual
acute
concentration
of
methamidophos
in
surface
water
is
likely
to
be
less
than
the
DWLOC.
To
demonstrate
this,
confirmatory
surface
water
monitoring
data
is
to
be
generated
to
address
this
risk
concern.

Short­
Term
Exposure
As
mentioned
above,
methamidophos
is
not
registered
for
use
in
residential
settings.
Previously,
acephate
had
numerous
residential,
recreational
and
institutional
uses
which
were
evaluated
in
the
acephate
IRED.
To
mitigate
risks
of
concern,
acephate
use
in
these
settings
have
been
limited
to
indoor
use
in
institutional
settings
such
as
schools
and
hospitals,
use
on
ornamentals
in
the
residential
settings,
spot
or
mound
treatments
for
fire
ant
control,
and
use
on
golf
course
turf.
The
risks
associated
with
the
degradation
of
acephate
to
methamidophos
for
these
uses
were
evaluated
in
the
acephate
IRED
and
were
found
to
be
negligible.
Therefore,
no
further
risk
mitigation
is
needed
with
respect
to
the
residential
uses
of
acephate
to
address
risks
associated
with
methamidophos
exposure.

Chronic
Exposure
Similarly,
the
chronic
aggregate
risk
assessment
for
methamidophos
combines
exposure
from
food
and
drinking
water
sources
only.
Chronic
dietary
(
food)
risk
estimates
are
well
below
100%
of
52
the
cPAD
for
the
US
population
and
all
population
subgroups.
Children
1­
6
years
old
is
the
most
highly
exposed
population
subgroup
and
result
in
a
chronic
DWLOC
of
0.9
ppb.
Based
on
screening­
level
model
predictions
of
the
remaining
supported
uses,
the
average
(
chronic)
estimated
concentration
in
surface
water
is
3.8
ppb,
which
is
of
risk
concern
to
the
Agency.
Similarly,
due
to
the
same
uncertainties
and
limitations
of
the
model
predictions
for
acute
exposure,
the
Agency
also
believes
that
actual
chronic
concentrations
of
methamidophos
in
surface
is
likely
to
be
less
than
the
DWLOC.
To
demonstrate
this
confirmatory
surface
water
monitoring
data
is
to
be
generated
to
address
the
risk
concern.

The
screening­
level
model
predictions
of
acute
concentrations
in
ground
water
is
0.033
ppb
for
methamidophos,
which
is
less
than
the
DWLOC
and
not
of
risk
concern
to
the
Agency.

d.
Occupational
Risk
Mitigation
1)
Agricultural
Uses
As
described
in
PR
Notice
2000­
9,
Worker
Risk
Mitigation
for
Organophosphate
Pesticides,
it
is
the
Agency's
policy
to
mitigate
occupational
risks
to
the
greatest
extent
necessary
and
feasible
with
personal
protective
equipment
and
engineering
controls.
In
managing
risk,
EPA
must
take
into
account
the
economic,
social,
and
environmental
costs
and
benefits
of
the
pesticide's
use.
A
wide
range
of
factors
are
considered
in
making
risk
management
decisions
for
worker
risks.
These
factors
include,
in
addition
to
the
calculated
MOEs,
incident
data,
the
nature
and
severity
of
adverse
effects,
uncertainties
in
the
risk
assessment,
the
cost,
availability
and
relative
risk
of
alternatives,
importance
of
the
chemical
in
integrated
pest
management
(
IPM)
programs,
and
other
similar
factors.

Handlers
As
summarized
in
Table
7,
occupational
risks
are
of
concern
(
i.
e.,
MOEs
<
100)
for
all
scenarios,
even
when
maximum
PPE
(
i.
e,
double
layer
clothing,
gloves,
and
a
respirator)
are
utilized.
Handler
risks
are
also
of
concern
for
many
scenarios
with
engineering
controls
(
closed
mixing/
loading,
enclosed
cabs).
Engineering
controls
are
considered
to
be
the
maximum
feasible
mitigation.
For
workers
wearing
the
maximum
PPE
described
above,
MOEs
range
from
2.5
to
38
for
mixer/
loaders
and
from
3.9
to
59
for
applicators
and
flaggers.
For
workers
using
the
engineering
controls
described
above,
MOEs
range
from
5
to
74
for
mixer/
loaders
and
from
8.4
to
626
for
applicators/
flaggers.
Current
labels
require
closed
mixing/
loading
systems
to
be
used.
To
mitigate
occupational
risks
associated
with
the
use
of
methamidophos,
the
following
measures
are
to
be
implemented
for
the
alfalfa,
cotton,
tomato
and
potato
uses
to
be
eligible
for
reregistration.

°
Applicators
must
be
in
an
enclosed
cab
or
cockpit.

°
Flaggers
must
be
in
enclosed
vehicles
or
mechanical
flaggers;
or
the
use
of
global
positioning
system
(
GPS)
equipment
that
negates
the
need
for
flaggers
for
aerial
application
must
be
used.

°
The
cotton
use
must
be
cancelled.

Even
with
maximum
engineering
controls
(
closed
mixing/
loading
system
and
enclosed
cabs)
the
MOEs
for
all
mixer/
loader
scenarios,
the
groundboom
applicator
for
cotton
scenario
and
all
aerial
53
application
scenarios
remain
less
than
the
Agency's
target
of
100.
For
cotton
scenarios,
the
Agency
has
determined
that
the
benefits
of
this
use
do
not
offset
the
risks.
However,
the
benefits
discussed
above
are
significant
enough
that
a
5­
year
phase
out
rather
than
immediate
cancellation
of
this
use
is
justified
to
allow
ample
time
for
transition
to
alternatives.

For
the
alfalfa
seed
use
of
methamidophos,
the
Agency
has
determined
that
significant
benefits
exist
to
support
reregistration
for
this
use.
Methamidophos
is
critical
for
the
control
of
lygus
bug
in
California
alfalfa
seed
fields.
It
is
an
important
element
of
California's
lygus
bug
resistance
management
program,
and
is
the
most
effective
control
of
lygus
pest
early
in
the
season,
prior
to
introducing
pollinators
into
the
fields.

For
the
potato
uses,
the
Agency
has
determined
that
significant
benefits
exist
to
support
reregistration
for
this
use.
As
mentioned
earlier,
post­
emergence
control
of
the
green
peach
aphid,
a
vector
for
the
potato
leafroll
virus,
is
the
critical
use
in
most
areas
of
the
country.
Only
imidacloprid
is
a
potential
alternative
for
post­
emergence
control
but
it
is
significantly
more
costly
and
does
not
have
the
period
of
residual
effectiveness
that
methamidophos
has
that
is
necessary
in
some
potato
growing
regions.
There
is
also
concern
for
potential
resistance
in
some
regions
for
imidacloprid.
These
circumstances
make
methamidophos
critical
to
potato
production,
especially
in
the
production
of
potatoes
for
seed
where
there
is
zero
tolerance
for
aphids
or
the
viruses
they
carry.

For
the
tomato
uses
of
methamidophos,
the
Agency
has
determined
that
significant
benefits
exist
to
support
reregistration
for
this
use.
In
the
Southeastern
U.
S.,
methamidophos
is
one
of
only
two
chemicals
available
for
the
control
of
the
Western
flower
thrip,
which
is
a
vector
for
Tomato
Spotted
Wilt
Virus,
which
can
cause
significant
economic
damage
to
a
tomato
crop.
For
fresh
and
processed
tomatoes
in
California,
methamidophos
is
the
only
effective
insecticide
available
for
controlling
the
economically
important
stink
bug.
The
limitations
mentioned
earlier
on
endosulfan,
dimethoate
and
imidacloprid
make
methamidophos
an
important
tool
in
fresh
and
processed
tomato
production
in
California.

In
addition
to
the
benefits
outlined
above,
there
is
some
uncertainty
associated
with
the
Agency's
risk
estimates
for
methamidophos.
This
uncertainty
is
explained
in
the
following
section
on
post
application
risk.

Post­
Application
Risk
EPA
develops
exposure
assessments
on
post­
application
workers
for
various
crops
and
activities
at
intervals
following
the
application
until
risk
falls
below
a
target
level.
For
methamidophos,
the
target
level
for
risk
concerns
is
an
MOE
of
100.

In
order
to
determine
the
REI
for
a
crop,
EPA
calculates
the
number
of
days
that
must
elapse
after
pesticide
application
until
residues
dissipate
and
risk
to
a
worker
falls
below
the
target
MOE.
Occupational
risks
are
regulated
under
the
FIFRA
section
3(
c)(
5)
standard
­
"
without
unreasonable
adverse
effects
on
the
environment"
­
which
means
that
both
risks
and
benefits
must
be
considered
in
making
a
risk
management
decision.
This
standard
may
be
met
at
a
level
below
the
target
MOE
when
there
are
significant
benefits
associated
with
a
specific
activity.
As
the
worker
exposure
database
has
improved,
risk
assessments
are
now
conducted
for
a
variety
of
post­
application
activities
based
on
the
level
of
exposure
for
each
worker
activity.
For
a
specific
crop/
pesticide
combination,
the
duration
54
required
to
achieve
the
target
MOE
can
vary
depending
on
the
activity
assessed.

In
general,
EPA
prefers
to
set
a
single
REI
for
all
activities
related
to
a
crop
or
crop
group
without
additional
activity­
based
labeling.
This
approach
is
favored
because
handlers
and
workers
are
more
likely
to
understand
and
comply
with
simpler
labels.
Also,
permitting
entry
for
some
activities
during
the
REI
could
cause
confusion
and
compromise
the
effectiveness
of
the
Worker
Protection
Standard
(
WPS).
However,
when
the
consideration
of
risks
and
benefits
indicate
that
a
single
REI
is
unworkable,
EPA
may
consider
either
setting
an
REI
with
early
entry
exceptions
for
one
or
more
critical
tasks
or
establishing
an
entry
prohibition
for
a
specific
task
after
the
REI
has
expired.
For
methamidophos,
no
critical
activities
have
been
identified
to
warrant
the
use
of
an
activity­
based
exception
or
prohibition.

In
weighing
worker
risks
and
benefits,
the
Agency
considered
the
timing
of
field
activities
that
are
critical
to
crop
production.
For
many
of
the
methamidophos
uses
discussed
below,
scouting
and
irrigation
are
critical
activities
in
crop
production,
and
these
activities
routinely
need
to
be
performed
soon
after
application.
In
evaluating
the
restricted
entry
intervals,
the
Agency
considered
the
exceptions
to
the
WPS
that
could
inform
the
decision.
EPA's
proposed
REIs
take
into
account
the
flexibility
already
provided
by
these
exceptions.
Scouting
is
a
handler
activity
under
the
WPS,
so
anyone
performing
this
activity
may
legally
enter
the
treated
field
during
the
REI
provided
they
use
the
handler
personal
protective
equipment
(
PPE)
specified
on
the
label.
In
addition,
if
the
scout
is
a
certified
crop
advisor
as
defined
in
the
WPS
(
40
CFR
170.204(
b)),
the
individual
can
determine
the
appropriate
PPE
to
be
used.
For
many
of
these
crops,
irrigation
equipment
is
not
routinely
moved
by
hand.
For
these
methods,
the
primary
activity
involves
entering
the
field
to
turn
the
watering
equipment
on
and
off.
This
activity
is
allowed
during
the
REI
under
the
no
contact
exception
to
WPS
(
40
CFR
170.112(
b)).
Should
irrigation
equipment
need
unexpected
repairs
during
the
REI,
WPS
allows
workers
to
enter
a
treated
field
provided
early
entry
PPE
is
used
(
40
CFR
170.112(
c)).

To
mitigate
post­
application
occupational
risks
associated
with
the
use
of
methamidophos,
the
following
measures
are
to
be
implemented
for
the
tomato
and
potato
uses
to
be
eligible
for
reregistration.

°
Increase
REIs
for
all
activities
for
tomatoes
to
4
days
in
all
states
except
California
where
the
REI
would
remain
at
3
days
per
the
current
labels.

°
Increase
REIs
for
all
activities
for
potatoes
to
4
days.

For
tomatoes
in
California,
hand
harvesting
re­
entry
risks
are
adequately
addressed
by
the
7­
day
and
14­
day
PHIs
currently
on
labels.
Methamidophos
is
applied
late
season
to
tomatoes
in
California
therefore
pruning,
staking,
tying
and
activities
associated
with
immature
plants
are
not
a
re­
entry
issue
there.
An
REI
of
3
days
would
result
in
an
MOE
of
70
for
irrigation
and
scouting
of
mature
plants
which
are
the
key
activities
of
concern.

For
tomatoes
in
Florida,
an
REI
of
4
days
would
result
in
an
MOE
of
31
for
irrigation
and
scouting
of
mature
plants
and
an
MOE
of
22
for
hand
harvesting
tying,
pruning
and
staking
which
are
the
key
activities
of
concern.
Re­
entry
risks
for
hand
harvesters
are
not
adequately
addressed
by
the
7­
day
PHI
currently
on
labels
(
MOE
=
30).
55
For
tomatoes
in
other
areas
of
the
country,
an
REI
of
4
days
would
result
in
an
MOE
of
45
for
irrigation
and
scouting
of
mature
plants
and
an
MOE
of
32
for
hand
harvesting,
tying,
pruning
and
staking
which
are
the
key
activities
of
concern.
Re­
entry
risks
for
hand
harvesters
are
not
adequately
addressed
by
the
7­
day
PHI
currently
on
labels
(
MOE
=
66).

