United
States
Prevention,
Pesticides
EPA
738­
R­
04­
012
Environmental
Protection
and
Toxic
Substances
August
2005
Agency
(
7508C)

Reregistration
Eligibility
Decision
for
Dimethipin
Reregistration
Eligibility
Decision
(
RED)
Document
for
Dimethipin
List
C
Approved
by:
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
August
16,
2005
Table
of
Contents
Dimethipin
Reregistration
Eligibility
Decision
Team
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
i
Glossary
of
Terms
and
Abbreviations
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
ii
Executive
Summary
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
iv
I.
Introduction
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
II.
Chemical
Overview
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
2
A.
Regulatory
History
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
2
B.
Chemical
Identification
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
2
C.
Use
Profile
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
3
D.
Estimated
Usage
of
Pesticide
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
III.
Summary
of
Dimethipin
Risk
Assessments
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
A.
Human
Health
Risk
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
1.
Toxicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
a.
Toxicity
Profile
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
b.
Food
Quality
Protection
Act
Safety
Factor
(
FQPA
SF)
.
.
.
.
.
.
.
.
.
.
.
.
.
6
c.
Carcinogenicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
6
d.
Toxicological
Endpoints
and
Doses
for
Risk
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
7
2.
Dietary
Exposure
and
Risk
from
Food
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
7
a.
Exposure
Assumptions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
7
b.
Population
Adjusted
Dose
(
PAD)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
8
c.
Dietary
Risk
from
Food
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
8
3.
Dietary
Risk
from
Drinking
Water
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
9
a.
Surface
Water
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
9
b.
Ground
Water
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
10
4.
Residential
and
Other
Non­
Occupational
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
10
5.
Aggregate
Exposure
and
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
10
a.
Chronic
Aggregate
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
11
6.
Occupational
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
11
a.
Occupational
Toxicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
12
b.
Occupational
Handler
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
12
c.
Summary
of
Handler
Risk
Estimates
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
12
d.
Occupational
Post­
Application
Risk
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
13
e.
Human
Incident
Data
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
14
B.
Environmental
Risk
Assessment
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
14
1.
Environmental
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
14
a.
Environmental
Fate
and
Transport
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
14
b.
Aquatic
Organism
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
15
c.
Terrestrial
Organism
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
16
d.
Non­
target
Terrestrial
Plant
Exposure
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
17
2.
Environmental
Effects
(
Hazard)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
17
a.
Toxicity
to
Aquatic
Organisms
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
17
b.
Toxicity
to
Terrestrial
Organisms
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
18
3.
Ecological
Risk
Estimation
(
RQs)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
19
a.
Risk
to
Aquatic
Organisms
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
20
b.
Risk
to
Non­
target
Terrestrial
Organisms
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
20
c.
Ecological
Incidents
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
22
d.
Endangered
Species
Concerns
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
22
e.
Risk
Characterization
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
22
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
.
.
.
.
.
.
.
.
.
.
.
23
A.
Determination
of
Reregistration
Eligibility
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
B.
Public
Comments
and
Responses
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
C.
Regulatory
Position
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
1.
Food
Quality
Protection
Act
Findings
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
a.
"
Risk
Cup"
Determination
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
24
b.
Determination
of
Safety
to
the
U.
S.
Population
Including
Infants
and
Children
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
24
c.
Endocrine
Disruptor
Effects
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
24
d.
Cumulative
Risks
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
25
2.
Tolerance
Reassessment
Summary
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
25
a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.406
.
.
.
.
.
.
.
.
.
.
.
.
.
25
b.
Codex
Harmonization
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
26
D.
Regulatory
Rationale
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
26
1.
Endangered
Species
Considerations
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
27
2.
Spray
Drift
Management
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
27
V.
What
Registrants
Need
to
Do
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
28
A.
Manufacturing
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
28
1.
Additional
Generic
Data
Requirements
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
28
2.
Labeling
for
Manufacturing­
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
29
B.
End­
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
29
1.
Additional
Product­
Specific
Data
Requirements
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
29
2.
Labeling
for
End­
Use
Products
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
29
VI.
Appendices
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
31
Appendix
A.
Food/
Feed
Use
Patterns
Subject
to
Reregistration
for
Dimethipin
.
.
.
.
32
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
34
Appendix
D.
Citations
Considered
to
Be
Part
of
the
Data
Base
Supporting
the
Reregistration
Decision
(
Bibliography)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
41
Appendix
E.
Generic
Data
Call­
In
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
62
Appendix
F.
Product
Specific
Data
Call­
In
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
63
Appendix
G.
EPA's
Batching
of
Dimethipin
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
65
Appendix
H.
List
of
Registrants
Sent
this
Data
Call­
In
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
67
Appendix
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
69
i
Dimethipin
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Biological
and
Economic
Analysis
Assessment
Steve
Jarboe
Allen
Vaughn
Environmental
Fate
and
Effects
Risk
Assessment
Larry
Liu
James
Felkel
Health
Effects
Risk
Assessment
Susan
Stanton
John
Liccione
Danette
Drew
Seyed
Tadayon
Registration
Support
John
Bazuin
Risk
Management
Karen
Jones
Amaris
Johnson
Thomas
Brennan
ii
Glossary
of
Terms
and
Abbreviations
ai
Active
Ingredient
AR
Anticipated
Residue
CFR
Code
of
Federal
Regulations
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DNT
Developmental
Neurotoxicity
DWLOC
Drinking
Water
Level
of
Comparison
EC
Emulsifiable
Concentrate
Formulation
EDWC
Estimated
Drinking
Water
Concentration
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EUP
End­
Use
Product
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
GENEEC
Tier
I
Surface
Water
Computer
Model
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOC
Level
of
Concern
LOAEL
Lowest
Observed
Adverse
Effect
Level

g/
g
Micrograms
Per
Gram

g/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Ambient
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEL
No
Observed
Adverse
Effect
Level
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
iii
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SAP
Science
Advisory
Panel
SF
Safety
Factor
SLN
Special
Local
Need
(
Registrations
Under
Section
24
©
)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
TRR
Total
Radioactive
Residue
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UF
Uncertainty
Factor
WPS
Worker
Protection
Standard
iv
Executive
Summary
This
document
presents
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
the
Agency
or
EPA)
decision
on
the
reregistration
eligibility
of
the
registered
uses
of
dimethipin
[
2,3­
dihydro­
5,6­
dimethyl­
1,4­
dithiin
1,1,4,4­
tetraoxide].
Dimethipin
is
a
plant
growth
regulator/
dessicant,
and
is
used
as
a
defoliant
and
herbicide
on
cotton
and
non­
bearing
apple
tree
nursery
stock
in
Washington
state.
The
Agency
made
its
reregistration
eligibility
determination
based
on
the
required
data,
and
the
current
guidelines
for
conducting
acceptable
studies
to
generate
such
data.
There
is
clarification
needed,
and
confirmatory
studies
are
required
to
fulfill
all
guideline
data
requirements.
However,
the
Agency
has
found
that
currently
registered
uses
of
dimethipin
are
eligible
for
reregistration.

The
Food
Quality
Protection
Act
(
FQPA)
of
1996
requires
EPA
to
consider
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
potential
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
FQPA
also
requires
the
Agency
to
determine
that
"
a
reasonable
certainty
of
no
harm"
results
in
exposure
from
each
pesticide.
When
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
There
are
currently
17
dimethipin
tolerances,
and
6
of
these
are
proposed
for
revocation
in
this
document.

Dietary
Risk
from
Food
Acute
dietary
risk
was
not
assessed
as
there
were
no
toxicological
endpoints
attributable
to
a
single
exposure.
Chronic
dietary
(
food)
risks
are
less
than
1%
of
the
chronic
Population
Adjusted
Dose
(
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.

Dietary
Risk
from
Water
Acute
dietary
risk
was
not
assessed
as
there
were
no
toxicological
endpoints
attributable
to
a
single
exposure.
There
were
no
chronic
dietary
risks
of
concern
for
either
surface
or
groundwater
sources
of
drinking
water.

Occupational
Risk
There
are
no
occupational
risks
of
concern
for
dimethipin,
as
all
Margins
of
Exposure
(
MOEs)
were
greater
than
100,
indicating
that
risks
are
below
EPA's
level
of
concern.
No
post­
application
scenarios
were
assessed
because
no
dermal
endpoints
were
identified;
therefore
post­
application
worker
risks
are
assumed
to
be
not
of
concern.

Residential
Risk
There
are
no
residential
uses;
thus
a
residential
assessment
was
not
conducted.

Chronic
Aggregate
Risk.
The
chronic
aggregate
risk
assessment
addresses
exposure
to
dimethipin
residues
in
food
and
water.
There
are
no
residential
uses
of
dimethipin;
hence
residential
exposure
is
not
included
in
this
aggregate
assessment.
The
chronic
Drinking
Water
Level
of
Comparison
(
DWLOCs)
are
greater
than
v
the
Estimated
Drinking
Water
Concentrations
(
EDWCs)
indicating
that
chronic
dietary
(
food
and
water)
risks
are
below
EPA's
Level
of
Concern
(
LOC).

Cumulative
Risk
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
dimethipin.
Also,
dimethipin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
Therefore,
for
the
purposes
of
tolerance
reassessment
and
a
decision
on
reregistration
eligibility,
EPA
has
not
assumed
that
dimethipin
shares
a
common
mechanism
of
toxicity
with
other
compounds.
Thus,
a
cumulative
assessment
was
not
conducted.

Ecological
Risk
There
are
few
scenarios
with
LOC
exceedances
for
small
mammals,
and
all
of
these
exceedances
are
slight.
Despite
the
lack
of
plant
toxicity
data
there
is
an
assumption
that
dimethipin
may
be
harmful
to
terrestrial
plants,
due
to
its
herbicidal
properties.
In
addition,
there
were
no
chronic
avian
data
available
to
the
Agency
for
its
assessment.
EPA
has
determined
that
no
risk
mitigation
is
appropriate
for
environmental
concerns
at
this
time,
but
the
Agency
is
calling
in
the
chronic
data
to
confirm.

Endangered
Species
The
screening
level
ecological
risk
assessment
indicates
that
dimethipin
has
the
potential
for
causing
acute
risk
of
concern
to
endangered
small
mammals
that
forage
on
grasses,
broadleaf
plants,
and
insects.
There
is
potential
for
direct
effects
on
terrestrial
plants,
should
exposure
to
listed
species
occur.
No
direct
acute
risks
of
concern
were
seen
for
aquatic
organisms
or
birds
in
the
preliminary
assessment.
In
addition,
there
is
a
presumption
of
no
direct
acute
effects
for
large
mammals.
The
Agency
cannot
at
this
time
make
a
clear
"
no
effect"
finding
for
indirect
effects
or
for
direct
chronic
effects.

Next
Steps
The
Agency
is
issuing
this
Reregistration
Eligibility
Decision
(
RED)
document
for
dimethipin
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
The
Agency
is
providing
a
30­
day
public
comment
period
for
stakeholders
to
respond
to
this
risk
management
decision.
If
substantive
information
is
received
during
the
comment
period
that
indicates
a
need
to
refine
any
of
EPA's
assumptions
or
need
for
additional
risk
mitigation,
then
this
decision
will
be
modified
as
appropriate
through
an
amendment
to
the
RED.

In
the
future,
EPA
will
issue
a
generic
DCI
for
additional
data
necessary
to
confirm
the
conclusions
of
this
RED
for
the
active
ingredient
dimethipin.
EPA
will
also
issue
a
product
specific
DCI
for
data
necessary
to
complete
product
reregistration
for
products
containing
dimethipin.
1
.
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
risks
arising
from
the
currently
registered
uses
of
the
pesticide;
to
determine
the
need
for
additional
data
on
health
and
environmental
effects;
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
and
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA)
to
require
reassessment
of
all
existing
tolerances
for
pesticides
in
food.
FQPA
also
requires
EPA
to
review
all
tolerances
in
effect
on
August
3,
1996,
by
August
3,
2006.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
When
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern
and
the
Agency
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure,
the
tolerances
are
considered
reassessed.
EPA
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
tolerance
reassessment
will
be
accomplished
through
the
reregistration
process.

As
mentioned
above,
FQPA
requires
EPA
to
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity"
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance.
Potential
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity
are
considered
because
low­
level
exposures
to
multiple
chemicals
causing
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
one
of
these
individual
chemicals.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
the
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
epa.
gov/
pesticides/
cumulative/.

Unlike
other
pesticides
for
which
EPA
has
considered
cumulative
risk
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
dimethipin.
The
Agency
has
found
no
information
indicating
dimethipin
shares
a
common
mechanism
of
toxicity
with
other
substances.
Dimethipin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
Therefore,
for
the
purposes
of
tolerance
reassessment
and
a
decision
on
reregistration
eligibility,
EPA
has
not
assumed
that
dimethipin
shares
a
common
mechanism
of
toxicity
with
other
compounds.
In
the
future,
if
additional
information
suggests
dimethipin
shares
a
common
mechanism
2
S
S
CH
3
CH
3
O
O
O
O
of
toxicity
with
other
compounds,
additional
testing
would
be
required
and
a
cumulative
assessment
would
be
necessary.

This
document
presents
EPA's
human
health
and
ecological
risk
assessments,
its
progress
toward
tolerance
reassessment,
and
the
reregistration
eligibility
decision
for
dimethipin.
The
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
human
health
and
environmental
effects
risk
assessments
based
on
data,
public
comments,
and
other
information
received;
Section
IV
presents
the
Agency's
reregistration
eligibility
and
risk
management
decisions;
Section
V
summarizes
potential
label
changes
necessary
to
implement
the
risk
mitigation
measures
outlined
in
Section
IV;
and
Section
VI
provides
information
on
how
to
access
related
documents.
Finally,
the
Appendices
list
related
information
and
supporting
documents.
The
preliminary
and
revised
risk
assessments
for
dimethipin
are
available
in
the
Public
Docket,
under
docket
number
OPP­
2004­
0380
and
on
the
Agency's
web
page,
http://
www.
epa.
gov/
edockets.

III.
Chemical
Overview
A.
Regulatory
History
Dimethipin
has
been
registered
in
the
United
States
since
1982
for
use
as
a
cotton
growth
regulator/
dessicant,
defoliant,
and
post­
emergent
herbicide.
In
June
1998
it
was
registered
for
herbicidal
use
under
a
Section
24(
c)
or
Special
Local
Need
(
SLN)
in
Washington
state
for
nonbearing
apple
nursery
stock.
Crompton
Manufacturing
Company
has
been
the
technical
registrant
since
1989,
with
Uniroyal
Chemical
preceeding
them
as
the
technical
registrant.
The
Agency
conducted
a
review
of
the
scientific
data
underlying
pesticide
registrations
and
identified
missing
or
inadequate
studies.
Subsequent
Data
Call­
Ins
(
DCIs)
were
issued
in
1989,
1991,
and
1995.
This
Reregistration
Eligibility
Decision
(
RED)
reflects
a
reassessment
of
all
data
submitted
to
date.

B.
Chemical
Identification
Common
Name:
Dimethipin
Trade
Name:
Harvade
®
Chemical
Name:
[
2,3­
dihydro­
5,6­
dimethyl­
1,4­
dithiin
1,1,4,4­
tetraoxide]
3
CAS
Registry
Number:
55290­
64­
7
OPP
Chemical
Code:
118901
Moleculer
Weight:
210.26
Empirical
Formula:
C
6
H
10
O
4
S
2
Basic
Manufacturers:
Crompton
Manufacturing
Company
Dimethipin
is
a
white
powder
or
solid
with
a
sweet,
molasses­
like
scent.
It
has
a
melting
point
of
162­
167

C.
Dimethipin
is
stable
in
neutral
and
acidic
aqueous
solutions;
however,
stability
decreases
with
increasing
pH.
Dimethipin
is
practically
insoluble
in
water,
but
is
soluble
in
most
organic
solvents.
Dimethipin
is
not
particularly
volatile
due
to
its
low
vapor
pressure
of
<
3.81
x
10­
7
mm
Hg
at
24

C
(
Merck
Index,
11th
Edition).

There
are
currently
four
products
containing
dimethipin
registered
under
Section
3
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
There
is
one
SLN
in
Washington
state
for
non­
bearing
apple
nursery
stock.
This
RED
evaluates
risk
from
all
currently
registered
uses.

C.
Use
Profile
The
following
is
information
on
the
currently
registered
uses
including
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
dimethipin
eligible
for
reregistration
is
contained
in
Appendix
A.

Type
of
Pesticide:
Cotton
growth
regulator,
defoliant
and
dessicant;
herbicide
Summary
of
Use:
Dimethipin
is
a
cotton
growth
regulator/
dessicant,
used
as
a
pre­
harvest
defoliant,
and
herbicide
on
cotton
and
non­
bearing
apple
trees.

Target
Organisms:
Morning
glory,
sicklepod
Mode
of
Action:
Dimethipin
functions
by
stressing
the
plant's
stomatal
system
causing
it
to
lose
water
and
resulting
in
leaf
abscission.

Use
Sites:
Cotton,
non­
bearing
apple
nursery
stock
Tolerances:
There
are
seventeen
dimethipin
tolerances
for
cotton
seeds
and
hulls,
cattle,
horse,
goat,
and
sheep
meat
and
meat
byproducts,
as
well
as
the
fat
of
horses,
goats,
sheep,
hogs,
and
cattle.

