United States Prevention, Pesticides EPA 738-R-05-013
Environmental Protection And Toxic Substances September 2005
Agency (7508C)
xvEPA
Reregistration Eligibility
Decision for Dodine
List A
Case No. 0161
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Reregistration Eligibility Decision (RED) Document
for
Dodine
Approved by: /S/
Debra Edwards, Ph. D.
Director
Special Review and Reregistration
Division
Date: 9/30/05
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TABLE OF CONTENTS
I. Introduction 13
II. Chemical Overview 14
A. Regulatory History 14
B. Chemical Identification 15
C. Use Profiles 16
1. Dodine Use Profile 16
2. DGH Use Profile 17
III. Summary of Dodine and DGH Risk Assessments 17
A. Human Health Risk Assessment 17
1. Toxicity 18
3. Acute Dietary Risk 20
4. Chronic Dietary Risk 20
5. Drinking Water 22
6. Residential Exposure 23
7. Aggregate Risk 24
8. Cumulative Risk Assessment 25
9. Occupational Risk from Dodine 26
10. Human Incident Data 28
B. Environmental Risk Assessment 29
1. Environmental Fate and Transport 29
2. Ecological Risk 29
3. Ecological Incidents 39
4. Endangered Species Concerns 39
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 41
A. Determination of Reregistration Eligibility and Tolerance Reassessment 41
B. Regulatory Position 41
1. Food Quality Protection Act Findings 41
2. Endocrine Disrupter Effects 42
3. Cumulative Risks 43
C. Tolerance Reassessment Summary 43
D. Regulatory Rationale 44
1. Human Health Risk 44
2. Environmental Risk 45
V. What Registrants Need to Do 50
A. Manufacturing Use Products 50
1. Additional Generic Data Requirements 50
2. Labeling Requirements 51
3. Spray Drift Management 51
B. End-Use Products 51
1. Additional Product-Specific Data Requirements 51
2. Labeling for End-Use Products 52
VI. Dodine Appendices 60
Appendix A. Uses of Dodine Eligible for Reregistration 61
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Dodine (PC 044301) 62
Appendix C. Technical Support Documents 67
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision 68
Appendix E. EPA's Batching of Dodine Products for Meeting Acute Toxicity Data
Requirements for Reregistration 77
Appendix F. List of Available Related Documents and Electronically Available Forms 78
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Dodine Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Environmental Fate and Effects Risk Assessment
Marietta Echiverria
Christopher Salice
Kevin Costello
Health Effects Risk Assessment
Jose Morales
David Soderberg
Kimyata Morgan
Wade Britton
Biological and Economic Analysis Division
Jihad Alsadek
Steve Jarboe
Leonard Yourman
Art Grube
Antimicrobials
Rebecca Miller
Cassi Walls
Kathryn Montague
Najm Shamim
Michelle Centra
Deborah Smegal
Registration
Lana Coppolino
MaryWaller
Risk Management
Cathryn OConnell
Dirk Helder
Tom Myers
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
DWLOC
EC
EDWC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LD
'50
LOC
LOD
LOAEL
MATC
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NAWQA
NPDES
NR
NOAEL
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-in
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Drinking Water Concentration
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
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/1, mg/kg or ppm.
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.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
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OP
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SFC
SFN
TCPSA
TGAI
TRR
USDA
USGS
UF
UV
WPS
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
2,3,3-trichloroprop-2-ene sulfonic acid (nitrapyrin Metabolite)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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Executive Summary
EPA has completed preliminary risk assessments, error correction, and is now issuing its
risk management decision for the fungicide dodine. EPA will accept public comments on this
decision and the supporting documents for 60 days. The dodine risk assessments are based on
review of the required database supporting the use patterns of the currently registered dodine
products. EPA has elected to proceed with its risk management decision at this time due to the
limited use and limited risks posed by this chemical. If during the comment period EPA receives
new or additional information that substantively changes the risk assessment findings or the risk
management decision, EPA will issue an amendment to this document.
Dodine is a fungicide used primarily on fruits and nuts. Approximately 70,000 pounds of
dodine are applied annually, with the most use on apples and pears. The use of dodine has
dropped from a 1992 high of approximately 265,000 pounds active ingredient. There are no
registered residential uses of dodine. This document addresses the tolerance reassessment and
reregi strati on eligibility decision for all the currently registered uses of dodine. Another active
ingredient of similar chemical composition and properties, dodecylguanidine hydrochloride
(DGH), is included with dodine in case no. 0161. DGH has only antimicrobial uses, some of
which may occur in a residential environment, i.e. treatment of paper that comes into contact
with food, paint additives, and anti-bacterial treatment of diapers. Because of the similarity of
these compounds, EPA has considered the contribution to overall risk of the DGH uses in its
aggregate assessment for dodine. However, the reregi strati on eligibility decision for the
antimicrobial uses of DGH will be issued at a later date.
Dietary Risk (food and drinking water)
No acute dietary toxicity endpoint was identified in the dodine data base. Thus, no acute
dietary assessments have been conducted.
An unrefined, screening level chronic dietary assessment indicates no risks of concern for
the general population or any sub-population. Risk estimates are 3% of the cPAD for the general
population and 16% of the cPAD for children 1-2 years old, the highest exposed sub-group.
These estimates are considered very conservative because they were conducted using tolerance
level values and assume treatment of all pome and stone fruits, not just those appearing on
current registered labels.
Aggregate Risks
An acute aggregate assessment has not been conducted because no appropriate acute
endpoint has been identified.
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Short-term aggregate risks were conservatively estimated for adults taking into account
dodine dietary exposures (food and water), as well as potential DGH exposure from treated paper
that comes into contact with food (indirect food additive) and from applying paint containing
DGH as a preservative. The short-term aggregate MOE for adults is 574 and does not exceed the
Agency's level of concern.
Short-, intermediate-, and long-term aggregate risks were conservatively estimated for
infants taking into account dodine dietary exposures (food and water), as well as potential DGH
exposure from the paper (indirect food additive) use and from infants wearing DGH-impregnated
diapers. The aggregate MOE for infants for all durations is 132, and does not exceed the
Agency's level of concern.
Both of these aggregate assessments are considered to be conservative because the
probability of repeated and simultaneous exposure to dodine/DGH from all sources for any given
individual is small. Because risks are below EPA's level of concern and EPA is highly confident
that actual risks will not exceed those estimated here, these screening level aggregate
assessments have not been further refined.
Cumulative Assessment
Unlike other pesticides for which EPA has followed a cumulative risk approach based on
a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding
for dodine and any other substances, and dodine does not appear to produce a toxic metabolite
produced by other substances. Dodine and DGH are both salts of the same chemical. They
dissociate similarly, are considered bioequivalents and lexicologically the same, as opposed to
separate chemicals that share a common mechanism of toxicity. For the purposes of this action,
therefore, EPA has assumed that dodine does not have a common mechanism of toxicity with
other substances, but has considered the contribution of DGH in the aggregate assessment for
dodine as noted above.
FQPA Finding
EPA has determined with reasonable certainty that no harm to the general population or
any sub-population will result from exposure to dodine.
Occupational Risks
EPA has evaluated handler exposure for both liquid and wettable powder formulations
and for groundboom and aerial spray applications. The majority of occupational handler
scenarios assessed resulted in MOEs greater than 100, and thus are not of concern, either at
baseline PPE or with the addition of gloves. Only two mixing/loading scenarios for the wettable
powder formulations would require additional levels of protection to achieve MOEs of 100. An
REI of 48 hours and a double notification requirement are adequate to address post-application
worker risks.
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Ecological Risks
EPA's screening level assessment for dodine indicate potential exceedences of levels of
concern (LOCs) for some classes of organisms. Most of the potential exceedences are based on
calculations that assume worst-case conditions, e.g., aerial application and maximum application
rates. In practice, usage data indicate that aerial application is not common for dodine; it is used
only when orchards floors are impassable for ground equipment. Orchard fungicides are most
frequently applied with an airblast system to ensure complete coverage of the plant surface.
Also, although the label for apples, for example, allows up to 1.95 Ibs/ai/A to be applied at once,
usage information indicates that only about 5% of all dodine applications to apples are made at
rates higher than 1.75 Ibs/ai/A. About 70% of all dodine applications to apples are made at rates
less than 1.25 Ibs/ai/A. Lower risk estimates are expected from these more typical use
parameters.
In some cases specific data are lacking and risks are assumed based on data derived from
related organisms. Data will be required to address these gaps and will allow further refinement
of the assessments.
Fish
EPA screening level assessment indicates that acute and chronic risk quotients (RQs) are
generally not of concern for fish, although there is a slight exceedence of the endangered species
acute RQ for freshwater fish from aerial application to apples in Pennsylvania, with current label
parameters.
Invertebrates
Some calculated RQs exceed LOCs for both freshwater and saltwater (marine/estuarine)
invertebrates. Estimated RQs range from < LOG to 2.4. No chronic toxicity data are available to
assess chronic risk to marine invertebrates.
Plants
The only data available indicate that dodine is highly toxic to green algae (an aquatic,
non-vascular plant) and RQs exceed LOCs for most uses No data are available for aquatic
vascular plants.
Tier 1 terrestrial plant toxicity studies indicate potential concern for phytotoxicity at the
maximum current label rate (2.6 Ibs/ai/A).
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Birds
Calculated acute RQs exceed the LOG for birds consuming many types of food items,
including short grass, tall grass, broadleaf plants, and small insects. Acute RQs range from 0-
5.6. Chronic LOCs are exceeded for many modeled scenarios and application rates, with RQs
ranging from 0.06 to 12.
Mammals
Calculated acute RQs exceed the LOG for mammals consuming many types of food
items, including short grass, tall grass, broadleaf plants, and small insects, across most weight
classes, with RQs ranging from 0 to 1. Chronic LOCs are exceeded for many modeled scenarios
and application rates, with RQs ranging from 0.03 to 34.
Both the bird and mammal assessments assume that all of the animal's diet consists of
dodine treated food items. Species specific information on behavior and dietary habits will
permit refinement of these assessments.
Summary of Mitigation Measures
EPA has determined that the currently registered uses of dodine are eligible for
reregi strati on provided the mitigation measures outlined in this document are implemented
through label amendments. Mitigation measures include:
For Occupational Risk:
To address risk to mixers and loaders of dodine:
• Risk to workers from wettable powder formulations of dodine can be addressed by use of
water-soluble packaging. However, registrants have chosen to voluntarily cancel
wettable powder formulations.
• Retain gloves for handlers for mixing and loading dodine.
Post application exposure to dodine, a toxicity category I eye and skin irritant, can be addressed
through the following measures:
• Require double notification; workers must be warned orally and by posting warning signs
at entrances to treated areas regarding potential for eye and skin irritation
• Require a 48 hour REI before workers can re-enter dodine treated fields.
For Ecological Risks:
Registrants have voluntarily agreed to numerous reductions in maximum application rates and
increased application intervals that will lessen risks to all non-target species. These include:
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Reduce maximum single application rate on peaches, pecans and walnuts from 2.6 to
1.951bs/ai/A.
Reduce maximum seasonal application rates on apples, cherries (sweet and sour), crab
apples, peaches, pears, pecans, and walnuts.
Increase application intervals for apples and pears from 5 to 7 days.
Specify medium to coarse droplet size and other spray drift management practices.
Specify erosion management practices to reduce runoff from vulnerable soils.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as EPA review of all submitted data. 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 of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require reassessment of all tolerances in effect on the day
before it was enacted. 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 among infants and children, and the cumulative effects of pesticides that
have a common mechanism of toxicity. When the Agency determines that aggregate risks are
not of concern and 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.
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 made a common mechanism of toxicity finding for dodine
and any other substances, and dodine does not appear to produce a toxic metabolite produced by
other substances. As noted in this document dodine and DGH are both salts of the same
chemical. They dissociate similarly, are considered bioequivalents and lexicologically the same,
as opposed to separate chemicals that share a common mechanism of toxicity. As such, EPA has
considered exposure to DGH in its aggregate exposure assessments for dodine. For the purposes
of this action, therefore, EPA has not assumed that dodine has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals,
see the policy statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA's website at http://www.epa.gov/pesicides/cumulative/.
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This document addresses the tolerance reassessment and reregi strati on eligibility
decisions for all the currently registered uses of dodine. Another active ingredient of similar
chemical composition and properties, dodecylguanidine hydrochloride (DGH), is included with
dodine in case no. 0161. DGH has only antimicrobial uses, some of which may occur in a
residential environment, i.e. treatment of paper that comes into contact with food, paint additives,
and anti-bacterial treatment of diapers. Because of the similarity of these compounds, EPA has
considered the contribution to overall risk of these DGH uses in its aggregate assessment for
dodine. However, the reregi strati on eligibility decision for the antimicrobial uses of DGH will
be issued at a later date.
The Agency made its reregi strati on eligibility determination based on the required data,
the current guidelines for conducting acceptable studies to generate such data, and published
scientific literature. The Agency has found that currently registered uses of dodine are eligible
for reregi strati on provided the mitigation and labeling outlined in the RED are implemented.
The document consists of six sections: Section I, the introduction, contains the regulatory
framework for reregistration/tolerance reassessment; Section II provides an overview of the
chemical, including a profile of its use and usage; Section III gives an overview of the human
health and environmental effects risk assessments; Section IV presents the Agency's
reregi strati on eligibility, tolerance reassessment, and risk management decisions; Section V
summarizes label changes necessary to implement the risk mitigation measures outlined in
Section IV; and Section VI includes the appendices, related supporting documents and Data Call-
in (DCI) information. The revised risk assessment documents and related addenda are not
included in this document, but are available on the Agency's web page
http://www.epa.gov/pesticides, and in the Public Docket under docket number OPP-2005-0266.
II. Chemical Overview
A. Regulatory History
The Registration Standard and associated DCIs for the dodine case, which includes the
three chemicals dodecylguanidine acetate (dodine), dodecylguanidine terephthalate (DGT), and
dodecylguanidine hydrochloride (DGH) as listed below in table 1, were issued in February 1987
with the determination that data may be shared among the chemicals in this case when
appropriate, due to their similar chemical properties. The last product for DGT was cancelled on
October 10, 1989; therefore, this RED does not consider potential risks associated with DGT.
This Reregi strati on Eligibility Decision (RED) reflects a reassessment of all the data reviewed to
date on dodine.
Table 1 : Ingredients in the Dodine Chemical Case (0161)
PC Code
044301
044302
044303
Chemical Name
dodine, a.k.a. dodecylguanidine acetate (DGA)
dodecylguanidine terephthalate (DGT)
dodecylguanidine hydrochloride (DGH)
CAS Number
2439-10-3
19727-17-4
13590-97-1
Status
Agricultural uses being reregistered
in this document.
Last product cancelled 10/10/1989.
Preservative uses undergoing
reregistration separately.