For
potatoes,
an
REI
of
4
days
would
result
in
an
MOE
of
44
for
irrigation
and
scouting
of
mature
plants
which
are
the
key
activities
of
concern.

While
the
MOEs
that
result
from
these
mitigation
steps
do
not
fully
address
the
risks
of
concern
(
i.
e.
MOEs
are
not
greater
than
100),
the
following
information
was
taken
into
consideration
in
making
these
risk
management
decisions.
These
considerations
are
in
addition
to
the
benefits
that
have
been
discussed
previously
in
this
document.

In
the
case
of
tomatoes,
as
mentioned
earlier,
the
Agency
evaluated
reentry
risk
based
on
data
available
from
CA,
FL
and
GA.
More
specifically,
the
data
from
FL
was
developed
in
the
southern
part
of
the
state
while
the
GA
data
was
collected
in
the
southern
part
of
that
state.
The
test
area
in
GA
is
significantly
closer
to
the
areas
in
FL
where
methamidophos
use
is
critical,
which
are
predominantly
in
the
northern
areas
of
the
state,
than
the
test
fields
where
the
data
were
developed
in
southern
FL.
Therefore,
it
is
likely
that
the
GA
data
and
the
associated
REIs
would
be
more
appropriate
when
considering
the
re­
entry
risks
in
the
major
methamidophos
use
areas
in
FL
resulting
in
significantly
increased
MOEs
for
the
FL
scenario.

Further,
there
is
some
uncertainty
associated
with
the
Agency's
worker
risk
estimates
from
the
endpoint
selected
for
methamidophos.
MOEs
are
calculated
by
dividing
the
hazard
endpoint
by
the
estimated
exposure.
At
present
time,
the
Agency
selects
endpoints
based
on
NOAELs
and
LOAELs
from
available
toxicology
studies.
By
definition,
NOAELs
and
LOAELs
are
actual
dose
levels
tested
in
these
studies.
The
value
of
the
NOAEL
or
LOAEL
is
determined
solely
by
the
dose
selection
in
the
toxicity
study.
NOAELs
and
LOAELs
may
be
numerically
close
(
e.
g.,
5
mg/
kg/
day
vs.
6.5
mg/
kg/
day);
or
they
may
also
be
orders
of
magnitude
apart
(
e.
g.,
5
mg/
kg/
day
vs.
500
mg/
kg/
day).
The
use
of
NOAELs
and
LOAELs
as
toxicological
endpoints
is
an
established
and
scientifically
accepted
method
of
performing
risk
assessments
and
will
continue
to
be
used
in
risk
assessments
performed
by
the
Agency.
However,
the
Agency
is
considering
the
use
of
benchmark
dose
modeling
techniques
for
determining
toxicological
endpoints
for
use
in
risk
assessment.
Benchmark
dose
modeling
involves
the
use
of
statistical
and
mathematical
curve
fitting
procedures
to
refine
the
endpoints
used
in
risk
assessment
In
the
case
of
methamidophos,
a
short­
term
dermal
endpoint
of
0.75
mg/
kg/
day
was
selected
for
use
in
occupational
exposure
assessments.
As
mentioned
earlier,
this
endpoint
is
based
on
the
NOAEL
from
a
21­
day
dermal
toxicity
study.
The
LOAEL
from
this
study
is
11.2
mg/
kg/
day
based
on
brain,
plasma
and
RBC
cholinesterase
inhibition.
For
this
dermal
toxicity
study,
the
value
of
the
NOAEL
is
approximately
15­
fold
smaller
than
the
LOAEL.

Methamidophos
was
selected
as
the
index
chemical
in
the
Preliminary
Cumulative
Risk
Assessment
(
PCRA)
for
the
OPs.
This
selection
was
based
on
the
availability
of
high
quality
doseresponse
data
for
brain,
plasma,
and
RBC
cholinesterase
inhibition
and
also
the
availability
of
data
for
all
of
the
exposure
routes
of
interest
(
oral,
dermal,
and
inhalation).
Due
to
the
complexity
of
issues
surrounding
the
estimation
of
cumulative
risk
of
a
large
group
of
chemicals,
it
was
determined
that
56
benchmark
dose
modeling
was
preferred
over
using
NOAELs/
LOAELs
for
determining
endpoints
for
use
in
cumulative
risk
extrapolations.
In
the
PCRA
the
BMD10,
or
the
estimated
dose
to
cause
a
10%
reduction
brain
cholinesterase
activity,
was
selected
as
an
appropriate
endpoint.
Because
methamidophos
is
being
used
as
the
index
chemical
in
the
cumulative
risk
assessment
of
OPs,
BMD10s
and
also
the
respective
BMDLs
(
the
lower
95%
confidence
limit
on
the
BMD10)
have
been
calculated
from
the
methamidophos
21­
day
dermal
toxicity
study
mentioned
above
for
male
and
female
rat
brain
cholinesterase.
These
BMD10s
and
BMDLs
for
male
and
female
rat
brain
cholinesterase
activity
are
shown
in
the
table
below.

Table
16.
BMD10s
and
BMDLs
from
the
methamidophos
21­
day
dermal
study
for
brain
cholinesterase
activity
measured
in
female
and
male
rats
Route
of
Administration
Sex
BMD10
(
mg/
kg/
day)
BMDL
(
mg/
kg/
day)
NOAEL
(
mg/
kg/
day)

Dermal
F
2.12
1.77
0.75
M
1.88
1.41
It
is
notable
that
the
BMDLs
are
very
close
to
the
BMD10s
indicating
very
narrow
confidence
limits.
Although
the
BMD10
s
and
BMDLs
have
not
been
calculated
for
plasma
and
RBC
cholinesterase
inhibition,
based
on
the
results
of
other
toxicity
studies
in
methamidophos,
the
Agency
does
not
expect
the
benchmark
dose
calculations
for
the
BMD10s
or
the
BMDLs
from
the
blood
compartments
to
be
significantly
different
from
the
results
shown
in
Table
16.

The
Agency's
draft
guidance
on
use
of
benchmark
dose
specifies
that
the
BMDL,
and
not
the
BMD10,
should
be
used
as
the
endpoint
for
risk
extrapolation.
As
the
Agency
expands
its
use
of
benchmark
dose
modeling
techniques
in
its
single
chemical
risk
assessments,
the
BMDLs,
not
BMD10s,
are
likely
to
be
used.

The
BMDL
for
male
brain
cholinesterase
inhibition
(
1.44
mg/
kg/
day)
is
approximately
1.9
times
larger
than
the
NOAEL
of
0.75
mg/
kg/
day
being
used
to
estimate
short­
term
dermal
occupational
risk.
In
order
to
better
characterize
the
potential
risks
to
persons
entering
treated
fields
and
being
exposed
to
methamidophos
residues,
the
Agency
looked
at
the
effect
of
using
the
BMDL
instead
of
the
NOAEL
as
is
customary
in
deriving
MOEs.
For
example,
using
the
NOAEL
of
0.75,
the
resulting
MOE
for
shortterm
post
application
risk
for
potatoes
at
day
4
after
treatment
is
44.
If
the
more
refined
endpoint
(
i.
e.,
the
BMDL
of
1.44
mg/
kg/
day)
were
used
instead
the
resulting
MOE
would
be
approximately
84.
Based
on
this
comparison,
the
Agency
believes
that
the
short­
term
dermal
occupational
risk
would
not
exceed
44
but
may
be
as
high
as
84.

In
summary,
when
deciding
whether
the
benefits
of
use
provided
by
methamidophos
outweigh
the
risk
the
Agency
takes
into
consideration
all
available
information.
This
includes
the
effects
of
the
use
of
the
BMDL
versus
the
NOAEL
on
MOEs,
dislodgeable
foliar
residue
data
specific
to
those
regions
of
the
country
where
methamidophos
is
most
likely
to
be
used,
and
the
need
for
growers
to
enter
treated
fields
at
a
particular
time
to
perform
specific
activities
and
the
consequences
of
not
being
able
to
complete
those
activities.
Therefore,
the
Agency
believes
that
the
REIs
set
forth
as
mitigation
in
this
IRED
are
appropriate.
57
2.
Environmental
Risk
Mitigation
The
Agency
has
ecological
risk
concerns
regarding
the
acute
risks
of
methamidophos
to
terrestrial
birds
and
mammals,
and
to
freshwater
and
estuarine
invertebrates;
and
chronic
risk
concerns
to
birds
and
mammals
and
freshwater
and
estuarine
invertebrates.
The
ecological
risk
assessments
exhibit
RQ
values
which
exceed
the
various
target
levels
of
concern
(
LOCs).

Birds
and
Mammals
The
Agency's
assessment
suggests
the
potential
for
the
liquid
formulation
to
cause
acute
effects
to
birds
for
broadcast
applications.
The
avian
acute
RQs
range
from
0.38
to
6.63.
The
highest
avian
acute
RQ
is
from
nine
1
lb
ai/
A
ground
or
aerial
applications
to
tomatoes.
For
the
same
use
patterns,
mammalian
acute
RQs
range
from
0.2
to
20.3.
Regarding
chronic
risk
to
birds,
the
RQs
range
from
2.49
to
32.87.
Again
the
same
use
patterns
resulted
in
chronic
RQs
for
mammals
ranging
from
0.75
to
9.86.
All
use
patterns
are
of
concern
to
the
Agency
for
acute
and
chronic
effects
to
birds
and
mammals.

Because
of
the
toxicity
of
methamidophos,
to
help
protect
terrestrial
birds
and
mammals,
it
is
very
important
to
reduce
their
potential
exposure
to
methamidophos
products
that
have
been
applied.
In
additional
to
the
phase
out
of
the
cotton
use
previously
described
in
this
document
to
mitigate
occupational
risks
of
concern
which
will
also
serve
to
reduce
risk
to
birds
and
mammals,
several
additional
mitigation
measures
are
needed
to
reduce
risks
to
birds
and
mammals.
These
are:

°
Require
all
labels
to
reduce
maximum
#
of
applications
to
2
per
season
during
phase
out
period
for
cotton.

°
Require
all
labels
to
reduce
maximum
#
of
applications
to
4
per
season
for
tomatoes.

It
should
also
be
noted
that
significant
benefits
exist
for
both
the
tomato
and
potato
uses
as
described
earlier.

Aquatic
Organisms
Acute
risk
to
freshwater
fish
and
estuarine
fish
is
not
of
concern
for
any
use
patterns,
with
RQs
ranging
from
<
0.05
to
0.07.
The
acute
high
risk,
restricted
use
risk
and
endangered
species
risk
is
of
concern
for
freshwater
invertebrates
at
the
maximum
application
rate
of
1.0
lb
ai/
A
with
RQs
ranging
from
1.1
to
3.0.
No
chronic
risk
assessment
was
conducted
since
there
are
no
chronic
data
for
aquatic
species.

Many
of
the
measures
previously
described
in
this
document
to
reduce
occupational
and
terrestrial
risks
will
also
serve
to
reduce
aquatic
risks
of
concern.
It
should
also
be
noted
that
significant
benefits
exist
for
both
the
tomato
and
potato
uses
as
described
earlier.

E.
Other
Labeling
In
order
to
remain
eligible
for
reregistration,
other
use
and
safety
information
need
to
be
placed
58
on
the
labeling
of
all
end­
use
products
containing
methamidophos.
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
(
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,
will
soon
be
proposed
for
public
comment
in
the
Federal
Register.

2.
Spray
Drift
Management
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices,
State
Lead
Agencies
for
pesticide
regulation,
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
has
completed
its
evaluation
of
the
new
database
submitted
by
the
Spray
Drift
Task
Force
and
is
developing
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast,
or
ground
hydraulic
spray.
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
application
or
other
application
methods
associated
with
drift,
where
appropriate.

Based
on
these
analyses,
the
Agency
is
in
the
process
of
developing
more
appropriate
label
statements
for
spray,
and
dust
drift
control
to
ensure
that
public
health,
and
the
environment
are
protected
from
unreasonable
adverse
effects.
In
August
2001,
EPA
published
draft
guidance
for
label
statements
in
a
pesticide
registration
(
PR)
notice
("
Draft
PR
Notice
2001­
X"
http://
www.
epa.
gov/
PR_
Notices/#
2001).
A
Federal
Register
notice
was
published
on
August
22,
2001
(
http://
www.
epa.
gov/
fedrgstr)
announcing
the
availability
of
this
draft
guidance
for
a
90­
day
public
comment
period.
After
review
of
the
comments,
the
Agency
will
publish
final
guidance
in
a
PR
notice
for
registrants
to
use
when
labeling
their
products.
59
In
the
interim,
registrants
may
choose
to
use
the
proposed
statements.
Registrants
should
read
and
refer
to
the
draft
PR
notice
to
obtain
a
full
understanding
of
the
proposed
guidance
and
its
intended
applicability,
exemptions
for
certain
products,
and
the
Agency's
willingness
to
consider
other
versions
of
the
statements.