Use
Classification:
General
use
4
Formulation
Types:
Dimethipin
is
formulated
as
a
flowable
and
emulsifiable
concentrate
Application
Methods:
Dimethipin
can
be
applied
aerially,
with
a
ground
boom
sprayer,
or
a
high
pressure
handwand.

Application
Rates:
Dimethipin
is
labeled
for
use
on
cotton
at
a
maximum
seasonal
rate
of
0.56
lbs
ai/
A,
however
0.31
lbs
ai/
A
is
most
commonly
used.
For
non­
bearing
apple
trees,
the
maximum
application
rate
is
0.077
lbs
ai/
A.

Application
Timing:
For
cotton
defoliation:
apply
7­
14
days
prior
to
anticipated
harvest,
at
70%
of
boll
opening,
when
the
last
boll
to
be
harvested
is
no
more
than
four
nodes
above
the
last
cracked
boll
showing
fiber,
when
the
last
boll
to
be
harvested
is
hard
to
cut
through
and
seed
coat
is
light
brown,
or
when
there
is
no
active
growth
and
lower
leaves
have
a
purple
tinge.
For
herbicide
use:
apply
when
the
young
weeds
are
at
least
4
inches
tall
and
the
cotton
is
at
least
10
inches
tall.
For
crop
maturation:
apply
at
30%
boll
opening
and
if
necessary
apply
a
follow­
up
treatment
of
a
harvest
aid
product
according
to
its
label
directions.
For
non­
bearing
apple
nursery
stock:
apply
after
the
terminal
bud
has
set,
and
preferably
after
a
light
frost.
Apply
a
second
application
6
to
7
days
after
the
first,
if
necessary.
Do
not
use
on
apple
trees
that
bear
fruit
for
harvest
within
one
year
of
application.

D.
Estimated
Usage
of
Pesticide
Dimethipin
is
used
on
approximately
5%
of
the
cotton
crop
nationally.
The
predominant
usage
is
in
Alabama,
North
Carolina,
Georgia,
and
Mississippi.
5
IV.
Summary
of
Dimethipin
Risk
Assessments
The
following
is
a
summary
of
EPA's
human
health
and
ecological
risk
findings
and
conclusions
for
dimethipin,
as
presented
fully
in
the
documents
"
Dimethipin:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)"
written
by
S.
Stanton,
J.
Liccione,
D.
Drew
and
S.
Tadayon,
(
8/
26/
04)
and
"
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Dimethipin"
written
by
L.
Liu,
and
J.
Felkel
(
11/
18/
04).

The
purpose
of
this
section
is
to
summarize
the
key
features
and
findings
of
the
risk
assessments
in
order
to
help
the
reader
better
understand
the
risk
management
decisions
reached
by
the
Agency.
While
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
in
the
OPP
Public
Docket
http://
epa.
gov/
edockets
(
docket
number
OPP­
2004­
0380)
and
may
also
be
accessed
on
the
Agency's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

A.
Human
Health
Risk
Assessment
1.
Toxicity
The
Agency
has
determined
that
the
toxicity
database
for
dimethipin
is
adequate
for
this
assessment.
Further
details
on
the
toxicity
of
dimethipin
can
be
found
in
the
Dimethipin:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED).

a.
Toxicity
Profile
Acute:
Dimethipin
has
moderate
(
Category
II)
acute
toxicity
via
the
oral
and
inhalation
routes,
and
low
(
Category
III)
acute
toxicity
via
the
dermal
route.
It
is
not
an
eye
or
skin
irritant
or
a
dermal
sensitizer.
The
acute
toxicity
for
dimethipin
is
listed
in
Table
1.

Table
1.
Acute
Toxicity
Data
for
Dimethipin.

Guideline
No./
Study
Type
MRID
Number
Results
Toxicity
Category
870.1100
Acute
Oral
Toxicity
42429601
LD50
=
458
mg/
kg­­
male
LD50
=
546
mg/
kg
 
female
II
870.1200
Acute
Dermal
Toxicity
42429602
LD50>
5000
mg/
kg
III
870.1300
Acute
Inhalation
Toxicity
42429603
LC50
=
1.2
mg/
L
II
870.2400
Acute
Eye
Irritation
85642
(
Accession
#
070237H)
Non­
irritant
IV
870.2500
Acute
Dermal
Irritation
42429604
Non­
irritant
IV
870.2600
Skin
Sensitization
42429605
Not
a
sensitizer
 
Chronic:
Data
from
long­
term
studies
indicate
that
organ
effects
and
decreased
weight
gain
are
the
primary
effects
of
exposure
to
dimethipin.
Observed
organ
effects
include
toxicity
in
the
kidney,
6
lungs,
duodenum
and
testes
of
male
rats
and
toxicity
in
the
liver
kidney,
glandular
stomach,
heart
and
aortic
artery
of
female
rats.
Dimethipin
is
not
mutagenic,
neurotoxic,
and
it
does
not
cause
developmental
or
reproductive
effects.
In
a
104­
week
dietary
study
in
the
rat,
effects
were
observed
in
males
treated
with
77.6
mg/
kg/
day
(
mid­
dose)
and
161
mg/
kg/
day
(
high­
dose),
and
in
females
treated
with
50.3
mg/
kg/
day
(
mid­
dose)
and
103
mg/
kg/
day
(
high­
dose).

Toxicity
occurred
in
the
gastrointestinal
tract
illustrated
by
a
higher
frequency
and
severity
of
epithelial
hyperplasia
in
the
nonglandular
stomach
in
high­
dose
male
rats,
mineralization
in
the
glandular
stomach
of
mid­
and
high­
dose
female
rats,
epithelial
hyperplasia
of
the
duodenum
in
midand
high­
dose
males
and
high­
dose
females,
and
crypt
abscesses
in
the
duodenum
of
mid­
and
highdose
male
rats.
In
addition,
testicular
lesions
occurred
in
male
rats
fed
the
mid
and
high­
doses,
and
epididymal
hypospermia
occurred
in
high­
dose
males.
Effects
occurring
only
in
females
included
cardiovascular
toxicity
(
mid­
and
high­
doses)
and
brain
degeneration
(
high­
doses).
The
NOAEL
in
males
is
2.18
mg/
kg/
day
and
in
females
is
1.75
mg/
kg/
day.

b.
Food
Quality
Protection
Act
Safety
Factor
(
FQPA
SF)

The
Food
Quality
Protection
Act
(
FQPA)
directs
the
Agency
to
use
an
additional
tenfold
(
10X)
safety
factor,
to
protect
for
special
sensitivity
in
infants
and
children
to
specific
pesticide
residues
in
food,
drinking
water,
or
residential
exposures.
FQPA
authorizes
the
Agency
to
modify
the
tenfold
safety
factor
only
if
reliable
data
demonstrate
that
the
resulting
level
of
exposure
would
be
safe
for
infants
and
children.

FQPA
Special
Safety
Factor:
After
evaluating
hazard
data
for
dimethipin,
EPA
reduced
the
10X
FQPA
special
safety
factor.
The
toxicity
database
for
dimethipin
includes
acceptable
developmental
and
reproductive
toxicity
studies.
No
quantitative
or
qualitative
sensitivity
was
observed
in
the
rat
and
rabbit
developmental
studies
or
in
the
2­
generation
reproduction
study
in
the
rat.
Based
on
the
lack
of
evidence
of
pre­
and/
or
postnatal
susceptibility
following
exposure
to
dimethipin,
and
considering
the
lack
of
residual
uncertainties
for
pre­
and/
or
postnatal
toxicity,
the
10X
FQPA
special
safety
factor
was
reduced
to
1X.

Database
Uncertainty
Factor:
The
toxicological
database
is
complete,
and
there
is
no
database
uncertainty
factor
for
dimethipin.

c.
Carcinogenicity
The
Agency
has
classified
dimethipin
as
a
possible
human
carcinogen
(
Group
C),
based
on
evidence
of
lung
adenomas
and
carcinomas
in
the
male
CD­
1
mouse.
The
Agency
concluded
that
the
original
rat
study
was
not
conducted
at
a
high
enough
dose
and
recommended
that
a
new
study
be
conducted.
The
results
of
the
new
study
indicated
no
evidence
of
carcinogenicity
in
the
rat.
Calculation
of
a
Q1*
was
not
recommended
for
dimethipin,
based
on
the
weight­
of­
evidence
(
i.
e.,
tumors
at
the
Highest
Dose
Tested
(
HDT)
in
only
one
sex,
strain,
species
and
only
one
experiment;
and
weak
mutagenicity
of
dimethipin).
7
d.
Toxicological
Endpoints
and
Doses
for
Risk
Assessment
No
endpoints
(
effects)
of
concern
attributable
to
a
single
exposure
(
dose)
were
identified
in
any
of
the
dimethipin
studies;
therefore
an
acute
reference
dose
(
RfD)
was
not
established.
In
addition,
no
dermal
endpoint
was
identified
from
the
studies
reviewed.
The
short­
and
intermediate­
term,
and
chronic
toxicological
endpoints
used
in
the
human
health
risk
assessment
for
dimethipin
are
listed
in
Table
2.
The
safety
factors
used
to
account
for
interspecies
extrapolation,
and
intraspecies
variability,
are
described
in
Table
2
as
well.
There
were
no
concerns
with
special
susceptibility
to
infants
and
children
(
FQPA
10X
reduced),
nor
were
there
database
uncertainties.

Table
2:
Summary
of
Toxicological
Doses
and
Endpoints
for
Dimethipin
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
(
mg/
kg/
day)
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Chronic
Dietary
(
all
populations)
NOAEL
=
2.18
UF
=
100
(
10x
for
intraspecies
variation,
10x
for
interspecies
extrapolation)

Chronic
RfD
=
0.0218
FQPA
SF=
1X
cPAD
=
0.0218
mg/
kg/
day
Oral
Chronic
Toxicity/
Carcinogenicity
Study
in
the
Rat
MRID#
43897601
LOAEL
=
50.3
mg/
kg/
day,
based
on
toxicity
in
the
kidney,
lungs,
duodenum,
and
testes
of
male
rats
and
depressed
body
weight
gain
and
toxicity
in
the
liver,
kidney,
glandular
stomach,
heart,
and
aortic
artery
of
female
rats.

Occupational
Inhalation
Short­
Term
(
1
­
30
days)
NOAEL
=
20
FQPA
SF=
1X
LOC:
MOE
=
100
(
10x
for
intraspecies
variation,
10x
for
interspecies
extrapolation)
Oral
Developmental
Study
in
the
Rabbit
MRID#
93089033
LOAEL
=
40
mg/
kg/
day,
based
on
decreased
body
weight
gain.

Occupational
Inhalation
Intermediate­
Term
(
1
­
6
months)
NOAEL
=
11.8
FQPA
SF=
1X
LOC:
MOE
=
100
(
10x
for
intraspecies
variation,
10x
for
interspecies
extrapolation)
Two­
Generation
Reproduction
Study
in
the
Rat
MRID#
93089034
LOAEL
=
31.2­
120.3
mg/
kg/
day,
based
on
decreased
body
weight/
body
weight
gain
in
F0
&
F1
females.

Cancer
(
oral,
inhalation)
Classification:
Class
C
­
quantification
not
recommended.

2.
Dietary
Exposure
and
Risk
from
Food
a.
Exposure
Assumptions
8
There
was
no
acute
dietary
assessment
conducted
for
dimethipin
because
no
acute
endpoints
were
identified
in
any
studies.
The
refined
chronic
dietary
exposure
assessment
was
conducted
using
the
Lifeline
 
Model
Version
2.0
and
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCID
 
)
,
Version
2.03.
DEEM­
FCID
and
Lifeline
use
food
consumption
data
from
the
United
States
Department
of
Agriculture
(
USDA's)
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998
and
determine
exposure
and
risk
estimates
resulting
from
food
intake
for
the
general
U.
S.
population
and
various
population
subgroups.
Risk
is
expressed
as
a
percent
of
the
cPAD.

The
chronic
dietary
risk
assessment
is
conservative
because
100%
crop
treated
was
assumed,
along
with
default
processing
factors,
and
tolerance­
level
residues
for
all
commodities
except
for
the
liver
of
cattle,
goats,
hogs,
and
sheep.

Although
dimethipin
is
used
solely
on
cotton,
and
in
some
parts
of
the
country,
on
nonbearing
apple
trees,
cotton
seed,
cotton
meal
and
cotton
gin
byproducts
may
be
part
of
the
diet
of
livestock.
Although
feeding
study
data
indicate
that
there
is
no
expectation
of
finite
residues
in
the
fat,
meat,
or
meat
byproducts
of
cattle,
goat,
horses,
hogs
or
sheep,
the
tolerances
for
dimethipin
in
livestock
meat
and
meat
byproducts
are
being
retained
in
order
to
harmonize
with
the
established
Codex
maximum
residue
limits
(
MRLs).
The
U.
S.
tolerances
for
dimethipin
in
the
fat
of
cattle,
goat,
horses,
hogs
and
sheep
are
being
revoked
as
there
is
no
expectation
of
finite
residues
in
these
commodities
and
there
are
no
Codex
MRLs
established.

The
chronic
analysis
could
be
refined
through
the
use
of
anticipated
residues
for
these
livestock
commodities,
average
residues
for
cottonseed
based
on
field
trial
data,
and
percent
crop
treated
data.

b.
Population
Adjusted
Dose
(
PAD)

The
Population
Adjusted
Dose
(
PAD)
is
a
modification
of
the
RfD
that
takes
into
account
the
FQPA
SF.
The
chronic
PAD
(
cPAD)
is
an
estimate
of
the
daily
exposure
of
the
human
population
(
including
susceptible
subgroups)
that
is
likely
to
be
without
an
appreciable
risk
of
adverse
health
effects
over
a
lifetime.
For
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
the
cPAD.
The
Agency
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
cPAD.

c.
Dietary
Risk
from
Food
Acute,
There
is
no
acute
endpoint
and
therefore,
an
acute
dietary
risk
assessment
was
not
conducted.

Chronic,
The
chronic
dietary
risk
from
food
alone
is
below
the
Agency's
level
of
concern.
Chronic
dietary
exposure
from
food
comprises
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
sub­
groups,
even
the
most
highly
exposed
group,
children
3­
5
years
old
(
see
Table
3).
Cotton
is
the
only
crop
considered
in
the
dietary
assessment
including
secondary
residues
in
livestock
from
the
consumption
of
cotton
feed
items.
The
bold
text
in
Table
3
represents
the
population
subgroup
with
the
highest
exposure.
9
Table
3.
Chronic
Dietary
Exposure
and
Risk
Estimates
for
Dimethipin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Lifeline
DEEM­
FCID
Lifeline
DEEM­
FCID
General
U.
S.
Population
0.0218
0
0.00004
<
1.0
<
1.0
All
Infants
(<
1
year
old)
0
0.000015
<
1.0
<
1.0
Children
1­
2
years
old
0.0001
0.000078
<
1.0
<
1.0
Children
3­
5
years
old
0.0001
0.000085
<
1.0
<
1.0
3.
Dietary
Risk
from
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
surface
and
ground
water
contamination.
EPA
considers
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
modeling
(
or
monitoring
data,
if
available
and
of
sufficient
quality),
to
estimate
those
exposures.
In
assessing
drinking
water
risks,
EPA
compares
model
results
to
concentrations
that
would
be
acceptable
in
drinking
water
from
a
human
health
perspective
(
e.
g,
DWLOCs).
The
DWLOC
is
the
maximum
concentration
in
drinking
water
that,
when
considered
together
with
dietary
(
food)
exposure,
does
not
exceed
a
level
of
concern.
If
the
estimated
drinking
water
concentrations
(
EDWCs)
in
water
are
less
than
the
DWLOCs,
EPA
does
not
have
concern
for
exposure
through
drinking
water.
If
the
EDWCs
are
greater
than
DWLOCs,
EPA
will
conduct
further
analysis
to
characterize
the
potential
dietary
risk
from
drinking
water.
Risks
from
exposure
to
dimethipin
in
drinking
water
are
further
discussed
in
this
document's
section
entitled
"
Aggregate
Exposure
and
Risk."

No
major
environmental
degradates
were
identified,
thus
parent
dimethipin
is
the
compound
of
concern
for
drinking
water.
The
high
mobility
and
persistence
of
dimethipin
could
result
in
exposure
through
leaching
into
ground
water
and
surface
water.
The
Screening
Concentration
in
Ground
Water
(
SCI­
GROW)
model
was
used
to
assess
the
concentrations
of
dimethipin
in
ground
water,
and
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
model
assessed
the
surface
water
concentrations
of
dimethipin.

a.
Surface
Water
The
Tier
I
screening
model,
FIRST
was
used
to
estimate
dimethipin
residues
in
surface
water
used
for
drinking
water.
It
provides
high­
end
values
for
the
concentrations
that
might
be
found
in
a
small
drinking
water
reservoir.