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Dodine was first registered by American Cyanamid in 1956. American Cyanamid then
transferred its DGH registrations to Cytec Industries. American Cyanamid sold the agricultural
chemical division to BASF and they subsequently sold the dodine registration and supporting
data to Shell Agror in 1988. In 2001, Chimac-Agriphar S.A. acquired the registrations of dodine
and is currently the only technical dodine registrant. In February 2003, Chimac-Agriphar's new
formulation, Syllit FL Fungicide, a liquid formulation, was registered and is presently replacing
the wettable powder formulation, Dodine 65W. BASF has one active dodine end use product
registration but is not currently marketing it. There are currently three DGH manufacturing-use
product registrants: Chimac-Agriphar S.A., Verichem, Inc., and Cytec Industries, Inc. There are
also three DGH end-use product registrants: Hercules, Inc., Nalco, and GE Betz, Inc. There are
currently 20 registrations containing DGH as the active ingredient. There is no registered
technical grade product for DGH.
B.
Chemical Identification
Table 2: Dodine and DGH Nomenclature
Chemical structure
Common name
Molecular Formula
Molecular Weight
ITJPAC name
CAS name
CAS#
Basic Manufacturer
Chemical structure
Common name
Molecular Formula
Molecular Weight
ITJPAC name
CAS name
CAS#
Basic Manufacturer
F: V
CH'CH-'"-VAW H,C
H L
X-]
Dodine or n-dodecyl guanidine acetate
C
5H33N302
287.4
1-dodecylguanidinium acetate
dodecylguanidine monoacetate
2439-10-3
Chimac-Agriphar SA
JH
CUfCH,),,^^
H
jHCl]
Dodecylguanidine hydrochloride (DGH) or dodine hydrochloride
C13H30N3C1
263.9
1 -dodecy Iguanidinium hydrochloride
dodecylguanidine hydrochloride
13590-97-1 (guanidine, dodecyl-, monohydrate); 112-65-2 (guanidine, dodecyl-)
Chimac-Agriphar S.A., Verichem, Inc., and Cytec Industries, Inc.
Page 15 of 80
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c.
Use Profiles
1. Dodine Use Profile
Type of Pesticide:
Summary of Use:
Target Organisms:
Mode of Action:
Tolerances:
Fungicide
Dodine is registered for use on apple, cherry (sweet and tart), peach, pear,
pecan, spinach, strawberry, and black walnut, and to control fungal
diseases on ornamentals, including crab apples in the State of Oregon
(SLN 24c).
Dodine is registered for control of a range of pathogenic fungi that affect a
number of agricultural and some ornamental crops.
Dodine's mode of action is through disruption of cell membranes.
There are 11 tolerances established under 40 CFR §180.172 for dodine or
apple, sweet cherry, tart cherry, peach, pear, strawberry, pecans, walnuts,
milk, meat, and spinach.
on
Use Classification: General Use
Formulation Types: Current formulations for dodine include liquid flowable concentrate and
wettable powder. The technical registrant has requested voluntary
cancellation of the wettable powder formulation. A dust formulation had
been registered but the registration was canceled for non-payment of
maintenance fees in October 2004; therefore this formulation was not
included in this assessment.
Application Methods : Most of the applications are by ground with an air blast sprayer (high or
low volume). When rain persists in the growing season applications are
made by aircraft.
Application Rates:
The currently labeled maximum application rates range from 1.3 to 2.6
Ibs. a.i./Acre/application. The minimum retreatment intervals range from
5-14 days and the pre-harvest intervals (PFfls) range from 5 to 15 days.
Application Timing: Dodine products can be applied at various stages of crop development
including dormant, delayed dormant, prebloom, early bloom, bloom,
foliar, petal fall, during mature fruit development, and postharvest (to the
trees).
Usage of Dodine:
Based on Agency data, the current average total annual domestic usage of
dodine is approximately 70,000 pounds active ingredient (a.i.), which has
dropped from a 1992 high of approximately 265,000 pounds active
ingredient. The highest usage, in pounds a.i., is on pears (30%), apples
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(30%), cherries (15%) and pecans (15%). Almonds, grapes, peaches,
strawberries, and walnuts together account for about 10% of the total
dodine applied.
2. DGH Use Profile
Type of Pesticide: Antimicrobial
Pesticide Category: Sanitizer, Bacteriostat, Microbiocide, Microbiostat, Fungicide, Algicide,
Molluscicide
Use Sites: Water cooling towers, sewage disposal lagoons, additive to preserve
finished paper and paperboard products (including food contact surfaces),
brewery pasteurizer water, industrial disposal water, air washer water
systems, waste water systems, sewage effluent water, sewage systems,
industrial processing water, non-potable water, adhesives, glues, coatings,
oil recovery drilling mud, secondary oil recovery injection water,
polymers, latex, resin emulsions, latex emulsions, paper-making
chemicals, alum solutions, printing pastes, evaporate condenser water,
heat exchange water, disposable diapers, and slurries.
Target Pests: Algae, animal pathogenic bacteria, deterioration/spoilage bacteria, fouling
organisms, fungal slime, fungi, mold, mollusks, slime-formulating
bacteria, slime-formulating fungi, and yeasts.
III. Summary of Dodine and DGH Risk Assessments
The following is a summary of EPA's human health findings and conclusions for dodine
as presented fully in the document, "Dodine: HED Chapter of the Reregi strati on Eligibility
Decision Document," revised per 30-day error only registrant comments, dated 9/26/05.
A. Human Health Risk Assessment
The Agency has conducted a human health risk assessment for dodine for the purposes of
making a reregi strati on eligibility decision. The Agency evaluated the toxicology, product and
residue chemistry, and occupational/residential exposure studies submitted and determined that
the data are adequate to support a reregi strati on decision. Details of the risk assessments and
separate supporting disciplinary documents are available in the electronic docket. A summary of
the human health risk assessment findings and conclusions are provided below.
The toxicological studies used in this risk assessment were all performed on dodine; the
Agency considers dodine and DGH lexicologically equivalent. The database for dodine is
complete and there are no data gaps. The available toxicity data are adequate to assess the
chemical=s hazard potential. The database for DGH contains a few toxicity studies, but they
were all conducted with end-use product formulations which contain 35% DGH. The Agency
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typically requires that studies submitted be conducted with the technical grade material.
Therefore, all endpoints were selected from the dodine database.
1. Toxicity
Technical grade dodine has moderate acute toxicity via the oral, dermal and inhalation
routes (Category III), is severely irritating to the skin and the eye (Category I), and is not a skin
sensitizer. See table 3 below.
Table 3: Acute Toxicity Profile - Dodine
Guideline
No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
Acute eye irritation [rabbit]
Primary dermal irritation [rabbit]
Skin sensitization [human]
MRID
00124280
00124280
00157300
00124280
00124280
00157386
Results
LC50 males =1931 mg/kg
LCso females =1171 mg/kg
LCso combined =1456 mg/kg
LD50 >2000 mg/kg
LC50 = 1.05 mg/kg
Severe
Primary Dermal Irritation Index,
PDII - 7.5
Negative
Toxicity
Category
III
III
III
I
I
Neg
The most common effects in intermediate- or long-term oral toxicity studies were a
decrease in food consumption, body weight and/or body weight gain. There were some clinical
signs noted including excessive salivation (dog and mice) and hunched posture/hypoactivity
(rats), but only the dog showed a treatment-related dose response.
Carcinogenicity
Based on the weight of evidence it can be concluded that there is no evidence of
carcinogenicity for dodine. In a mouse feeding study, females showed an increase in combined
hepatocellular adenomas/carcinomas; however, when compared to historical controls the
increase of incidence of combined tumors is marginal. In a rat feeding study there was no
evidence of carcinogenicity. Dodine was negative in three studies for gene mutation
Developmental Toxicity
There is no evidence of increased sensitivity in pups versus adults based on rat and rabbit
developmental studies and the rat multi-generation reproduction study. In prenatal
developmental studies in both rats and rabbits treated with dodine, there was no toxicity
identified in the pups at the highest dose tested. In the two generation study, reduced body
weight gain and decreased food consumption were seen in pups at the same dose at which
maternal toxicity (decreased body weight, body weight gain and food consumption) was present.
There is no concern for pre- or postnatal toxicity resulting from exposure to dodine.
ee 18 of 80
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Reproductive Toxicity
Dodine did not adversely affect reproductive parameters in rats over two generations. A
decrease in parental body weight, body weight gain and food consumption was recorded in both
generations of rats. The offspring of both generations demonstrated decreased body weight in the
highest dose group. This continued through pre-mating of the parental animals.
Neurotoxicity
There is no evidence of neurotoxicity in the available studies. Based on the weight of
evidence, a developmental neurotoxicity (DNT) study is not required for dodine.
Table 4 contains endpoints selected for the dietary and residential assessments.
Table 4: Summary of Toxicological Doses and Endpoints for Use in Human Risk Assessments
Exposure
Scenario
Acute Dietary
(females 13-49 and
general population)
Chronic Dietary
(all populations)
Dermal
Short-(l - 30 days),
Intermediate-(l - 6
months), and
Long-(> 6 months)
Term
Inhalation
Short-Term(l -30
days)
Dose Used in Risk
Assessment, TJF
NA
NOAEL = 2
mg/kg/day
UF= 100
Chrome RfD = 0.02
mg/kg/day
NOAEL = 200
mg/kg/day (highest
dose tested)
Developmental
study
NOAEL = 10
mg/kg/day
(inhalation
absorption rate
assumed to be
100%)
Special FQPA SF* and
Level of Concern for
Risk Assessment
FQPA SF = IX
cPAD =chronic RfD
FQPA SF
= 0.02 mg/kg/day
ResrdentralMOE=100
Occupational MOE =
100
Residential MOE =100
Occupational MOE =
100
Study and Toxicological Effects
No appropriate endpoint for females
age 1 3 -49 or for the general
population attributable to a single
exposure.
Chronic toxicity - dog
LOAEL = 10 mg/kg/day (f) based
on body weight loss in females.
28 -Day Dermal Toxicity
LOAEL = not identified*
* Anticipated body weight effects
based on weight of evidence from
effects seen in acute dermal study
and across the entire database (see
explanation section 4.4.6 of the
HED Chapter).
Developmental toxicity study - rat
LOAEL = 45 mg/kg/day based on
decreased body weight gain and
food consumption.
Cancer Classification: Carcinogenic potential; no evidence of carcinogenicity.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of
exposure, LOG = level of concern, NA = Not Applicable
se 19 of 80
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2. FQPA Safety Factor
After evaluating hazard and exposure data for dodine and DGH, EPA reduced the default
10X Food Quality Protection Act (FQPA) special safety factor to IX. The toxicity database
includes acceptable developmental and reproductive toxicity studies, and there is no evidence in
the developmental toxicity study of susceptibility following in utero exposure. The Agency has
a low level of concern and no residual uncertainties regarding exposure or concerns for the
effects seen in the developmental toxicity studies after establishing toxicity endpoints and
including the traditional uncertainty factors in the risk assessment. The dietary food exposure
assessment utilizes tolerance level residues and percent crop treated information for all
commodities. The drinking water assessment utilizes Estimated Drinking Water Concentrations
(EDWCs) generated by models which are designed to provide conservative, health protective,
high-end estimates of water concentrations. By using these conservative assumptions, exposures
and risks will not be underestimated. Therefore, the 10X FQPA special safety factor was
reduced to IX. Thus the cPAD for dodine is the same as the cRfD of 0.02 mg/kg/day.
3. Acute Dietary Risk
No appropriate acute dietary endpoint was identified in any of the available toxicity
studies. Therefore, no acute dietary exposure assessment (food + water) was performed.
4. Chronic Dietary Risk
A chronic dietary (food + water) risk assessment was conducted using the Dietary
Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-
FCID™, Version 2.03), which uses food consumption data from the USDA's Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The chronic dietary
exposure and risk analysis was conducted using tolerance values, DEEM default processing
factors, percent crop treated for all commodities, and an Estimated Drinking Water
Concentration (EDWC) point estimate value for drinking water contribution to exposure. This
dietary assessment is conservative since the crop group tolerances for pome and stone fruits were
included in the risk assessment, even though some of the crops within these groupings do not
presently have registered uses. No monitoring data are available for dodine.
The chronic dietary assessment incorporates both exposure to and toxicity of dodine. The
chronic dietary endpoint is decreased food consumption and decreased weight gain in a chronic
toxicity dog study at the lowest observed adverse effect level (LOAEL) of 10 mg/kg/day. The
no observed adverse effect level (NOAEL) was 2 mg/kg/day. An uncertainty factor of 100 (10X
for inter-species extrapolation and 10X for intra-species variation and IX FQPA) was applied to
the NOAEL. The chronic Population Adjusted Dose (cPAD) is the dose at which an individual
could be exposed over the course of a lifetime and no adverse health effects would be expected.
The cPAD was calculated as 2 mg/kg/day + 100 = 0.02 mg/kg/day. Risk is expressed as a
percentage of the cPAD. A risk estimate less than 100% of the cPAD does not exceed the
Agency's level of concern.
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Dietary risk estimates were calculated for the general U.S. population and various
population subgroups. Dodine chronic dietary exposure estimates (food + water) for the U.S.
population (3% of the cPAD) and for the most highly exposed population subgroups, non-
nursing infants and children 1-2 years of age (16% of the cPAD), are below the Agency's level
of concern. The highest contributors to estimated exposures were pome fruits (71% of total
exposure) and water (24% of total exposure).
Table 5 : Chronic Dietary (food + water) Exposure and Risk for Dodine
Population Subgroup
General U.S. Population
Children 1-2 years old
Non-nursing Infants
cPAD (mg/kg/day)
0.02
Exposure
(mg/kg/day)
0.000493
0.003152
0.003252
% cPAD
3
16
16
Chronic dietary risk from DGH used as an indirect food additive was also calculated
using the same chronic dietary endpoint. DGH is used as a slimicide in food handling paper, as a
preservative applied to paper, and in paper adhesives used in food packaging. None of these uses
exceed the Agency's level of concern for the chronic exposure durations. This assessment is
very conservative because it assumes 100% migration of DGH from the paper and packaging
into the food. Data to refine the migration value have been submitted to the Agency and are
under review.
Dietary risk estimates were calculated for the general U.S. population and various
population subgroups for the individual uses and were also combined. Combined DGH chronic
dietary exposure estimates for all paper and packaging uses were estimated for the U.S.
population (13 % of the cPAD) and for children (45.5 % of the cPAD), and are below the
Agency's level of concern. The large degree of difference between exposure to paper and
packaging for children and adults is due to the smaller body weight assumption for kids (10 kg)
compared to adults (70 kg) in the dietary risk calculation.