Registrants
may
elect
to
adopt
the
appropriate
sections
of
the
proposed
language
below,
or
a
version
that
is
equally
protective,
for
their
end­
use
product
labeling
for
the
purpose
of
complying
with
the
deadlines
for
label
submission
outlined
in
this
document.
The
proposed
label
language
is
as
follows:

For
products
applied
outdoors
as
liquids:

"
Do
not
allow
spray
to
drift
from
the
application
site
and
contact
people,
structures
people
occupy
at
any
time
and
the
associated
property,
parks
and
recreation
areas,
nontarget
crops,
aquatic
and
wetland
areas,
woodlands,
pastures,
rangelands,
or
animals."

"
For
ground
boom
applications,
apply
with
nozzle
height
no
more
than
4
feet
above
the
ground
or
crop
canopy,
and
when
wind
speed
is
10
mph
or
less
at
the
application
site
as
measured
by
an
anemometer.
Use
_____
(
registrant
to
fill
in
blank
with
spray
quality,
e.
g.
fine
or
medium)
or
coarser
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
for
spinning
atomizer
nozzles."

"
For
aerial
applications,
the
boom
width
must
not
exceed
75%
of
the
wingspan
or
90%
of
the
rotary
blade.
Use
upwind
swath
displacement,
and
apply
only
when
wind
speed
is
3
­
10
mph
as
measured
by
an
anemometer.
Use
_____
(
registrant
to
fill
in
blank
with
spray
quality,
e.
g.
fine
or
medium)
or
coarser
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
for
spinning
atomizer
nozzles.
If
application
includes
a
no­
spray
zone,
do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground
or
the
crop
canopy."

For
overhead
chemigation:

"
Apply
only
when
wind
speed
is
10
mph
or
less."

On
all
product
labels:

"
The
applicator
also
must
use
all
other
measures
necessary
to
control
drift."
"
For
ground
rig
applications,
apply
product
no
more
than
4
feet
above
the
ground
or
the
crop
canopy,
and
only
when
wind
speed
is
10
mph
or
less
at
the
application
site
as
measured
by
an
anemometer."

"
For
aerial
applications,
use
upwind
swath
displacement,
and
apply
only
when
wind
speed
is
3
­
10
mph
as
measured
by
an
anemometer.
If
application
includes
a
no­
spray
zone,
do
not
release
dust
at
a
height
greater
than
10
feet
above
the
ground
or
the
crop
canopy."

Or
"
The
applicator
also
must
use
all
other
measures
necessary
to
control
drift."
60
Alternatively,
registrants
may
elect
to
use
the
following
language,
which
is
the
current
Agency
policy
on
drift
labeling:

For
products
that
are
applied
outdoors
in
liquid
sprays
(
except
mosquito
adulticides),
regardless
of
application
method,
the
following
must
be
added
to
the
labels:

"
Do
not
allow
this
product
to
drift."

The
Agency
recognizes
that
the
above
option
does
not
address
other
application
types.
Registrants
may
therefore
wish
to
adapt
some
variation
of
the
old,
and
proposed
new
language
for
their
particular
products,
depending
on
their
application
methods.

F.
Methamidophos
Risk
Mitigation
Summary
Based
on
the
rationale
for
the
interim
decisions
associated
with
the
use
of
methamidophos,
the
following
risk
mitigation
measures
are
also
necessary
to
be
incorporated
in
their
entirety
into
labels
for
methamidophos­
containing
products
in
order
for
methamidophos
to
be
eligible
for
reregistration.
Registrants
may
propose,
and
EPA
will
consider,
alternative
mitigation
measures
that
provide
appropriate
mitigation
of
the
identified
risks.
Specific
language
of
these
revisions
is
set
forth
in
the
summary
tables
of
Section
V
of
this
document.
Likewise,
the
data
required
to
be
provided
to
the
Agency
to
confirm
these
regulatory
decisions
are
also
listed
in
Section
V.

1.
Dietary
Risk
°
No
label
changes
necessary,
however
certain
confirmatory
data
listed
in
Section
V
is
required.

2.
Occupational
Risk
The
following
measures
are
necessary
to
mitigate
handler
risk:

°
Applications
must
be
made
using
enclosed
cab
tractors
or
enclosed
cockpit
aircraft.

°
Mechanical
flaggers
for
aerial
application;
or
the
use
of
global
positioning
system
(
GPS)
equipment
that
negates
the
need
for
flaggers.

The
following
measures
are
necessary
to
mitigate
risk
to
post­
application
workers:

°
For
foliar
application
of
the
liquid
formulation,
a
4
day
REI
is
necessary
for
tomatoes
in
all
states
except
CA
°
For
foliar
application
of
the
liquid
formulation,
a
4
day
REI
is
necessary
for
potatoes.

The
following
additional
measures
are
necessary
to
mitigate
risks
of
concern
for
specific
crops:

Cotton:
Implement
a
5­
year
phase
out
of
the
use
on
cotton.
61
3.
Ecological
Risks
EPA
has
determined
that
remaining
uses
are
eligible
for
reregistration
provided
that:

°
The
maximum
#
of
applications
on
all
labels
be
reduced
to
2
per
season
during
phase
out
period
for
cotton.

°
The
maximum
#
of
applications
on
all
labels
be
reduced
to
4
per
season
for
tomatoes.
62
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,
which
include
submission
of
the
following:

A.
Data
Call­
In
Responses
For
methamidophos
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
Mark
Hartman
at
(
703)
308­
0734
with
questions
regarding
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)
Mark
A.
Hartman
Mark
A.
Hartman
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
B.
For
products
containing
the
active
ingredient
methamidophos,
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:
63
(
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
17
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
Bonnie
Adler
at
(
703)
308­
8523
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)
Bonnie
Adler
Bonnie
Adler
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
B.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
methamidophos
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
The
following
data
gaps
remain:

1.
Drinking
water
monitoring
data
for
surface
water
sources
for
methamidophos
in
potato
and
tomato
growing
regions.
This
data
is
requested
in
order
to
confirm
that
the
level
of
methamidophos
is
lower
than
predicted
in
the
Agency's
water
models
(
OPPTS
167­
1­
SS)

2.
Chronic
Estuarine
Invertebrate
Study
using
Mysid
shrimp
(
OPPTS
850.1350)

3.
Photolysis
on
Soil
(
OPPTS
161­
3)

4.
Anaerobic
Aquatic
Metabolism
(
OPPTS
835.4400)

5.
Terrestrial
Field
Dissipation
(
OPPTS
164­
1)

6.
Daphnid
Chronic
Toxicity
Study
(
OPPTS
850.1300)
64
7.
Terrestrial
Plant
Toxicity,
Seedling
Emergence
(
OPPTS
850.4100)

8.
Terrestrial
Plant
Toxicity,
Vegetative
Vigor
(
OPPTS
850.4150)

9.
Dermal
Passive
Dosimetry
Exposure
(
OPPTS
133­
3)

10.
Mixer/
Loader
exposure
data
for
dry
coupling
closed
mixing/
loading
system
(
OPPTS
875.1100
and
875.1300)

11.
Confined
Accumulation
in
Rotational
Crops
(
OPPTS
860.1850)

12.
Product
chemistry
data
requirements
for
all
technical
and
manufacturing
use
products
have
not
been
fulfilled.
(
830
series\
60
series)

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
64FR44922­
44923).
DCI
requirements
included
acute,
subchronic,
and
developmental
neurotoxicity
studies;
the
developmental
neurotoxicity
study
is
currently
in
review.
Acceptable
acute
and
subchronic
studies
have
been
received
and
reviewed
by
the
Agency.

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
17
at
the
end
of
this
section.

C.
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
17
at
the
end
of
this
section.

D.
Existing
Stocks
65
Registrants
may
generally
distribute
and
sell
products
bearing
old
labels/
labeling
for
26
months
from
the
date
of
the
issuance
of
this
interim
RED.
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
methamidophos
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
preexisting
label
requirements
and
existing
stocks
requirements
applicable
to
products
they
sell
or
distribute.
66
E.
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
17:
Summary
of
Labeling
Changes
for
methamidophos
Description
Amended
Labeling
Language
Placement
on
Label
Manufacturing
Use
Products
Formulation
Instructions
required
on
all
MUPs
"
Only
for
formulation
into
an
insecticide
for
the
following
use(
s):
alfalfa
grown
for
seed,
cotton,
tomatoes
and
potatoes."
Directions
for
Use
One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"
This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."

"
This
product
may
be
used
to
formulate
products
for
any
additional
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Description
Amended
Labeling
Language
Placement
on
Label
67
Environmental
Hazards
Statements
Required
by
Agency
Label
Policies
"
Environmental
Hazards"
"
This
chemical
is
extremely
toxic
to
birds,
mammals,
and
aquatic
invertebrates.
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."
Precautionary
Statements
under
Environmental
Hazards
End
Use
Products
Intended
for
Occupational
Use
(
WPS)

Restricted
Use
Pesticide
"
RESTRICTED
USE
PESTICIDE"

Due
to
Acute
Toxicity.
"
For
retail
sale
to
and
use
only
by
certified
applicators
or
persons
under
their
direct
supervision,
and
only
for
those
uses
covered
by
the
certified
applicator's
certification."
Top
of
Front
Panel
Description
Amended
Labeling
Language
Placement
on
Label
68
Handler
PPE
requirements
"
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,
applicators,
and
flaggers
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
engaged
in
those
activities
for
which
use
of
an
engineering
control
is
not
possible,
such
as
cleaning
up
a
spill
or
leak
and
cleaning
or
repairing
contaminated
equipment,
must
wear:

Coveralls
over
long­
sleeved
shirt
and
long
pants,

Chemical­
resistant
gloves,

Chemical
resistant
footwear
plus
socks,

Chemical­
resistant
headgear
if
overhead
exposure,
In
addition,
handlers
exposed
to
the
concentrate
must
wear:

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
N,
R
or
P
or
He
prefilter;

Chemical­
resistant
apron"
Immediately
following/
below
Precautionary
Statements:

Hazards
to
Humans
and
Domestic
Animals
Description
Amended
Labeling
Language
Placement
on
Label
69
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
or
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
Amended
Labeling
Language
Placement
on
Label
70
Engineering
Controls
"
Engineering
Controls
"
Mixers
and
loaders
must
use
a
closed
system
that
provides
dermal
and
inhalation
protection
and
must
use
and
maintain
this
system
in
a
manner
that
meets
the
requirements
specified
in
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[
40
CFR
170.240(
d)(
4)].
The
system
must
be
capable
of
removing
the
pesticide
from
the
shipping
container
and
transferring
it
into
mixing
tanks
and/
or
application
equipment.
At
any
disconnect
point,
the
system
must
be
equipped
with
a
dry
disconnect
or
dry
couple
shut­
off
device
that
is
warranted
by
the
manufacturer
to
minimize
drippage
to
not
more
than
2
mL.
per
disconnect
point."
Mixers
and
loaders
must
also:

­­
wear
the
personal
protective
equipment
required
above
for
mixers/
loaders
using
engineering
controls,

­­
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
PPE
specified
above
for
handlers
engaged
in
those
activities
for
which
use
of
an
engineering
control
is
not
possible."

"
Applicators
using
motorized
ground
equipment
and
flaggers
supporting
aerial
applications
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
and
flaggers
must:
­­
wear
the
personal
protective
equipment
required
above
for
applicators
using
engineering
controls,

­­
be
provided
and
must
have
immediately
available
for
use
in
an
emergency
when
they
must
exit
the
cab
in
the
PPE
specified
above
for
handlers
engaged
in
those
activities
for
which
use
of
an
engineering
control
is
not
possible.

­­
take
off
any
extra
PPE
that
was
put
on
and
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
in
a
manner
that
meets
the
requirements
listed
in
the
Worker
protection
Standard
(
WPS)
for
agricultural
pesticides
[
40
CFR
170.240(
d)(
6)];"
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
(
Immediately
following
PPE
and
User
Safety
Requirements.)
Description
Amended
Labeling
Language
Placement
on
Label
71
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
"
This
pesticide
is
extremely
toxic
to
birds,
mammals,
and
aquatic
invertebrates.
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high­
water
mark.

Drift
and
runoff
may
be
hazardous
to
aquatic
organisms
in
neighboring
areas.
Do
not
contaminate
water
when
disposing
of
equipment
washwater
or
rinsate."

"
This
product
may
contaminate
water
through
drift
of
spray
in
wind.
This
product
has
a
high
potential
for
runoff.
Poorly
draining
soils
and
soils
with
shallow
watertables
are
more
prone
to
produce
runoff
that
contains
this
product."

"
This
pesticide
is
toxic
to
bees.
Application
should
be
timed
to
coincide
with
periods
of
minimum
bee
activity,
usually
between
late
evening
and
early
morning."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Description
Amended
Labeling
Language
Placement
on
Label
72
Restricted­
Entry
Interval
(
all
products
except
those
listed
below)
"
Do
not
enter
or
allow
workers
to
enter
into
treated
areas
during
the
restricted
entry
interval
(
REI).

The
REI
for
cotton
and
alfalfa
is
is
48
hours.
The
REI
for
cotton
and
alfalfa
is
72
hours
in
areas
where
average
rainfall
is
less
than
25
inches
a
year.