There
are
no
concerns
for
exposure
to
dimethipin
through
surface
water.
The
estimated
chronic
concentration
is
7.3
ppb.
Acute
DWLOCs
were
not
calculated,
since
an
acute
endpoint
of
concern
has
not
been
identified
for
dimethipin.
The
calculated
chronic
DWLOCs
for
the
U.
S.
population
and
various
population
subgroups
are
between
217
ppb
(
infants
and
children)
and
762
ppb
(
adults).
The
estimated
chronic
concentration
in
surface
water
of
7.3
ppb
is
well
below
the
calculated
DWLOCs
and,
therefore,
not
of
concern.
10
b.
Ground
Water
There
were
no
available
ground
water
monitoring
data
for
the
Agency
to
review.
As
a
result,
modeling
was
used
to
estimate
impacts
from
dimethipin
use
on
ground
water
quality.
Estimated
ground
water
concentrations
are
based
on
the
SCI­
GROW
model,
which
is
a
Tier
1
model
that
provides
high­
end
concentration
estimates.
The
SCI­
GROW
model
generates
a
single
Estimated
Drinking
Water
Concentration
(
EDWC)
of
a
pesticide
in
ground
water
used
for
drinking
water
and
provides
an
estimated
ground
water
screening
concentration
for
use
in
determining
potential
risk
to
human
health
from
drinking
water
contaminated
with
a
pesticide.

For
the
chronic
assessment,
a
Tier
I
drinking
water
analysis
was
completed.
Dimethipin's
Koc
was
1,
which
is
very
low
and
outside
the
range
of
Koc
values
used
in
the
development
of
SCI­
GROW.
When
the
model
was
run
using
the
Koc
of
1,
an
EDWC
of
423
ppb
resulted.
This
EDWC
significantly
overestimated
ground
water
concentrations,
in
part,
because
of
the
limitations
of
the
SCIGROW
model.
Based
on
input
from
M.
Barrett,
the
developer
of
SCI­
GROW,
the
model
was
run
again
with
a
Koc
of
10.
The
Agency
believes
the
Koc
of
10
is
more
representative
of
the
concentration
of
dimethipin
in
groundwater,
resulting
in
an
EDWC
of
99
ppb
compared
to
a
DWLOC
of
762.
Table
4
displays
the
modeled
EDWC
values
for
surface
and
ground
water
arising
from
the
Tier
I
assessment.

Table
4.
Surface
and
Ground
Water
Estimated
Drinking
Water
Concentrations
(
EDWCs)

Water
Segment
Duration
EDWC
(
ppb)

Surface
Water
Chronic
7.3
Ground
Water
All
Duration
99
4.
Residential
and
Other
Non­
Occupational
Exposure
There
are
no
residential
or
other
non­
occupational
uses
of
dimethipin.

5.
Aggregate
Exposure
and
Risk
The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA,
Section
408(
b)(
2)(
A)(
ii))
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure.
In
the
case
of
dimethipin,
there
are
no
residential
or
non­
occupational
sources
of
exposure,
so
the
aggregate
assessment
included
dietary
risks
only.
Furthermore,
no
acute
assessment
was
done
because
there
were
no
acute
endpoints
of
concern
identified.

a.
Chronic
Aggregate
Risk
11
The
chronic
aggregate
risk
assessment
for
dimethipin
includes
food
and
drinking
water.
Dimethipin
residues
on
food
items
account
for
less
than
1%
of
the
cPAD
for
all
population
subgroups.
The
Agency
used
the
LifeLine
food
exposure
estimates
to
calculate
chronic
DWLOCs
for
the
U.
S.
population
and
various
population
subgroups.
The
calculated
DWLOCS
ranged
from
762
ppb
for
adults
to
217
ppb
for
infants
and
children.
The
chronic
surface
water
EDWC
(
7.3
ppb)
and
chronic
ground
water
EDWC
(
99
ppb)
are
well
below
the
calculated
DWLOCs
for
chronic
exposure
to
dimethipin
for
the
U.
S.
population
and
each
population
subgroup.
Based
on
these
comparisons,
the
Agency
is
reasonably
certain
that
the
chronic
aggregate
risk
associated
with
the
use
of
dimethipin
does
not
exceed
our
level
of
concern
for
the
overall
U.
S.
population
or
population
subgroups,
including
infants
and
children.
(
see
Table
5).

Table
5.
DWLOCs
for
Chronic
Aggregate
Risk
Population
Subgroup
Estimated
Drinking
Water
Concentration
(
EDWC)
of
Dimethipin
(
ppb)
Chronic
DWLOC
(
ppb)
Groundwater
Surface
Water
U.
S.
Population
99
7.3
762
Infants
<
1
99
7.3
218
6.
Occupational
Risk
Workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
flagging
in
cotton
fields,
applying
a
pesticide,
or
re­
entering
treated
sites.
Occupational
handlers
of
dimethipin
include:
mixers/
loaders,
flaggers,
and
applicators
to
cotton
and
non­
bearing
apple
nurseries.
Occupational
risk
for
these
potentially
exposed
populations
is
measured
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(
NOAEL).

MOEs
are
the
ratio
of
estimated
exposure
to
an
established
dose
level
NOAEL.
Dimethipin
MOEs
are
determined
by
a
comparison
of
specific
exposure
scenario
estimates
to
the
inhalation
NOAEL
of
20
mg/
kg/
day
from
a
rabbit
developmental
study
for
short­
term
assessment,
or
11.8
mg/
kg/
day
from
a
rat
two­
generation
reproduction
study
for
intermediate­
term
assessment.
No
dermal
endpoint
was
identified
in
any
of
the
available
studies,
thus
only
inhalation
risk
was
assessed.
For
dimethipin
users,
an
MOE
of
100
or
greater
has
been
determined
to
be
adequately
protective
(
for
both
short­
and
intermediate­
term
exposure)
based
on
the
standard
uncertainty
factors
of
10x
for
interspecies
extrapolation
and
10x
for
intraspecies
variability.
Long­
term
worker
exposure
is
not
expected
for
dimethipin
and
thus
was
not
assessed.

For
more
information
on
the
assumptions
and
calculations
of
potential
risk
of
dimethipin
to
workers,
see
the
Occupational
Exposure
Assessment
(
Section
2.2.2),
6/
8/
04,
or
the
Dimethipin
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)
(
Section
9)
dated
8/
26/
04.

a.
Occupational
Toxicity
12
Table
6
below
provides
a
listing
of
the
toxicological
endpoints
used
in
the
dimethipin
occupational
risk
assessment.

Table
6:
Summary
of
Toxicological
Endpoints
for
the
Occupational
Risk
Assessment
Exposure
Scenario
Dose
used
in
Risk
Assessment
(
mg/
kg/
day)
Level
of
Concern/
MOE
Study
and
Toxicological
Effects
Short­
Term
(
1­
30
days)
Inhalation
NOAEL=
20
MOE
=
100
Developmental
toxicity
study
in
rabbits
LOAEL
=
40
mg/
kg/
day
based
on
decreases
in
maternal
body
weight
gain.
MRID#:
93089033
Intermediate­
Term
(
1­
6
months)
Inhalation
NOAEL=
11.8
MOE
=
100
Two­
generation
reproduction
study
in
rats
LOAEL
=
31.2
­
120.3
mg/
kg/
day
based
on
decreased
body
weight/
body
weight
gain
in
F0
&
F1
females.
MRID#:
93089034
Cancer
Classification:
Class
C
(
possible
carcinogen)
calculation
of
a
Q1*
was
not
recommended
b.
Occupational
Handler
Exposure
The
Agency
has
determined
that
there
are
potential
exposures
to
individuals
who
mix,
load,
apply,
and
otherwise
handle
dimethipin
during
the
usual
uses
associated
with
the
pesticide.
Based
on
the
use
patterns,
the
following
7
major
occupational
handler
exposure
scenarios
were
identified:

(
1)
mixing/
loading
liquids
for
aerial
applications;
(
2)
mixing/
loading
liquids
for
groundboom
applications;
(
3)
mixing/
loading
liquids
for
high­
pressure
handwand
applications;
(
4)
applying
aerially
using
sprays;
(
5)
applying
using
groundboom
equipment;
(
6)
applying
using
high­
pressure
handwand;
and
(
7)
flagging
for
sprays
application.

For
more
detail
on
the
assumptions
and
calculations
of
potential
risk
of
dimethipin
to
workers,
see
the
Occupational
Exposure
Assessment
(
section
2.1)
dated
June
8,
2004.

c.
Summary
of
Handler
Risk
Estimates
Short­
and
intermediate­
term
inhalation
MOE
estimates
for
all
occupational
handler
scenarios
are
greater
than
100
at
either
baseline
level
of
protection
(
i.
e.
long
sleeve,
long
pants,
socks,
shoes,
and
no
respirator)
or
using
engineering
controls
(
i.
e.
closed
cockpit
for
fixed
wing
aircraft).
Baseline
personal
protective
equipment
(
PPE)
is
sufficient
for
all
exposure
scenarios
except
the
aerial
spray
application
which
requires
a
closed
cockpit.
Short­
term
MOEs
range
from
1,500
to
1,300,000,
and
intermediate­
term
MOEs
range
from
880
to
770,000.
Therefore,
short­
and
intermediate­
term
13
occupational
risk
are
not
of
concern.
Table
7
below
provides
a
listing
of
the
short­
and
intermediateterm
risk
estimates
for
handlers.

Table
7:
Summary
of
Occupational
Handler
Risk
for
Dimethipin
(
Baseline
PPE)

Exposure
Scenario
(
Scenario
#
referenced
above)
Crop
Application
Rate
lb
ai/
A
Daily
Area
Treated
A
or
gal/
day
Short­
Term
Inhalation
MOE
Intermediate­
Term
Inhalation
MOE
Mixer/
Loader
Mixing/
Loading
Liquids
for
Aerial
Application
(
1)
Cotton
0.56
1200
1500
880
Mixing/
Loading
Liquids
for
Groundboom
application
(
2)
200
8900
5300
Mixing/
Loading
Liquids
for
High­
Pressure
Hand
Wand
(
3)
Apple
0.00077/
gal
1000
gals
1300000
770000
Applicator
Sprays
for
Aerial
Application
(
4)
(
closed
cockpit)
Cotton
0.56
1200
26000
15000
Sprays
for
Groundboom
Application
(
5)
200
14000
8500
Spray
for
High
Pressure
Hand
Wand
Application
(
6)
Apple
0.00077/
gal
1000
gals
20000
12000
Flagger
Flagging
for
Sprays
Application
(
7)
Cotton
0.56
350
17000
10000
d.
Occupational
Post­
Application
Risk
EPA
did
not
assess
post­
application
dermal
exposure
risks
to
agricultural
workers
following
treatments
to
cotton
or
non­
bearing
apple
nursery
stock,
since
no
short­
or
intermediate­
term
dermal
endpoint
of
concern
was
identified
and
long­
term
dermal
exposures
are
not
expected.
Also,
since
postapplication
inhalation
exposure
is
expected
to
be
negligible,
a
risk
assessment
for
this
route
was
not
conducted.

Access
to
pesticide­
treated
areas
is
limited
after
an
application
while
the
pesticide
may
still
present
a
hazard.
In
the
absence
of
specific
data
to
determine
the
appropriate
length
of
the
restrictedentry
interval
(
REI),
it
is
established
based
on
the
acute
dermal
toxicity
and
eye
and
skin
irritation
potential
of
the
active
ingredient.
The
dimethipin
technical
material
has
been
classified
in
Toxicity
Category
III
for
acute
dermal
toxicity
and
Toxicity
Category
IV
for
primary
eye
and
skin
irritation
potential.
In
accordance
with
the
Worker
Protection
Standard
(
WPS),
a
12­
hour
REI
is
indicated
for
chemicals
classified
under
Toxicity
Category
III
or
IV.
In
the
Worker
Protection
Standard
(
WPS),
an
REI
is
defined
as
the
duration
of
time
which
must
elapse
before
residues
decline
to
a
level
so
entry
into
a
previously
treated
area
and
engaging
in
any
task
or
activity
would
not
result
in
exposures
which
are
of
concern.
Thus,
EPA
has
determined
that
dimethipin­
only
products
would
be
eligible
for
a
12
hour
REI
(
currently
dimethipin
labels
have
a
48
hour
REI).
14
e.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
the
National
Poison
Control
Centers
(
PCC),
and
the
Agency's
Office
of
Pesticide
Program's
Incident
Data
System
(
IDS),
the
National
Pesticide
Information
Center
(
NPIC),
the
National
Institute
of
Occupational
Safety
and
Health's
Sentinel
Event
Notification
System
for
Occupational
Risks
(
NIOSH
SENSOR)
and
the
California
Pesticide
Illness
Surveillance
Program.
Only
one
incident
of
an
oral
ingestion
of
dimethipin
was
reported
to
the
PCC,
which
involved
a
forty­
three
year
old
man
who
ingested
the
product
(
Harvade)
and
reported
throat
irritation
and
itching.
No
further
information
on
the
disposition
of
the
case
was
reported.

There
were
no
dimethipin
exposures
reported
in
the
Incident
Data
Systems
(
1992
to
present),
NPIC
(
1984­
1991),
NIOSH
SENSOR
(
1998­
2002)
or
California
Pesticide
Illness
Surveillance
Program
(
1982­
2002)
data
bases.
The
absence
of
reported
incidences
serves
to
reinforce
the
occupational
risk
assessment
conclusions.

B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
for
dimethipin
is
presented
below.
Dimethipin
has
the
following
registered
uses
which
result
in
environmental
exposures:
cotton
defoliation
and
post­
emergence
herbicide.
More
detailed
information
associated
with
the
environmental
risk
from
the
use
of
dimethipin
can
be
found
in
the
"
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Dimethipin,"
dated
November
18,
2004.
The
complete
environmental
risk
assessment
may
be
accessed
in
the
OPP
Public
Docket
(
OPP­
2004­
0380)
and
on
the
Agency's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

1.
Environmental
Exposure
a.
Environmental
Fate
and
Transport
The
environmental
fate
database
is
sufficient
to
characterize
the
environmental
exposure
associated
with
dimethipin
use.
However,
EPA
does
intend
to
issue
a
DCI
as
part
of
this
RED
to
require
submission
of
additional
data
for
the
parent
compound
to
address
areas
of
uncertainty.
Studies
on
vegetative
vigor,
plant
and
aquatic
toxicity,
and
chronic
avian
toxicity
will
help
to
refine
the
environmental
risk
assessments
and
provide
the
Agency
with
necessary
data.
These
data
are
expected
to
confirm
the
conclusions
of
this
environmental
risk
assessment.

The
environmental
fate
of
dimethipin
varies
somewhat
based
on
the
site­
specific
properties
of
the
soil
to
which
it
is
applied,
but
generally,
dimethipin
is
persistent
in
soil,
with
a
half­
life
ranging
from
several
weeks
to
several
months.
Dimethipin
is
practically
insoluble
in
water,
and
stable
to
hydrolysis
and
photolysis
in
soil.
The
aqueous
photolysis
half­
lives
for
dimethipin,
at
a
pH
of
5,
7,
and
9
are
approximately
60,
224,
and
72
days
respectively.
The
aerobic
soil
half­
life
is
approximately
400
days
in
sandy
loam,
and
the
anaerobic
aquatic
half­
life
is
estimated
to
be
2
years.
15
Dimethipin
has
very
high
mobility
in
all
soils,
according
to
available
laboratory
mobility
studies.
In
a
terrestrial
field
dissipation
study
conducted
on
cotton
in
Georgia,
dimethipin
was
detected
at
depths
of
75­
90
cm
below
the
soil
surface
(
MRID
43216001).
A
second
terrestrial
field
dissipation
study
conducted
on
cotton
in
Mississippi
resulted
in
dimethipin
detections
at
60
 
75
cm
soil
depth
(
MRID
43216002).

Dimethipin
is
mobile
in
soils
and
it
has
the
potential
to
enter
surface
water
by
runoff
and
enter
groundwater
by
leaching.
However,
no
ground
or
surface
water
monitoring
data
are
available
at
this
time,
and
the
U.
S.
Geological
Survey's
National
Ambient
Water
Quality
Assessment
(
NAWQA)
program
is
not
currently
analyzing
for
dimethipin
Additional
information
on
the
environmental
fate
of
dimethipin
can
be
found
in
the
drinking
water
section
of
this
document
and
in
the
supporting
documents
referenced
in
Appendix
C.

b.
Aquatic
Organism
Exposure
For
exposure
to
fish
and
aquatic
invertebrates,
EPA
considers
surface
water
only,
since
most
aquatic
organisms
are
not
found
in
ground
water.
The
Agency
used
Tier
I
surface
water
modeling
to
derive
estimated
environmental
concentrations
(
EECs)
for
the
concentration
of
dimethipin
residues
in
surface
water.
The
modeling
results
used
in
risk
calculations
for
dimethipin
are
detailed
in
the
Environmental
Fate
and
Effects
Division
chapter:
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Dimethipin,
dated
November
18,
2004.

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
(
IR)
and
Percent­
Crop
Area
(
PCA)
factor
refinements.
The
IR
and
PCA
factors
represent
a
drinking
water
reservoir,
not
the
variety
of
aquatic
habitats,
such
as
ponds
adjacent
to
treated
fields,
relevant
to
a
risk
assessment
for
aquatic
animals.
Therefore,
the
EEC
values
used
to
assess
exposure
to
aquatic
animals
are
not
the
same
as
the
values
used
to
assess
human
dietary
exposure
from
drinking
water
sources.