Table 5: Chronic Dietary Risks of DGH as an Indirect Food Additive
Use Site
Pulp/Paper-Slimicide
Paper Coating-Preservative
Paper Adhesive-Preservative
Combined Exposures
cPAD (mg/kg/day)
0.02
Daily Dietary Dose
(mg/kg bw/day)
0.00080 (adult)
0.0028 (child)
0.001 5 (adult)
0.0053 (child)
0.00030 (adult)
0.0011 (child)
0.0026 (adult)
0.0091 (child)
%cPAD
4.0% (adult)
14.0% (child)
7.5% (adult)
26.3% (child)
1.5% (adult)
5.3% (child)
13.0% (adult)
45.6% (child)
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5. Drinking Water
(For a complete discussion, see the ATier I Drinking Water Assessment for Dodine," dated
4/20/2005, and the "Drinking Water Exposure to DGH from Once-Through Cooling Uses" found
in Appendix 4.0 of the HED Chapter.)
Drinking water exposure to pesticides can occur through ground and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or actual monitoring data, if available, to estimate those risks. A
separate DGH assessment was conducted to estimate potential contribution from the
antimicrobial uses of DGH in drinking water. The PDM4 Model was used to estimate the
concentration of DGH in receiving surface waters following application to once-through cooling
systems, the application site considered to potentially contribute the highest amount of DGH to
drinking water. The PDM4 model provided probabilities of exceeding various concentrations of
concern (COCs) over time. The worst-case scenario in the model indicated the probability of
exceeding the concentration of concern over a chronic (365 days) timeframe is negligible.
Therefore, chronic drinking water concerns are not expected from the once-through cooling uses
of DGH. See appendix 4.0 in the HED Chapter for further explanation.
The drinking water assessment for dodine considers contribution from dodine alone, due
to the negligible estimated contribution from DGH. Since no monitoring data were available for
dodine, EDWCs were calculated from models. The EDWCs were incorporated directly into the
chronic dietary exposure assessment. The EDWCs were based on application methods, rates and
use sites that would likely yield the highest drinking water concentrations.
Dodine is immobile and is generally not expected to persist in aerobic soils. Because of
dodine's high partitioning coefficient, the potential to reach drinking water sources via runoff or
leaching is limited. Based on a low estimated vapor pressure, volatilization is an unlikely route
of dissipation. Dodine may, however, be transported off-site to drinking water sources as
sediment or via spray drift during aerial, airblast or ground spray applications. Once in aquatic
environments, dodine is resistant to hydrolysis and photolysis. In aerobic aquatic environments,
dodine is likely to be moderately persistent. In anaerobic aquatic environments, dodine is likely
to be very persistent. In the field, dodine was almost exclusively confined to the 0-6 inch depth
of soils and is immobile in soil (sand, sandy loam, clay loam, and silt loam), regardless of
organic matter content. With adsorption occurring in the upper layer of soil it is unlikely that
lexicologically- important concentrations of either the parent compound or degradates will reach
surface or ground water. Because of dodine's high partitioning coefficient, relative non-
persistence in aerobic soils, and demonstrated fate and transport in the field, leaching to
groundwater is not expected to be a major route of dissipation.
Surface Water - Tier 1 EDWCs in surface water were calculated using the FIFRA Index
Reservoir Screening Tool (FIRST). As shown in table 6, the Agency calculated a chronic
EDWC in surface water of 4.0 ppb, based on the use of dodine on pecans at a maximum annual
application rate of 13 Ibs/a.i./A/year.
Page 22 of 80
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Ground Water - Tier I EDWCs for ground water were calculated using the Screening
Concentration In Ground Water (SCI-GROW) model. The Agency calculated a chronic EDWC
in ground water of 0.08 ppb, based on the pecan use at the application rate of 13 Ibs/a.i./A/year.
Table 6: Estimated Drinking Water Concentrations (EDWCs) for Dodine
Duration of Exposure
Chronic
Surface Water EDWCs
4 ppb
Ground Water EDWCs
0.08 ppb
6. Residential Exposure
(For a complete discussion see, "Dodine: HED Chapter of the Reregi strati on Eligibility Decision
Document (RED)," revised per 30-day error only registrant comments, dated 9/26/2005 and,
"Dodecylguanidine hydrochloride (DGH) - Dietary and Non-dietary Exposures and Risks from
Antimicrobial Uses," dated 6/21/2005.)
Residential risk is expressed as a Margin of Exposure (MOE), which measures how close
the residential exposure comes to the NOAEL selected from toxicity studies. MOEs that are
greater than 100 do not exceed the Agency's level of concern (the residential MOE incorporates
the uncertainty factors of lOx for interspecies variability, lOx for intraspecies variability, and IX
for FQPA safety factor).
Dodine has no registered residential (non-occupational) uses and, therefore, no residential
handler or postapplication exposures or risks are expected. However, the Agency determined
that there are potential residential exposures to DGH because it is used as a preservative in paint
and is impregnated in disposable diapers to inhibit the growth of fungus.
EPA assessed the short-, intermediate-, and long-term dermal risks using a NOAEL that
is greater than 200 mg/kg/day from a 28-day dermal toxicity study in rats where no treatment
related deaths or clinical signs of systemic toxicity were observed at the highest dose tested. A
LOAEL from the study was not established. EPA assessed the short-term inhalation risks using
a NOAEL of 10 mg/kg/day from a developmental toxicity study in rats in which decreased body
weight gain and food consumption was observed at the LOAEL of 45 mg/kg/day.
Residential-Painter Exposure
The residential painter assessment considered both inhalation and dermal exposures of
adults exposed to DGH while applying paint with a paint brush, with an airless sprayer, and with
an aerosol can. Both inhalation and dermal exposures were considered to be short-term in
duration (1-30 days). Since the toxicological effects from both the dermal and inhalation routes
of exposure are the same, the Agency combined the margins of exposure (MOEs). All MOEs
exceeded 100, and therefore are not of concern.
Post-application dermal contact with wet paint was not assessed because the paint is
expected to dry within a short amount of time, so any potential exposure is expected to be
negligible. DGH has a low vapor pressure, therefore it is not likely to generate sufficient vapor
to cause an inhalation concern to residential populations performing post-application tasks or
Page 23 of 80
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occupying recently painted areas. Thus, although post-application exposures were not
quantitatively evaluated, EPA has determined that any such risks would be below EPA's LOG.
Residential-Diaper Exposure
The impregnated disposable diaper assessment considered dermal exposure of infants (<
1 year old) wearing DGH treated diapers. DGH can be used as a bacteriostat in the
manufacturing of the absorbent material used in disposable diapers. Since infants typically wear
diapers on a continuous basis, short-, intermediate- and long-term dermal exposure durations
were considered. However, because the same dermal toxicity NOAEL of 200 mg/kg/day was
used for all durations, the risk estimates are the same. It was assumed that an infant wears 8
diapers per day.
The Agency calculated exposures using a value of 5% to estimate the potential transfer of
DGH residues out of the absorbent material onto the skin. Using the 5% transfer value, which is
based on the % transfer factor for pesticide residues migrating from carpets to skin surfaces (US
EPA. 2001), resulted in risks that are not of concern to the Agency (MOE = 714). The
registrants have submitted a residue migration study that is currently under review by the Agency
to confirm the transfer value.
7. Aggregate Risk
In accordance with the FQPA, the Agency must consider pesticide exposures and risks
from all potential sources. These usually include food, drinking water, and residential exposures.
In an aggregate assessment, exposures from relevant sources are added together and compared to
quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be
aggregated. When aggregating exposures and risks from various sources, the Agency considers
both the route and duration of exposure. Because dodine and DGH are considered bioequivalents
having equal toxicity, and endpoints selected for dodine are used for DGH, their exposures can
be aggregated. Therefore, EPA aggregated exposures from dodine in food and water with
exposures to DGH in food and residential uses.
Acute Aggregate Risk
An acute aggregate risk assessment is not required, since no appropriate endpoint
attributable to a single exposure was identified in the dodine database.
Short-, Intermediate-, and Long-Term Aggregate Risk
Short-term adult aggregate risk estimates were calculated based on dodine exposures
from chronic dietary (food + water), DGH exposure from use as an indirect food additive, and
exposure to homeowners using DGH-preserved paint products. Intermediate-, and long-term
exposures to DGH in preserved paint products are not anticipated. The short-term aggregate
MOE for adults was 574; therefore, the risk does not exceed the Agency's level of concern.
Page 24 of 80
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Short-, Intermediate-, and Long-term infant risk estimates were calculated based on
contributions of dodine to exposure from chronic dietary (food + water), and contributions of
DGH to exposure from use as an indirect food additive, and exposure to infants wearing DGH-
impregnated diapers. MOEs were calculated for the impregnated disposable diapers using a 5%
Transfer Factor. MOEs calculated using the 5% transfer factor (MOE = 132) do not exceed the
Agency's level of concern.
The aggregate exposure assessment was conducted using tolerance values for
commodities with registered uses and a conservative EDWC point estimate for drinking water
contribution to exposure. In addition, it was assumed that 100% of the DGH would migrate out
of the food handling paper products. The registrants have submitted a migration study that is
currently under review by the Agency to confirm the DGH transfer factor.
Table 7 : Short-, Intermediate-, and Long-Term Aggregate MOEs for Dodine and DGH
Target
population
Adults
Infants
Scenario
Preserved Paint Products
(Short -Term)
Impregnated Disposable Diapers
5% Transfer Factor
(Short-, Intermediate-, Long-
Term)
MOE Food
+ Water +
indirect
food
additive
647
162
MOE Dermal
7,000
714
MOE
Inhalation
16,000
n/a
MOE Total
Target = 100
574
132
Both the adult and infant aggregate assessments are considered to be screening level
because they do not take into account the probability of simultaneous exposure to dodine and
DGH from all sources, which is likely to be low.
8. Cumulative Risk Assessment
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 made a common mechanism of toxicity finding for dodine
and any other substances, and dodine does not appear to produce a toxic metabolite produced by
other substances. As noted in this document, dodine and DGH are both salts of the same
chemical. They dissociate similarly, are considered bioequivalents and lexicologically the same,
as opposed to separate chemicals that share a common mechanism of toxicity. For the purposes
of this action, therefore, EPA has not assumed that dodine has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to determine which chemicals
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have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals,
see the policy statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA's website at http://www.epa.gov/pesicides/cumulative/.
9. Occupational Risk from Dodine
(For a complete discussion, see section 9.0 of the "Dodine: HED Chapter of the Reregi strati on
Eligibility Decision Document (RED)," revised per 30-day error only registrant comments,
dated 9/26/2005.)
Workers can be exposed to dodine through mixing, loading, applying a pesticide, or re-
entering treated sites. Occupational handlers of dodine include mixers, loaders, and applicators
in agricultural settings only. Occupational risk for all of these potentially exposed populations is
measured by a Margin of Exposure (MOE). An MOE = 100 has been determined to be
adequately protective for both short-term (1 to 30 days) and intermediate-term (1 to 6 months)
exposures for dodine handlers based on the standard uncertainty factors of 10X for interspecies
extrapolation and 10X for intraspecies variability. Long-term worker exposure to dodine is not
expected.
a. Occupational Toxicity
The dodine dermal endpoint is based a toxicity study in rats in which no effects were seen
at the highest dose tested, NOAEL = 200 mg/kg/day. No LOAEL was established.
The dodine inhalation endpoint is based on decreased body weight gain and food
consumption in a developmental rat study at the LOAEL of 45 mg/kg/day. The NOAEL was 10
mg/kg/day.
Table 8: Occupational Doses and Endpoints for Dodine
Exposure
Scenario
Dermal
Short -Term
(1 - 30 days) and
Intermediate -Term
(1-6 months)
Inhalation
Short -Term
(1 - 30 days) and
Intermediate -Term
(1-6 months)
Dose Used in Risk
Assessment
NOAEL = 200
mg/kg/day
NOAEL = 10
mg/kg/day
(inhalation absorption
rate= 100%)
Level of Concern for
Risk Assessment
Occupational MOE = 100
Occupational MOE = 100
Study and Toxicological
Effects
28-Day Dermal Toxicity-rat
LOAEL = not identified
Developmental toxicity study -rat
LOAEL = 45 mg/kg/day
Based on decreased body weight
gain and food consumption.
NOAEL = no observed adverse effect level,
LOAEL = lowest observed adverse effect level,
MOE = margin of exposure
Page 26 of 80
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b. Occupational Handler Exposure
The Agency has determined that there are potential exposures to individuals who mix,
load, apply, and otherwise handle dodine during the usual use associated with the pesticide.
Based on the use patterns, the following major occupational handler exposure scenarios were
identified and evaluated in the occupational risk assessment:
Mixer/ Loaders:
(la) Liquids for Aerial Applications
(Ib) Liquids for Groundboom Applications
(Ic) Liquids for Airblast Applications
(2a) Wettable Powders for Aerial Applications
(2b) Wettable Powders for Airblast Applications
Applicators:
(3) Aerial Spray Applications
(4) Groundboom Spray Applications
(5) Airblast Spray Applications
Flaggers:
(6) Flagging for Aerial Spray Applications
Mixer/ Loader/ Applicators:
7a) Liquids for Low Pressure Handwand Applications
7b) Liquids for Backpack Sprayer Applications
7c) Liquids for High Pressure Handwand Applications
c. Occupational Handler Risk Summary
The majority of occupational handler exposure scenarios assessed had risks below the
Agency's level of concern with MOEs greater than 100 with baseline attire and gloves.
However, the following two wettable powder scenarios require additional engineering controls
(water soluble packaging) to achieve an estimated risk which is above the Agency's target MOE:
(1) The mixer/ loader of wettable powders for aerial application to pecans with an
application rate of 2.6 Ib ai/acre.
(2) The mixer/ loader of wettable powders for aerial application to apples or pears with an
application rate of 1.90 Ib ai/acre.
Page 27 of 80
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Table 9: Summary of Short- and Intermediate -term Dodine Occupational MOEs
Exposure
Scenario
Wettable
Powders
for Mixer/
Loaders for
Aerial
application
App. rate
(Ibai/
acre)
2.60
1.90
Area
Treated
(acres/
day)
350
350
MOEs
Target MOE = 100
Baseline
Derm
MOE
4.2
6
Inh
MOE
18
24
Total
3.4
4.6
Double Layers + Gloves
+ PF10 Respirator
Derm
MOE
120
160
Inh
MOE
180
250
Total
71
97
Engineering Controls
(water soluble packages)
Derm
MOE
1600
2100
Inh
MOE
3200
4400
Total
1100
1400
d. Occupational Postapplication Risk Summary
For workers entering a treated site, MOEs are calculated for each day after application to
determine the minimum length of time required before workers can safely re-enter the treated
site. Postapplication occupational risks were calculated for all crops and all postapplication tasks
assessed and are below EPA's level of concern for dodine with MOEs that range from 99 to
57,509 approximately 24 hours after application. Based on dodine's classification as a category I
eye irritant and skin irritant, the current restricted-entry interval (REI) of 48 hours is adequate for
all postapplication workers. In addition, double notification for workers under the Worker
Protection Standard is required when dodine is applied due to the potential for eye and skin
irritation Workers must be notified by warning them orally and by posting warning signs at
entrances to treated areas.
10. Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from five sources
including the OPP Incident Data System (IDS), Poison Control Centers, California Department
of Pesticide Regulation, National Pesticide Telecommunications Network (NPTN), and National
Institute of Occupational Safety and Health's Sentinel Event Notification System for
Occupational Risks (NIOSH SENSOR). Of all poisoning incident data reported, there were 6
reports filed, but almost no reports of ill effects concerning human poisoning or other adverse
effects from exposure to dodine and DGH. Of the reports that were filed, there were no known
direct exposures to dodine or insufficient information to draw a conclusion from the reports.
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment for dodine is presented
below. More detailed information associated with the environmental risk from the use of dodine
can be found in the "Review of the 30-day Error Correction Comments on the Draft Level 1
Screening Ecological Risk Assessment for the Reregi strati on of Dodine," dated September 23,
2005.
1. Environmental Fate and Transport
The environmental fate database is sufficient to characterize the environmental exposure
and toxicity associated with dodine use. However, EPA does intend to issue a DCI as part of this
RED to require submission of additional data for dodine to address areas of uncertainty. The
following studies will help to refine the environmental risk assessments: aquatic plant toxicity
data and chronic saltwater invertebrate toxicity data. These data are expected to confirm the
conclusions of this environmental risk assessment.
The environmental fate and toxicity data for both dodine and DGH are considered as a
combined data set because these compounds behave similarly under environmental conditions.
Dodine and DGH are water soluble salts of the strong base dodecylguanidine, and are expected
to dissociate to the same degree under normal environmental conditions. As strong bases, these
compounds will be completely dissociated in aqueous solutions at normal environmental pHs
and will be present as the dodecylguanidinium ion and either the acetate or chloride ion in the
environment.
Dodine is likely to be immobile in soils based on its soil partition coefficient; therefore
the potential to reach aquatic ecosystems via runoff or leaching is limited. Aerobic soil
metabolism half-lives range between 17.5-22.3 days so dodine is generally not expected to
persist in aerobic soils. Dodine is stable in anaerobic aquatic environments. Based on a low
vapor pressure, volatilization is an unlikely route of dissipation.
There are no anticipated major environmental degradates of dodine. Based on fate
characteristics, dodine may be transported off-site to aquatic ecosystems adsorbed to eroded
sediment or via spray drift during aerial, airblast or ground spray applications. Once in aquatic
environments, dodine is resistant to hydrolysis and photolysis.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data. Since the use patterns of dodine are different and distinct
from DGH, a separate ecological risk assessment is being completed to specifically address the
environmental risk from DGH. To evaluate the potential risk to non-target organisms from the
use of dodine 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 (LDso) or the
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median lethal concentration (LCso). These RQ values are then compared to the Agency's levels
of concern (LOCs), 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 LOG for a particular
category, the Agency presumes a risk of concern. These risks of concern may be addressed by
further refinements of the risk assessment or mitigation measures. Use, toxicity, fate, and
exposure are considered when characterizing the risk, as well as the levels of certainty and
uncertainty in the assessment. EPA further characterizes ecological risk based on any reported
incidents to non-target terrestrial or aquatic organisms in the field (e.g., fish or bird kills).
Table 10: EPA's Levels of Concern and Associated Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk
Acute Restricted Use - there is potential for acute risk, but may be
mitigated through restricted use classification
Acute Endangered Species - endangered species may be
adversely affected
Chronic Risk - there is potential for chronic risk
LOC
Terrestrial
Animals
0.5
0.2
0.1
1
LOC
Aquatic
Animals
0.5
0.1
0.05
1
LOC Plants
1
N/A
1
N/A
a. Risk to Aquatic Organisms
i. Fish and Invertebrate Exposure and Toxicity
For exposure to aquatic fish and invertebrates, EPA considers surface water only, since
most aquatic organisms are not found in ground water. The aquatic exposure assessment for
dodine has relied on Tier II models. The Pesticide Root Zone Model (PRZM version 3.12)
simulates fate and transport on the agricultural field, while the water body is simulated with
Exposure Analysis Modeling System (EXAMS version 2.98). Simulations are run for multiple
(usually 30) years and the reported EECs represent the values that are expected once every ten
years based on the thirty years of daily values generated during the simulation.
PRZM/EXAMS modeling of dodine was done for nine scenarios using the current
maximum label rate, maximum number of applications per year and the minimum application
interval, see table 11 below. All scenarios were assessed for aerial and ground applications. A
complete listing of EECs, including those used for dodine RQ calculations included in this
summary can be found in the risk tables in the EFED risk assessment, dated September 23, 2005.
se 30 of 80
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Table 1 1 : Estimated aquatic Estimated Environmental Concentrations (EEC) calculated with PRZM/EXAMS.
Dodine uses
(EPA Reg. #)
Apples (55260-5)
Cherries (55260 -6)
Peaches (55260-5)
Pears (55260-5)
Pecans (55260-5)
Strawberries (55260-5)
Walnuts (55260-5)
Scenario
NC apple
OR apple
PA apple
MI cherries
GA peaches
CA fruit
GA pecans
FL strawberry
CA almond
(walnut)
Yearly Max.
App. Rate
(Ibs. a.i./A)
11.7
11.7
11.7
7.8
13.0
11.7
13.0
6.5
13.0
l-in-10
Year Acute
(ug/L)
7.5
6.4
43
24
16
6.0
19
0.80
7.8
l-in-10 Year 21-
day Chronic
(ug/L)
3.1
2.7
8.7
4.5
3.2
2.4
4.8
0.28
2.6
l-in-10 Year 60-
day Chronic
(Mg/L)
2.8
2.4
7.8
4.0
2.9
2.1
4.6
0.26
2.4
The acute toxicity data, outlined in table 12 below, indicate that dodine is highly toxic to
freshwater fish and moderately toxic to estuarine/marine fish on an acute exposure basis.
Further, the available data show that dodine is highly toxic to estuarine/marine invertebrates and
estuarine/marine mollusks, and very highly toxic to freshwater invertebrates.
Table 12: Summary of Acute Aquatic Toxicity Data for Dodine and DGH
Toxicity Study
Freshwater Fish (96-hr)
Freshwater Invertebrate
(48-hr)
Estuarine/ Marine Fish
Estuarine/ Marine
Molluscs
Estuarine/ Marine
Invertebrate
Test Species
Rainbow trout
Oncorhynchus mykiss
(TGAI)
Water flea
Daphnia magna
(TGAI)
Sheepshead minnow
Cyprinodon variegatus
Eastern oyster
Crassostrea virginica
Mysid shrimp
Americamysis bahia
LC50 or EC50
(ppb)
570
17.8
1782
69.3
59.4
Toxicity
Category
Highly toxic
Very highly toxic
Moderately toxic
Highly toxic
Highly toxic
MRID/
Accession No.
132149
42339601
43485506
43485508
43485507
Page 31 of 80
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A freshwater fish early life-stage chronic toxicity test was used to evaluate the chronic
toxicity of dodine. Results from the study indicated a NOAEL of 99 ppb and an associated
LOAEL of 200 ppb. The basis of these effect levels was an observed decrease in both larval
weight and larval length of dodine-exposed fish. An aquatic invertebrate life cycle test was
conducted to evaluate the chronic toxicity of dodine to freshwater aquatic invertebrates. The
most sensitive endpoint was the number of young produced with a NOAEC of 7.3 ppb and a
LOAEC of 13 ppb. There were no chronic estuarine/marine invertebrate toxicity data available
for this assessment.
Table 1 3 : Summary of Chronic Aquatic Toxicity Data for Dodine
Toxicity Study
Freshwater Fish Early
Life -Stage
Freshwater Invertebrate
Test Species
Fathead Minnow
Pimephales promelas
(TGAI)
Water flea
Daphnia magna
(TGAI)
NOAEC /
LOAEC
(ppb)
997 200
7.3/13
Effects at LOAEC
Larval length and weight
Number young produced
MRID
43876502
43876501
11.
Fish and Invertebrates Risk
Freshwater Fish
For freshwater fish all RQs are below the LOG, with the exception of the RQ for aerial
applications to apples in Pennsylvania (RQ = 0.08). Modeled results in Pennsylvania are likely
the result of higher erosion and subsequent off-site transport of dodine adsorbed to eroded
sediment into water bodies adjacent to treated fields. Using the highest annual dodine use rates,
as simulated for peaches, pecans and walnuts, did not produce EECs that resulted in LOG
exceedences. Chronic risks of concern associated with freshwater fish exposed to dodine are not
likely based on the RQs calculated, which range from 0.04 to 1.19.
Estuarine'/Marine Fish
Acute risk to estuarine/marine fish is unlikely, given the lack of acute risks and the low
chronic risks to freshwater fish species as a result of dodine use.
No chronic estuarine/marine fish toxicity data were submitted or located in the open
literature for dodine; therefore, chronic risks associated with estuarine/marine fish exposure to
dodine are unknown.
Freshwater Invertebrates
Most freshwater invertebrate RQs exceed the acute restricted use and endangered species
LOCs. Acute LOCs are exceeded for aerial applications to Pennsylvania apples, Michigan
Page 32 of 80
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cherries, Georgia pecans, and Georgia peaches. See table 14 below for a complete list of RQs
for invertebrates.
For freshwater invertebrates, the chronic LOG is exceeded based on aerial application of
dodine to Pennsylvania apples only. Analysis based on one study of benthic invertebrates
indicated that for benthic invertebrate species, the chronic risk LOG was not exceeded and risks
are expected to be low.
Although the label rate for apples allows up to 1.95 Ibs ai/A to be applied at once,
Agency use information indicate that only 5% of all dodine applications to apples are made at
rates higher than 1.75 Ibs ai/A. About 70% of all dodine applications to apples are made at rates
less than 1.25 Ibs ai/A. Lower RQs are expected to result from these more typical use rates. See
section IV, part D for further discussion on risk to freshwater invertebrates.
Estuarine/Marine Invertebrates
Endangered species acute risk LOCs for estuarine/marine invertebrates were exceeded for
all uses of dodine except strawberries. The estuarine/marine invertebrate RQ based on apples
exceeded the acute risk LOG.
No chronic estuarine/marine invertebrate toxicity data were available for dodine;
therefore, chronic risks associated with estuarine/marine invertebrate exposure to dodine are
unknown. The acute risks to estuarine/marine invertebrates suggest the potential for chronic
risks as well. Also, given the sensitivity of freshwater invertebrates to dodine, studies on the
chronic toxicity of dodine to estuarine/marine invertebrates are warranted.
Table 14: Acute RQs for Freshwater and Estuarine/Marine Invertebrates
Crop
Apples (PA)
Cherries (MI)
Peaches (GA)
Pears (CA)
Pecans (GA)
Strawberries (FL)
Walnuts (CA)
Maximum
Single
Application
Rate
(Ibs ai/A)
1.95
1.3
2.6
1.95
2.6
1.3
2.6
Peak
EEC
43
24
16
6.0
19
0.80
7.8
Acute Invertebrates RQs
Freshwater
(EC50=0.95 ppb)
2.42
1.35
0.90
0.34
1.07
0.04
0.44
Saltwater
(EC50=59.4 ppb)
0.72
0.40
0.27
0.10
0.32
0.00
0.13
Boldvalues indicate LOG exceedances.
Molluscs
For molluscs, acute restricted use and endangered species LOCs are exceeded for all
modeled scenarios except strawberries. The effects of dodine on molluscs are not all together
unexpected as DGH is used to control some invasive mollusc species.
Page 3 3 of 80
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iii. Non-target Aquatic Plants Exposure and Toxicity
Aquatic plant toxicity testing indicate that the non-vascular plant, Selenastrum
capricornutum (green algae), is particularly sensitive to dodine at the concentrations tested. The
estimated 120-hour EC50 was 0.95 ppb based on cell density effects. The corresponding 120-
hour NOAEC for this effect was 0.082 ppb. Based on these results, dodine is classified as very
highly toxic to green algae. A complete evaluation of the toxicity of a compound to aquatic
plants requires at least one study on aquatic vascular plants. This study was not available for
dodine, but will be required.
iv. Non-target Aquatic Plant Risk
For aquatic non-vascular plants, l-in-10 year peak EECs were compared to acute ECso
values to derive acute non-listed species RQs. In addition, peak EECs were also compared to
NOAEC values for non-vascular plants to derive listed species RQs for these taxonomic groups.
RQs for aquatic non-vascular plants are summarized in table 15. Given the high toxicity of
dodine to non-vascular aquatic plants and the lack of sufficient information on the toxicity of
dodine to aquatic vascular plants, both non-vascular and vascular aquatic plants are considered
together as "aquatic plants". The greatest contribution to predicted dodine exposure in water is
from erosion, particularly at sites that are vulnerable to sediment loss. To reduce the potential
for effects to aquatic plants, the Agency is requiring label language to limit the use of dodine on
areas where erosion is high. This is further outlined in Section IV of this document.
Table 1 5 : Acute RQs for Aquatic Non-vascular Plants
Crop
Apples (PA)
Cherries (MI)
Peaches (GA)
Pears (CA)
Pecans (GA)
Strawberries (FL)
Walnuts (CA)
Maximum
Single
Application
Rate
(Ibs ai/A)
1.95
1.3
2.6
1.95
2.6
1.3
2.6
Peak
EEC
43
24
16
6.0
19
0.80
7.8
Acute Non-Vascular Plants
Aquatic Plants
(EC50=0.95 ppb)
45.26
25.26
16.84
6.31
20.00
0.84
8.21
Aquatic
End. Sp.
(NOAEC=0.082
ppb)
524
293
195
73
232
10
95
Boldvalues indicate LOG exceedences.
b. Risk to Terrestrial Organisms
L Birds and Mammals Exposure and Toxicity
The Agency assessed exposure to terrestrial organisms by first predicting the amount of
dodine 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 is based on the Fletcher nomogram,
Page 34 of 80
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which is a model developed by Hoerger and Kenaga (1972) and modified by Fletcher (1994),
and the current maximum application rates for dodine.
Estimated exposure concentrations for terrestrial receptors were determined using the
standard screening-level exposure model, TREX (v.1.1), which is a simulation model that, in
addition to incorporating the nomogram relationship, also includes pesticide degradation in the
estimation of EECs. TREX considers exposure only in the area where dodine is applied. The
underlying assumption is that most, if not all, of the applied pesticide will settle in the use area.
However, depending on weather conditions and type of application, spray drift of pesticides may
occur, increasing the likelihood of wildlife exposure outside the use area. Since dodine is
applied via spray methods, spray drift is likely in some cases. Particularly for air blast
applications, spray drift could be significant.
EPA's estimates of dodine residues on various wild animal food items are summarized in
table 16. EPA used these EECs and standard food consumption values to estimate dietary
exposure levels for dodine to birds and mammals.