The
REI
for
potatoes
is
4
days.
Directions
for
Use,
Agricultural
Use
Requirements
Box
Special
Local
Needs
Registrations
in
California
(
CA78016300;
CA79009600)
The
REI
for
tomatoes
is
3
days.

Special
Local
Needs
Registrations
in
states
other
than
California
(
AL89000800;
AR97000400;
DE91000200;
DE92000200;

FL80004600;
FL89000700;

FL89004100;
FL90000300;

FL92000400;
GA86000400;

GA90000100;
IN79000100;

IN93000300;
LA91000800,
LA99001100;
MD91000900;

MI78001600;
MI93000300;

NC89000700;
NJ96001000;

OH79000800;
OH79001000;

PR92000100;
SC78001600;

TN89000700;
TN93000300;
TN96000600;
TX91001200;

TX91001600;
VA91000500;

VA93000200)
The
REI
for
tomatoes
is
4
days.
Description
Amended
Labeling
Language
Placement
on
Label
73
Early
Re­
entry
Personal
Protective
Equipment
established
by
the
IRED.
Early
Entry
PPE
(
WPS)

"
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
(
if
overhead
exposure)

*
protective
eyewear"

**"
Notify
workers
of
the
application
by
warning
them
orally
and
by
posting
warning
signs
at
entrances
to
treated
area."

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

Other
Application
Restrictions
Crop­
Specific
Application
Restrictions
(
labels
must
be
amended
to
reflect
the
requirements
specified
below)

All
Crops:
An
advisory
that
application
of
methamidophos
products
after
applications
of
acephate
may
result
in
illegal
residues.

Tomatoes:
The
different
use
directions
for
tomatoes
destined
to
be
processed
is
not
considered
to
be
practical
and
must
be
removed
from
the
label.

Cotton:
The
cotton
grazing/
feeding
restrictions
are
not
considered
practical
and
must
be
removed.

Cotton:
Maximum
number
of
applications
per
season
is
two.
Directions
for
Use
Description
Amended
Labeling
Language
Placement
on
Label
74
Other
Application
Restrictions
(
SLNs)
Tomatoes:
Maximum
number
of
applications
per
season
is
four.

Other
Application
Restrictions
(
SLNs
currently
w/
<
3
apps)
Tomatoes:
Maximum
number
of
applications
per
season
is
two.

Spray
Drift
Restrictions
for
Outdoor
Products
Applied
as
a
Liquid
"
Do
not
allow
spray
to
drift
from
the
application
site
and
contact
people,
structures
people
occupy
at
any
time
and
the
associated
property,
parks
and
recreation
areas,
nontarget
crops,
aquatic
and
wetland
areas,

woodlands,
pastures,
rangelands,
or
animals."
Directions
for
Use
in
General
Precautions
and
Restrictions
Spray
Drift
language
"
Aerial
Spray
Drift
Management"

"
For
aerial
applications,
the
boom
width
must
not
exceed
75%
of
the
wingspan
or
90%
of
the
rotary
blade.

Use
upwind
swath
displacement
and
apply
only
when
wind
speed
is
3­
10
mph
at
the
application
site
as
measured
by
an
anemometer.
Use
_____
(
registrant
to
fill
in
blank
with
spray
quality,
e.
g.
fine
or
medium)

or
coarser
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
for
spinning
atomizer
nozzles.
If
application
includes
a
no­
spray
zone,
do
not
spray
at
a
height
greater
than
10
feet
above
the
ground
or
the
crop
canopy."

"
For
overhead
chemigation,
apply
only
when
wind
speed
is
10
mph
or
less."

"
For
ground
boom
applications,
apply
with
nozzle
height
no
more
than
four
feet
above
the
ground
or
crop
canopy
and
when
wind
speed
is
10
mph
or
less
at
the
application
site
as
measured
by
an
anemometer.

Use
_____
(
registrant
to
fill
in
blank
with
spray
quality,
e.
g.
fine
or
medium)
or
coarser
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
for
spinning
atomizer
nozzles.

"
The
applicator
also
must
use
all
other
measures
necessary
to
control
drift."
Directions
for
Use
in
General
Precautions
and
Restrictions
1
PPE
that
is
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.
The
75
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.

2
If
the
product
contains
oil
or
bears
instructions
that
will
allow
application
with
an
oil­
containing
material,
the
"
N"
designation
must
be
dropped.

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.
76
VI.
Related
Documents
and
How
to
Access
Them
This
interim
Reregistration
Eligibility
Document
is
supported
by
documents
that
are
presently
maintained
in
the
OPP
docket.
The
following
sections
indicate
the
means
to
view
or
obtain
copies
of
paper
or
electronic
versions
of
these
documents
and
lists
titles
of
documents
that
are
now
in
the
docket
files.

A.
Availability
at
OPP
Docket
Room
The
OPP
docket
is
located
in
Room
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays
from
8:
30
am
to
4
p.
m.

The
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
1999.
Sixty
days
later
the
first
public
comment
period
closed.
The
EPA
then
considered
comments,
revised
the
risk
assessment,
and
added
the
formal
"
Response
to
Comments"
document
and
the
revised
risk
assessment
to
the
docket
on
February
22,
2000.

B.
Availability
on
the
Internet
Many
of
the
supporting
documents
may
be
viewed
or
downloaded
from
the
Internet.
The
web
site
is
as
follows:
http://
www.
epa.
gov/
oppsrrd1/
op/.
77
VII:
Appendices
Appendix
A.
Use
Patterns
Eligible
for
Reregistration
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
ai)
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
(
ai)
Preharvest
Interval,
(
Days)
Use
Directions
and
Limitations
Alfalfa
Foliar
Ground
or
aerial
4
lb/
gal
EC
[
CA980013]
1.0
lb/
A
1
1.0
lb/
A
N/
A
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground,

3
gal/
A
by
air.
Do
not
feed
refuse
to
livestock.
Alfalfa
seed
from
treated
fields
may
not
be
used
for
growing
sprouts
for
human
or
animal
consumption.

Do
not
apply
through
any
type
of
irrigation
system.

Cotton
Foliar
(
Before
bolls
open)

Ground
or
aerial
4
lb/
gal
EC
[
3125­
280]

[
AR870007]

[
MS810014]
1.0
lb/
A
2
2.0
lb/
A
50
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground,

3
gal/
A
by
air,
or
by
irrigation
systems.
The
feeding
of
gin
trash
to
livestock
or
grazing
of
animals
on
treated
fields
is
prohibited.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
ai)
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
(
ai)
Preharvest
Interval,
(
Days)
Use
Directions
and
Limitations
78
4
lb/
gal
EC
[
59639­
56]
1.0
lb/
A
2
2.0
lb/
A
50
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
3
gal/
A
by
air.
The
feeding
of
gin
trash
to
livestock
or
grazing
of
animals
on
treated
fields
is
prohibited.

Foliar
Ground
or
aerial
4
lb/
gal
EC
[
AR810044]

[
AR890005]

[
CA780189]

[
CA790188]

[
LA830018]

[
MS810055]

[
MS830013]

[
TN880004]
1.0
lb/
A
2
2.0
lb/
A
NS
Use
limited
to
AR,
CA,
LA,
MS,

and
TN.
Applications
after
65%
of
the
bolls
are
open
are
prohibited.
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
1
gal/
A
by
air
(
MS810055
only).
The
feeding
of
gin
trash
to
livestock
or
grazing
of
animals
on
treated
fields
is
prohibited.

Potato
Foliar
Ground
or
aerial
4
lb/
gal
EC
[
3125­
280]

[
59639­
56]
1.0
lb/
A
4
4.0
lb/
A
14
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground,

3
gal/
A
by
air,
or
by
sprinkler
irrigation
systems
with
a
retreatment
interval
of
7­
to
10­

days
as
a
preventative
program
or
as
needed.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
ai)
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
(
ai)
Preharvest
Interval,
(
Days)
Use
Directions
and
Limitations
79
Tomato
Foliar
Ground
4
lb/
gal
EC
[
FL890041]
1.0
lb/
A
4
4.0
lb/
A
7
Tank
mix
use
limited
to
FL.

4
lb/
gal
EC
[
FL920004]
1.0
lb/
A
4
4.0
lb/
A
7
Use
limited
to
FL.
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
with
a
retreatment
interval
of
5­
to
7­

days.

4
lb/
gal
EC
[
IN790001]

[
IN930003]

[
MI780016]

[
MI930003]

[
OH790008]

[
OH790010]
1.0
lb/
A
3
3.0
lb/
A
7
Use
limited
to
IN,
MI,
and
OH.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
with
a
retreatment
interval
of
7­

to
10­
days.

4
lb/
gal
EC
[
SC780016]
1.0
lb/
A
4
4.0
lb/
A
14
Use
limited
to
SC.
Applications
may
be
made
in
a
minimum
of
50
gal/
A
by
ground
with
a
retreatment
interval
of
7­
to
10­

days.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
ai)
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
(
ai)
Preharvest
Interval,
(
Days)
Use
Directions
and
Limitations
80
4
lb/
gal
EC
[
AL890008]
0.75
lb/
A
4
3.0
lb/
A
7
Use
limited
to
AL
and
GA.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
with
a
retreatment
interval
of
5­

to
7­
days.

4
lb/
gal
EC
[
PR920001]
0.75
lb/
A
4
3.0
lb/
A
7
Use
limited
to
PR.
Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
with
a
retreatment
interval
of
7­
to
10­

days.

Foliar
Ground
or
aerial
4
lb/
gal
EC
[
TX910016]
1.0
lb/
A
4
4.0
lb/
A
14
Use
limited
to
TX.
Applications
may
be
made
alone
or
as
a
tank
mix
with
a
pyrethroid.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
5
gal/
A
by
air
with
a
retreatment
interval
of
7­
to
10­

days.

4
lb/
gal
EC
[
FL800046]

[
FL890007]

[
LA910016]

[
TX910012]
1.0
lb/
A
4
4.0
lb/
A
7
Use
limited
to
FL,
LA,
and
TX.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
3
gal/
A
by
air
with
a
retreatment
interval
of
7­
to
10­

days.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
(
ai)
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
(
ai)
Preharvest
Interval,
(
Days)
Use
Directions
and
Limitations
81
4
lb/
gal
EC
[
AR970004]

[
CA780163]

[
CA790096]

[
DE910002]

[
DE920002]

[
LA910008]

[
MD910009]

[
NC890007]

[
NJ900006]

[
NJ960010]

[
TN890007]

[
TN930003]

[
TN960006]

[
VA910005]

[
VA930002]
1.0
lb/
A
4
4.0
lb/
A
7
Use
limited
to
AR,
CA,
DE,
LA,

MD,
NC,
NJ,
TN,
and
VA.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
5
gal/
A
by
air
with
a
retreatment
interval
of
7­
to
10­

days.

Foliar
Ground
or
aerial
4
lb/
gal
EC
[
CA780163]
1.0
lb/
A
4
4.0
lb/
A
14
Use
limited
to
CA
for
processing
tomatoes.

Applications
may
be
made
in
a
minimum
of
25
gal/
A
by
ground
or
5
gal/
A
by
air
with
a
retreatment
interval
of
7­
to
10­

days.
82
Appendix
B:
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Methamidophos
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
A,
B
00014037,
43661001,
Data
Gap
830.1620
61­
2A
Start.
Mat.
&
Mnfg.
Process
A,
B
00014024,
43661001,
Data
Gap
830.1670
61­
2B
Formation
of
Impurities
A,
B
00014024,
43661001,
Data
Gap
830.1700
62­
1
Preliminary
Analysis
A,
B
00014024,
43661002,
Data
Gap
830.1750
62­
2
Certification
of
limits
A,
B
00014024,
43661002,
Data
Gap
830.1800
62­
3
Analytical
Method
A,
B
00014023,
00014025­
00014030,
00014032,
00014033,
43661001,
Data
Gap
830.6302
63­
2
Color
A,
B
00014021,
43661001,
43661003,
Data
Gap
830.6303
63­
3
Physical
State
A,
B
00014021,
43661001,
43661003,
Data
Gap
830.6304
63­
4
Odor
A,
B
00014021,
43661001,
43661003,
Data
Gap
830.6313
63­
13
Stability
A,
B
00014021,
Data
Gap
830.6314
63­
14
Oxidizing/
Reducing
Action
A,
B
Data
gap
830.6315
63­
15
Flammability
A,
B
Data
gap
830.6316
63­
16
Explodability
A,
B
Data
gap
REQUIREMENT
USE
PATTERN
CITATION(
S)