The
Tier
1
model
GENEEC2
was
used
to
estimate
surface
water
concentrations
of
dimethipin.
Exposures
are
typically
calculated
for
invertebrates
and
fish.
Fish
serve
as
surrogates
for
aquatic­
phase
amphibians.
The
GENEEC2
model
was
run
for
two
different
crops,
cotton
and
apple/
non­
bearing
nursery
stock,
using
the
proposed
maximum
label
application
rates
(
0.56
lbs
ai/
A
and
0.077
lbs
ai/
A,
respectively)
with
aerial
application.

Exposure
to
non­
target
aquatic
plants
may
occur
through
runoff
or
spray
drift
from
adjacent
treated
sites.
16
Table
8.
Tier
I
Estimated
Environmental
Concentrations
(
EECs)
of
Dimethipin
in
Surface
Water
Crop/
Scenario
EECs
of
Dimethipin
in
Surface
Water
(
ppb)

App.
Rate
Peak,
24­
Hour
96­
hour
Average
21­
day
Average
60­
day
Average
Cotton
0.56
lbs
ai/
A
33.89
33.88
33.83
33.7
Non­
Bearing
Apple
Nursery
Stock
0.08
lbs
ai/
A
4.66
4.66
4.65
4.63
c.
Terrestrial
Organism
Exposure
The
Agency
assessed
exposure
to
terrestrial
organisms
by
first
predicting
the
amount
of
dimethipin
residues
found
on
animal
food
items
and
then
using
information
on
typical
food
consumption
by
various
species
of
birds
and
mammals
to
determine
the
amount
of
pesticide
consumed.
The
amount
of
residues
on
animal
feed
items
are
based
on
the
Fletcher
nomogram,
which
is
a
model
developed
by
Hoerger
and
Kenaga
(
1972)
and
modified
by
Fletcher
(
1994),
and
the
current
maximum
application
rate
for
dimethipin.
Thus,
EPA
modeled
the
maximum
residues
of
dimethipin
on
cotton
and
nonbearing
apple
nurseries,
immediately
following
application
at
the
maximum
application
rates,
which
are
0.56
lbs
ai/
A
on
cotton
for
post­
emergence
herbicidal
usage,
and
0.077
lbs.
ai/
A
on
non­
bearing
apple
nurseries.
The
Agency
assumed
no
dilution
due
to
the
growth
of
the
plants
or
degradation
of
dimethipin.
EPA's
estimates
of
dimethipin
residues
on
various
wild
animal
food
items
are
summarized
in
Table
9.
EPA
used
these
EECs
and
standard
food
consumption
values
to
estimate
dietary
exposure
levels
for
dimethipin
to
birds
and
mammals.

Table
9.
Maximum
Residue
EECs
on
Avian
and
Mammalian
Food
Items
(
ppm)
Following
a
Single
Application
of
Dimethipin
at
0.56
lbs
ai/
A
for
Cotton
and
0.077
lbs
ai/
A
for
Apples
Crop
and
Food
Group
Classification
Acute
EECs
(
ppm)

Cotton
Non­
Bearing
Apple
Nursery
Stock
Short
grass
134
18
Tall
grass
62
8
Broadleaf/
forage
plants
and
small
insects
76
10
Fruits/
pods/
seeds/
large
insects
8
1.16
The
terrestrial
EECs
used
to
determine
the
chronic
risk
quotients
(
RQs)
were
estimated
using
the
ELL­
FATE
model,
which
calculates
the
decay
of
a
chemical
applied
to
foliar
surfaces
for
single
and/
or
multiple
applications.
Pesticide
food
residues
are
based
on
the
assumption
that
organisms
are
exposed
to
a
single
pesticide
residue
in
a
given
exposure
scenario.
A
35­
day
foliar
dissipation
half­
life
was
assumed
due
to
a
lack
of
data
on
dissipation
from
foliar
surfaces,
which
is
the
default
value.
17
d.
Non­
target
Terrestrial
Plant
Exposure
Terrestrial
plants
inhabiting
dry
and
semi­
aquatic
areas
may
be
exposed
to
pesticides
from
runoff
and
spray
drift.
In
the
case
of
dimethipin,
it
is
applied
by
ground
boom
and
aerially
to
cotton,
and
hand­
held
spray
applicator
for
non­
bearing
apple
nursery
stock.
Due
to
the
lack
of
acceptable
studies
on
plant
toxicity,
exposure
modeling
was
not
conducted
for
non­
target
terrestrial
plants.

2.
Environmental
Effects
(
Hazard)

a.
Toxicity
to
Aquatic
Organisms
Freshwater
and
Estuarine/
Marine
Fish
The
available
acute
toxicity
data,
outlined
in
Table
10
below,
indicate
that
dimethipin
is
slightly
toxic
to
freshwater
fish
on
an
acute
basis,
based
on
an
LC
50
value
of
20.9
ppm
for
bluegill
sunfish.

Chronic
data
for
freshwater
fish
show
that
larval
survival
was
the
most
sensitive
endpoint
for
dimethipin.
The
toxicity
endpoints
for
aquatic
species
are
listed
in
Table
10.

Table
10.
Dimethipin
Toxicity
Reference
Values
(
TRVs)
for
Aquatic
Organisms
Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
ppm
ai)
Reference
Freshwater
Fish
Acute
Bluegill
sunfish
96
hours
LC50
=
20.9
ppm
ai
MRID
41945902
Chronic
Fathead
minnow
31
days
NOAEC
=
12
ppm
ai
MRID
00126069
Freshwater
Invertebrates
Acute
Daphnia
magna
48
hours
LC50
=
20
ppm
ai
00086315
LeBlanc
1977
Chronic
Daphnia
magna
21
days
NOAEC
(
length)
=
0.61
ppm
ai
MRID
00128803
Estuarine/
Marine
Fish
Acute
Sheepshead
minnow
96
hours
LC50
=
17.8
ppm
ai
MRID
41663901
Chronic
no
data;
an
extrapolated
NOAEC
value
based
on
the
acute­
to­
chronic
ratio
in
freshwater
fish
is
10.2
ppm
ai1
Estuarine/
Marine
Invertebrates
Acute
Mysid
shrimp
48
hour
LC50
=
13.9
ppm
ai
MRID
41663902
Chronic
no
data;
an
extrapolated
NOAEC
value
based
on
the
acute­
to­
chronic
ratio
in
freshwater
invertebrates
is
0.42
ppm
ai2
Table
10.
Dimethipin
Toxicity
Reference
Values
(
TRVs)
for
Aquatic
Organisms
Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value
(
ppm
ai)
Reference
18
Aquatic
Plants
Acute
Lemna
gibba
14
days
EC50
=
2.1
ppm
ai
NOAEC
=
0.8
ppm
ai
MRID
42627104
1
Acute­
to­
Chronic
ratio
for
freshwater
fish
is
20.9:
12
=
1.7;
17.8
ppm/
1.7
=
10.2
ppm
2
Acute­
to­
Chronic
ratio
for
freshwater
invertebrates
is
20:
0.61
=
32.8;
13.9
ppm/
32.8
=
0.42
ppm
Freshwater
and
Estuarine/
Marine
Invertebrates
Acute
data
on
technical
dimethipin
show
that
it
is
slightly
toxic
to
freshwater
invertebrates
(
daphnid
LC
50
of
20
ppm)
and
estuarine/
marine
invertebrates
(
mysid
shrimp
LC
50
of
13.9
ppm).
Table
10
above
displays
the
acute
and
chronic
toxicity
endpoints
for
freshwater
invertebrates.

Aquatic
Plants
The
EC
50
value
of
2.1
ppm
ai
in
duckweed
suggests
that
dimethipin
is
acutely
toxic
to
freshwater
plants
(
macrophytes).

b.
Toxicity
to
Terrestrial
Organisms
Birds
Dimethipin
is
classified
as
slightly
toxic
to
birds
on
an
acute
oral
basis,
since
the
LD
50
value
is
between
501
mg/
kg
and
2,000
mg/
kg
(
see
Table
11).
Additionally,
with
LC
50
values
>
5,000
ppm,
dimethipin
is
classified
as
slightly­
to­
practically
nontoxic
to
birds
on
a
subacute
dietary
basis.
An
LC
50
is
a
statistically
estimated
measure
(
concentration)
expected
to
be
lethal
to
50%
of
the
test
population.
Table
11
summarizes
the
data
that
support
the
acute
toxicity
endpoints
used
in
assessing
the
risks
to
birds.

Table
11.
Summary
of
Toxicity
Endpoints
for
Birds
Toxicity
Study
Test
Species
%
ai
Endpoint
Toxicity
Category
MRID#

Acute
(
single
dose
administered
by
gelatin
capsule)

Avian
Oral
Mallard
Ducks
(
Anus
platyrhynchos)
98.64
LD50
880
mg
ai/
kg
Slightly
Toxic
41955901
Subchronic
(
5­
Day
dietary
exposure
followed
by
3­
day
observation
period)

Avian
Dietary
Mallard
Ducks
(
Anus
platyrhynchos)
98.64
LC50
>
5,000
ppm
ai
Practically
nontoxic
41955902
Chronic
(
reproductive):
NOT
ASSESSED
DUE
TO
LACK
OF
DATA
Mammals
19
Dimethipin
is
classified
as
moderately
toxic
to
small
mammals
on
an
acute
oral
basis
with
an
LD
50
value
of
458
mg/
kg
(
see
Table
12).
Chronic
toxicity
data
for
mammals
from
the
2­
generation
rat
reproduction
study
indicate
decreased
body
weight
in
pups
with
a
NOAEL
of
200
ppm.
Table
12
discusses
the
data
that
support
the
acute
toxicity
and
chronic
endpoints
used
in
assessing
the
risks
to
mammals.

Table
12.
Summary
of
Toxicity
Endpoints
for
Mammals
Species
Test
Type
Toxicity
Value
Affected
Endpoints
Identification
Number
Rat
Acute
Oral
Toxicity
LD50
=
458
mg/
kg
(

)
LD50
=
546
mg/
kg
(

)
Mortality
MRID
42429601
Rat
2­
Generation
Reproductive
study
Dietary
exposure
to
0,
50,
200,
or
800
ppm
Parental
systemic
NOAEL
for

=
200
ppm;
NOAEL
for

>
800
ppm
Reproductive
toxicity
NOAEL
for

and

>
800
ppm
Offspring
toxicity
NOAEL
for

and

=
200
ppm
Decreased
body
weight
MRID
93089034
Non­
Target
Insects
Available
data
from
a
honey
bee
acute
toxicity
study
indicated
that
technical
dimethipin
is
practically
non­
toxic
to
the
honey
bee
(
with
an
LD
50
greater
than
100
micrograms
per
bee;
MRID#
41264606).

Non­
Target
Terrestrial
Plants
No
acceptable
data
for
terrestrial
plants
have
been
submitted
to
the
Agency.
However,
dimethipin
is
an
herbicide,
therefore
plant
toxicity
is
expected.

3.
Ecological
Risk
Estimation
(
RQs)

The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
EECs
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
non­
target
organisms
from
the
use
of
dimethipin
products,
the
Agency
calculates
a
Risk
Quotient
(
RQ),
which
is
the
ratio
of
the
EEC
to
the
most
sensitive
toxicity
endpoint
values,
such
as
the
median
lethal
dose
(
LD
50)
or
the
median
lethal
concentration
(
LC
50).
These
RQ
values
are
then
compared
to
the
Agency's
levels
of
concern
(
LOCs),
given
in
Table
13,
which
indicate
whether
a
pesticide,
when
used
as
directed,
has
the
potential
to
cause
adverse
effects
to
non­
target
organisms.
When
the
RQ
exceeds
the
LOC
for
a
particular
category,
the
Agency
presumes
a
risk
of
concern
to
that
category.
These
risks
of
concern
may
be
addressed
by
further
refinements
of
the
risk
assessment
or
mitigation.
Use,
toxicity,
fate,
and
exposure
are
considered
when
characterizing
the
risk,
as
well
as
the
levels
of
certainty
and
uncertainty
in
the
assessment.
EPA
further
characterizes
ecological
risk
20
based
on
any
reported
incidents
to
non­
target
terrestrial
or
aquatic
organisms
in
the
field
(
e.
g.,
fish
or
bird
kills).

Table
13.
EPA's
Levels
of
Concern
and
Associated
Risk
Presumptions
Risk
Presumption
LOC
Terrestrial
Animals
LOC
Aquatic
Animals
LOC
Plants
Acute
Risk
­
there
is
potential
for
acute
risk;
regulatory
action
may
be
warranted
in
addition
to
restricted
use
classification.
0.5
0.5
1
Acute
Restricted
Use
­
there
is
potential
for
acute
risk,
but
may
be
mitigated
through
restricted
use
classification.
0.2
0.1
N/
A
Acute
Endangered
Species
­
endangered
species
may
be
adversely
affected;
regulatory
action
may
be
warranted.
0.1
0.05
1
Chronic
Risk
­
there
is
potential
for
chronic
risk;
regulatory
action
may
be
warranted.
1
1
N/
A
a.
Risk
to
Aquatic
Organisms
Fish
and
Aquatic
Invertebrates
No
acute
or
chronic
risks
are
predicted
for
freshwater
fish,
estuarine
fish,
and
aquatic
invertebrates.

Aquatic
Plants
Aquatic
plant
toxicity
dose
response
data
were
available
for
four
aquatic
plant
species.
Acute
RQ
values
for
aquatic
plants
are
well
below
the
LOC
for
acute
risk
for
both
cotton
and
non­
bearing
apple
nursery
stock
crop
applications.
Based
on
the
screening
level
assessment,
it
appears
unlikely
that
adverse
effects
in
aquatic
plants
would
be
observed
at
the
current
labeled
rates
of
dimethipin.
Methods
are
not
currently
available
to
assess
chronic
risks
to
aquatic
plants.

b.
Risk
to
Non­
target
Terrestrial
Organisms
Birds
Acute
RQs
from
two
applications
of
dimethipin
(
for
a
seasonal
maximum
application
of
0.56
lbs
ai/
A)
range
from
less
than
0.0002
to
less
than
0.03.
There
are
no
exceedances
for
any
acute
LOCs
for
birds.
Chronic
RQs
for
birds
could
not
be
estimated
due
to
a
lack
of
chronic
avian
data.

Mammals
There
are
no
exceedances
for
acute
mammalian
LOCs
when
dimethipin
is
applied
to
nonbearing
apple
nursery
stock.
For
application
on
cotton,
RQs
range
from
0.001
(
1000g
granivore,
seeds)
to
0.28
(
15g
mammal,
short
grass).
For
acute
restricted
use
risk,
the
RQ
exceeds
the
LOC
(
0.2)
21
for
a
15g
mammal
feeding
on
short
grass.
All
chronic
RQs
for
mammals
are
below
the
LOC
of
1
for
dimethipin
application
to
cotton
(
including
endangered
species).

Table
14.
Acute
Risk
Quotient
(
RQ)
Calculations
for
Mammalian
Consumption
of
Plant
and
Insect
Forage
Material
Crop
and
Forage
Item
Maximum
EEC
(
ppm)
Acute
LD50
(
mg/
kg
bw/
d)
Weight
of
Mammal
15
g
35
g
1000
g
Acute
Risk
Quotients
1
Cotton
Short
grass
134.4
458
0.28
0.19
0.04
Tall
grass
61.6
0.13
0.09
0.02
Broadleaf/
forage
plants
and
small
insects
75.6
0.16
0.11
0.02
Fruits/
pods/
large
insects
8.4
0.02
0.01
0
Seeds
(
granivore)
8.4
0.004
0.003
0.001
Apple/
nonbearing
nursery
stock
Short
grass
18.48
458
0.04
0.03
0.01
Tall
grass
8.47
0.02
0.01
0.003
Broadleaf/
forage
plants
and
small
insects
10.4
0.02
0.01
0.003
Fruits/
pods/
large
insects
1.16
0.002
0.002
0.004
Seeds
(
granivore)
1.16
0.0005
0.0004
0.0001
1
RQ
=
EEC
(
ppm)
LD50
(
mg/
kg)/
%
Body
Weight
Consumed
Note:
RQs
in
bold
print
signify
an
exceedence
of
the
acute
restricted
use
LOC
for
risk
to
mammals,
and
the
endangered
species
LOC.

Non­
Target
Insects
Available
data
from
a
honeybee
acute
contact
toxicity
study
indicated
that
technical
dimethipin
is
practically
nontoxic
to
the
honeybee
(
with
an
LD
50
>
100
ug/
bee)
and
its
uses
on
cotton
and
nonbearing
apple
nursery
stock
are
predicted
to
pose
minimal
risk
to
non­
target
insects.

Non­
Target
Terrestrial
Plants
22
There
is
insufficient
toxicity
data
to
evaluate
risk
to
non­
target
terrestrial
plants
from
use
of
dimethipin.
Dimethipin
is
used
as
an
herbicide
in
terrestrial
settings,
therefore
risk
to
terrestrial
plants
from
dimethipin
is
probable.

c.
Ecological
Incidents
No
ecological
incidents
reports
have
been
received
for
dimethipin.

d.
Endangered
Species
Concerns
The
Agency's
screening
level
ecological
assessment
for
dimethipin
resulted
in
a
determination
that
dimethipin
will
have
no
direct
acute
effects
on
threatened
and
endangered
avian,
and
aquatic
species
from
its
use
on
cotton
and
non­
bearing
apple
nursery
stock.
Additionally,
no
direct
acute
effects
are
expected
for
large
(>
1000g)
mammals,
as
well
as
no
chronic
effects
for
mammals
or
aquatic
animals.