Table 16: Maximum Residue EECs on Avian and Mammalian Food Items
Crop
Apples, Pears
Cherries
Crab Apples
(OR only)
Ornamental Shade Trees
(OR only)
Peaches
Pecans, Walnuts
Strawberries
Application
Rate Ibs.
a.i./A
1.95
1.3
0.34
0.85
2.6
2.6
1.3
# Apps /
Interval
(days)
(6/5)
(6/7)
(6/5)
(6 / 10)
(5/7)
(5/ 10)
(5/7)
Range of Maximum EECs for:
(1) Short grass,
(2) Tall grass,
(3) Broadleaf plants/small insects, and
(4) Fruits, pods, seeds, and large insects
(mg/kg)
139 - 2224
85- 1361
24 - 388
49 - 789
151 -2410
136-2183
75- 1205
The acute toxicity of dodine to mammals was evaluated using the common laboratory rat
to calculate an LD50 of 1056 mg/kg. Chronic studies in both dogs and rats show that the
endpoint most sensitive to dodine exposure seems to be reduced body weight/growth in adults
and/or offspring.
Page 3 5 of 80
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Table 17: Summary of Acute and Chronic Toxicity Data for Terrestrial Organisms Exposed to Dodine.
Species
Brrd
Mammal
Insect
Northern
bobwhite quail
Colinus
virginianus
Mallard duck
Anas
platyrhynchos
Dog Canis
familiaris
Laboratory rat
Rattus
norvegicus
Honey bee
Apis meliferus
Acute Toxicity
LD50
(mg/kg)
690
2214
--
1056
>200
(wg/bee
contact)
Acute Oral
Toxicity
(MRID)
Slightly toxic
(Acc.#
130888)
Practically
non-toxic
(Acc.#
131455)
--
Practically
non-toxic
(449224-01)
Practically
non-toxic
(4013155-05)
8-day
LC50
(mg/kg
diet)
8413
> 10000
-
-
-
Subacute
Dietary
Toxicity
(MRID)
Practically
non-toxic
(Acc.#
226855)
Practically
non-toxic
(Acc.#
226855)
-
-
-
Chronic Toxicity
NOAEC/
LOAEC
(mg/kg
diet)
(MRID)
<75/75
(458197-
24)
200/600
(432746-
02)
2.0/10.0
Mg/kg/d
(442461-
01)
30.28
/60.5
(442460-
01)
-
Affected
Endpoints
growth (14-day
survivor weight);
reproduction
(eggs cracked)
multiple
reproductive
body weight
decreased pup
body weights
-
11.
Birds and Mammals Risk
Risk quotients were calculated for both birds and mammals using the dose-based and
dietary-based toxicity values. Generally dose-based RQs are higher than those calculated using
the dietary-based values because the dose-based RQs are calculated with the assumption that a
bird or mammal will experience a very short-term high intensity exposure from the pesticide.
The dietary-based approach assumes that animals in the field are consuming food at a rate
similar to that of confined laboratory animals despite the fact that energy content in food items
differs between the field and the laboratory. There are benefits and uncertainties by considering
both methods which are outlined in more detail in section 4.2.2 of the EFED Chapter. RQs
calculated using both methods are included in the discussion below.
In addition, in order to bound the estimates of RQs, mean Kenega residue values were
calculated along with upper-bound values. Log-normal distributions were generated that
describe residue levels on the various food items. The analysis, demonstrates that mean Kenega
values range from about 62-87 percent of the possible dodine residue values, indicating that 13 to
38 percent of the higher-end food item residue estimates are not captured in estimating exposure
by using the mean Kenega values. For the upper-end Kenega residue estimates, about 3-13
se 36 of 80
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percent of the upper-end residue estimates were not captured. Using the mean Kenaga residue
values for calculating RQs would not protect birds and mammals that consume food items that
have residues on the higher end of the residue distribution.
A range of RQs was calculated using dose and dietary based toxicity values and mean or
upper-bounds Kenaga residue values. A summary of the high- and low-end RQs are outlined in
the following tables; for a complete list of calculated RQs, refer to Section 4.1.2 of the EFED
Chapter.
Birds
Using dose-based (LDso = 690mg/kg-bw for bobwhite quail) toxicity values, acute, acute
restricted use, and listed species LOCs are exceeded for birds that consume short grass, tall grass,
broadleaf plants, and small insects for all modeled scenarios and application rates, with RQs
ranging from 0.01 to 5.62 (see table 18 below for a range of RQs). Based on the dose-based
endpoint, acute restricted use and listed species LOCs are also exceeded for birds that consume
fruits, pods, seeds, and large insects at application rates for all modeled scenarios, except crab
apples (2.04 Ibs ai/A/yr), at the smallest weight class, and in some cases at the medium weight
class.
Using the dietary-based (LCso = 8413 mg/kg-diet for bobwhite quail) toxicity values,
acute listed species LOCs are exceeded for only two scenarios, birds that consume broadleaf
plants/small insects with the cherry scenario (RQ=0.11) and bird that consume short grass with
the peach scenario (RQ=0.10).
Table 18: Acute RQs for Birds
Use
Apples (PA)
Cherries (MI)
Crab Apples (OR)
Ornamental Shade Tree (OR)
Peaches (GA)
Pears (CA)
Pecans (GA)
Strawberries (FL)
Walnuts (CA)
Maximum Single
Application Rate
(Ibs ai/A)
1.95
1.3
0.34
0.85
2.6
1.95
2.6
1.3
2.6
# Applications /
Retreatment
Interval (days)
6/5
6/7
6/5
6/10
5/7
6/7
5/10
5/7
5/10
Acute RQ Ranges
Based on Avian Diet
Dose -Based
Upper Bound
Kenaga Value
0.05-5.19
0.03 -3.18
0.01 -0.90
0.02 - 1.04
0.05 - 5.62
0.05-5.19
0.05 - 5.09
0.02-2.81
0.05 - 5.09
Dietary -Based
Mean Kenaga
Value
0.01 -0.09
0.01 -0.11
0.001 - 0.02
0.003 - 0.03
0.01 -0.10
0.01 -0.09
0.01 -0.09
0.003 - 0.03
0.01 -0.09
Boldvalues indicate LOG exceedences.
Chronic RQs were calculated using both upper and mean Kenaga residue values. LOCs
are exceeded for birds that consume short grass, tall grass, broadleaf plants, and small insects for
many modeled scenarios and application rates, with RQs ranging from 0.12 to 12.05 when
calculated with upper bound Kenaga values and ranging from 0.06 to 4.27 for mean Kenaga
values. See table 19 below for a summary of RQs.
Page 37 of 80
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Table 19: Chronic RQs for Birds
Use
Apples (PA)
Cherries (MI)
Crab Apples (OR)
Ornamental Shade Tree (OR)
Peaches (GA)
Pears (CA)
Pecans (GA)
Strawberries (FL)
Walnuts (CA)
Maximum Single
Application Rate
(Ibs ai/A)
1.95
1.3
0.34
0.85
2.6
1.95
2.6
1.3
2.6
# Applications /
Retreatment
Interval (days)
6/5
6/7
6/5
6/10
5/7
6/7
5/10
5/7
5/10
Chronic RQ Ranges
Based on Avian Diet
Dietary-Based
Upper Bound
Kenaga Value
0.69-11.12
0.43 -6.81
0.12-1.94
0.25 -3.95
0.75 - 12.05
0.69- 11.12
0.68 - 10.91
0.38-6.03
0.68 - 10.91
Dietary -Based
Mean Kenaga
Value
0.32-3.94
0.20-2.41
0.06 - 0.69
0.12-1.40
0.35-4.27
0.32-3.94
0.32-3.87
0.18-2.13
0.32-3.87
Boldvalues indicate LOG exceedences.
Mammals
Acute, acute restricted use and listed species LOCs are exceeded for mammals that
consume short grass, tall grass, broadleaf plants, and small insects across most weight classes for
most modeled scenarios and application rates, with RQs ranging from 0 to 0.99. See Section
4.1.2.2 of the dodine EFED assessment for a complete list of the acute RQs for mammals.
Chronic RQs were calculated using mean and upper-bound Kenaga residue values, as
well as considering both dose and dietary based toxicity values. LOCs are exceeded for wild
mammals that consume short grass, tall grass, broadleaf plants, and small insects across most
assessed weight classes for most modeled scenarios and application rates. RQs are summarized
in table 20 below for two different RQ calculation values.
Table 20: Chronic RQs for Mammals
Use
Apples (PA)
Cherries (MI)
Crab Apples (OR)
Ornamental Shade Tree (OR)
Peaches (GA)
Pears (CA)
Pecans (GA)
Strawberries (FL)
Walnuts (CA)
Maximum Single
Application Rate
(Ibs ai/A)
1.95
1.3
0.34
0.85
2.6
1.95
2.6
1.3
2.6
# Applications /
Retreatment
Interval (days)
6/5
6/7
6/5
6/10
5/7
6/7
5/10
5/7
5/10
Chronic RQ Ranges
Based on Mammal Size and Diet
Dose -Based
Upper Bound
Kenaga Value
0.18-31.74
0.08 - 19.43
0.03 - 5.53
0.06 - 11.27
0.19-34.41
0.18-31.74
0.18-31.16
0.10-17.20
0.18-31.16
Dietary -Based
Mean Kenaga
Value
0.16-1.97
0.10-1.21
0.03 - 0.34
0.06 - 0.70
0.18-2.14
0.16-1.97
0.16-1.93
0.09 - 1.07
0.16-1.93
Boldvalues indicate LOG exceedences.
ee 38 of 80
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iii. Non-target Terrestrial Plant Toxicity, Exposure, and Risk
Dodine exposure to terrestrial plants was estimated using the Terr Plant (v 1.0) model.
The model produces EECs for plants residing near a use area that may be exposed to pesticides
via runoff and/or spray drift. The EECs apply to plants that inhabit both dry and semi-aquatic
(wetland) habitats.
Risk quotients could not be calculated for dodine because even though Tier I plant studies
indicated between 20-25% effect, no Tier II studies which would give appropriate endpoints
were submitted. The Agency indicated Tier II plant data would be required in the revised EFED
chapter dated 9/23/2005, but upon further review this data is not being required because no major
effects were observed in the tier one plant studies.
iv. Non-Target Insects Risks
Currently, the Agency does not estimate RQs for terrestrial non-target insects. However,
based on acute toxicity studies on honeybees, dodine is classified as practically non-toxic to non-
target insects. Therefore, no label statement is required.
3. Ecological Incidents
No incidents of wildlife or aquatic species poisonings associated with uses of dodine
were found in the Ecological Incident Information System (EIIS) database.
4. Endangered Species Concerns
The Agency's screening level risk assessment indicates that uses of dodine will have no
direct acute effects on estuarine/marine fish, no direct chronic risks on freshwater fish, and no
effects on non-target insects. However, the screening-level risk assessment has identified
potential concerns for direct effects on listed species taxa listed below in table 21. In addition to
those effects expressed in table 21, there are no data with which to adequately assess the
potential chronic risk to estuarine/marine fish and invertebrates, or risks to aquatic vascular
plants. Therefore, potential risk to these species can not be precluded at the present time.
Further, there could be indirect effects to any listed species dependent upon a species that may
experience effects from the use of dodine. Finally, potential risks to reptiles and terrestrial
phase amphibians are characterized by the risks to birds; and potential risks to aquatic phase
amphibians is characterized by the risks to freshwater fish. Therefore, potential acute and
chronic risks to reptiles and terrestrial phase amphibians, and potential acute risk to aquatic
phase amphibians, can not be precluded based on the screening level assessment.
A preliminary analysis of the co-occurrence of listed species and proposed re-registration
of dodine uses was conducted using the Agency's LOCATES database. In general, for all
labeled uses of dodine there is at least one, and usually more, listed species that may potentially
occur in or near a use area. This preliminary analysis indicates that there is a potential for dodine
use to overlap with listed species and that a more refined assessment is warranted.
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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 use and species-specific analysis. When conducted,
this species-specific analysis will take into consideration any regulatory changes recommended
in this RED that have been 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
dodine, other measure to mitigate any potential impact, or consultations with the Fish and
Wildlife Service and/or the National Marine Fisheries Service as necessary. If the Agency
determines use of dodine "may affect" listed species or adversely modify their designated critical
habitat, EPA will employ the provisions in the Services regulations (50 CFR Part 402). Until
that species specific analysis is completed, the risk mitigation measures being implemented
through this RED will reduce the likelihood that endangered and threatened species may be
exposed to dodine at levels of concern
Table 21 : Summary of Direct Effects for Federally Listed Species Based on Screening Assessment
Listed Species Taxonomic Group of
Concern
Freshwater fish
Freshwater invertebrates
Saltwater mollusc
Aquatic Plants:
Non-vascular
Birds
Mammals
Terrestrial Plants:
Monocots
Dicots
Direct Effects
Acute: mortality
Acute: mortality /immobilization
Chronic: growth/reproduction
Acute: shell deposition
Acute: reduced cell density
Acute: mortality /sublethal
Chronic: reproduction
Acute: mortality
Chronic: reduced body weight/
growth
Acute: dry weight/ shoot height
Acute: dry weight
RQ Range
-------
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility and Tolerance Reassessment
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 reregi strati on. The Agency has previously identified and required the
submission of the generic data to support reregi strati on of products containing dodine. The
Agency has determined that the data are sufficient to support reregi strati on of dodine.
The Agency has completed its assessment of the dietary, occupational and ecological risk
associated with the use of dodine. Because of the similarity of dodine and DGH, EPA has also
considered the contribution to overall exposure of the DGH uses that may occur in a residential
environment, i.e. treated paper that comes into contact with food, paint additives, and
antimicrobial treatment of diapers, in its aggregate assessment for dodine. Based on this
assessment the Agency has sufficient information on dodine to make decisions as part of the
tolerance reassessment process under FFDCA and reregi strati on process under FIFRA, as
amended by FQPA. The Agency has determined that dodine containing products are eligible for
reregi strati on provided that label amendments are made as outlined in this RED. Note, however,
that the RED for the antimicrobial uses of DGH will be issued later. Appendix A summarizes
the uses of dodine that are eligible for reregi strati on. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregi strati on eligibility,
and lists the submitted studies that the Agency found acceptable.
Based on its evaluation of dodine, the Agency has determined that dodine products,
unless labeled and used as specified in this document, would present risks inconsistent with
FIFRA and FQPA. Accordingly, should a registrant fail to implement any of the reregi strati on
requirements identified in this document, the Agency may take regulatory action to address the
risk concerns from the use of dodine. If all changes outlined in this document are incorporated
into the product labels, then all current risks for dodine will be adequately mitigated for the
purposes of this determination. Once an Endangered Species assessment is completed, further
changes to these registrations may be necessary as explained under "Endangered Species
Concerns" above.