83
830.6317
63­
17
Storage
Stability
A,
B
Data
gap
830.6319
63­
19
Miscibility
A,
B
Data
gap
830.6320
63­
20
Corrosion
characteristics
A,
B
00014021,
Data
gap
830.7000
63­
12
pH
A,
B
Data
gap
830.7050
None
UV/
Visible
Absorption
A,
B
Data
gap
830.7100
63­
18
Viscosity
A,
B
Data
gap
830.7200
63­
5
Melting
Point
A,
B
43661001,
43661003,
Data
Gap
830.7220
63­
6
Boiling
Point
A,
B
43661001,
43661003
830.7300
63­
7
Density
A,
B
00014021,
43661001,
43661003,
Data
Gap
830.7370
63­
10
Dissociation
Constant
A,
B
43661003,
Data
Gap
830.7550
63­
11
Octanol/
Water
Partition
Coefficient
A,
B
43661003,
Data
Gap
830.7840
830.7860
63­
8
Solubility
A,
B
00014021,
43661001,
43661003
830.7950
63­
9
Vapor
Pressure
A,
B
00014021,
4361001,
43661003
ECOLOGICAL
EFFECTS
850.1010
72­
2A
Invertebrate
Toxicity
A,
B
00041311,
00014110,
00014305
850.1075
72­
1A
Fish
Toxicity
Bluegill
A,
B
00041312,
00144432,
44484402,
00014063
REQUIREMENT
USE
PATTERN
CITATION(
S)

84
850.1075
72­
1C
Fish
Toxicity
Rainbow
Trout
A,
B
00041312,
00144429,
00144432,
00014063
850.2100
71­
1
Avian
Acute
Oral
Toxicity
A,
B
00014094,
00014095,
00041313,
00093914,
00109717,
00109718,
00144428
850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
A,
B
00093904,
00014304,
00145655,
00130823,
00014064,
44484404
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
A,
B
00041658,
00130823,
00014304,
00145655,
44484403
850.2300
71­
4A
Avian
Reproduction
­
Quail
A,
B
00014114
850.2300
71­
4B
Avian
Reproduction
­
Duck
A,
B
00014113
None
72­
3A
Estuarine/
Marine
Toxicity
­
Fish
A,
B
00144431
850.1025
72­
3B
Estuarine/
Marine
Toxicity
­
Mollusk
A,
B
40088601
850.1035
72­
3C
Estuarine/
Marine
Toxicity
­
Shrimp
A,
B
00144430
850.1300
72­
4A
Daphnid
Chronic
Toxicity
A,
B
Data
gap
850.1350
72­
4B
Estuarine/
Marine
Invertebrate
Life
Cycle
A,
B
Data
gap
850.4100
122­
1
Terrestrial
Plant
Toxicity
(
Seedling
Emergence)
A,
B
Data
gap
REQUIREMENT
USE
PATTERN
CITATION(
S)

85
850.4150
122­
1
Terrestrial
Plant
Toxicity
(
Vegetative
Vigor)
A,
B
Data
gap
850.3020
141­
1
Honey
Bee
Acute
Contact
A,
B
00036935
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity­
Rat
A,
B
00014044
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit/
Rat
A,
B
00014049
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
A,
B
00148449
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
A,
B
00014221
870.2500
81­
5
Primary
Skin
Irritation
A,
B
00014220
870.2600
81­
6
Dermal
Sensitization
A,
B
00147929
870.3100
82­
1A
90­
Day
Feeding
­
Rodent
A,
B
00014155
870.3150
82­
1B
90­
Day
Feeding
­
Non­
rodent
A,
B
00014153
870.3200
82­
2
21­
Day
Dermal
­
Rabbit/
Rat
A,
B
44525301
870.3700
83­
3A
Developmental
Toxicity
­
Rat
A,
B
00148454,
43906901
870.3700
83­
3B
Developmental
Toxicity
­
Rabbit
A,
B
00041315,
44040601
870.3800
83­
4
2­
Generation
Reproduction
­
Rat
A,
B
00148455,
41234301,
44466001,
44815401,
44815402
870.3465
82­
4
90­
Day
Inhalation­
Rat
A,
B
41402401
REQUIREMENT
USE
PATTERN
CITATION(
S)

86
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Non­
Rodent
A,
B
00147938,
41234304
870.4300
83­
1A/
83­
2A
Combined
Chronic
Toxicit/
Carcinogenicity
­
Rodent
A,
B
00148952,
43248102
870.4200
83­
2B
Oncogenicity
­
Mouse
A,
B
00145579,
00147937,
43248101
870.6100
81­
7
Acute
Delayed
Neurotoxicity
­
Hen
A,
B
00041317
870.6200
81­
8
Acute
Neurotoxicity
Screen
A,
B
43025001,
43345801
None
82­
1SS
8­
Week
Subchronic
Oral
Toxicity
Cholinesterase
Study
­
Rodent
A,
B
41867201
None
82­
5A
90­
Day
Delayed
Neurotoxicity
­
Hens
A,
B
40985202
None
82­
5B
90­
Day
Neurotoxicity
­
Rat
A,
B
43197901
870.5140
84­
2
Gene
Mutation
(
Ames
Test)
A,
B
00098457
870.5375
84­
2
Structural
Chromosomal
Aberration
A,
B
41234306,
41461401
870.5300
84­
2
Gene
Mutation
­
Mammalian
Cells
A,
B
42854701
870.5900
84­
2
Other
Mutagenic
Mechanisms
­
in
vitro
A,
B
41234305
REQUIREMENT
USE
PATTERN
CITATION(
S)

87
870.6200
82­
7
Subchronic
Neurotoxicity
Screening
Study
­
Rodent
A,
B
43197901
870.6200
82­
7
Subchronic
Oral
Delayed
Neurotoxicity
­
Hen
A,
B
40985202
870.7485
85­
1
General
Metabolism
A,
B
00015224
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2100
132­
1A
Foliar
Residue
Dissipation
A,
B
40985203,
44685501,
44685502,
44685503
875.2200
132­
1B
Soil
Residue
Dissipation
A,
B
Waived
875.2400
133­
3
Dermal
Passive
Dosimetry
Exposure
A,
B
Data
Gap
875.2500
133­
4
Inhalation
Passive
Dosimetry
Exposure
A,
B
Waived
875.1100
231
Estimation
of
Dermal
Exposure
at
Outdoor
Sites
A,
B
Data
gap
875.1300
232
Estimation
of
Inhalation
Exposure
at
Outdoor
Sites
A,
B
Waived
ENVIRONMENTAL
FATE
835.1240
163­
1
Leaching/
Adsorption/
Desorptio
n
A,
B
40504811
835.1850
165­
1
Confined
Rotational
Crop
A,
B
42758701,
Data
Gap
REQUIREMENT
USE
PATTERN
CITATION(
S)

88
835.2120
161­
1
Hydrolysis
A,
B
00150609
835.2240
161­
2
Photodegradation
­
Water
A,
B
00150610
835.2410
161­
3
Photodegradation
­
Soil
A,
B
00150611,
Data
gap
835.4100
162­
1
Aerobic
Soil
Metabolism
A,
B
41372201
835.4200
162­
2
Anaerobic
Soil
Metabolism
A,
B
43541202
835.4300
162­
4
Aerobic
Aquatic
Metabolism
A,
B
Data
gap
(
can
be
fulfilled
by
835.4400)

835.4400
162­
3
Anaerobic
Aquatic
Metabolism
A,
B
43541202,
Data
gap
163­
2
Volatility
A,
B
40985206
835.6100
164­
1
Terrestrial
Field
Dissipation
A,
B
40985206,
43541201,
Data
gap
None
165­
4
Bioaccumulation
in
Fish
A,
B
00014015
None
167­
1­
SS
Drinking
Water
Monitoring
A,
B
Data
Gap
RESIDUE
CHEMISTRY
860.1300
171­
4A
Nature
of
Residue
­
Plants
A,
B
00014077,
00014081,
44209701,
44209702
860.1300
171­
4B
Nature
of
Residue
­
Livestock
A,
B
00014555,
00014995,
00015222,
4429703,
44209704
860.1340
171­
4C
Residue
Analytical
Method
­
Plants
A,
B
00014085,
44209705,
44209706
860.1340
171­
4D
Residue
Analytical
Method
­
Animals
A,
B
44209707,
44209708
REQUIREMENT
USE
PATTERN
CITATION(
S)

89
860.1380
171­
4E
Storage
Stability
A,
B
44514302
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry
/
Egg
(
Milk
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Cattle,
Goats,
Hogs,
Horses,
and
Sheep)
A,
B
00015183,
00015225
860.1500
171­
4K
Crop
Field
Trials­
Root
and
Tuber
Vegetables
Group
(
Beets,
sugar,
roots)
A,
B
00013677,
00014266,
00014269
860.1500
171­
4K
Crop
Field
Trials­
Root
and
Tuber
Vegetables
Group
(
Potatoes)
A,
B
00014075,
40747301,
44512201
860.1500
171­
4K
Crop
Field
Trials­
Leaves
of
Root
and
Tuber
Vegetables
Group
(
Beets,
sugar,
tops)
A,
B
00013677,
00014266,
00014269
860.1500
171­
4K
Crop
Field
Trials­
Leafy
Vegetables
(
except
Brassica)
Vegetables
Group
(
Lettuce)
A,
B
00014073
860.1500
171­
4K
Crop
Field
Trials­
Brassica
(
Cole)
Vegetables
Group
(
Broccoli)
A,
B
00014069
REQUIREMENT
USE
PATTERN
CITATION(
S)

90
860.1500
171­
4K
Crop
Field
Trials­
Brassica
(
Cole)
Vegetables
Group
(
Brussels
sprouts)
A,
B
00014070
860.1500
171­
4K
Crop
Field
Trials­
Brassica
(
Cole)
Vegetables
Group
(
Cabbage)
A,
B
00014071
860.1500
171­
4K
Crop
Field
Trials­
Brassica
(
Cole)
Vegetables
Group
(
Cauliflower)
A,
B
00014072
860.1500
171­
4K
Crop
Field
Trials­
Fruiting
Vegetables
(
Except
Cucurbits)
Group
(
Eggplant)
A,
B
00014119,
00014120,
00014130,
00014131
860.1500
171­
4K
Crop
Field
Trials­
Fruiting
Vegetables
(
Except
Cucurbits)
Group
(
Pepper)
A,
B
00014121,
00014122,
00014123,
00014140
860.1500
171­
4K
Crop
Field
Trials­
Fruiting
Vegetables
(
Except
Cucurbits)
Group
(
Tomato)
A,
B
00014124­
00014129,
40007401,
44514301
860.1500
171­
4K
Crop
Field
Trials­
Cucurbits
Vegetables
Group
(
Cucumber)
A,
B
00014132,
00014133,
00014138,
00014139
860.1500
171­
4K
Crop
Field
Trials­
Cucurbits
Vegetables
Group
(
Melon)
A,
B
00014134,
00014135
REQUIREMENT
USE
PATTERN
CITATION(
S)

91
860.1500
171­
4K
Miscellaneous
Commodities­
Cotton,
Seed
and
Gin
Byproducts
A,
B
00014074,
44558801
860.1520
171­
4L
Processed
Food/
Feed
(
Cotton,
seed)
A,
B
41966302
860.1520
171­
4L
Processed
Food/
Feed
(
Potato)
A,
B
44815406
860.1520
171­
4L
Processed
Food/
Feed
(
Tomato)
A,
B
40007401
92
Appendix
C:
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4
pm.

The
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
January
8,
1999.
Sixty
days
later
the
first
public
comment
period
closed.
The
EPA
then
considered
comments,
revised
the
risk
assessment,
and
added
the
formal
"
Response
to
Comments"
document
and
the
revised
risk
assessment
to
the
docket
on
February
3,
2000.

All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
site:

www.
epa.
gov/
pesticides/
op
These
documents
include:

°
Methamidophos:
Revision
of
EFED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
to
Include
Registrant's
Comments.

°
EFED
Response
to
Comments
Submitted
to
the
Methamidophos
Docket
During
the
60­
day
Comment
Period
on
the
EFED
Methamidophos
RED
Chapter.

°
Methamidophos:
HED
Risk
Assessment
and
Disciplinary
Chapters
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
List
A
Reregistration
Case
0043.
Chemcal
No.
101201.
DP
Barcode:
D250644.
October
30,
1998
°
Human
Health
Risk
Assessment:
Methamidophos.
February
3,
2000
°
Methamidophos
Summary.
December
2,
1999
°
Overview
of
the
Revised
Methamidophos
Risk
Assessment.
January
13,
2000
°
Acephate
and
Methamidophos:
Technical
Briefing.
February
3,
2000
°
Methamidophos:
Revised
Toxicology
Chapter
for
RED.
February
3,
2000
°
Final
Usage
Analysis
for
Methamidophos
RED.