Using
the
data
available,
RQs
for
15g
mammals
feeding
on
short
grass,
tall
grass,
and
broadleaf
plants
and
small
insects
exceed
the
acute
endangered
risk
LOC
of
0.1.
Additionally,
the
RQs
exceed
the
acute
endangered
risk
LOC
for
35g
mammals
feeding
on
short
grass
and
broadleaf
plants
and
small
insects.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
affect"
findings
under
the
ESA.
The
LOC
exceedences
for
these
endangered
animals
are
based
on
the
maximum
application
rate
of
0.56
lb
ai/
A
on
cotton,
0.077
lb
ai/
A
on
nonbearing
apple
nursery
stock,
and
a
35­
day
half­
life
default
value
in
the
exposure
analysis.

There
is
a
potential
for
direct
effects
on
terrestrial
plants,
should
exposure
to
listed
species
occur
(
since
dimethipin
is
a
defoliant).
Chronic
risks
have
not
been
assessed
for
avian
species
based
on
the
lack
of
available
chronic
data.
Additionally,
there
is
a
potential
for
indirect
effects
on
any
listed
species
that
is
either
dependent
upon
mammals
<
1000
grams
and
/
or
dependent
upon
terrestrial
plants,
and
occurs
within
areas
where
exposure
is
sufficient
to
produce
adverse
effects
on
small
mammals
and/
or
terrestrial
plants.
There
have
been
no
previous
consultations
with
the
Services
on
endangered
species
concerns
from
the
use
of
dimethipin.

e.
Risk
Characterization
The
screening
level
risk
assessment
for
dimethipin
is
conservative,
conducted
with
the
maximum
application
rate
of
0.56
lb
ai/
A
for
cotton
and
0.077
lb
ai/
A
for
nonbearing
apple
nursery
stock.
In
addition,
the
default
foliar
half
life
of
35
days
was
used
for
residues
of
dimethipin.

Freshwater
fish
and
aquatic
invertebrates
do
not
appear
to
be
at
acute
or
chronic
risk
from
exposure
to
dimethipin.
Similarly,
there
is
no
risk
of
concern
for
aquatic
plants
for
the
crop
scenarios
considered.
23
The
LOC
for
acute
restricted
use
(
LOC
0.2)
is
exceeded
for
15g
mammals
feeding
on
short
grass.
The
assessment
assumed
that
small
15g
mammals
were
consuming
100%
of
their
diet
from
short
grass.
The
small
mammals
were
the
only
category
that
exceeded
the
restricted
use
LOC.
There
are
no
exceedances
for
acute
mammal
LOCs
for
application
of
dimethipin
to
nonbearing
apple
nursery
stock.
None
of
the
chronic
LOCs
are
exceeded
for
application
of
dimethipin
to
cotton
or
nonbearing
apple
nursery
stock.

There
are
no
acute
risks
to
birds,
yet
chronic
risk
for
birds
cannot
be
precluded
as
there
are
no
chronic
data
available.
For
terrestrial
plants,
there
is
insufficient
data
to
evaluate
risk;
yet,
dimethipin's
herbicidal
properties
indicate
that
risk
is
probable.

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

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

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
provides
the
opportunity
for
stakeholders
and
the
public
to
engage
in
the
regulatory
process
for
dimethipin.
However,
during
the
public
comment
period
on
the
risk
assessments,
which
closed
on
April
26,
2005,
the
Agency
received
no
comments.

The
RED
and
technical
supporting
documents
for
dimethipin
are
available
to
the
public
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets,
under
docket
number
OPP­
2004­
0380.
The
public
may
access
EPA
Dockets
at
http://
www.
epa.
gov/
edockets.
In
addition,
24
the
dimethipin
RED
may
be
downloaded
or
viewed
through
the
Agency's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
this
pesticide.
EPA
has
determined
that
risk
from
dietary
(
food
sources
only)
exposure
to
dimethipin
is
within
its
own
"
risk
cup."
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
drinking
water.
The
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
In
other
words,
EPA
has
concluded
that
the
tolerances
for
dimethipin
meet
FQPA
safety
standards.

In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
exposure
to
residues
of
dimethipin,
the
Agency
considered
the
completeness
of
the
hazard
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children.
The
FQPA
Safety
Factor
has
been
reduced
to
1X
for
dimethipin
because:
1)
there
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
2)
no
residual
uncertainties;
and
3)
the
dietary
exposure
assessments
do
not
underestimate
the
potential
exposures
to
infants
and
children.

b.
Determination
of
Safety
to
the
U.
S.
Population
Including
Infants
and
Children
The
Agency
has
determined
that
the
established
tolerances
for
dimethipin
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
D)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
no
harm
will
result
to
the
general
population,
infants
and
children
or
any
subgroup
from
the
use
of
dimethipin.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
dimethipin.
As
discussed
in
Chapter
3,
the
total
acute
dietary
(
food
and
water)
risk
was
not
assessed,
since
no
appropriate
acute
endpoint
was
identified.
Chronic
aggregate
risks,
which
included
drinking
water
and
food,
do
not
exceed
levels
of
concern.
Estimated
aggregate
exposure
was
less
than
1%
of
the
cPAD
for
all
U.
S.
population
subgroups.

c.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
25
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
EPA
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
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
EDSP
have
been
developed,
dimethipin
may
be
subject
to
additional
screening
and/
or
testing.

d.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
dimethipin.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
assumed
that
dimethipin
shares
a
common
mechanism
of
toxicity
with
other
compounds.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

2.
Tolerance
Reassessment
Summary
a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.406
The
existing
tolerances
for
residues
of
dimethipin
(
2,3­
dihydro­
5,6­
dimethyl­
1,4­
dithiin
1,1,4,4­
tetraoxide)
are
established
under
40
CFR
§
180.406.
The
Agency
plans
to
revoke
the
tolerances
on
cotton
hulls,
and
the
fat
of
cattle,
goat,
hog,
horse,
and
sheep
(
see
Table
15).

Table
15.
Tolerance
Reassessment
Summary
for
Dimethipin
Commodity
Current
Tolerance
(
ppm)
Range
of
Residues
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
Tolerances
Listed
Under
40
CFR
§
180.406(
a):

Cotton,
undelinted
seed
0.5
<
0.10­
0.260
0.5
Cotton,
hulls
0.7
average
processing
factor
=
0.95x
Revoke
No
tolerance
for
cotton
hulls
is
necessary
because
residues
do
not
concentrate.
Table
15.
Tolerance
Reassessment
Summary
for
Dimethipin
Commodity
Current
Tolerance
(
ppm)
Range
of
Residues
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
26
Cattle,
fat
0.02
<
0.01
at
a
9.6x
dosing
level
Revoke
The
available
feeding
study
data,
reflecting
exaggerated
dosing
levels,
indicate
that
there
is
no
expectation
of
finite
residues.
However,
tolerances
should
be
maintained,
except
for
fat,
to
harmonize
with
CODEX
MRLs.
Tolerances
for
fat
should
be
revoked
as
there
are
no
CODEX
MRLs
for
fat.
Cattle,
meat
0.02
0.02
Cattle,
meat
byproducts
0.02
0.02
Goat,
fat
0.02
Revoke
Goat,
meat
0.02
0.02
Goat,
meat
byproducts
0.02
0.02
Hog,
fat
0.02
Revoke
Hog,
meat
0.02
0.02
Hog,
meat
byproducts
0.02
0.02
Horse,
fat
0.02
Revoke
Horse,
meat
0.02
0.02
Horse,
meat
byproducts
0.02
0.02
Sheep,
fat
0.02
Revoke
Sheep,
meat
0.02
0.02
Sheep,
meat
byproducts
0.02
0.02
Tolerances
to
be
Established
Under
40
CFR
180.406(
a):

Cotton,
gin
byproducts
­­
­­
TBD
b.
Codex
Harmonization
Results
from
feeding
studies,
reflecting
exaggerated
dosing
levels,
indicate
that
there
is
no
expectation
of
finite
residues
in
the
fat,
meat,
or
meat
byproducts
of
cattle,
goats,
horses,
hogs
or
sheep.
However,
the
Agency
recommends
that
the
tolerances
for
dimethipin
in
livestock
meat
and
meat
byproducts
be
retained
in
order
to
reflect
those
established
by
the
Codex
MRLs.
The
U.
S.
tolerances
for
livestock
meat
and
meat
byproducts
are
0.02
and
the
Codex
MRLs
for
livestock
meat
and
meat
byproducts
are
established
at
0.01
ppm.
The
Agency
recommends
that
tolerances
for
dimethipin
in
the
fat
of
cattle,
goats,
horses,
hogs
and
sheep
be
revoked
as
there
is
no
expectation
of
finite
residues
in
these
commodities
and
there
are
no
Codex
MRLs
established.
There
is
no
U.
S.
tolerance
for
dimethipin
in
milk
as
there
is
no
expectation
of
finite
residues.

D.
Regulatory
Rationale
The
Agency
has
determined
that
dimethipin
is
eligible
for
reregistration.
At
this
time,
the
Agency
has
not
identified
risks
that
require
mitigation
for
the
reregistration
of
dimethipin.
27
1.
Endangered
Species
Considerations
From
the
screening
level
assessment,
there
were
no
direct
acute
or
chronic
risks
noted
for
any
aquatic
animal
or
aquatic
plant.
In
addition,
no
direct
acute
risks
were
identified
for
endangered
birds.
The
screening
level
assessment
for
dimethipin
resulted
in
acute
endangered
species
risks
above
EPA's
level
of
concern
for
15g
mammals
feeding
on
short
grass,
tall
grass,
and
broadleaf
plants
and
small
insects.
In
addition,
the
RQ
exceeded
the
LOC
for
35g
mammals
feeding
on
short
grass
and
broadleaf
plants
and
small
insects.
There
are
no
chronic
risks
above
EPA's
level
of
concern
for
listed
mammals.
Chronic
risks
have
not
been
assessed
for
avian
species
based
on
the
lack
of
available
chronic
data.
There
is
a
potential
for
direct
effects
on
terrestrial
plants,
should
exposure
to
listed
species
occur.
In
addition,
there
is
a
potential
for
indirect
effects
on
any
listed
species
that
is
either
dependent
upon
mammals
<
1000
grams
and
/
or
dependent
upon
terrestrial
plants,
and
occurs
within
areas
where
exposure
is
sufficient
to
produce
adverse
effects
on
small
mammals
and/
or
terrestrial
plants.

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

Following
this
future
species­
specific
analysis,
a
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
or
its
critical
habitat
may
result
in:
limitations
on
the
use
of
dimethipin,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.
EPA
is
not
requiring
specific
dimethipin
label
language
at
the
present
time
relative
to
threatened
and
endangered
species.
If
in
the
future,
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.

2.
Spray
Drift
Management
The
Agency
has
been
working
closely
with
stakeholders
to
develop
improved
approaches
for
mitigating
risks
to
human
health
and
the
environment
from
pesticide
spray
and
dust
drift.
As
part
of
the
reregistration
process,
we
will
continue
to
work
with
all
interested
parties
on
this
important
issue.

From
its
assessment
of
dimethipin,
as
summarized
in
this
document,
the
Agency
concludes
that
no
additional
drift
mitigation
measures
are
needed
for
dimethipin.
In
the
future,
dimethipin
product
labels
may
need
to
be
revised
to
include
additional
or
different
drift
label
statements.
28
VI.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
dimethipin
is
eligible
for
reregistration
provided
that
additional
data
are
submitted
to
confirm
this
decision.
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
Notices
(
DCIs)
requiring,
product
specific
data
and
generic
(
technical
grade)
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extension
and/
or
waiver
requests
with
a
full
written
justification.
For
product
specific
data,
the
registrant
will
have
8
months
to
submit
data
and
amended
labels.
For
generic
data,
due
dates
can
vary
depending
on
the
specific
studies
being
required.
Below
are
tables
of
additional
generic
data
that
the
Agency
intends
to
require
for
dimethipin
to
be
eligible
for
reregistration.

A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
dimethipin
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
data
listed
below
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.

Table
16.
Data
Requirements
for
the
Reregistration
Eligibility
Decision
on
Dimethipin
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Crop
Field
Trials
(
Cotton
Gin
Byproducts
Group)
860.1500
171­
4K
Confined
Accumulation
in
Rotational
Crops
860.1850
165­
1
Storage
Stability
Data
­
Plant
Commodities
860.1380
171­
4E
Avian
Reproduction
Tests
(
Bobwhite
Quail
and
Mallard
Duck)
850.2300
71­
4A,
71­
4B
Early­
Life
Stage
Freshwater
Fish
850.1400
72­
4A
Fish
Life
Cycle
Study
850.1500
72­
5
Seedling
Germination
and
Seedling
Emergence,
Tier
II
850.4225
123­
1A
Vegetative
Vigor,
Tier
II
850.4250
123­
1B
The
Agency
is
also
asking
for
some
clarification
on
the
following
three
previously
submitted
studies:

1)
Prenatal
Developmental
Toxicity
(
Teratogenicity),
Rat:
Data
must
be
submitted
on
test
material
stability,
homogeneity,
and
concentration
in
the
dosing
medium.
2)
Prenatal
Developmental
Toxicity
(
Teratogenicity),
Rabbit:
Data
must
be
submitted
on
test
material
stability,
homogeneity,
and
concentration
in
the
dosing
medium.
3)
Chronic
Feeding
Toxicity
Study,
Non­
Rodent:
Data
must
be
submitted
on
historical
controls,
and
diet
homogeneity
and
stability.
29
2.
Labeling
for
Manufacturing­
Use
Products
To
ensure
compliance
with
FIFRA,
manufacturing
use
product
(
MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices,
and
applicable
policies.
Based
on
the
review
of
the
available
data,
the
EPA
has
determined
that
dimethipin
is
eligible
for
a
12
hour
REI
on
all
product
labels
except
for
those
containing
other
active
ingredients
with
more
restrictive
REIs.

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

2.
Labeling
for
End­
Use
Products
Currently,
there
are
no
required
labeling
changes
for
dimethipin.
30
31
VII.
Appendices
32
Appendix
A.
Food/
Feed
Use
Patterns
Subject
to
Reregistration
for
Dimethipin
Site
Application
Tyoe
Application
Timing
Application
Equipment
Maximum
Single
Application
Rate
(
lb
ai/
A)
Maximum
Number
of
Applications
Per
Year
Maximum
Yearly
Rate
(
lb
ai/
A)
Preharvest
Interval
(
Days)
Limitations
Cotton
Use
Directions:

Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.

Do
not
apply
through
any
type
of
irrigation
system.

Do
not
apply
when
drift
is
likely
to
occur.

Do
not
apply
when
wind
velocity
is
10
mph
or
greater.

Do
not
contaminate
water
by
cleaning
of
equipment
or
disposal
of
equipment
wash
waters.

Do
not
contaminate
water,
food,
or
feed
by
storage
or
disposal.

Rotational/
plant
back
crop
restriction.

Spray
After
boll­
opening
Aircraft/
Ground
0.31
2
NS
7­
14
Geographic
Allowable:
CA
Broadcast/
Low
volume
spray
(
concentrate)/
Spray
Ground
Fixed
boom
0.31
2
NS
7­
14
Geographic
Allowable:
AL,
AR,

FL,
GA,
KS,
LA,
MO,
MS,
NC,

NM,
OK
(
eastern),
SC,
TN,
TX
(
eastern
including
the
Rio
Grande)

Spray
Pre­
harvest
Defoliant
Aircraft/
Ground
0.38
2
0.56
7­
14
Geographic
Allowable:
AL,
AR,

FL,
GA,
KS,
LA,
MO,
MS,
NC,

OK
(
eastern),
SC,
TN,
TX
(
eastern
including
the
Rio
Grande),
VA
33
Spray
Post­
Emergent
Herbicide
Aircraft/
Ground
0.56
2
0.54
­
0.56
7­
14
Geographic
Allowable:
AL,
AR,

FL,
GA,
LA,
MO,
MS,
NC,
OK
(
eastern),
SC,
TN,
TX
(
eastern
including
the
Rio
Grande),
VA
NonBearing
Apple
Nursery
Stock
Use
Directions:

Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.

Do
not
apply
through
any
type
of
irrigation
system.

Do
not
apply
when
drift
is
likely
to
occur.

Do
not
apply
when
wind
velocity
is
10
mph
or
greater.

Do
not
contaminate
water
by
cleaning
of
equipment
or
disposal
of
equipment
wash
waters.

Do
not
contaminate
water,
food,
or
feed
by
storage
or
disposal.

Rotational/
plant
back
crop
restriction.

Spray
0.08
NS
NS
5
Geographic
Allowable:
WA­
24(
c)
34
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

PRODUCT
CHEMISTRY
New
Guideline
Number
Old
Guideline
Number
830.1550
61­
1
Product
Identity
and
Composition
AB
41943801,
CSF
12/
17/
92
830.1600
830.1620
830.1650
61­
2A
Starting
Material
&
Manufacturing.