B. 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 dodine and DGH. EPA has determined that risk from dietary (food + water) exposure is
within its own "risk cup." An aggregate assessment was conducted for dodine and DGH for
exposures through dietary (food + water + indirect food additive) and residential (diaper and
paint) exposures. 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
Page 41 of 80
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for dodine meet FQPA safety standards. In reaching this determination, EPA has considered the
available information on the special sensitivity of infants and children, as well as aggregate
exposure from food and residential sources.
b. Determination of Safety to U.S. Po pulation
The Agency has determined that the established tolerances for dodine, with amendments
and changes as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) of the FFDCA, as amended by FQPA, and that there is a
reasonable certainty no harm will result to the general population or any subgroup from the use
of dodine. In reaching this conclusion, the Agency has considered all available information on
the toxicity, use practices, and the environmental behavior of dodine, as well as residential and
dietary exposure to DGH. As discussed in Section III, aggregate short-, intermediate-, and long-
term risks from food, drinking water, and residential exposures are below the Agency's LOG.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for dodine, with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants
and children. The safety determination for infants and children considers factors on the toxicity,
use practices and environmental behavior noted above for the general population, but also takes
into account the possibility of increased dietary exposure due to the specific consumption
patterns of infants and children, as well as the possibility of increased susceptibility to the toxic
effects of dodine residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from exposure to residues of dodine, the Agency considered the completeness of the
hazard database for developmental and reproductive effects, the nature of the effects observed,
and other information. The FQPA Safety Factor has been reduced to IX, because there are no
residual uncertainties for pre- and/or post-natal toxicity, exposure is not underestimated, and
there is no evidence of increased susceptibility.
2. Endocrine Disrupter 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 Disrupter 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,
Page 42 of 80
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screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP). In the available toxicity studies on dodine submitted for registration purposes,
there was no estrogen, androgen, and/or thyroid mediated toxicity. When the appropriate
screening and/or testing protocols being considered under the EDSP have been developed,
dodine may be subject to additional screening and/or testing.
3. Cumulative Risks
The FFDCA, as amended by the 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 made a common mechanism of toxicity
finding for dodine and any other substances, and dodine does not appear to produce a toxic
metabolite produced by other substances. As noted in this document dodine and DGH are both
salts of the same chemical. They dissociate similarly, are considered bioequivalents and
lexicologically the same, as opposed to separate chemicals that share a common mechanism of
toxicity. For the purposes of this action, therefore, EPA has not assumed that dodine has a
common mechanism of toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesicides/cumulative/.
C. Tolerance Reassessment Summary
Table 22: Tolerance Reassessment Summary for Dodine (40 CFR § 180. 172)
Commodity
Apple
Pear
Peach
—
Cherry, Sweet
Cherry, Tart
Strawberry
Established
Tolerance
(ppm)
5
5
5
—
5
5
5
Recommended
Tolerance (ppm)
5
5
5
5
3
3
TBD1
Comments (correct commodity definition)
-
—
-
Plum
See Codex MRL comment regarding cherries below.
Insufficient data were available to determine if the residue data
support the established tolerance of 5 ppm.
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Table 22: Tolerance Reassessment Summary for Dodine (40 CFR § 180. 172)
Commodity
Pecans
Walnut, Black
Spinach
Milk
Meat
Apple, Wet
Pomace
Established
Tolerance
(ppm)
0.3
0.3
12.0 (Regional)
0
0
--
Recommended
Tolerance (ppm)
0.3
0.3
Revoke tolerance
Revoke tolerance
Revoke Tolerance
15
Comments (correct commodity definition)
Change to Pecan. The data submitted were for nutmeat and shells
combined. The Agency previously determined that a tolerance of
0.3 ppm is appropriate and data for nutmeats only are not
required (SF0655; 12/22/67; J. Iverson and R.S. Quick)
The correct commodity name should be: "Walnut".
The use of dodine on spinach is not supported by the registrant.
HED concludes that there is no reasonable expectation of
residues 180.6(a)(3) in milk.
HED concludes that there is no reasonable expectation of
residues 180.6(a)(3) in any livestock or poultry tissue.
A tolerance of 1 5 ppm is required for dodine residues in apple
pomace based upon the 5. 1 3X concentration factor and HAFT
residue of 2.36 ppm in/on apples (RAC).
TBD = To be determined. Tolerances cannot be determined at this time because additional data are required.
Conservative exposure assumptions were used in the dietary risk assessment to ensure that risks are not
underestimated.
Codex maximum residue limits (MRLs) for dodine currently exist on apples, grapes,
peaches, pears, and strawberries at 5 ppm and on cherries at 2 ppm. The MRLs are in agreement
with the U.S. tolerances for apples, pears, and strawberries. There are no Codex MRLs for milk,
meat, pecans, spinach, walnuts, or apple pomace. For cherries, the current U.S. tolerance of 5
ppm is higher than Codex MRL of 2 ppm. According to the Residue and Analytical Aspects of
Dodine, evaluated within the Periodic Review Programme of the Codex Committee on Pesticide
Residues (http://www.fao.org/DOCREP/006/Y5221E/y5221eOd.htm) the committee is
recommending the withdrawal of the current CXL of 2 mg/kg for cherries to be replaced by 3
mg/kg, which will be consistent with the reassessed US tolerance.
D. Regulatory Rationale
The Agency has determined that dodine is eligible for reregi strati on provided that the risk
mitigation measures and label amendments specified in this RED are implemented. The
following is a summary of the rationale for managing risks associated with the use of dodine.
1.
Human Health Risk
There are no dodine dietary (food + drinking water) residential, or aggregate risks that
exceed the Agency's level of concern. Moreover, this assessment is protective of the general
U.S. population and all population subgroups, including infants and young children. Therefore,
no mitigation is necessary for these scenarios.
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There are mitigation measures necessary to address occupational risks that exceed the
Agency's level of concern.
Risk to workers from mixing and loading the wettable powder formulations of dodine can
be addressed by use of water-soluble packaging. However, technical registrants have chosen to
voluntarily cancel wettable powder formulations. If wettable powder formulations are registered
in the future, water soluble packages would be needed to protect these workers from risks
associated with dodine.
There are some concerns to workers when mixing and loading both liquid and wettable
powder formulations of dodine. All mixers and loaders handling dodine, including potential
future water soluble bag formulations, are required to wear chemical resistant gloves for dermal
protection.
Dodine is classified as a category I for eye and skin irritation which requires double
notification Workers must be notified by warning them orally and by posting warning signs at
entrances to treated areas.
A 48 hour REI is also required to protect workers re-entering treated fields after dodine
applications. In addition, workers who want to enter a dodine treated field before the REI has
expired must wear coveralls over long-sleeve shirt and long pants, chemical-resistant gloves
made of any waterproof material, chemical-resistant footwear plus socks, protective eyewear,
and chemical-resistant headgear if overhead exposure occurs.
2. Environmental Risk
The Agency has conducted a screening-level ecological and environmental risk
assessment for the registered uses of dodine. Based on the available data, the Agency has
identified potential acute and chronic risks of concern to freshwater and estuarine/marine
invertebrates, birds, mammals, and non-vascular plants. However, the screening-level risk
assessment does not indicate a risk concern for freshwater fish.
While there are slight estimated exceedences of the LOG for some terrestrial and aquatic
species, the ecological risks associated with the use of dodine are expected to be limited based on
its use pattern and usage information. Dodine is used on apples, cherries, peaches, pears, pecans,
strawberries, walnuts, ornamentals, and crab apples. The use of dodine has dropped to
approximately 70,000 pounds active ingredient used per year from a 1992 high of approximately
265,000 pounds active ingredient used per year. Of the estimated 70,000 pounds of dodine used,
57% or 40,000 pounds are used on apples and pears and 28 % or 20,000 pounds are used on
cherries and pecans. The remaining 5 crops account for 15% or 10,000 pounds of use per year of
dodine.
The registrant for dodine has agreed to decrease the maximum single application rate for
3 of the 7 food crops and decrease the maximum seasonal rates for 6 of the 7 food crops. Also,
for apples and pears, the minimum retreatment interval will be increased from 5 days to 7 days.
All other crops already have a minimum retreatment interval of at least 7 days.
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For peaches, peacans, and walnuts the maximum single application rate will be reduced
by approximately 25%. The single application rate will be decreased from 2.6 Ibs ai/A to 1.95
Ibs ai/A. The maximum seasonal rate will be reduced by approximately 60 % from 13 Ibs
ai/A/year to 7.8 Ibs. ai/A/year.
For apples, even though the maximum single application rate will remain at 1.95 Ibs ai/A
for a rescue treatment (post-infection), the maximum seasonal rate will be reduced at least 20%
from 11.7 Ibs ai/A/year to 9.1 Ibs ai/a/year. For apples, the modeled rate is the 1.95 Ibs ai/A.
However, typical use rates range between 0.25 and 1.25 Ibs ai/A and approximately 70% of
apple applications are made between these rates. Only 5% of applications to apples occur at the
higher rate.
For pears, the maximum single application rate will remain at 1.95 Ibs ai/A. However,
the maximum seasonal rate will be reduced at least 20% from 11.7 Ibs ai/A/year to 9.1 Ibs
ai/a/year.
For cherries, the modeled maximum single application rate will remain at 1.3 Ibs ai/A.
However, the maximum seasonal rate will be reduced approximately 40% from 7.8 Ibs ai/A/year
to 5.2 Ibs ai/a/year. For cherries, the typical use rates range between 0.25 and 1.25 Ibs ai/A and
approximately 70% of cherry applications are made between these rates. Approximately 30% of
applications to cherries occur at the higher rates.
Many orchard fungicides are applied with airblast systems to ensure complete coverage
of plant surfaces. Since dodine is a fungicide applied mostly to fruit and nut orchard crops, the
Agency does not anticipate large numbers of applications are made with aerial equipment. In
discussions with the registrant, it appears that aerial applications are only made as a rescue
treatment when substantial rainfall prevents ground applications of dodine. The use of ground
equipment reduces the potential for off-site drift.
The following summary of ecological concerns does not reflect the mitigation measures
mentioned above. Thus, the actual exposure to dodine will be less for all non-target species than
current estimates reflect. See table 23 for a list of new and original dodine use rates.
a. Fish and Aquatic Invertebrate Risk
Acute and Chronic Freshwater and Estuarine/Marine Fish
For freshwater fish and aquatic-phase amphibians the acute RQ value of 0.08 based on
aerial application of dodine to Pennsylvania apples (1.95 Ib ai/A) with a 5 day retreatment
interval exceeds the listed species acute risk LOG (RQ > 0.05). The acute RQ values associated
with all other modeled scenarios are less than the LOG.
For estuarine/marine fish acute RQ values calculated for all modeled scenarios are less
than the LOCs (RQs < 0.05).
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Chronic Freshwater and Estuarine/Marine Fish
For freshwater fish and aquatic-phase amphibians, the chronic RQ values associated with
all modeled scenarios are less than the chronic risk LOG (RQ < 1).
Chronic RQ values were not derived for estuarine/marine fish because data on the
chronic toxicity of dodine are not available. However, since acute risks to fresh and saltwater
fish are minimal and there were no chronic risks to freshwater fish, chronic risks to saltwater fish
is not likely.
A fish bioconcentration (BCF) study was not available so this is a source of uncertainly
in this assessment. However, the Hazardous Substances Data Bank (HSDB, 2005) reports an
estimated BCF for dodine of 16 suggesting that the potential for bioaccumulation in aquatic
organisms is low.
Acute and Chronic Freshwater Invertebrates
Acute LOCs for all modeled scenarios, except Florida strawberry, were exceeded for
freshwater invertebrates (RQs = 0.34 - 2.4) and estuarine/marine invertebrates LOCs (RQs =
0.10-0.72).
For freshwater invertebrates, the chronic RQ value based on aerial application of dodine
to Pennsylvania apples (1.95 Ib ai/A) exceeds the chronic LOG (RQ = 1.2).
Chronic RQ values were not derived for estuarine/marine invertebrates because data on
the chronic toxicity of dodine are not available.
b. Avian Risk
Terresterial Birds
Acute risk LOCs are slightly exceeded for birds that consume short grass, tall grass,
broadleaf plants, and small insects across most weight classes for all modeled scenarios and
application rates, with acute RQs ranging from 0.06 to 5.6. In addition, acute RQ values also
exceed acute risk LOCs for birds that consume fruits, pods, seeds, and large insects at application
rates for all modeled scenarios, except crab apples, at the smallest weight class, and in some
cases at the medium weight class (RQs that represent exceedances = 0.12 - 0.35).
For avian chronic risk, LOCs are exceeded for birds that consume short grass, tall grass
(in most cases), broadleaf plants, and small insects for all modeled scenarios and application
rates, with chronic RQs that represent exceedances ranging from 1.09 to 12.
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c. Mammalian Risk
Terrestrial Mammals
Acute risk LOCs are exceeded for mammals that consume short grass, tall grass,
broadleaf plants, and small insects across all weight classes for all modeled scenarios and
application rates, except crab apples and ornamentals, with acute RQs that represent LOG
exceedences ranging from 0.10 to 0.99.
The chronic mammalian dose-based RQs exceed the LOG for mammals that consume
short grass, tall grass, and broadleaf plants and small insects across all weight classes for all
modeled scenarios and application rates, with chronic RQs that represent exceedances ranging
from 1.0 to 34. For mammals that consume fruits, pods, and/or large insects, RQs exceeded the
chronic LOCs for all uses with the exception of 1000 kg mammals in most cases. For seed
eating mammals, no RQs exceeded the chronic LOG for any use.
Exposure estimates for terrestrial birds and mammals are generated assuming these
species feed exclusively on the treated field soon after application of the pesticide. Moreover,
the assumption is that these organisms will consume at a particular daily ingestion rate while on
the treated field. Although some individuals at particular times may feed exclusively on a treated
field, the actual frequency and duration of this type of behavior is a source of uncertainty. While
the current approach may overestimate exposure for some individuals, it does capture the
potential exposures that may occur.
d. Non-Target Terrestrial and Aquatic Plant Risk
For non-listed non-vascular plants, the acute RQs for all modeled scenarios, except
Florida strawberry, exceed the acute risk LOG (RQs = 6.3 - 45). Similarly, for listed non-
vascular plants, RQs for all scenarios exceed the listed species acute risk LOG (RQs = 10 - 524).
Risk to aquatic vascular plants cannot be assessed since there are no available toxicity data.
Although there are no listed endangered nonvascular plant species, indirect effects on a number
of aquatic listed species are possible. The most obvious indirect effects would likely relate
directly to reductions in food availability or habitat alterations associated with reduced aquatic
plant and invertebrate biomass. The Endangered Species Protection Program will further explore
the risk of endangered species from dodine use in the future.
e. Non-Target Insects
Currently, the Agency does not estimate RQs for terrestrial non-target insects. However,
based on acute toxicity studies on honeybees, dodine is classified as practically non-toxic to non-
target insects. Therefore, no label statement is required.