°
Methamidophos.
List
A
Case
No.
0043.
Chemical
No.
101201.
Revised
Dietary
93
Exposure
and
Risk
Analyses
for
the
HED
Revised
Human
Health
Risk
Assessment
and
HED
Review
of
the
Bayer
Corporation
Probabilistic
(
Monte
Carlo)
Acute
Dietary
Exposure
Assessment.
DP
Barcodes
D256039,
D256042.
MRID
No.
448154­
10.
October
4,
1999
°
Methamidophos:
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document.
PC
Code
101201;
DP
Barcode:
D258447.
August
9,
1999
°
Review
of
Methamidophos
Incident
Reports.
DP
Barcode
D258608,
Chemical
#
101201.
October
5,
1999
°
Methamidophos
List
B
Reregistration
Case
No.
0043/
Chemical
ID
No.
101201.
Response
to
Comments
to
the
Draft
Methamidophos
Reregistration
Eligibility
Decision
(
RED)
Document.
DP
Barcode
D254708.
August
18,
1999
°
Response
to
Public
Comments
on
the
Preliminary
Risk
Assessments
for
the
Organophosphate
Methamidophos.
February
16,
2000
°
Methamidophos:
Review
of
21­
day
Dermal
Toxicity
in
Rats
(
MRID
No.
44525301
and
Addendum
to
MRID
No.
44525301)/
Short­
and
Intermediate­
Term
Dermal
Risk
assessments.
May
18,
1999
°
Methamidophos:
Review
of
Two
Generation
Reproduction
Toxicity
Study
in
Rats
(
MRID
No.
4466001
and
Addenda
MRID
No.
44815402)/
Impact
on
Dietary
and
Non­
dietary
Risk
Assessments.
June
16,
1999
°
Methamidophos:
Review
of
Potato
Processing
Study;
Chemical
ID
No.
101201;
Reregistration
Case
No.
0043;
MRID
No.
44815406;
DP
Barcode
D256034.
August
11,
1999
°
Methamidophos.
Chemical
ID
No.
101201.
Sensitivity
Analysis.
November
29,
1999
94
Appendix
D:
Bibliography
GUIDE
TO
APPENDIX
D
1.
CONTENTS
OF
BIBLIOGRAPHY.
This
bibliography
contains
citations
of
all
studies
considered
relevant
by
EPA
in
arriving
at
the
positions
and
conclusions
stated
elsewhere
in
the
Reregistration
Eligibility
Document.
Primary
sources
for
studies
in
this
bibliography
have
been
the
body
of
data
submitted
to
EPA
and
its
predecessor
agencies
in
support
of
past
regulatory
decisions.
Selections
from
other
sources
including
the
published
literature,
in
those
instances
where
they
have
been
considered,
are
included.

2.
UNITS
OF
ENTRY.
The
unit
of
entry
in
this
bibliography
is
called
a
"
study".
In
the
case
of
published
materials,
this
corresponds
closely
to
an
article.
In
the
case
of
unpublished
materials
submitted
to
the
Agency,
the
Agency
has
sought
to
identify
documents
at
a
level
parallel
to
the
published
article
from
within
the
typically
larger
volumes
in
which
they
were
submitted.
The
resulting
"
studies"
generally
have
a
distinct
title
(
or
at
least
a
single
subject),
can
stand
alone
for
purposes
of
review
and
can
be
described
with
a
conventional
bibliographic
citation.
The
Agency
has
also
attempted
to
unite
basic
documents
and
commentaries
upon
them,
treating
them
as
a
single
study.

3.
IDENTIFICATION
OF
ENTRIES.
The
entries
in
this
bibliography
are
sorted
numerically
by
Master
Record
Identifier,
or
"
MRID"
number.
This
number
is
unique
to
the
citation,
and
should
be
used
whenever
a
specific
reference
is
required.
It
is
not
related
to
the
six­
digit
"
Accession
Number"
which
has
been
used
to
identify
volumes
of
submitted
studies
(
see
paragraph
4(
d)(
4)
below
for
further
explanation).
In
a
few
cases,
entries
added
to
the
bibliography
late
in
the
review
may
be
preceded
by
a
nine
character
temporary
identifier.
These
entries
are
listed
after
all
MRID
entries.
This
temporary
identifying
number
is
also
to
be
used
whenever
specific
reference
is
needed.

4.
FORM
OF
ENTRY.
In
addition
to
the
Master
Record
Identifier
(
MRID),
each
entry
consists
of
a
citation
containing
standard
elements
followed,
in
the
case
of
material
submitted
to
EPA,
by
a
description
of
the
earliest
known
submission.
Bibliographic
conventions
used
reflect
the
standard
of
the
American
National
Standards
Institute
(
ANSI),
expanded
to
provide
for
certain
special
needs.

a
Author.
Whenever
the
author
could
confidently
be
identified,
the
Agency
has
chosen
to
show
a
personal
author.
When
no
individual
was
identified,
the
Agency
has
shown
an
identifiable
laboratory
or
testing
facility
as
the
author.
When
no
author
or
laboratory
could
be
identified,
the
Agency
has
shown
the
first
submitter
as
the
author.

b.
Document
date.
The
date
of
the
study
is
taken
directly
from
the
document.
When
the
date
is
followed
by
a
question
mark,
the
bibliographer
has
deduced
the
date
from
the
evidence
contained
in
the
document.
When
the
date
appears
as
(
1999),
the
Agency
was
unable
to
determine
or
estimate
the
date
of
the
document.

c.
Title.
In
some
cases,
it
has
been
necessary
for
the
Agency
bibliographers
to
create
or
enhance
a
95
document
title.
Any
such
editorial
insertions
are
contained
between
square
brackets.

d.
Trailing
parentheses.
For
studies
submitted
to
the
Agency
in
the
past,
the
trailing
parentheses
include
(
in
addition
to
any
self­
explanatory
text)
the
following
elements
describing
the
earliest
known
submission:

(
1)
Submission
date.
The
date
of
the
earliest
known
submission
appears
immediately
following
the
word
"
received."

(
2)
Administrative
number.
The
next
element
immediately
following
the
word
"
under"
is
the
registration
number,
experimental
use
permit
number,
petition
number,
or
other
administrative
number
associated
with
the
earliest
known
submission.

(
3)
Submitter.
The
third
element
is
the
submitter.
When
authorship
is
defaulted
to
the
submitter,
this
element
is
omitted.

(
4)
Volume
Identification
(
Accession
Numbers).
The
final
element
in
the
trailing
parentheses
identifies
the
EPA
accession
number
of
the
volume
in
which
the
original
submission
of
the
study
appears.
The
six­
digit
accession
number
follows
the
symbol
"
CDL,"
which
stands
for
"
Company
Data
Library."
This
accession
number
is
in
turn
followed
by
an
alphabetic
suffix
which
shows
the
relative
position
of
the
study
within
the
volume.

MRID
Citation
00013677
Morse
Laboratories,
Incorporated
(
1976)
Chemagro
Agricultural
Division­­
Mobay
Chemical
Corporation
Residue
Experiment:
462­
5746­
75D:
Report
No.
49920.
(
Unpublished
study
including
report
nos.
49921,
50844
and
50845,
received
Aug
24,
1978
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
097318­
H)

00014015
Baychem
Corporation
(
1972)
Chemagro,
Division
of
Baychem
Corporation,
Residue
Experiment:
Report
No.
31933.
(
Unpublished
study
received
on
unknown
date
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
G)

00014021
Chevron
Chemical
Company
(
1970)
Monitor
Insecticide
Residue
Tolerance
Petition:
Physical
and
Chemical
Properties.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
CDL:
093266­
M)

00014023
Hayman,
E.
L.
(
1969)
Monitor
by
Gas
Chromatography.
Method
dated
Oct
16,
1969.
(
Unpublished
study
received
Mar
5,
1970
under
96
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
Q)

00014024
Chevron
Chemical
Company
(
19??)
Monitor
Insecticide
Residue
Tolerance
Petition:
Manufacturing
Process.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
CDL:
093266­
R)

00014025
Leary,
J.
B.
(
1969)
Determination
of
Monitor
Insecticide
and
the
Thiono
Isomer
Impurity
in
Technical
Monitor
Insecticide.
Method
dated
Apr
23,
1969.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
S)

00014026
Leary,
J.
B.
(
1968)
Determination
of
N,
O,
S­
Trimethyl
phosphoramidothioate
in
Monitor
Insecticide.
Method
dated
Jun
13,
1968.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
T)

00014027
Leary,
J.
B.
(
1968)
Determination
of
N,
O,
O­
Trimethyl
phosphoramidothioate
in
Monitor
Insecticide.
Method
dated
Jun
13,
1968.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
1
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
U)

00014028
Leary,
J.
B.
(
1969)
Determination
of
O,~
S­
Dimethyl
phosphorothioate
in
Monitor
Insecticide.
Method
dated
Dec
12,
1969.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
V)

00014029
Leary,
J.
B.
(
1968)
Determination
of
Dimethyl
sulfate
in
Monitor
Insecticide.
Method
dated
Jun
13,
1968.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
W)

00014030
Leary,
J.
B.
(
1970)
Determination
of
Methyl
sulfuric
acid
in
Monitor
Insecticide.
Method
dated
Jan
21,
1970.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
X)

00014032
Leary,
J.
B.
(
1968)
Determination
of
N,
N,
O,
S
­
Tetramethyl
phosphoramidothioate
in
Monitor
Insecticide.
Method
dated
Jun
13,
1968.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
Z)

00014033
Leary,
J.
B.
(
1968)
Determination
of
N,
N,
O,
O­
Tetramethyl
phosphoramidothioate
in
Monitor
Insecticide.
Method
dated
Jun
13,
1968.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
97
Chemical
Co.,
Richmond,
Calif.;
CDL:
093266­
AA)

00014037
Chevron
Chemical
Company
(
19??)
Monitor
Insecticide
Residue
Tolerance
Petition:
Name
and
Chemical
Identity.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
CDL:
093266­
AF)

00014044
Cavalli,
R.
D.;
Hallesy,
D.
W.
(
1968)
Acute
Oral
Toxicity
of
RE
9006
(
95%)
in
Rats:
SOCO
14/
I:
87.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093265­
B)

00014049
Cavalli,
R.
D.;
Hallesy,
D.
W.
(
1968)
Acute
Dermal
Toxicity
of
Monitor
Technical:
SOCO
30/
I:
121­
8.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093265­
G)

00014063
Schoenig,
G.
(
1968)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Four­
Day
Fish
Toxicity
Study
on
Monitor
(
RE­
9006)
75%
Technical
SX­
171:
IBT
No.
A6482.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093265­
W)

00014064
Jackson,
G.
L.
(
1968)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Quail
Toxicity
of
Monitor
(
RE
9006):
IBT
No.
J6483.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093265­
X)

00014069
Mayberry,
T.
W.;
Sakamoto,
S.
S.;
Leary,
J.
B.;
et
al.
(
1969)
Residue
Data
Sheet:
Broccoli.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
B)

00014070
Cinereski,
J.
E.;
Leary,
J.
B.;
Sakamoto,
S.
S.;
et
al.
(
1969)
Residue
Data
Sheet:
Brussels
Sprouts.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
I)

00014071
Cinereski,
J.
E.;
Leary,
J.
B.;
Mayberry,
T.
W.;
et
al.
(
1969)
Residue
Data
Sheet:
Cabbage.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
L)

00014072
Mayberry,
T.
W.;
Sakamoto,
S.
S.;
Leary,
J.
B.;
et
al.
(
1970)
Residue
Data
Sheet:
Cauliflower.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
R)

00014073
Sakamoto,
S.
S.;
Leary,
J.
B.;
Klaich,
M.;
et
al.
(
1969)
Residue
Data
Sheet:
98
Lettuce.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
W)

00014074
Sakamoto,
S.
S.;
Kalens,
K.
J.;
Witherspoon,
B.
(
1969)
Residue
Data
Sheet:
Cotton.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
AC)

00014075
Gerber,
C.
E.;
Leary,
J.
B.;
Sakamoto,
S.
S.
(
1970)
Residue
Data
Sheet:
Potatoes.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
AG)

00014077
Chevron
Chemical
Company
(
1968)
Metabolism
of
Monitor
Insecticide
by
Plants.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
CDL:
093264­
AO)

00014081
Tutass,
H.
O.
(
1968)
Uptake
and
Translocation
of
Monitor
Insecticide
by
Tomato,
Cabbage
and
Bean
Plants.
(
Unpublished
study
received
Mar
5,
1970
under
0F0956;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093264­
AU)

00014085
Chevron
Chemical
Company
(
1968)
Monitor
Residue
Analysis
by
Thermionic
Gas
Chromatography.
Method
RM­
10
dated
May
31,
1968.
(
Unpublished
study
including
letter
dated
Oct
17,
1969
from
D.
E.
Pack
to
Kenneth
J.
Kalens,
received
Mar
5,
1970
under
0F0956;
CDL:
093264­
AY)

00014094
Fletcher,
D.
(
1971)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Acute
Oral
Toxicity
Study
with
Monitor
Technical
in
Bobwhite
Quail:
IBT
No.
J261.
(
Unpublished
study
received
Mar
22,
1972
under
0F0956;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
092118­
C)

00014095
Fletcher,
D.
(
1971)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Acute
Oral
Toxicity
Study
with
Monitor
Technical
in
Mallard
Ducks:
IBT
No.
J262.
(
Unpublished
study
received
Mar
22,
1972
under
0F0956;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
092118­
D)

00014110
Wheeler,
R.
E.
(
1978)
48
Hour
Acute
Static
Toxicity
of
Monitor
(
SX887)
to
1st
Stage
Nymph
Water
Fleas
(
Daphnia
magna
Straus).
(
Unpublished
study
received
Sep
15,
1978
under
239­
2404;
submit­
ted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
235153­
A)
99
00014113
Fink,
R.
(
1977)
Final
Report:
One­
Generation
Reproduction
Study
 