Process
AB
42282701,41943802
830.1670
61­
2B
Formation
of
Impurities
AB
41943803
830.1700
62­
1
Preliminary
Analysis
AB
40361401,
41457601,
41967001
830.1750
62­
2
Certification
of
Limits
AB
41967002,
CSF
12/
17/
92
830.1800
62­
3
Analytical
Method
AB
41967003
830.6302
63­
2
Color
AB
40410302
830.6303
63­
3
Physical
State
AB
40410302
830.6304
63­
4
Odor
AB
40410302
830.6313
63­
13
Stability
to
Normal
and
Elevated
Temperature,
Metals
and
Metal
Ions
AB
40410302,
41655605,
41655606
830.7200
63­
5
Melting
Point/
Melting
Range
AB
41655601,
40410302
830.7300
63­
7
Density
AB
40410302,
41655602
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

35
830.7840
63­
8
Water
Solubility
AB
41967004,
41967005,
40410302
830.7950
63­
9
Vapor
Pressure
AB
40410302,
43898701
830.7370
63­
10
Dissociation
Constant
AB
41655603
830.7550
63­
11
Octanol/
Water
Partition
Coefficient
AB
42282702,
40410302
830.7000
63­
12
pH
AB
40410302,
41655604
ECOLOGICAL
EFFECTS
850.2100
71­
1A
Avian
Acute
Oral
Toxicity
­
Quail/
Duck
AB
41955901
850.2200
71­
2A
Avian
Dietary
Toxicity
­
Quail
AB
41945901­
Supplemental
850.2200
71­
2B
Avian
Dietary
Toxicity
­
Duck
AB
41955902
850.2300
71­
4A
Avian
Reproduction­
Quail
AB
DATA
GAP
850.2300
71­
4B
Avian
Reproduction­
Duck
AB
DATA
GAP
850.1075
72­
1A
Freshwater
Fish
Acute
Toxicity
Bluegill
AB
41945902
850.1075
72­
1C
Freshwater
Fish
Acute
Toxicity
Rainbow
Trout
AB
41945903
850.1010
72­
2A
Freshwater
Invertebrate
Acute
Toxicity
AB
41945904,
00086315
850.1010
72­
2B
Freshwater
Invertebrate
Acute
Toxicity
(
Formulated
Product)
46063401­
Supplemental
850.1075
72­
3A
Estuarine/
Marine
Toxicity
­
Fish
AB
41663901
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

36
850.1025
72­
3B
Estuarine/
Marine
Toxicity
­
Mollusk
AB
42643101,
41666501
­
Supplemental
850.1035
72­
3C
Estuarine/
Marine
Toxicity
­
Shrimp
AB
41663902
850.1350
72­
4B
Freshwater
Aquatic
Invertebrate­
Life
Cycle
AB
128803
850.1500
72­
4B
Fish
Life
Cycle
Study
AB
DATA
GAP
850.1400
72­
4A
Freshwater
Fish­
Early
Life
Stage
AB
DATA
GAP,
00126069
­
Supplemental
850.3020
141­
1
Honey
Bee
Acute
Contact
(
Formulated
Product)
AB
41264606
850.4225
123­
1A
Seed
Germ/
Seedling
Emergence
AB
DATA
GAP
850.4250
123­
1B
Vegetative
Vigor
AB
DATA
GAP
850.4400
123­
2
Aquatic
Plant
Growth,
Tier
2
AB
41264605,
42627103,
42627102,
42627101,
42627104
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity­
Rat
AB
42429601
870.1200
81­
2
Acute
Dermal
Toxicity­
Rabbit
AB
42429602
870.1300
81­
3
Acute
Inhalation
Toxicity­
Rat
AB
42429603
870.2400
81­
4
Primary
Eye
Irritation­
Rabbit
AB
70236
870.2500
81­
5
Primary
Skin
Irritation
AB
42429604
870.2600
81­
6
Dermal
Sensitization
AB
42429605
870.3100
82­
1A
90­
Day
Oral
Toxicity
­
Rat
AB
43065901
870.3200
82­
2
21/
28­
Day
Dermal
Toxicity­
Rat
AB
41944901
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

37
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Non­
Rodent
(
Dog)
AB
93089030,
9389008**
Upgradeable
870.4200
83­
2A
Carcinogenicity
­
Rat
AB
43897601
870.4200
83­
2B
Carcinogenicity
­
Mouse
AB
93089031,
93089008
870.3700A
83­
3A
Developmental
Toxicity
­
Rat
AB
93089032,
93089009
**
Upgradeable
870.3700B
83­
3B
Developmental
Toxicity
­
Rabbit
93089033,
93089010,
44988701**
Upgradeable
870.3800
83­
4
2­
Generation
Reproduction
­
Rat
AB
93089034,
93089011
870.5100
84­
2
Bacterial
Reverse
Gene
Mutation
Assay
Test
93089035,
93089012
870.5140
84­
2A
Gene
Mutation
(
Ames
Test)
AB
133302
870.5300
84­
2
Gene
Mutations
in
Somatic
Cells
in
Culture
(
In
Vitro),
Mammalian
AB
93089041,
93089029
870.5375
84­
2B
In­
Vitro
Mammalian
Cytogenetics
Tests
(
Structural
Chromosomal
Aberration)
AB
40479602,
133302
870.5395
84­
2
In­
Vitro
Mammalian
Cytogenetics
Tests
(
Erythrocyte
Micronucleus
Assay)
AB
40479602,
41708201
870.5900
84­
2
In­
Vitro
Sister
Chromatid
Exchange
Assay
AB
93089036,
93089015,
42282705
870.5550
84­
4
Other
Genotoxic
Effects
AB
40479601,
93089016
870.7485
85­
1
General
Metabolism
AB
41323301,
41323302,
41612401
ENVIRONMENTAL
FATE
None
160­
5
Chemical
Identity
41943801
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

38
835.2120
161­
1
Hydrolysis
AB
80106­
Supplemental
835.2240
161­
2
Photodegradation
­
Water
AB
41967101­
Supplemental
835.2410
161­
3
Photodegradation
­
Soil
AB
42237601­
Supplemental
835.2370
161­
4
Photodegradation
in
Air
AB
N/
A
835.4100
162­
1
Aerobic
Soil
Metabolism
AB
42429606­
Supplemental
835.4200
162­
2
Anaerobic
Soil
Metabolism
AB
N/
A
835.4400
162­
3
Anaerobic
Aquatic
Metabolism
AB
42673501­
Supplemental
835.4300
162­
4
Aerobic
Aquatic
Metabolism
AB
N/
A
835.1410
163­
2
Laboratory
Volatility
AB
N/
A
835.8100
163­
3
Field
Volatility
AB
N/
A
835.1240
835.1230
163­
1
Leaching/
Adsorption/
Desorption
AB
41660901­
Supplemental
835.6100
164­
1
Terrestrial
Field
Dissipation
AB
43216001,
43216002
835.6200
164­
2
Aquatic
Field
Dissipation
AB
N/
A
850.1700
165­
4
Accumulation
in
Fish
AB
N/
A
850.2000
165­
5
Accumulation
Aquatic
Non­
Target
Organisms
AB
N/
A
RESIDUE
CHEMISTRY
860.1300
171­
4A
Nature
of
Residue
­
Plants
AB
43436901,
00136860,
00085669
93089025
93089038
42467002,
42920903,
43109801,
43979103
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dimethipin
REQUIREMENT
USE
PATTERN
CITATION(
S)

39
860.1300
171­
4B
Nature
of
Residue
­
Livestock
AB
42706001,
43086701,
43922101
860.1340
171­
4C
Residue
Analytical
Method
­

Plants/
Animals
AB
43109801*
Method
should
be
forwarded
to
FDA,
42920903,

93089038,
42467002,00085669
00136860
93089025
431098011
439791032
860.1340
171­
4D
Residue
Analytical
Method­
Animal
AB
43966401,
44147201,
44147202
860.1360
171­
4M
Multiresidue
Method
AB
43096501
860.1380
171­
4E
Storage
Stability
Data
­
Plant
Commodities
AB
DATA
GAP­
42712701,
43931401
*
Storage
stability
data
are
required
to
support
the
field
rotational
crop
studies
Storage
Stability
Data­
Livestock
Commodities
AB
43966401,
44190001
860.1480
171­
4J
Magnitude
of
Residues
­
Meat/
Milk/
Poultry
/
Egg
AB
43966401,44147201,44147202
860.1500
171­
4K
Crop
Field
Trials
(
Cotton,
seed,
gin
byproducts)
AB
DATA
GAP­
42467001,
42920901,
43184101*
Crop
field
trial
data
for
cotton
gin
byproducts
must
be
submitted
860.1520
171­
4L
Magnitude
of
Residue
in
Processed
Food/
Feed
AB
00080098,
00085666,
93089026,
93089039,
42920902
860.1850
165­
1
Confined
Accumulation
in
Rotational
Crops
AB
DATA
GAP­
42666301,
42757801,
43768201,
43768202,

43931301*
Additional
storage
stability
data
information
comparing
the
chromatographic
profiles
of
stored
samples
with
those
from
the
original
analysis
is
required
to
support
the
supplemental
confined
rotational
crop
data
860.1900
165­
2
Field
Accumulation
in
Rotational
Crops
AB
43979101,
43979102
40
41
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,
1801
South
Bell
Street,
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
August
10,
1998.
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
June
16,
1999.

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/
reregistration
These
documents
include:

HED
Documents:

8.
Dimethipin:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED).
August
26,
2004.

9.
Dimethipin:
Residue
Chemistry
Considerations
for
Reregistration
Eligibility
Decision.
July
22,
2004.

10.
Dimethipin
Chronic
Dietary
Exposure
Assessment
for
the
Reregistration
Eligibility
Decision.
August
18,
2004.

11.
Tier
I
Estimated
Environmental
Concentrations
of
Dimethipin,
for
use
in
Human
Health
Risk
Assessment.
June
24,
2004.

12.
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Dimethipin.
June
8,
2004.

13.
Dimethipin.
HED
Product
Chemistry
Chapter
for
Reregistration
Eligibility
Decision.
March
25,
2004.

14.
Dimethipin.
Report
of
the
Health
Effects
Division
(
HED)
Risk
Assessment
Review
Committee
(
RARC).
August
5,
2004.

EFED
Documents:

8.
Environmental
Fate
and
Ecological
Effects
Risk
Assessment
for
the
Reregistration
of
Dimethipin.
November
18,
2004.

9.
Reregistration
Environmental
Risk
Assessment
for
Dimethipin.
November
18,
2004.
42
Appendix
D.
CITATIONS
CONSIDERED
TO
BE
PART
OF
THE
DATA
BASE
SUPPORTING
THE
INTERIM
REREGISTRATION
DECISION
(
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.
43
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
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
selfexplanatory
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.
44
Appendix
D.
Bibliography
for
Dimethipin
MRID
CITATION
80098
Uniroyal
Chemical
(
1981)
Residue
of
Harvade
in
Cottonseed.

(
Compilation;
unpublished
study
received
Aug
19,
1981
under
1F2560;
CDL:
070238­
M)

80106
Harned,
W.
H.;
Fitzpatrick,
K.
C.
(
1981)
Hydrolysis
of
Harvade­­
Part
A,

Half­
life
Determinations:
Project
No.
7603­
A.
(
Unpublished
study
received
Aug
19,
1981
under
1F2560;
submitted
by
Uniroyal
Chemical,

Bethany,
Conn.;
CDL:
070240­
C)

85666
Uniroyal
Chemical
(
1981)
Harvade
(
R)
I
Residues
in
Cottonseed.
(

Unpublished
study
received
Aug
19,
1981
under
1F2560;
CDL:
070238­

L)

85669
Womer,
J.
M.;
Sisken,
H.
R.
(
1975)
Determination
of
N252
Residues
in
Cottonseed:
Project
No.
7524.
Method
dated
Oct
29,
1975.
(

Unpublished
study
received
Aug
19,
1981
under
1F2560;
submitted
by
Uniroyal
Chemical,
Bethany,
Conn.;
CDL:
070238­
P)

85676
Blem,
A.
R.
(
1981)
Letter
sent
to
R.
B.
Ames
dated
Jul
22,
1981:

Response
of
greenhouse­
grown
plants
to
Harvade^(
R)
I
applied
as
an
irrigation
water
contaminant
and
as
a
spray
drift
to
freshly
sown
soil
or
to
plant
foliage.
(
Unpublished
study
received
Aug
19,
1981
under
1F2560;

submitted
by
Uniroyal
Chemical,
Bethany,
Conn.;
CDL:
070239­
F)

86315
LeBlanc,
G.
A.
(
1977)
Acute
Toxicity
of
N252
to
the
Water
Flea
(
Daphnia
magna).
(
Unpublished
study
received
Mar
31,
1978
under
400­
EX­
53;

prepared
by
EG
&
G,
Bionomics,
submitted
by
Uniroyal
Chemical,
Bethany,

Conn.;
CDL:
097014­
D)

126069
LeBlanc,
G.;
Mastone,
J.;
Wilson,
B.;
et
al.
(
1982)
The
Toxicity
of
Harvade
to
Fathead
Minnow
...
Embryos
and
Larvae:
Report
#
BW­
82­
4­
1147.
45
(
Unpublished
study
received
Jan
31,
1983
under
400­
155;
prepared
by
EG
&

G,
Bionomics,
submitted
by
Uniroyal
Chemical,
Bethany,
CT;
CDL:
249420­

A)

126070
LeBlanc,
G.;
Mastone,
J.;
Surprenant,
D.;
et
al.
(
1982)
The
Chronic
Toxicity
of
Harvade
to
the
Water
Flea
...:
Report
#
BW­
82­
4­
1159.

(
Unpublished
study
received
Jan
31,
1983
under
400­
155;
pre­
pared
by
EG
&
G,
Bionomics,
submitted
by
Uniroyal
Chemical,
Bethany,

CT;
CDL:
249420­
B)

128803
Forbis,
A.;
Franklin,
L.;
Lawman,
K.;
et
al.
(
1982)
Chronic
Toxicity
of
Harvade
to
Daphnia
magna
under
Flow­
through
Test
Conditions
ABC
#
29355.
Final
rept.
(
Unpublished
study
received
Jan
31,
1983
under
400­
155;
prepared
by
Analytical
Bio­
Chemistry
Laboratories,
Inc.,
submitted
by
Uniroyal
Chemical,
Bethany,
CT;

CDL:
249420­
C)

133302
Sorg,
R.;
Naismith,
R.;
Matthews,
R.
(
1983)
CHO
Metaphase
Analysis
in
vitro
Chromosome
Aberration
Analysis
in
Chinese
Hamster
Ovary
Cells
(
CHO):
Harvade:
PH
320­
UN­
001­
83.
(
Unpublished
study
received
Oct
18,
1983
under
400­
155;
prepared
by
Pharmakon
Re­
search
International,
Inc.,
submitted
by
Uniroyal
Chemical,
Bethany,
CT;

CDL:
072195­
A)

160460
Najarian;
Piccirillo,
V.
(
1977)
4­
Week
Toxicity
Study
in
Mice:
N­
252
Harvade
Technical:
Final
Report:
Project
No.
798­
179.
Un­
published
study
prepared
by
Hazleton
Laboratories
America,
Inc.
13
p.

40361401
Tsai,
A.;
Mertz,
J.;
Hageman,
F.
(
1987)
Preliminary
Analysis
of
Product
Samples
to
Support
Registration
of
Harvade
(
Dimethipin)
Technical.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.
26
p.

40410302
Spare,
W.;
Steeves,
S.;
Harned,
W.
(
1987)
Chemical
and
Physical
Properties
of
Harvade
(
Dimethipin)
Technical.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.
117
p.

40479601
Benford,
D.
(
1987)
In
vivo/
in
vitro
UDS
Study:
8604
(
Harvade):
Report
46
No.
4/
86/
TX.
Unpublished
study
prepared
by
University
of
Surrey,
The
Robens
Institute.
29
p.

40479602
Mosesso,
P.
(
1984)
Micronucleus
Test:
Dimethipin
Technical:
Project
No.
131002­
M­
00184.
Unpublished
study
prepared
by
Life
Sciences
Research.
42
p.

41264605
Richards,
C.;
Kaiser,
F.
(
1982)
Acute
Toxicity
of
Technical
Grade
Harvade
to
Selenastrum
capricornutum
Printz:
Project
ID
Static
Acute
Bioassay
Report
#
29462.
Unpublished
study
prepared
by
Analytical
Bio­

Chemistry
Laboratories,
Inc.
37
p.

41264606
Cole,
J.
(
1985)
The
Acute
Oral
and
Contact
Toxicity
to
Honey
Bees
of
Harvade­
25F:
Project
ID
URL
26/
85835.
Unpublished
study
prepared
by
Huntingdon
Research
Centre,
Ltd.
11
p.

41323301
McManus,
J.
(
1989)
Metabolism
of
(
Carbon
14)
Dimethipin
(
Harvade)
in
the
rat:
Lab
Project
Number:
85125.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.
23
p.

41323302
McManus,
J.
(
1987)
Analysis
of
Urine
Samples
from
Dimethipin
(
Harvade)
Rat
Pharmaco­
kinetic
Study:
Lab
Project
Number:
8681.

Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.
21
p.

41457601
Uniroyal
Chemical
Co.,
Inc.
(
1990)
Submittal
of
Samples
of
TGAI
and
Sample
of
PAI
Analytical
Standard
with
Analytical
Method
for
Active
Ingredient
To
Support
Registration
Application
for
Harvade
Tech.
(...):
Lab
Method
No.
AC­
1086C.
Unpublished
study.
33
p.