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Table 23 : Original and New Dodine Usage Information
Crop
Apples
Cherries (sour
and sweet)
Crab
Apples(SLN
OR)
Ornamental
Shade Trees
(SLN OR)
Peaches
Pears
Pecans
Strawberries '
Walnuts
Original
Maximum
Application
Rate
(Ibs a.i./A/app)
1.95
1.3
0.35
0.85
2.6
1.95
2.6
1.3
2.6
New
Max. Typical
Application
Rate
(Ibs a.i./acre)
1.3
(max 4 apps/yr)
0.65
(max 4 apps/yr)
0.35
0.85
1.3
(max 3 apps/yr)
1.3
(max 4 apps/yr)
1.3
(max 4 apps/yr)
1.3
1.3
(max 3 apps/yr)
New
Maximum/Rescue
Application Rate
(Ibs a.i./acre)
1.95
(max 2 apps. per year)
1.3
(max 2 apps. per year)
0.35
0.85
1.95
(max 2 apps. per year)
1.95
(max 2 apps. per year)
1.95
(max 2 apps. per year)
1.3
1.95
(max 2 apps. per year)
Original Yearly
Maximum App
Rates
(Ibs a.i./A/yr)
11.7
7.8
2.10
5.1
13.0
11.7
13.0
6.5
13.0
New Yearly
Maximum App
Rates
(Ibs a.i./A/yr)
9.1
5.2
1.4
5.1
7.8
9.1
7.8
6.5
7.8
Maximum
Number of
Applications
6 per year
6 per year
6 per year
6 per year
5 per year
6 peryear
6 per year
(originally 5)
5 per year
5 per year
New
Minimum
Retreatment
Interval
7 days
(originally 5)
7 days
7 days
(originally 5)
10 days
7 days
7 days
(originally 5)
10 days
7 days
10 days
1 Stawberries are the only crop with no aerial application supported.
NA = Not Applicable
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V. What Registrants Need to Do
The Agency has determined that dodine is eligible for reregi strati on provided that the
mitigation measures and label changes identified in this RED are implemented. Registrants will
need to amend their product labeling to incorporate the label statements set forth in the Label
Changes Summary Table (table 25). The Agency intends to issue Data Call-Ins (DCIs) requiring
generic and product specific data. Generally, the registrant will have 90 days from receipt of a
DCI to complete and submit response forms or request time extensions and/or waivers with a full
written justification. For product-specific data, the registrant will have eight months to submit
data and amended labels.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of dodine for currently registered uses
has been reviewed and determined to be substantially complete. However, the data listed below
are necessary to confirm the reregi strati on eligibility decision documented in this RED.
Table 24. Guideline Requirements for Dodine
Data Requirement
Mysid Chronic Toxicity Test
Aquatic Plant Toxicity Test using Lemna spp. - Tiers I and II
Crop Field Trials - Strawberry
An adequate set of field trials on strawberry is required.
Only a minimal number of the trials using a PHI of 14 days were
conducted and no trials were conducted using an application rate of
1.3 Ib ail A/application (the maximum application rate); therefore,
insufficient data were available to support or reassess the
established tolerance of 5 ppm
The geographic locations of the crop field trials for strawberry are
not adequate based on the current recommended locations provided
in OPPTS Guideline 860. 1 500. These field trials will need to be
supported by appropriate storage stability data, and labels will need
to be amended as appropriate following the results of these field
trials
Crop Field Trials using the flowable concentrate formulation.
No crop field trials were conducted using the flowable concentrate
formulation. According to the OPPTS Guideline 860. 1500, side-
by-side studies are required for the flowable concentrate
formulation because foliar applications are allowable in the mid -to-
late season. Such side -by -side trials must be submitted.
Confined Accumulation in Rotational Crops
Old Guideline
Number
72-4c
123-2
171-4k
171-4k
165-1
New OPPTS
Guideline No.
850.1350
850.4400
860.1500
860.1500
860.1850
se 50 of 80
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Table 24. Guideline
Requirements for Dodine
Data Requirement
Confined rotational
use.
studies are needed to support the strawberry
Old Guideline
Number
New OPPTS
Guideline No.
Additional Residue Chemistry Clarifications
A maximum number of applications per season was not provided on the labels for the
following commodities: apple, peach, cherry, pecan, walnut, and strawberry. The labels need to
be amended to specify the maximum number of applications and the maximum seasonal
application rate and as necessary to be made consistent with application rates used in the field
trials.
2. Labeling Requirements
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MUP labeling should bear the labeling contained in Table XX.
3. 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 reregi strati on process, the EPA will continue to work with all interested parties on this
important issue.
Specific spray drift language for dodine is outlined in the "spray drift management"
section of table 25. Due to concerns with risk to non-target species the following spray drift
language will be required on all dodine labels:
- Droplet size restricted to medium or coarse sprays.
- Wind speeds must not exceed 10 mph at the application site.
- Release heights for airblast and ground applications must not exceed 4 feet above the crop
canopy, and must not exceed 10 feet above the crop canopy for aerial applications.
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
Page 51 of 80
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specific data requirements. For any questions regarding the PDCI, please contact Veronica
Dutch at (703) 308-8585.
2. Labeling for End-Use Products
To be eligible for reregistration, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in table
25. Generally, conditions for the distribution and sale of products bearing old labels/labeling
will be established when the label changes are approved. However, specific existing stocks time
frames will be established case-by-case, depending on the number of products involved, the
number of label changes, and other factors.
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Labeling Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to incorporate the risk mitigation measures outlined in
Section IV. The following table describes how language on the labels should be amended.
Table 25: Summary of Labeling Changes for Dodine
Description
Dodine Amended Labeling Language for Manufacturing Use Products
Placement on Label
For all Manufacturing Use
Products
AOnly for formulation into a fungicide for the following use(s) [fill blank only with those uses
that are being supported by MP registrant].®
AWettable powder end use product formulations must be packaged in water soluble packaging.®
Directions for Use
One of these statements may be
added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by a
formulator or user group
AThis product may be used to formulate products for specific use(s) not listed on the MP label if
the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s).@
AThis product may be used to formulate products for any additional use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s).@
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
" This product is toxic to aquatic invertebrates. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with
the requirements of a National Pollution Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do not discharge
effluent containing this product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance contact your State Water Board or Regional Office of
the EPA."
Precautionary Statements
Page 5 3 of 80
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Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
PPE Requirements Established
by the RED1
for Liquid and Wettable
Powder Formulations in Water
Soluble Packaging
APersonal Protective Equipment (PPE)®
ASome materials that are chemical-resistant to this product are® (registrant inserts correct chemical-
resistant material). Alf you want more options, follow the instructions for category® [registrant
inserts A,B,C,D,E,F,G,or H\ Aon an EPA chemical-resistance category selection chart.®
AA11 mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes.
In addition, mixers and loaders must wear:
- chemical-resistant apron, and
- chemical-resistant gloves.
See engineering controls for additional requirements.®
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
User Safety Requirements
AFollow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.®
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
Engineering Controls
for Wettable Powder
Formulations
AEngineering Controls
Water-soluble packaging when used correctly qualify as a closed mixing/loading system under the
Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4)]. Mixers and
loaders using water soluble packets must:
B wear the personal protective equipment on this labeling for mixers/loaders,
B be provided and have immediately available for use in an emergency, such as a broken package,
spill, or equipment breakdown: chemical-resistant footwear.®
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following PPE
and User Safety
Requirements.)
Engineering Controls
for Enclosed Cockpits
Enclosed Cockpits
AEngineering Controls:
Pilots must use an enclosed cockpit that meets the requirements listed in the Worker Protection
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following PPE
and User Safety
Page 54 of 80
-------
Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)]. 8
Requirements.)
User Safety Recommendations
AUser Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing.®
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"This pesticide is toxic to aquatic invertebrates. Do not apply directly to water, or to areas where
surface water is present or to intertidal areas below the mean high water mark. Do not contaminate
water when disposing of equipment washwater or rinsate. Drift and runoff may be hazardous to
aquatic organisms in water adjacent to treated areas."
Surface Water and Erosion Control Statement:
"A level, well maintained vegetative buffer strip between areas to which this product is applied and
surface water features such as ponds, steams, and springs will reduce the potential for
contamination of water from rainfall-runoff. Runoff of this product will be reduced by avoiding
applications when rainfall is forecasted to occur within 48 hours. Sound erosion control practices
will reduce this product's contribution to surface water contamination."
Precautionary Statements
immediately following the
User Safety
Recommendations
Restricted-Entry Interval
ADo not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 48
hours for all crops.®
Directions for Use, Under
Agricultural Use
Requirements Box
Early Entry Personal Protective
Equipment established by the
RED.
APPE required for early entry to treated areas that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated, such as plants, soil, or water, is:
B coveralls worn over long-sleeve shirt and long pants,
B chemical-resistant gloves made of any waterproof material,
B chemical-resistant footwear plus socks,
B protective eyewear, and
B chemical-resistant headgear (if overhead exposure).®
Direction for Use
Agricultural Use
Requirements box
Page 5 5 of 80
-------
Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
Double Notification
Requirement
ANotify workers of the application by warning them orally and by posting warning signs at
entrances to treated areas.®
Directions for Use,
Agricultural Use
Requirements Box
General Application
Restrictions
ADo not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application.®
Place in the Direction for Use
directly above the
Agricultural Use Box.
Application Restrictions
ADo not apply this product through any type of irrigation system.®
ADo not apply in greenhouses.®
Directions for Use
Use-Specific Application
Restrictions
(Note: the maximum allowable
application rate and maximum
allowable rate per year must be
listed as pounds or gallons of
formulated products per acres,
not just as pounds active
ingredient per acre.)
Apples
"Do not apply more than 9.1 Ibs ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.95 Ibs ai/acre/application."
ADo not apply more than 4 applications per year at a rate of 1.3 Ibs ai/acre/application.®
ADo not apply less than 7 days from the last application.®
ADo not apply within 7 days of harvest.®
Cherries (sour and sweet)
"Do not apply more than 5.2 ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.3 Ibs ai/acre/application."
ADo not apply more than 4 applications per year at a rate of 0.65 Ibs ai/acre/application.®
ADo not apply less than 7 days from the last application.®
ADo not apply within 7 days of harvest.®
Crab apples (SLN in Oregon)
ADo not apply more than 0.35 Ibs ai/acre/application.®
ADo not apply more than 6 times per year.®
ADo not apply less than 7 days from the last application.®
Directions for Use
se 56 of 80
-------
Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
Ornamental Shade Trees (SLN in Oregon)
ADo not apply more than 0.85 Ibs ai/acre/application.®
ADo not apply more than 6 times per year.®
ADo not apply less than 10 days from the last application.®
Peaches
"Do not apply more than 7.8 Ibs ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.95 Ibs ai/acre/application."
ADo not apply more than 3 applications per year at a rate of 1.3 Ibs ai/acre/application.®
ADo not apply less than 7 days from the last application.®
ADo not apply within 15 days of harvest.®
Pears
"Do not apply more than 9.1 Ibs ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.95 Ibs ai/acre/application."
ADo not apply more than 4 applications per year at a rate of 1.3 Ibs ai/acre/application.®
ADo not apply less than 7 days from the last application.®
ADo not apply within 7 days of harvest.®
Pecans
"Do not apply more than 7.8 Ibs ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.95 Ibs ai/acre/application."
ADo not apply more than 4 applications per year at a rate of 1.3 Ibs ai/acre/application.®
ADo not apply less than 10 days from the last application.®
ADo not apply after shucks have started to open.®
Page 57 of 80
-------
Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
Strawberries
ADo not apply more than 1.3 Ibs ai/acre/application.®
ADo not apply more than 5 times per year.®
ADo not apply less than 7 days from the last application.®
ADo not apply within 14 days of harvest.®
"Do not apply aerially to strawberries."
Walnuts
"Do not apply more than 7.8 Ibs ai/acre/year."
ADo not apply more than 2 applications per year at a rate of 1.95 Ibs ai/acre/application."
ADo not apply more than 3 applications per year at a rate of 1.3 Ibs ai/acre/application.®
ADo not apply less than 10 days from the last application.®
ADo not apply within 7 days of harvest.®
Spray Drift Label Language for
ALL Products Applied as a
Spray
SPRAY DRIFT MANAGEMENT:
"A variety of factors including weather conditions (e.g., wind direction, wind speed, temperature,
relative humidity) and method of application (e.g., ground, aerial, airblast) can influence pesticide
drift. The applicator and grower must evaluate all factors and make appropriate adjustments when
applying this product.
WIND SPEED:
Do not apply at wind speeds greater than 10 mph at the application site.
DROPLET SIZE:
Apply as a medium or coarser spray (ASAE standard 572)."
Directions for Use under
General Precautions and
Restrictions
Spray Drift Label Language for
Products Applied as a Spray
through ground equipment
RELEASE HEIGHT:
"Apply using a nozzle height of no more than 4 feet above the ground or crop canopy."
AIRBLAST:
"Sprays must be directed into the crop canopy."
"Outward pointing nozzles should be turned off at row ends and when spraying outer rows.'
Directions for Use under
General Precautions and
Restrictions
ee 58 of 80
-------
Labeling for Dodine End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
Spray Drift Label Language for
Products Applied as an Aerial
Spray
RELEASE HEIGHT:
ADo not release spray at a height greater than 10 feet above the ground or crop canopy.®
BOOM LENGTH:
AThe boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter.®
SWATH ADJUSTMENT:
AWhen applications are made with a cross-wind, the swath will be displaced downwind. The
applicator must compensate for this displacement at the downwind edge of the application area by
adjusting the path of the aircraft upwind. Leave at least one swath unsprayed at the downwind edge
of the treated field.®
Directions for Use under
General Precautions and
Restrictions
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
se 59 of 80
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VI. Dodine Appendices
se 60 of 80
-------
Appendix A. Uses of Dodine Eligible for Reregistration
Crop
Apples
Cherries (sour
and sweet)
Crab
Apples(SLN
OR)
Ornamental
Shade Trees
(SLN OR)
Peaches
Pears
Pecans
Strawberries
Walnuts
Typical
Application
Rate (Ibs
a.i./acre)
1.3
0.65
0.17
0.85
1.3
1.3
1.3
0.975
1.3
Maximum/Rescue
Application Rate(lbs
a.i./acre)
1.95
(max 2 apps. per year)
1.3
(max 2 apps. per year)
0.35
0.85
1.95
(max 2 apps. per year)
1.95
(max 2 apps. per year)
1.95
(max 2 apps. per year)
1.3
1.95
(max 2 apps. per year)
Maximum Total
Pounds A.I. Applied
Per Acre Per Year
9.1
5.2
1.4
5.1
7.8
9.1
9.1
6.5
7.8
MaximumNum
her of
Applications
6 per year
6 per year
6 per year
6 per year
5 per year
6 per year
6 per year
5 per year
5 per year
Minimum
Retreatment
Interval
7 days
7 days
7 days
10 days
7 days
7 days
10 days
7 days
10 days
Application
Method
aerial & ground
aerial & ground
aerial & ground
aerial & ground
aerial & ground
aerial & ground
aerial & ground
ground only
aerial & ground
REI
48 hours
48 hours
48 hours
48 hours
48 hours
48 hours
48 hours
48 hours
48 hours
Pre Harvest
Interval (PHI)
7 days
7 days
Not applicable
Not applicable
15 days
7 days
Do not apply
after shucks
have opened.