Mallard
Duck:
Project
No.
149­
104;
Report
No.
54030.
(
Unpublished
study
received
Apr
9,
1979
under
239­
2404;
prepared
by
Wildlife
International,
Ltd.
in
cooperation
with
Glencoe
Mills,
Inc.
and
Washington
College
for
Mobay
Chemical
Corp.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
238015­
B)

00014114
Beavers,
J.
B.;
Fink,
R.
(
1978)
One­
Generation
Reproduction
Study
 
Bobwhite
Quail­­
Technical
Monitor:
Final
Reports:
Report
No.
66155.
(
Unpublished
study
received
Apr
9,
1979
under
239­
2404;
prepared
by
Wildlife
International,
Ltd.
in
cooperation
with
Glencoe
Mills,
Inc.
and
Washington
College
for
Mobay
Chemical
Corp.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
238015­
C)

00014119
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
2:
Report
No.
37305.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
D)

00014120
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
1:
Report
No.
37306.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
E)

00014121
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
1:
Report
No.
37307.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
F)

00014122
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
1:
Report
No.
37308.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
G)

00014123
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37309.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
H)

00014124
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
1:
Report
No.
37310.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
I)
100
00014125
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
2:
Report
No.
37311.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
J)

00014126
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
1:
Report
No.
37312.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
K)

00014127
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37313.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
L)

00014128
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
1:
Report
No.
37314.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
M)

00014129
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37315.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
N)

00014130
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
1:
Report
No.
37316.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
O)

00014131
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37317.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
P)

00014132
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37318.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
Q)

00014133
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37319.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
101
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
R)

00014134
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
1:
Report
No.
37320.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
S)

00014135
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Los
Mochis
2:
Report
No.
37321.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
T)

00014138
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
2:
Report
No.
37389.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
W)

00014139
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan­­
1:
Report
No.
37390.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
X)

00014140
Baychem
Corporation
(
1973)
Chemagro
Division
of
Baychem
Corporation
Residue
Experiment:
Culiacan
2:
Report
No.
37391.
Rev.
(
Unpublished
study
received
Jul
20,
1973
under
4F1424;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
093798­
Y)

00014153
Loser,
E.
(
1970)
Subchronic
Toxicological
Studies
on
Dogs:
(
Three­
Month
Feeding
Experiment):
Report
Nos.
2164;
27986.
(
Unpublished
study
received
Nov
18,
1974
under
5F1571;
prepared
by
Farbenfabriken
Bayer,
A.
G.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
095175­
F)

00014155
Loser,
E.
(
1970)
Subchronic
Toxicological
Studies
on
Rats:
(
Three­
Month
Feeding
Experiment):
Report
Nos.
2165;
28043.
(
Unpublished
study
received
Nov
18,
1974
under
5F1571;
prepared
by
Farbenfabriken
Bayer,
A.
G.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
095175­
I)

00014220
Levy,
J.
E.
(
1979)
The
Skin
Irritation
Potential
of
Monitor
Technical:
Socal
1445/
39:
24.
(
Unpublished
study
received
Sep
11,
1979
under
239­
2452;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
241023­
A)

00014221
Rittenhouse,
J.
R.
(
1977)
The
Eye
Irritation
Potential
of
Monitor
Technical:
Socal
1108/
30:
110.
(
Unpublished
study
received
Jun
22,
1978
under
239­
2452;
102
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
234801­
A)

00014266
Chemonics
Industries,
Incorporated
(
1977)
Chemagro
Agricultural
Division­­
Mobay
Chemical
Corporation
Residue
Experiment:
263­
5736­
76H:
Report
No.
53030.
(
Unpublished
study
received
Aug
24,
1978
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
097317­
D)

00014269
Analytical
Biochemistry
Laboratories
(
1975)
Chemagro
Agricultural
Division­­
Mobay
Chemical
Corporation
Residue
Experiment:
461­
5725B­
74D:
Report
No.
43802.
(
Unpublished
study
including
report
no.
43875,
received
Aug
24,
1978
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
097318­
D)

00014304
Lamb,
D.
W.;
Burke,
M.
A.
(
1977)
Dietary
Toxicity
of
Monitor
¼
(
R)
:
Technical
to
Bobwhite
Quail
and
Mallard
Ducks:
Report
No.
51596.
(
Unpublished
study
received
Mar
27,
1978
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
238096­
B)

00014305
Nelson,
D.
L.;
Burke,
M.
A.
(
1977)
Acute
Toxicity
of
¼
(
R)
Monitor
Technical
to
Daphnia
magna:
Report
No.
54045.
(
Unpublished
study
received
Mar
27,
1978
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Agricultural
Div.,
Kansas
City,
Mo.;
CDL:
238096­
C)

00014555
Tucker,
B.
V.
(
1974)
Characterization
of
14C
in
Tissues
and
Milk
from
Goats
Fed
S­
Methyl­
14C­
Orthene
or
S­
Methyl­
14C­
Ortho
9006.
(
Unpublished
study
including
test
no.
T­
3201,
received
Nov
10,
1976
under
239­
2418;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
095572­
K)

00014995
Crossley,
J.;
Lee,
H.
(
1971)
The
Fate
of
Orthene
in
Lactating
Ruminants
(
Goats).
(
Unpublished
study
including
letter
dated
Oct
18,
1971
from
R.
Barth
to
John
Crossley,
received
Feb
23,
1972
under
2G1248;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
091774­
AD)

00015222
Crossley,
J.;
Lee,
H.
(
1972)
The
Fate
of
Orthene
in
Lactating
Ruminants
(
Goats)­­
Final
Report.
(
Unpublished
study
including
letter
dated
Oct
18,
1971
from
R.
Barth
to
John
Crossley,
received
Mar
27,
1973
under
239­
EX­
60;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
223489­
D)

00015224
Crossley,
J.;
Tutass,
H.
O.
(
1969)
Metabolism
of
Monitor
Insecticide
by
Rats.
(
Unpublished
study
received
Mar
27,
1973
under
239­
EX­
60;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
223489­
F)
103
00015183
Ladd,
R.
(
1972)
Report
to
Chevron
Chemical
Company,
Ortho
Division,
Meat
and
Milk
Residue
Study
with
Orthene­
Ortho
9006
(
SX­
434)
in
Dairy
Cattle:
IBT
No.
J2042.
(
Unpublished
study
received
Mar
27,
1973
under
3F1375;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
093669­
H)

00015225
Tucker,
B.
V.
(
1973)
Meat
and
Milk
Residue
Study
with
Orthene
and
Ortho
9006
in
Dairy
Cattle.
(
Unpublished
study
received
Mar
27,
1973
under
239­
EX­
60;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
223489­
G)

00036935
Atkins,
E.
L.;
Greywood,
E.
A.;
Macdonald,
R.
L.
(
1975)
Toxicity
of
Pesticides
and
Other
Agricultural
Chemicals
to
Honey
Bees:
Laboratory
Studies.
By
University
of
California,
Dept.
of
Entomology:
UC,
Cooperative
Extension.
(
Leaflet
2287;
published
study.)

00041311
Nelson,
D.
L.;
Roney,
D.
J.
(
1979)
Acute
Toxicity
of
Monitor
¼
(
R)
:
Technical
to
Daphnia
magna:
Report
No.
67732.
(
Unpublished
study
received
Mar
19,
1980
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242410­
B)

00041312
Nelson,
D.
L.;
Roney,
D.
J.
(
1979)
Acute
Toxicity
of
Monitor
¼
(
R)
Technical
to
Bluegill
and
Rainbow
Trout:
Report
No.
67739.
(
Unpublished
study
received
Mar
19,
1980
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242410­
C)

00041313
Nelson,
D.
L.;
Burke,
M.
A.;
Burnett,
R.
M.
(
1979)
Acute
Oral
Toxicity
of
Monitor
¼
(
R)
:
Technical
to
Bobwhite
Quail:
Report
No.
67993.
(
Unpublished
study
received
Mar
19,
1980
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242410­
E)

00041315
Machemer,
L.;
Lorke,
D.
(
1979)
SRA
5172
(
Methamidophos):
Studies
of
Embryotoxic
and
Teratogenic
Effects
on
Rabbits
following
Oral
Administration:
Report
No.
8410;
Report
No.
67990.
(
Unpublished
study
received
Mar
19,
1980
under
3125­
280;
prepared
by
Bayer,
AG,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242411­
B)

00041317
Kruckenberg,
S.
M.;
Fenwick,
B.
W.;
Brown,
S.
M.;
et
al.
(
1979)
Acute
Delayed
Neurotoxicity
Study
on
Monitor
Technical:
Study
No.
79
ANHO1;
Report
No.
68037.
(
Unpublished
study
including
published
data,
received
Mar
19,
1980
under
3125­
280;
prepared
by
Kansas
State
Univ.,
Dept.
of
Pathology,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242411­
D)

00041658
Nelson,
D.
L.;
Burke,
M.
A.;
Burnett,
R.
M.
(
1979)
Acute
Dietary
LC
:
50
¼
of
104
Monitor
¼
(
R)
:
Technical
to
Ducks:
Report
No.
67844.
(
Unpublished
study
received
Mar
19,
1980
under
3125­
280;
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
242410­
D)

00093904
Fink,
R.;
Beavers,
J.
B.;
Brown,
R.;
et
al.
(
1979)
Final
Report:
Eight­
day
Dietary
LC50­­
Bobwhite
Quail:
Technical
Monitor:
Project
No.
149­
111.
(
Unpublished
study
received
Jan
26,
1982
under
239­
2404;
prepared
by
Wildlife
International,
Ltd.
and
Washington
College,
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
246656­
A)

00093914
Zinkl,
J.
G.;
Roberts,
R.
B.;
Shea,
P.
J.;
et
al.
(
1981)
Toxicity
of
acephate
and
methamidophos
to
dark­
eyed
junkos.
Archives
of
Environmental
Contamination
and
Toxicology
10:
185­
192.
(
Also
in
unpublished
submission
received
Jan
26,
1982
under
239­
2471;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
246657­
L)

00098457
Machado,
M.
L.
(
1982)
Salmonella
Mammalian
Microsome
Mutagenicity
Test
(
Ames
Test)
with
Monitor
Technical:
Socal
1711.
(
Unpublished
study
received
Apr
6,
1982
under
239­
2404;
submitted
by
Chevron
Chemical
Co.,
Richmond,
Calif.;
CDL:
247222­
A)

00109717
Fletcher,
D.
(
1971)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Acute
Oral
Toxicity
Study
with
Monitor
Technical
in
Bobwhite
Quail:
IBT
No.
J261.
(
Unpublished
study
received
Mar
22,
1972
under
239­
2326;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
CA;
CDL:
001565­
C)

00109718
Fletcher,
D.
(
1971)
Report
to
Chevron
Chemical
Company,
Ortho
Division:
Acute
Oral
Toxicity
Study
with
Monitor
Technical
in
Mallard
Ducks:
IBT
No.
J262.
(
Unpublished
study
received
Mar
22,
1972
under
239­
2326;
prepared
by
Industrial
Bio­
Test
Laboratories,
Inc.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
CA;
CDL:
001565­
D)

00130823
Lamb,
D.;
Burke,
M.
(
1977)
Dietary
Toxicity
of
Monitor
Technical
to
Bobwhite
Quail
and
Mallard
Ducks:
51596.
(
Unpublished
study
received
Sep
13,
1983
under
239­
2452;
prepared
by
Mobay
Chemical
Co.,
submitted
by
Chevron
Chemical
Co.,
Richmond,
CA;
CDL:
251220­
C)

00144428
Lamb,
D.;
Roney,
D.
(
1972)
Acute
Oral
Toxicity
of
Monitor
to
the
Common
Grackle:
Report
No.
31952.
Unpublished
study
prepared
by
Chemagro
Div.
of
Baychem
Corp.
4
p.

00144429
Hermann
(
1980)
Fish
Toxicity
to
Methamidophos:
Report
No.
FF106.
105
Unpublished
Mobay
report
no.
88500
prepared
by
Bayer
AG.
4
p.

00144431
Larkin,
J.
(
1983)
The
Acute
Toxicity
of
Methamidophos
(
Technical)
to
Sheepshead
Minnow
(
Cyprinodon
variegatus):
Project
No.
83­
E­
402S.
Unpublished
Mobay
study
No.
86640
prepared
by
Biospherics
Inc.
16
p.

00144432
Lamb,
D.;
Roney,
D.
(
1972)
Acute
Toxicity
of
Monitor
4
to
Fish:
Report
No.
32312.
Unpublished
study
prepared
by
Chemagro
Div.
of
Baychem
Corp.
4
p.

00145579
Hayes,
R.
(
1984)
Oncogenicity
Study
of
Methamidophos
Technical
(
Monitor)
on
Mice:
Study
No.
80­
332­
01.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
667
p.

00145655
Lamb,
D.;
Burke,
M.
(
1977)
Dietary
Toxicity
of
Monitor
Technical
to
Bobwhite
Quail
and
Mallard
Ducks:
Report
No.
51596;
Reference
74­
103.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
2
p.

00147929
Korenaga,
G.
(
1984)
Modified
Buehler
Test
for
the
Skin
Sensitization
Potential
of
Methamidophos
Technical
(
SX­
1490):
SOCAL
2135.
Unpublished
study
prepared
by
Standard
Oil
Company
of
California,
Environmental
Health
&
Toxicology.
45
p.