41612401
Byrd,
J.
(
1989)
A
(
Carbon
14)­
Radiolabeled
Pharmacokinetics
and
Metabolism
Study
in
the
Rat
Using
Harvade
(
Dimethipin):
Lab
Pro­
ject
Number:
8656R;
8732.
Unpublished
study
prepared
by
South­
west
Labs,

Inc.
169
p.

41655601
Riggs,
A.
(
1990)
The
Melting
Point
Range
of
Technical
Harvade:
Lab
Project
Number:
89120:
GRL­
10066.
Unpublished
study
prepared
by
Uniroyal
Chemical
Ltd.
14
p.
47
41655602
Thomson,
P.
(
1989)
Determination
of
the
Density
of
Harvade
Using
a
Helium
Pycnometer:
Lab
Project
Number:
89121:
GRL­
10031.
Unpub­
lished
study
prepared
by
Uniroyal
Chemical
Ltd.
15
p.

41655603
Thomson,
P.
(
1990)
Determination
of
the
Dissociation
Constant
of
Harvade
Using
a
Spectrophotometric
Method:
Lab
Project
Number:
89124:
GRL­
10034.

Unpublished
study
prepared
by
Uniroyal
Chemi­
cal
Ltd.
19
p.

41655604
Thomson,
P.
(
1990)
Determination
of
the
pH
of
Harvade:
Lab
Project
Number:

89125:
GRL­
10035.
Unpublished
study
prepared
by
Uniroyal
Chemical
Ltd.
13
p.

41655605
Riggs,
A.
(
1990)
Accelerated
Storage
Test
for
Technical
Harvade:
Lab
Project
Number:
89126A:
GRL­
10063.
Unpublished
study
pre­
pared
by
Uniroyal
Chemical
Ltd.
25
p.

41655606
Riggs,
A.
(
1990)
The
Stability
of
Technical
Harvade
in
the
Presence
of
Metals
and
Metal
Ions:
Lab
Project
Number:
89126B:
GRL­
1006.
Unpublished
study
prepared
by
Uniroyal
Chemical
Ltd.
31
p.

41660901
Spare,
W.
(
1990)
Dimethipin:
Harvade
Technical:

Adsorption/
Desorption
of
Carbon
14
Harvade:
Lab
Project
Number:

1917:
9063.
Unpublished
study
prepared
by
Agrisearch
Inc.
68
p.

41663901
Ward,
G.
(
1990)
Harvade
Technical:
Acute
Toxicity
to
Sheepshead
minnow,

Cyprinodon
variegatus,
Under
Flow­
through
Test
Condition
Lab
Project
Number:
J9002002B:
HAR00062.
Unpublished
study
pre­
pared
by
Toxikon
Environmental
Sciences.
34
p.

41663902
Ward,
G.
(
1990)
Harvade
Technical:
Acute
Toxicity
to
the
Mysid,

Mysidopsis
bahia,
Under
Flow­
through
Test
Conditions:
Lab
Pro­
ject
Number:
J90020022A:
HAR00063.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
33
p.

41666501
Ward,
G.
(
1990)
Harvade
Technical:
Acute
Effect
on
New
Shell
Growth
of,

the
Eastern
Oyster,
Crassostrea
virginica,
Under
Flow­
through
Conditions:

Lab
Project
Number:
J900200C:
HAR00064.
Un­
published
study
prepared
48
by
Toxikon
Environmental
Sciences.
40
p.

41708201
Mosesso,
P.
(
1986)
Micronucleus
Test/...:
Dimethipin
Technical:
Lab
Project
Number:
LSR­
RTC
180001­
M­
06886.
Unpublished
study
prepared
by
Life
Science
Research/
Roma
Toxicology
Centre.
61
p.

41943801
Pierce,
J.
(
1991)
Dimethipin
(
Harvade):
Chemical
Identity:
Lab
Pro­
ject
Number:

9181.
Unpublished
study
prepared
by
Uniroyal
Chem­
ical
Co.,
Inc.
8
p.

41943802
Pierce,
J.
(
1991)
Dimethipin:
Beginning
Materials
and
Manufacturing
Process:
Lab
Project
Number:
9102.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.

70
p.

41943803
Pierce,
J.
(
1991)
Theoretical
Discussion
of
Possible
Impurities
in
Dimethipin:
Lab
Project
Number:
9178.
Unpublished
study
prepar­
ed
by
Uniroyal
Chemical
Co.,

Inc.
10
p.

41944901
Goldenthal,
E.
(
1991)
21­
Day
Dermal
Toxicity
Study
in
Rats:
Lab
Project
Number:
399­
116.
Unpublished
study
prepared
by
Interna­
tional
Research
and
Development
Corp.
199
p.

41945901
Pedersen,
C.
(
1991)
Harvade
Technical:
8­
Day
Acute
Dietary
LC50
Study
in
Bobwhite
Quail:
Supplement:
Lab
Project
No:
109­
004­
01.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
67
p.

41945902
Pedersen,
C.
(
1991)
Harvade
Technical:
8­
Day
Acute
Dietary
LC50
Study
in
Bobwhite
Quail:
Supplement:
Lab
Project
No:
J9011001C.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
35
p.

41945903
Ward,
G.
(
1991)
Harvade
Technical:
Acute
Toxicity
to
Rainbow
Trout,

Oncorhynchus
mykiss,
Under
Flow­
through
Test
Conditions:
Supple­
mental
Submission:
Lab
Project
Number:
J9011001D.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
34
p.

41945904
Ward,
G.
(
1991)
Harvade
Technical:
Acute
Toxicity
to
the
Water
Flea
Daphnia
magna,
under
Flow­
through
Test
Conditions:
Lab
Project
Number:

J9011001B.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
34
p.
49
41955901
Pedersen,
C.;
Helsten,
B.
(
1991)
Harvade
Technical:
Acute
Oral
LD50
Study
in
Mallard
Ducks:
Lab
Project
Number:
109­
006­
04.
Unpubl­
ished
study
prepared
by
Bio­
Life
Associates,
Ltd.
46
p.

41955902
Pedersen,
C.
(
1991)
Harvade
Technical:
Acute
Oral
LC50
study
in
Mallard
Ducklings:
Lab
Project
Number:
109­
005­
02.
Unpublished
study
prepared
by
Bio­
Life
Assoc.
Ltd.
74
p.

41967001
Mitchell,
D.
(
1991)
Compositional
Analysis
of
Technical
Harvade:
Lab
Project
Number:
GRL­
10134:
9061.
Unpublished
study
prepared
by
Uniroyal
Chemical
Ltd.
61
p.

41967002
Pierce,
J.
(
1991)
Dimethipin:
Guaranteed
Limits
and
Confidential
Statement
of
Formula:
Lab
Project
Number:
91106.
Unpublished
prepared
by
Uniroyal
Chemical
Co.
12
p.

41967003
Mitchell,
D.
(
1991)
Development
of
Analytical
methods
for
the
Comp­
ositional
Analysis
of
Technical
Harvade:
Lab
Project
Number:
GRL
10201:
9112.

Unpublished
study
prepared
by
Uniroyal
Chemical
Ltd.
86
p.

41967004
Spare,
W.
(
1987)
Solubility
of
Harvade:
Lab
Project
Number:
1904:
8
8709.

Unpublished
study
prepared
by
Agrisearch,
Inc.
43
p.

41967005
Young,
K.
(
1991)
Solubility
of
Harvade
in
Organic
Solvents
and
Aqu­
eus
Buffers:
Lab
Project
Number:
GRL­
10133:
9060.
Unpublished
study
prepared
by
Uniroyal
Chem.
Ltd.
56
p.

41967101
Fackler,
P.
(
1991)
Harvade:
Determination
of
Aqueous
Photolysis
Rate
Constant
and
Half
Life:
Final
Report:
Lab
Project
Number:
91­
7­
3830:

41.0391.6121.720.
Unpublished
study
prepared
by
Springborn
Labs,

Inc.
55
p.

42237601
Fackler,
P.
(
1992)
Harvade­­
Determination
of
Soil
Photolysis
Rate
Constant
and
Half­
Life:
Lab
Project
Number:
91­
9­
3910:
41.

0391.6120.721:
9117.
Unpublished
study
prepared
by
Springborn
Labs.,

Inc.
39
p.
50
42282701
Pierce,
J.
(
1992)
Supplemental
Information
for:
Dimethipin:
Beginning
Materials
and
Manufacturing
Process:
Lab
Project
Number:
9102.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.
5
p.

42282702
Steeves,
E.
(
1986)
Octanol/
Water
Partition
Coefficient
of
Dimethipin:
Lab
Project
Number:
8670.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,

Inc.
10
p.

42282705
Story,
D.
(
1992)
Phase
3
Summary
of
MRID
80000:
Mutagenicity
Evaluation
of
Harvade
(
N252)
98%
D­
11401
in
the
Sister
Chromatid
Exchange
Assay
with
Chinese
Hamster
Ovary
(
CHO)
Cells:
Lab
Project
Number:
20990.
Unpublished
study
prepared
by
Litton
Bionetics,
Inc.
7
p.

42429601
Blaszcak,
D.
(
1992)
Acute
Oral
Toxicity
Study
in
Rats
with
Harvade
Technical:
Final
Report:
Lab
Project
Number:
6169­
91.
Unpublished
study
prepared
by
Bio/
Dynamics,
Inc.
22
p.

42429602
Blaszcak,
D.
(
1992)
Acute
Dermal
Toxicity
Study
in
Rabbits
with
Harvade
Technical:
Final
Report:
Lab
Project
Number:
6170­
90.
Unpublished
study
prepared
by
Bio/
Dynamics,
Inc.
15
p.

42429603
Hoffman,
G.
(
1992)
An
Acute
Nose­
Only
Inhalation
Toxicity
Study
of
Harvade
Technical
in
the
Rat:
Final
Report:
Lab
Project
Number:
91­
8376.

Unpublished
study
prepared
by
Bio/
Dynamics,
Inc.
110
p.

42429604
Blaszcak,
D.
(
1992)
Primary
Dermal
Irritation
Study
in
Rabbits
with
Harvade
Technical:
Final
Report:
Lab
Project
Number:
6171­
91.

Unpublished
study
prepared
by
Bio/
Dynamics,
Inc.
14
p.

42429605
Glaza,
S.
(
1992)
Supplemental
Information:
Generic
Protocol
for
Dermal
Sensitization
Study
with
Harvade
Technical
Grade:
Lab
Project
Number:

RT
735698.
Unpublished
study
prepared
by
Bio/
Dynamics,
Inc.
9
p.

42429606
Dzialo,
D.
(
1992)
Harvade
carbon
14|
Aerobic
Soil
Metabolism
on
Sandy
Loam
Soil:
Lab
Project
Number:
9054.
Unpublished
study
51
prepared
by
Uniroyal,
Crop
Protection
Dept..
36
p.

42467001
Korpalski,
S.
(
1992)
Harvade
5F
on
Cotton:
Magnitude
of
the
Residue:
Lab
Project
Number:
A026.010:
RP­
91034.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services.
575
p.

42467002
Korpalski,
S.
(
1992)
Harvade
in
Cotton
Seed:
Method
Validation:
Lab
Project
Number:
A026.009:
RP­
91056.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services.
73
p
42627101
McElwee,
C.
(
1993)
Harvade
Technical:
Acute
Toxicity
to
the
Freshwater
Blue­
green
Alga,
Anabaena
flos­
aquae,
under
Static
Test
Conditions:
Lab
Project
Number:
J9209004D.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
26
p.

42627102
McElwee,
C.
(
1993)
Harvade
Technical:
Acute
Toxicity
to
the
Freshwater
Diatom,
Nitzschia
palea,
under
Static
Test
Conditions:
Lab
Project
Number:
J9209004E.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
28
p.

42627103
McElwee,
C.
(
1993)
Harvade
Technical:
Acute
Toxicity
to
the
Saltwater
Diatom,
Skeletonema
costatum,
under
Static
Test
Conditions:
Lab
Project
Number:
J9209004F.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
27
p.

42627104
McElwee,
C.
(
1993)
Harvade
Technical:
Acute
Toxicity
to
Duckweed,

Lemna
gibba
G3,
under
Static
Test
Conditions:
Lab
Project
Number:

J9209004G.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
25
p.

42643101
McElwee,
C.
(
1993)
Harvade
Technical:
Acute
Effect
on
New
Shell
Growth
of
the
Eastern
Oyster,
Crassostrea
Virginica,
Under
Flow­
Through
Conditions:
Lab
Project
Number:
J9210002.
Unpublished
study
prepared
by
Toxikon
Environmental
Sciences.
38
p.

42666301
Perhach,
M.;
Jalal,
M.
(
1993)
A
Confined
Rotational
Crop
Study
on
Harvade
(
30
Day
Aging):
Dimethipin:
Lab
Project
Number:
ML­
91­

725:
9174.
Unpublished
study
prepared
by
Pan­
Agricultural
Labs.,
52
Inc.
165
p.

42673501
Dzialo,
D.
(
1993)
Anaerobic
Aquatic
Metabolism:
(
carbon
14)­

Harvade:
Lab
Project
Number:
9018.
Unpublished
study
prepared
by
Uniroyal.
45
p.

42706001
Lau,
R.;
Gay,
M.
(
1993)
Nature
of
the
Residue
of
(
carbon
14)­

Harvade
in
Laying
Hen:
Lab
Project
Number:
91121:
91104:
URC­

01­
91.
Unpublished
study
prepared
by
Uniroyal
and
Enviro­
Bio­

Tech,
Ltd.
435
p.

42712701
Korpalski,
S.
(
1993)
Freezer
Storage
Stability
of
Harvade
(
Dimethipin)
in
Cottonseed:
Lab
Project
Number:
A026.011:
RP­

91055.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services,
Division
of
Empire
Soils
Investigations,
Inc.
95
p.

42757801
Perhach,
M.
(
1993)
A
Confined
Rotational
Crop
Study
on
HARVADE
(
183
Day
Aging):
Dimethipin:
A
Supplement:
Lab
Project
Number:
9183:
ML­
91­
726.
Unpublished
study
prepared
by
Pan­
Agricultural
Labs,
Inc.
233
p.

42920901
Korpalski,
S.
(
1993)
HARVADE
5F
on
Cotton:
Magnitude
of
the
Residue:
Lab
Project
Number:
RP­
92026:
ML92­
0345­
UNI.

Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
299
p.

42920902
Korpalski,
S.
(
1993)
HARVADE
5F
on
Cotton:
Processing
Study:

Lab
Project
Number:
ML92­
0346­
UNI:
RP­
92027.
Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
293
p.

42920903
Korpalski,
S.
(
1993)
Method
Validation
for
HARVADE
in
Cottonseed
and
Commodities
Generated
from
Cottonseed
Processing:

Lab
Project
Number:
ML92­
0347­
UNI:
RP­
92033.
Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
89
p.

43065901
Goldenthal,
E.
(
1993)
13
Week
Dietary
Toxicity
Study
in
Rats:
Dimethipin:

Lab
Project
Number:
399­
133.
Unpublished
study
prepared
by
International
Research
and
Development
Corp.
248
p.
53
43086701
Byrd,
J.
(
1992)
Nature
of
the
Residue
of
Radiolabeled
HARVADE
in
Lactating
Goat:
Part
I.
(
Dimethipin)
Lab
Project
Number:
9202,

9275G.
Unpublished
study
prepared
by
Southwest
Bio­
Labs,
Inc.
109
p.

43096501
Thiem,
D.;
Rhoads,
W.
(
1994)
Multiresidue
Study:
Testing
of
Dimethipin
Through
FDA
Multiresidue
Protocols
C,
D,
and
E:
Final
Report:
Lab
Project
Number:
RP/
93032:
UNIROYAL/
1208.

Unpublished
study
prepared
by
Colorado
Analytical
Research
&

Development
Corp.
100
p.

43109801
Koch,
D.;
Cooper,
J.
(
1994)
Independent
Laboratory
Method
Validation
for
Dimethipin
in
Cottonseed:
Final
Report:
Lab
Project
Number:
41344:
RP/
93033.
Unpublished
study
prepared
by
ABC
Laboratories,
Inc.
121
p.

43184101
Korpalski,
S.
(
1994)
HARVADE
5F
on
Cotton:
Magnitude
of
the
Residue:
Amended
Final
Report:
Lab
Project
Number:
A026.010:
RP­

91034:
WSM­
91­
009.
Unpublished
study
prepared
by
Huntingdon
Analytical
Services,
Mid­
South
Ag
Research
and
S­
L
Agri­

Development.
580
p.

43216001
Dzialo,
D.
(
1994)
Field
Dissipation
of
Dimethipin
(
Harvade
5F)
on
Cotton
in
Georgia:
Lab
Project
Number:
9113/
9175:
1641/
90/

115/
04/
11B:
32100.
Unpublished
study
prepared
by
Landis
International,
Inc.,
Research
Options,
Inc.,
NET,
Inc.
559
p.

43216002
Dzialo,
D.
(
1994)
Field
Dissipation
of
Dimethipin
(
Harvade
5F)
on
Cotton
in
Mississippi:
Lab
Project
Number:
9114/
9176:
1641/

90/
115/
04/
11B/:
32200.
Unpublished
study
prepared
by
Landis
International,
Inc.,
Stoneville
Associates,
Inc.,
NET,
Inc.
459
p.

43436901
Burke,
B.;
Johnson,
K.
(
1994)
Metabolism
of
(
Carbon
13)/(
Carbon
14)­
HARVADE
Used
as
Defoliant
in
Cotton:
Lab
Project
Number:

92206:
PRT/
15/
2UON/
01:
PRT/
15/
2UON/
01/
003.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.;
Plant
Research
Technologies,
Inc.
78
p.
54
43768201
Perhach,
M.;
Jalal,
M.
(
1995)
A
Confined
Rotational
Crop
Study
on
Harvade
(
Dimethipin)
(
30
Day
Aging):
Amended
(
Final
Report
#
3):

Lab
Project
Number:
ML­
91­
725:
9174.
Unpublished
study
prepared
by
Pan­
Agricultural
Labs,
Inc.
166
p.

43768202
Perhach,
M.
(
1995)
A
Confined
Rotational
Crop
Study
on
Harvade
(
Dimethipin)
(
183
Day
Aging):
Amended
(
Final
Report
#
1):
Lab
Project
Number:
ML­
91­
726:
9183.
Unpublished
study
prepared
by
Pan­
Agricultural
Labs,
Inc.
244
p.

43897601
Goldenthal,
E.
(
1996)
Two
Year
Dietary
Chronic
Toxicity
and
Oncogenicity
Study
in
Rats
(
with)
Harvade
Technical
(
Dimethipin):
Lab
Project
Number:

399­
134.
Unpublished
study
prepared
by
MPI
Research.
1745
p.

43898701
Spare,
W.
(
1987)
Vapor
Pressure
Determination
of
Harvade
Using
Gas
Saturation:
Final
Report:
Lab
Project
Number:
1908:
8734:
UCC
8734.

Unpublished
study
prepared
by
Agrisearch,
Inc.
52
p.

43922101
Lau,
R.;
Gay,
M.
(
1996)
Nature
of
the
Residue
of
Dimethipin
in
Lactating
Goat:
Lab
Project
Number:
9202:
9275G:
95089G.

Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.
and
Southwest
Bio­
Labs,
Inc.
363
p.

43931301
Ryan,
J.
(
1996)
Upgrade
of
HARVADE
(
Dimethipin)
Confined
Rotational
Crop
Study:
30
and
183
Days
Aging:
Lab
Project
Number:

XBL95082:
RPT00264:
95119.
Unpublished
study
prepared
by
XenoBiotic
Laboratories,
Inc.
188
p.

43931401
Korpalski,
S.
(
1996)
Freezer
Storage
Stability
of
Dimethipin
in
Cottonseed
Processed
Commodities:
Lab
Project
Number:
ML95­

0510­
UNI:
RP­
94025:
SJK17\
SK60123D.
Unpublished
study
prepared
by
Morse
Labs,
Inc.
146
p.

43966401
Singh,
H.;
Eckert,
J.
(
1996)
In­
Life
Feeding
Study
of
Dimethipin:
55
Determination
of
the
Magnitude
of
Residues
in
Milk,
Tissues,
and
Dosing
Capsules;
Method
Validation
in
Various
Substrates;
and
Freezer
Storage
Stability
of
Dimethipin
in
Milk
and
Tissues:
Lab
Project
Number:
UR­
01­
95:
95156:
EBT
220.02.
Unpublished
study
prepared
by
Enviro­
Bio­
Tech,
Ltd.
168
p.

43979101
Korpalski,
S.
(
1996)
Thirty­
Day
HARVADE
Field
Rotational
Crop
Study:
Lab
Project
Number:
ML94­
0467­
UNI:
RP­
94009:
METH­
74.

Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
336
p.

43979102
Korpalski,
S.
(
1995)
Six
Month
HARVADE
Field
Rotational
Crop
Study:
Lab
Project
Number:
RP­
93014:
ML93­
0392­
UNI:
METH­
74.

Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
279
p.

43979103
Korpalski,
S.
(
1995)
Method
Validation
for
Dimethipin
in
Rotational
Crop
Matrices:
Lab
Project
Number:
ML94­
0498­
UNI:
RP­
94021:

METH­
74.
Unpublished
study
prepared
by
Morse
Laboratories,
Inc.
94
p.

44147201
Hughes,
D.;
Patzer,
S.
(
1996)
Determination
of
1,2­
Ethanedisulfonic
Acid
in
Beef
Kidney:
Final
Report:
Lab
Project
Number:
6111­
155:

96037:
CHW
6111­
155.
Unpublished
study
prepared
by
Corning
Hazleton
Inc.
33
p.

44147202
Batorewicz,
W.;
Long,
S.
(
1996)
Confirmational
Analysis:
Analytical
Method
for
Determination
of
1,2­
Ethanedisulfonic
Acid
in
Beef
Kidney:
Lab
Project
Number:
96099:
93179.
Unpublished
study
prepared
by
Uniroyal
Chemical
Co.,
Inc.
38
p.

44190001
Hughes,
D.;
Halverson,
R.
(
1996)
Storage
Stability
of
1,2­

Ethanedisulfonic
Acid
in
Beef
Kidney:
Final
Report:
Lab
Project
Number:
CHW
6111­
156:
96039:
6111­
156.
Unpublished
study
prepared
by
Corning
Hazleton,
Inc.
48
p.

44988701
Schroeder,
R.
(
1999)
Teratology
Study
in
Rabbits
with
N252
(
Dimethipin):
Audited
Tabulation
of
IRDC
Developmental
Toxicity
Historical
Control
Data
for
Dutch
Belted
Rabbits
(
1977­
1983):
Lab
56
Project
Number:
339­
028.
Unpublished
study
prepared
by
MPI
Research.

10
p.
{
OPPTS
870.3700}

46063401
Czech,
P.
(
2003)
Acute
Toxicity
of
Harvade
25F
to
Daphnia
Magna
in
a
48­
Hour
Immobilisation
Test.
Project
Number:
842758.

Unpublished
study
prepared
by
RCC
Umweltchemie
Ag.
39
p.

93089007
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00079500.
1­
Year
Dietary
Toxicity
Study
in
Dogs
with
N252:
IRDC
Project
No.
399­
019.
Prepared
by
International
Research
and
Development
Corp.
8
p.

93089008
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00079998
and
Related
MRIDs
00127918.
18
Month
Toxicity
and
Oncogenicity
Study
in
Mice/
N252
Technical:
Project
No.
798­
180.

Prepared
by
Hazleton
Raltech,
Inc.
9
p.

93089009
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00086316
and
Related
MRIDs
00127918.
Teratologic
Evaluation
of
N252
(
HARVADE)
Technical
in
Sprague
Dawley
Rats:
Laboratory
Study
No.
5584.
Prepared
by
Food
and
Drug
Research
Laboratories,
Inc.
8
p.

93089010
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00079502.
Teratology
Study
in
Rabbits/
Test
Article
N252
(
HARVADE)
Technical:
IRDC
Project
No.
399­
028.
Prepared
by
International
Research
and
Development
Corp.
7
p.

93089011
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00079996
and
Related
MRIDs
00094792.
Two­
generation
Rat
Reproduction
Study
with
N252:
Study
No.
79033.
Prepared
by
Hazleton
Raltech,
Inc.
8
p.
57
93089012
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00080002.
Mutagenicity
Evaluation
of
HARVADE
(
N252)
98%

D­
11401
in
the
Ames
Salmonella/
Microsome
Plate
Test:
LBI
Project
No.
20988.
Prepared
by
Litton
Bionetics,
Inc.
7
p.

93089013
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00133302.
CHO
Metaphase
Analysis:
in
vitro
Chromosome
Aberration
Analysis
in
Chinese
Hamster
Ovary
Cells
(
CHO):
Project
No.

PH
320­
UN­
001­
83.
Prepared
by
Pharmakon
Research
Int.
Inc.
7
p.

93089014
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
40479602.
Mouse
Micronucleus
Test/
Test
Substance:
Dimethipin
Tech.:
Project
No.
131002­
M­
00184.
Prepared
by
Life
Science
Research,

Roma
Toxicology
Centre.
7
p.

93089015
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00080000.
Mutagenicity
Evaluation
of
Harvade
(
N252)
98%
D­

11401
in
the
Sister
Chromatid
Exchange
Assay
with
Chinese
Hamster
Ovary
(
CHO)
Cells:
LBI­
Project
No.
20990.
Prepared
by
Litton
Bionetics,
Inc.
7
p.

93089016
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
40479601.
in
vivo/
in
vitro
UDS
Study:
Study
No.
4/
86/
TX.

Prepared
by
Robens
Institute
of
Industrial
and
Health
Safety.
7
p.

93089017
McManus,
J.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
41323301.
Metabolism
of
(
Carbon
14)
Dimethipin
(
Harvade)

in
the
Rat:
Project
85125.
Prepared
by
Uniroyal
Chemical
Co.
6
p.

93089018
McManus,
J.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
41323302
and
Related
MRIDs
41612401.
Analysis
of
Urine
Samples
from
Dimethipin
(
Harvade)
Rat
Pharmacokinetic
Study:
Project
No.
8671
Part
B
with
Additional
Study;
and
a
(
Carbon
14)­
radiolabeled
Pharmacokinetics
and
Metabolism
Study
in
the
Rat
Using
Harvade:

Project
No.
8732
Part
A.
Prepared
by
Southwest
Bio­
Labs,
Inc.
15
p.

93089024
Putterman,
G.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
58
Summary
of
MRID
00028831.
Fate
of
Harvade­
[
carbon
14]
on
Cotton:
Project
7864.
Prepared
by
Uniroyal
Chemical
Co.
Inc.
8
p.

93089025
Mertz,
J.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00136860
and
Related
MRIDs
00085669.
Determination
of
N252
Residues
in
Cottonseed:
Project
No.
7524.
Prepared
by
Uniroyal
Chemical
Co.
Inc.
11
p.

93089026
Gaydosh,
K.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00080098
and
Related
MRIDs
00085666.

Harvade
Residues
in
Cottonseed
Fractions
and
Harvade
Residues
in
Processed
Cottonseed.
Prepared
by
Uniroyal
Chemical
Co.
Inc.
9
p.

93089028
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00127918
and
Related
MRIDs
00085653,
00086324,
00145225.

104­
Week
Chronic
Toxicity
Study
in
Rats/
N252
(
Harvade)
Technical:

Laboratory
Study
No.
798­
177.
Prepared
by
Hazleton
Labs.
America,

Inc.
12
p.

93089029
Story,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Summary
of
MRID
00080003.
Mutagenicity
Evaluation
of
Harvade
(
N252)
in
the
Mouse
Lymphoma
Forward
Mutation
Assay:
LBI
Project
No.
20989.

Prepared
by
Litton
Bionetics,
Inc.
7
p.

93089030
Homan,
S.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00079500.
1­
Year
Dietary
Toxicity
Study
in
Dogs
with
N252:
IRDC
Project
No.
399­
019.
Prepared
by
International
Research
and
Devel.
Corp.

300
p.

93089031
Serota,
D.;
Alsaker,
R.;
Banas,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.

Phase
3
Reformat
of
MRID
00079998
and
Related
MRIDs
00127918.
18
Month
Toxicity
and
Oncogenicity
Study
in
Mice
/
N252
Technical:
Project
No.
798­
180.
Prepared
by
Hazleton
Raltech,
Inc.
773
p.

93089032
Knickerbocker,
M.;
Re,
T.;
Babish,
J.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00086316
and
Related
MRIDs
00127918.
Teratologic
Evaluation
of
N252
(
Harvade)
Technical
in
59
Sprague
Dawley
Rats:
Laboratory
Study
No.
5584.
Prepared
by
Food
and
Drug
Research
Laboratories,
Inc.
462
p.

93089033
McMeekin,
S.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00079502.
Teratology
Study
in
Rabbits/
Test
Article
N252
(
Harvade)
Technical:
IRDC
Project
No.
399­
028.
Prepared
by
International
Research
and
Devl.
Corp.
69
p.

93089034
MacKenzie,
K.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00079996
and
Related
MRIDs
00094792.
Two­

Generation
Rat
Reproduction
Study
with
N252:
Study
No.
79033.

Prepared
by
Hazleton
Raltech,
Inc.
791
p.

93089035
Jagannath,
D.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00080002.
Mutagenicity
Evaluation
of
Harvade
(
N252)
98%

D­
11401
in
the
Ames
Salmonella/
Microsome
Plate
Test:
LBI
Project
No.

20998.
Prepared
by
Litton
Bionetics,
Inc.
19
p.

93089037
Curtiss,
K.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00028831.
Fate
of
Harvade­[
carbon
14]
on
Cotton:
Project
No.
7864.
Prepared
by
Uniroyal
Chemical
Co.
Inc.
16
p.

93089038
Womer,
J.;
Sisken,
H.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00136860
and
Related
MRIDs
00085669.

Determination
of
N252
Residues
in
Cottonseed:
Project
No.
7524.

Prepared
by
Uniroyal
Chemical
Co.
48
p.

93089039
Ball,
J.;
Ames,
R.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00080098
and
Related
MRIDs
00085666.

Harvade
Residues
in
Cottonseed
Fractions
and
Harvade
Residues
in
Processed
Cottonseed.
Prepared
by
Uniroyal
Chemical
Company.
75
p.

93089040
Serota,
D.;
Alsaken,
R.;
Dawkins,
K.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00127918
and
Related
MRIDs
00085653,
00086324,
00145225.
104­
Week
Chronic
Toxicity
Study
in
60
Rats/
N252
(
Harvade)
Technical:
Laboratory
Study
No.
798­
177.

Prepared
by
Hazleton
Laboratories
America,
Inc.
2081
p.

93089041
Myhr,
B.
(
1990)
Uniroyal
Chemical
Company
Inc.
Phase
3
Reformat
of
MRID
00080003.
Mutagenicity
Evaluation
of
(
Harvade)
(
N252)
in
the
Mouse
Lymphoma
Forward
Mutation
Assay:
LBI­
Project
No.
20989.

Prepared
by
Litton
Bionetics,
Inc.
21
p.
61
Appendix
E.
Generic
Data
Call­
In
The
Agency
intends
to
issue
a
Generic
Data
Call­
In
at
a
later
date.
See
Chapter
V
of
the
Dimethipin
RED
for
a
list
of
studies
that
the
Agency
plans
to
require.
62
Appendix
F.
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
at
a
later
date.
63
Appendix
G.
EPA'S
BATCHING
OF
DIMETHIPIN
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
dimethipin
as
the
active
ingredient,
the
Agency
has
batched
products
which
can
be
considered
similar
for
purposes
of
acute
toxicity.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
identity,
percent
composition
and
biological
activity),
type
of
formulation
(
e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular,
etc.),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling,
etc.).
Note
that
the
Agency
is
not
describing
batched
products
as
"
substantially
similar"
since
some
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

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

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

If
more
than
one
confidential
statement
of
formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
which
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"
Data
Call­
In
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"
Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
A
registrant
who
wishes
to
participate
in
a
batch
must
decide
whether
he/
she
will
provide
the
data
or
depend
on
someone
else
to
do
so.
If
a
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
select
one
of
the
following
options:
Developing
Data
(
Option
1),
Submitting
an
Existing
Study
(
Option
4),
Upgrading
an
Existing
Study
(
Option
5)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
Cost
Sharing
(
Option
2),
Offers
to
Cost
Share
(
Option
3)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
does
not
want
to
participate
in
a
batch,
the
choices
are
Options
64
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.

Four
products
were
found
which
contain
dimethipin
as
the
active
ingredient.
These
products
have
not
been
placed
into
batch
group
based
on
the
active
and
inert
ingredients
and
type
of
formulation.

Batching
Instructions:

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

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

No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
400­
432
90.0
400­
155
48.0
400­
505
32.7
400­
398
22.4
65
Appendix
H.
List
of
Registrants
Sent
this
Data
Call­
In
Company
Number:
400
Company
Name:
Crompton
Manufacturing
Company
Inc.

Address:
74
Amity
Road,
Bethany,
CT
06524­
3402
Contact:
Dr.
Allen
Blem
66
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
67
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570­
5.
pdf
8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570­
17.
pdf
8570­
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf
8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570­
27.
pdf
8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570­
28.
pdf
8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570­
30.
pdf
8570­
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
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.
68
2.
Pesticide
Registration
(
PR)
Notices
a.
83­
3
Label
Improvement
Program­­
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(
Chemigation)

e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
the
Acrobat
reader.)

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

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

a.
Registration
Division
Personnel
Contact
List
j.
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
Contacts
j.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(
PDF
format)
69
e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(
PDF
format)

f.
40
CFR
Part
158,
Data
Requirements
for
Registration
(
PDF
format)

g..
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(
November
27,
1985)

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

1.
The
Office
of
Pesticide
Programs'
website.

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

National
Technical
Information
Service
(
NTIS)

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

3.
The
National
Pesticide
Information
Retrieval
System
(
NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(
765)
494­
6614
or
through
their
website.

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,

toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
website:

ace.
orst.
edu/
info/
nptn.
70
The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,

or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self­
addressed
postcard.

The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

1.
Date
of
receipt;

2.
EPA
identifying
number;
and
3.
Product
Manager
assignment.

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.