00147937
Hayes,
R.
(
1984)
Oncogenicity
Study
of
Methamidophos
Technical
(
Monitor)
on
Mice:
Study
No.
80­
332­
01:
Mobay
Report
No.
87479.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
664
p.

00147938
Hayes,
R.
(
1984)
One­
year
Feeding
Study
of
Methamidophos
(
Monitor)
in
Dogs:
Study
No.
81­
174­
01:
Mobay
Report
No.
87474.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
413
p.

00148449
Sangha,
G.
(
1984)
Acute
Inhalation
Toxicity
Study
with
Technical
Methamidophos
(
Monitor)
in
Rats:
Study
No.
84­
041­
02:
Toxicology
Report
No.
519.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
19
p.

00148454
Hixson,
E.
(
1984)
Embryotoxic
and
Teratogenic
Effects
of
Methamidophos
(
Monitor)
in
Rats:
Study
No.
82­
611­
01:
Toxicology
Report
No.
542.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
101
p.

00148455
Hixson,
E.
(
1984)
Effect
of
Methamidophos
(
Monitor)
on
Reproduction
in
Rats:
Study
No.
82­
671­
01:
Toxicology
Report
No.
553.
Unpublished
study
prepared
by
Mobay
Chemical
Corp.
174
p.
106
00148952
Reagan,
E.
(
1985)
Primary
Eye
Irritation
Study
of
Saf­
Sol
Brand
Sanitizer
Lot
#
S414501
in
New
Zealand
White
Rabbits:
Study
No.
8422B:
Test
Article
ID
85­
0028.
Unpublished
study
prepared
by
Food
&
Drug
Research
Laboratories,
Inc.
27
p.

00150609
Chopade,
H.
(
1985)
Hydrolysis
of
Carbon­
14
Methamidophos
in
Sterile
Aqueous
Buffers:
Report
No.
88829.
Unpublished
study
prepared
by
Stanley
Research
Center,
Mobay
Chemical
Corp.
18
p.

00150610
Chopade,
H.
(
1985)
Photodecomposition
of
Carbon­
14
Methamidophos
in
Aqueous
Solution:
Report
No.
88830.
Unpublished
study
prepared
by
Stanley
Research
Center
of
Mobay
Chemical
Corp.
17
p.

00150611
Chopade,
H.;
Freeseman,
P.
(
1985)
Photodecomposition
of
Carbon­
14
Methamidophos
on
Soil:
Report
No.
88831.
Unpublished
study
prepared
by
Stanley
Research
Center
of
Mobay
Chemical
Corp.
20
p.

40007400
Fujie,
G.
(
1986)
Monitor
(
Methamidophos)
Residue
on
Tomatoes:
Laboratory
Project
ID:
8613652.
Unpublished
study
prepared
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carbon
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44209703
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44209704
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Validation
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9
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96­
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44209706
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Validation
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9
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96­
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44209707
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RM­
12A­
9
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96­
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44466001
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44484402
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44484403
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34
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44484404
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44512201
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MN001­
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297
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44514302
Williams,
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44514301
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Monitor
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567
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122­
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238
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44685502
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44685503
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A
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325­
34.

Senanayake,
N.
and
Johnson,
M.
K.
(
1982).
Acute
polyneuropathy
after
poisoning
by
a
new
organophosphate
insecticide.
Medical
Intelligence
306(
3)
p
155­
157.

Zheng,
R.
Y.
(
1990).
Clinical
features
of
delayed
polyneuropathy
induced
by
acute
methamidophos
toxicosis
in
74
cases.
Chung­
Hua­
Nei­
Ko­
Tsa­
Chin
29(
2)
p
113
79­
82.

Ecological
Risk
Assessment
Allen,
jr,
B.
W.,
M.
C.
Barber,
S.
L.
Bird,
L.
A.
Burns,
J.
M.
Cheplick,
M.
J.
Fendley,
D.
R.
Hartel,
C.
A.
Kittner,
F.
L.
Mayer,
jr.,
L.
A.
Suarez,
and
S.
E.
Wooten.
1992.
PIRANHA:
Pesticide
and
Industrial
Chemical
Risk
Analysis
and
Hazard
Assessment,
version
3.0.
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.

Bennett,
R.
S.,
R.
Bentley,
T.
Shiroyama
and
J.
K.
Bennett.
1990.
Effects
of
the
Duration
and
Timing
of
Dietary
Methyl
Parathion
Exposure
on
Bobwhite
Reproduction.
Environ.
Toxicol.
Chem.
9:
1473­
1480.

Bennett,
R.
S.,
B.
A.
Williams,
D.
W.
Schmedding
and
J.
K.
Bennett.
1990.
Effects
of
Dietary
Exposure
to
Methyl
Parathion
on
Egg
Laying
and
Incubation
in
mallards.
Environ.
Toxicol.
Chem.
10:
501­
507.

Bennett,
R.
S.
and
L.
M.
Ganio.
1991.
Overview
of
Methods
for
Evaluating
Effects
of
Pesticides
on
Reproduction
in
Birds.
U.
S.
EPA,
Office
of
Research
and
Development,
Environ.
Res.
Lab.,
Corvallis,
OR.
106
pages.

Bertem,
P.
E.,
R.
E.
Chiles.
Studies
on
the
Inhalation
Toxicity
of
Two
Phosphoramidothioate
Insecticides
to
Rodents
and
Quail.
University
of
California,
School
of
Public
Health,
Naval
Biosciences
Laboratory,
Naval
Supply
Center,
Oakland,
California.

Blus,
L.
J.,
C.
S.
Stanley,
C.
J.
Henny,
G.
W.
Pendleton,
T.
H.
Craig,
E.
H.
Craig,
D.
K.
Halford.
1989.
Effects
of
organophosphorous
Insecticides
on
Sage
Grouse
in
Southeastern
Idaho.
J.
Wildl.
Manage.
53(
4):
1139­
1146.

Brewer,
L.
W.,
C.
J.
Driver,
R.
J.
Kendall,
C.
Zenier,
and
T.
E.
Lacher,
Jr.
1987.
The
Effects
of
Methyl
Parathion
in
Ducks
and
Duck
Broods.
Environmental
Toxicology
and
Chemistry,
Vol.
7,
pp.
375­
379,
1988.

Burns,
L.
A.
1997.
Exposure
Analysis
Modeling
System
(
EXAMS
II):
User's
Guide
for
Version
2.97.5.
Ecosystem
Research
Division,
National
Exposure
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.

Busby,
D.
G.,
L.
M.
White
and
P.
A.
Pearce.
1990.
Effects
of
Aerial
Spraying
of
Fenitrothion
on
114
Breeding
White­
Throated
Sparrows.
J.
Appl.
Ecol.
27:
743­
755.

Cardozo,
C.
et
al.
1986­
present.
Sampling
for
Pesticide
Residues
in
California
Well
Water;
Well
Inventory
Database.
Environmental
Hazards
Assessment
Program,
California
Department
of
Food
and
Agriculture,
State
Water
Quality
Control
Board.

Carsel,
R.
F.,
J.
C.
Imhoff,
P.
R.
Hummel,
J.
M.
Cheplick,
and
A.
S.
Donigan,
Jr.
Undated.
PRZM­
3,
A
Model
for
Predicting
Pesticide
and
Nitrogen
Fate
in
the
Crop
Root
and
Unsaturated
Soil
Zones:
User's
Manual
for
Release
3.1,
Draft.
National
Exposure
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.

Clarke
Jr.,
D.
R.,
B.
A.
Rattner.
1987.
OrtheneR
Toxicity
to
Little
Brown
Bats
(
Myotis
lucifugus):
Acetylchlorinesterase
Inhibition,
Coordination
Loss,
and
Mortality.
Environ.
Toxicol.
and
Chem.
Vol
6
pp.
705­
708.

Fleming
1982.
Anticholinesterase
Poisoning
in
birds:
Field
Monitoring
and
Diagnosis
of
Acute
Poisoning.
Environ.
Toxicol.
Chem.
1:
27­
38
Grue,
C.
E.
1988.
Postfledging
Survival
of
European
Starlings
Exposed
as
Nestlings
to
an
Organophosphorous
Insecticide.
Ecology
69:
590­
601.
1988
Haegele,
M.
A.
and
R.
K.
Tucker.
1974.
Effects
of
15
Common
Environmental
Pollutants
on
Eggshell
Thickness
in
Mallards
and
Coturnix.
Bull.
Environ.
Contam.
Toxicol.
11:
98­
102.

Hussain,
M.
A.,
R.
B.
Mohamad,
P.
C.
Oloffs.
1985.
Studies
on
the
Toxicity,
Metabolism,
and
Anticholinesterase
Properties
of
Acephate
and
Methamidophos.
J.
Environ.
Sci.
Health,
B20
(
1),
p.
129­
147.
(
1985).

Juarez,
L.
M.,
J.
Sanchez,
1989.
Toxicity
of
the
Organophosphorous
Insecticide
Methamidophos
(
O,
S­
Dimethyl
Phosphoramidothioate)
to
Larvae
of
the
Freshwater
Prawn,
Macrobachium
rosenbergii
(
DeMan)
and
the
Blue
Shrimp,
Penaeus
stylirostris
Stimpson.
Bull.
Environ.
Contam.
Toxicol.
(
1989)
43:
302­
309.

Mineau,
P.
1991.
Cholinesterase­
Inhibiting
Insecticides:
Their
Impact
on
Wildlife
and
the
Environment.

Mullins,
J.
A.,
R.
F.
Carsel,
J.
E.
Carborough,
and
A.
M.
Avery.
1993.
PRZM­
2
User's
Manual,
Version
1.0.
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.
115
Neil,
C.
et
al.
1987.
Second
annual
report:
Pesticides
in
ground
water.
Maine
Geological
Survey,
Department
of
Conservation.

Neil,
C.
et
al.
1989.
Pilot
study:
Pesticides
in
ground
water
­
Final
report.
Maine
Geological
Survey,
Department
of
Conservation.

Smith,
G.
J.
1987.
Pesticides
Used
and
Technology
in
Relation
to
Wildlife:
Organophosphorous
and
Carbamate
Compounds.
U.
S.
Fish
and
Wildlfe
Service
Resource
Publication
170.
171
pp.

Rattner,
B.
A.,
D.
J.
Hoffman.
1984.
Comparative
toxicity
of
acephate
in
laboratory
mice,
whitefooted
mice,
and
meadow
voles.
Arch.
Environ.
Contam.
Toxicol.
13:
483­
491.

Rattner,
B.
A.,
S.
D.
Michael.
1985.
Organophosphorous
insecticide
induced
decrease
in
plasma
luteinizing
hormone
concentration
in
white­
footed
mice.
Toxicology
Letters,
24:
65­
69.

Appendix
E:
Generic
Data
Call
In
116
Appendix
F:
Product
Specific
Data
Call
In
117
Appendix
G:
EPA'S
Batching
of
Methamidophos
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
Methamidophos
as
the
primary
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
the
Agency
is
not
describing
batched
products
as
"
substantially
similar"
since
some
products
with
in
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Notwithstanding
the
batching
process,
the
Agency
reserves
the
right
to
require,
at
any
time,
acute
toxicity
data
for
an
individual
product
should
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
in
a
batch,
or
to
generate
all
the
required
acute
toxicological
studies
for
each
of
their
own
products.
If
the
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
the
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
to­
days
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,
the
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
the
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
select
the
one
of
the
following
options:
Developing
data
(
Option
1),
Submitting
an
existing
Study
(
Option
4),
Upgrading
an
existing
Study
(
Option
5),
or
Citing
an
Existing
Study
(
Option
).
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.
118
Five
products
were
found
which
contain
Methamidophos
as
the
active
ingredient.
These
products
have
been
placed
into
one
batch
and
a
No
Batch
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.

Batch
1
EPA
Reg.
No.
Percent
active
ingredient
Formulation
Type
3125­
280
40.58
Solid
59639­
56
40.58
Solid
No
Batch
EPA
Reg.
No.
Percent
active
ingredient
Formulation
Type
3125­
341
74.6
Solid
3125­
348
60.0
Liquid
59639­
68
72.0
Solid
119
Appendix
H:
List
of
Registrants
Sent
DCIs
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
121
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
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.)
122
Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices
3.
Pesticide
Product
Registration
Application
Forms
(
These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

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

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

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

1.
The
Office
of
Pesticide
Programs'
website.

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

National
Technical
Information
Service
(
NTIS)
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(
703)
605­
6000.

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
Information
Center
(
NPIC)
can
provide
information
on
active
ingredients,
123
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPIC
by
telephone
at
(
800)
858­
7378
or
through
their
website:
http://
npic.
orst.
edu..

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

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

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

To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(
including
"
blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
chemical
abstract
system
(
CAS)
number
if
one
has
been
assigned.

Documents
Associated
with
this
RED
The
following
documents
are
part
of
the
Administrative
Record
for
this
RED
document
and
may
be
included
in
the
EPA's
Office
of
Pesticide
Programs
Public
Docket.
Copies
of
these
documents
are
not
available
electronically,
but
may
be
obtained
by
contacting
the
person
listed
on
the
respective
Chemical
Status
Sheet.

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