14 days
7 days
Page 61 of 80
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Dodine (PC 044301)
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregistration for
active ingredients within the dodine case covered by this RED. It contains generic data
requirements that apply dodine in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following formats:
1. Data requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which is available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. (703) 487-
4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number is no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
Page 62 of 80
-------
Data Requirement
New
Guideline
Number
Old
Guideline
Number
Description
Use Patterns
Citations
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.6314
830.6316
830.6317
830.6320
830.7000
830.7050
830.7200
830.7300
830.7370
830.7550
830.7840
830.7950
61-1
61-2A
61-2B
61-2B
62-1
62-0
62-3
63-2
63-3
63-4
63-13
63-14
63-16
63-17
63-20
63-12
None
63-5
63-7
63-10
63-11
63-8
63-9
Product Identity and
Composition
Description of materials used to
produce the product
Description of production
process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated
temperatures, metals, and metal
ions
Oxidation/reduction: chemical
incompatibility
Explodability
Storage stability
Corrosion characteristics
pH
UV/Visible Absorption
Melting Point
Density
Dissociation Constants in Water
Partition coefficient, shake flask
method
Solubility
Vapor Pressure
All
All
Al
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
40315501,45322701,
46165601
40315501,45322701,
46165601
40315501,45322701,
46165601
40315501,45322701,
46165601
40315502,45322702,
46146501 , 46165602
40315502,45322703,
46165601
40315502,45322702,
46165601
40315503,45322704
40315503,45322704
40315503,45322704
40315503,40975701,
45322708,
45322704
45322704
45322708
45322708
45322705, 40315503
40975701, 46621301
40315503
40315503,45322704
40315503,45322705
40315503,45322707
40315503,45322706,
45322709
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
71-1A
71-2A
71-2B
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
A, B, D
A, B, D
A, B, D
Ace. 130888, Ace.
131455,41671001
(under review),
41671003 (under
review)
Ace. 226855,
4 167 1002 (under
review)
Ace. 226855,
4 167 1004 (under
review)
Page 63 of 80
-------
Data Requirement
New
Guideline
Number
850.2300
850.2300
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1300
850.1350
850.1400
850.4225
850.4250
850.4400
850.5400
Old
Guideline
Number
71-4A
71-4B
72-1A
72-1 C
72-2A
72-3A
72-3B
72 -3 C
72-3
72-4A
72-4B
72-4C
123-1 A
123-1C
123-2
122-2B
Description
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Freshwater Fish Toxicity
Rainbow Trout
Freshwater Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Panaeid Acute Toxicity Test
Daphnid Chronic Toxicity Test
Estuarine/Marine Invertebrate
Life Cycle
Early -life Stage Freshwater Fish
Seedling Germination and
Seedling Emergence, Tier 2
Vegetative Vigor, Tier 2
Aquatic Plant Toxicity
Aquatic Plant Growth, Tier 2
Use Patterns
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
Citations
43274601, 44985805
44985705
Ace. 132149,
41900301 (under
review)
Ace. 132149,
43485505, 41900302
(under review)
42339601,42653501,
Ace. 226855,
40756805, 46621305
(under review),
46621307 (under
review)
42653502, 43485506,
42501501 (under
review)
42653503, 43485508,
4250 1502 (under
review)
42653504, 43485507,
42501503 (under
review)
40940802
43876501
Data Gap
43876502
42695102
42695103
42695 101, Data Gap
4662 1308 (under
review), 46621309
(under review)
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-
Day Study Rodent
Subchronic Oral Toxicity: 90-
Day Study Non-rodent
21 -Day Dermal - Rabbit/Rat
All
All
All
All
All
All
A, B, D
A, B, D
A,B, D
44922401, 00124280
00124280
00157300
00124280
00124280
00157386
44704401,46585001
41316903(DGH)
46420701, 41316901
(DGH)
Page 64 of 80
-------
Data Requirement
New
Guideline
Number
870.3700A
870.3700B
870.3800
870.4100B
870.4200
870.4300
870.5100
870.5300
870.5375
870.5385
870. 5395
870.5550
870.7485
870.7600
Old
Guideline
Number
83 -3 A
83-3B
83-4
83 -IB
83-2B
83-5
84-2
84-2
84-2
85-1
Description
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2- Generation Reproduction - Rat
Chronic Feeding Toxicity Study -
Non-rodent
Carcinogenicity Mice
Combined Chronic
Toxicity /Carcinogenicity: Rats
Bacterial Reverse Gene Mutation
Gene Mutation (CHO)
Cytogenics- Human
Lymphocytes Chromosome
Aberration Test
Mammalian Bone Marrow
Chromosomal Aberration Test
In Vitro Mammalian
Cytogenetics Tests
Unscheduled DNA Synthesis in
Mammalian Cells in Culture
General Metabolism
Dermal Penetration (Rat)
Use Patterns
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A,B, D
A,B, D
A, B, D
A,B,D
A,B,D
Citations
41900304,41316902
(DGH)
41900303
44246001
44246101
44703201
44704401
40315504
41711002
41711001
42311601
41418901 (DGH),
41 41 8902 (DGH)
41 41 8903 (DGH)
42479001
46621303, 46621304
(under review)
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4400
835.4300
835.1240
835.6100
161-1
161-2
161-3
162-1
162-3
162-4
163-1
164-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
L eaching/Adsorption/Desorption
Terrestrial Field Dissipation
A,B, D
A,B, D
A,B,D
A,B, D
A, B, D
A, B, D
A, B, D
A, B, D
42242601,00101402,
00134831,00144366,
42242601
42419001, 46438203
46438204, 43506401
43945201, 00058169,
40894801
42763001, 00058169,
42763002
42327401, 46438202,
4394520,42327401,
42414601
42148901, 5001190
44985701, 44985702,
00094615, 00101375
RESIDUE CHEMISTRY
860.1300
860.1300
860.1300
860.1300
860.1340
171-4A
171-4A
171-4A
171-4B
171-4C
Nature of Residue - Strawberry
Nature of Residue - Apple
Nature of Residue - Pecan
Nature of Residue - Livestock
(Goat)
Residue Analytical Method -
Plants
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
42703001
58170, 42553201
44717601
44146401
34562,89415,90258,
94615, 101357,
101358, 101371,
101385, 101393,
Page 65 of 80
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Data Requirement
New
Guideline
Number
860.1380
860.1500
860.1850
860.1520
Old
Guideline
Number
171-4E
171-4K
165-1
171-4L
Description
Plant commodities
Use Patterns
A, B, D
Citations
43945202, 44146402,
44176402, 44176401
44985704, Data Gap
Crop Field Trials
Apple
Pear
Peach
Plum
Cherry
Strawberry
Pecan
Spinach
Walnut
Confined Accumulation in
Rotational Crops
Magnitude of Residue in
Processed Food/Feed - Apple
(juice and wet pomace)
A, B, D
A, B, D
A, B, D
A, B, D
A, B, D
A, B,D
A, B,D
A, B,D
A, B,D
A, B,D
A, B, D
34962, 35127, 35128,
89415, 96154, 97630
101360, 101380,
101391, 101393,
44 182801, Data Gap
34562, 44182802,
Data Gap
35128,29036, 93588,
101357,90258
44171801, Data Gap
4643 8205, Data Gap
89417, 101357,29036,
90111,44171802,
Data Gap
89881, Data Gap
101358, Data Gap
101371, 101373, Data
Gap
Data Gap
699066, Data Gap
44176401
OTHER
885.4380
875.2100
Non-
guideline
Study
154A-24
132-1
Non-
guideline
Study
Honey Bee Testing, Tier 1
Foliar Dislodgeable Reside
Dissipation
Acute Toxicity Study in Daphnia
Magna
A, B, D
A, B, D
A, B, D
401315505
45192201
46621 306 (under
review)
ee 66 of 80
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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.
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:
1. "Corrections to Phase III - Revised as per 30-day Error Only Registrant Comments.
Dodine: HED Chapter of the Reregi strati on Eligibility Decision Document (RED)."
11/15/2005
2. "Dodine and Salts. Revised Reregi strati on Eligibility Decision (RED). Summary of
Analytical Chemistry and Residue Data." 9/14/2005
3. "Dodine RED - Revised Reregi strati on Eligibility Decision. Product Chemistry
Considerations. Case No. 0161" 9/14/2005
4. "Review of Dodine and Dodecylguanidine hydrochloride Incident Reports." 5/10/2005
5. "Dodine. Chronic Dietary Exposure Assessment for the Reregi strati on Eligibility
Decision." 6/30/2005
6. "Dodecylguanidine hydrochloride (DGH) - Dietary and Non-dietary Exposures and Risks
from Antimicrobial Uses" 6/21/2005
7. "Tier I Drinking Water Assessment for Dodine." 4/20/2005
8. "Dodine: Occupational and Residential Exposure Assessment and Recommendations for
the Reregi strati on Eligibility Decision Document." 6/29/2005
EFED Documents:
1. "Correction to the 'Review of the 30-day Error Correction Comments on the Draft Level 1
Screening Ecological Risk Assessment for the Reregi strati on of Dodine'." 11/15/2005
2. "Review of the 30-day Error Correction Comments on the Draft Level 1 Screening
Ecological Risk Assessment for the Reregi strati on of Dodine." 9/23/2005
3. "Ecological Risk Assessment in Support of the Reregi strati on Eligibility Decision on
Dodine." 6/30/2005
4. "Level I Screening Ecological Risk Assessment for the Reregi strati on of Dodine."
Attached to the Cover Memo dated 9/23/2005
ee 67 of 80
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision
MRID Citation
00034562 American Cyanamid Company (1958) Cyprex, Dodecylguanidine acetate
Residues from Pears. (Unpublished study received Mar 17, 1968 under 241-51;
CDL:001692-E)
00035127 American Cyanamid Company (1958) Dodecylguanidine acetate Residues from
Apples. (Unpublished study received Nov 25, 1959 under 241-51; CDL:001688-
D)
00058170 Curry, A.N. (1962) Translocation and metabolism of Dodecylguanidine acetate
(Dodine) fungicide in apple trees, using CA14I radio- tagged Dodine. Journal of
Agricultural and Food Chemistry 10 (1):13-17. (Also~In~unpublished
submission received Nov 28, 1977 under 1730-43; submitted by American
Cyanamid Co., Consumer Products Research Div., Wayne, N.J.; CDL:232344-
E)
00089415 American Cyanamid Company (1958) Dodecylguanidine Acetate Residues from
Apples. (Unpublished study received Oct 17, 1958 under PP0211; CDL:090237-
A)
00089417 American Cyanamid Company (1958) Dodecylguanidine Acetate Residues from
Sour Cherries: Summary. (Compilation; unpublished study received Oct 17,
1958 under PP0211; CDL:090237-D)
00089881 American Cyanamid Company (1960) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical Method Used:
?Cyprex 65-W|. Includes method D 20 e dated Jul 2, 1958. (Compilation;
unpublished study received Aug 7, 1960 under PP0324; CDL:-090352-A)
00090258 American Cyanamid Company (1964) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical Method Used:
?Cyprex|. (Compilation; unpublished study received May 5, 1964 under PP0416;
CDL:090450-B)
00093588 Orloski, E.J.; Caruso, M. (1965) CyprexA(R)I Dodine Residues in Peaches:
Report No. C-101. (Unpublished study received Jan 26, 1967 under 7F0577;
submitted by American Cyanamid Co., Princeton, N.J.; CDL:090739-B)
00094615 Larsen, D.J. (1979) Spinach Foliar Fungicide Study. Includes method dated Apr
17, 1978. (Unpublished study, including letter dated Sep 25, 1979 from R.W.
Vetro to C.F. Niven, Jr., received Feb 9, 1982 under 4E1474; submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:070669-H)
00096154 Terriere, L.C.; Kiigemagi, U. (1960) Cyprex Residues on Apples. (Unpublished
study received Feb 24, 1961 under 241-12; prepared by Oregon State Univ.,
Agricultural Experiment Station, Dept. of Agricultural Chemistry, submitted by
American Cyanamid Co., Princeton, N.J.; CDL:026957-C)
00101357 American Cyanamid Co. (1962) ?Residues of Cyprex in Peaches and Cherries|.
(Compilation; unpublished study received Nov 29, 1962 under 241-51;
CDL:026949-A)
00101358 American Cyanamid Co. (1967) ?Residues of Dodine in Pecans and Peanuts).
(Compilation; unpublished study received Oct 12, 1967 under 8F0655;
CDL:091143-A)
Page 68 of 80
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00101371 Interregional Research Project No. 4 (1974) The Results of Tests on the Amount
of Dodine Residue Remaining in or on Spinach, Including a Description of the
Analytical Method Used. (Compi- lation; unpublished study received Feb 28,
1974 under 4E1474; CDL:093922-A)
00101385 Steller, W.; Klotsas, K.; Kuchar, E. (1960) Colorimetric esti- mation of
dodecylquanidine acetate residues. Agricultural and Food Chemistry 8(6):460-
464. (Also In unpublished sub- mission received on unknown date under
unknown admin, no.; sub- mitted by American Cyanamid Co., Princeton, NJ;
CDL: 125047-A)
00101393 American Cyanamid Co. (1958) Results of Tests on the Amounts of Residues of
Cyprex Dodine Remaining on Apples. (Compilation; unpublished study received
Feb 8, 1960 under unknown admin, no.; CDL:125134-B)
00124280 Fischer, J. (1983) ?Toxicity Data: Dodine|: Report No. A83-1. (Unpublished
study received Jan 24, 1983 under 241-269; sub- mitted by American Cyanamid
Co., Princeton, NJ; CDL:249349-A)
00157300 Hinz, J. (1978) Determination of the One Hour LC50 for Cytox-2160: [Rats]:
Rev. Final Report: Project No. 7710-454A. Unpublished American Cyanamid
Co. study no. 78-23 prepared by Huntingdon Re- search Center.
00157386 Kligman, A. (1977) The Evaluation of Irritating and Sensitizing Properties of
Cytox 2160 by Means of the Modified Draize-Shelan- ski Patch Test: Protocol
3422. Unpublished study prepared by Ivy Research Labs, Inc. 7 p.
40315501 Haefele, L. comp. (1987) Drexel Dodine Technical: Product Identity and
Composition. Unpublished compilation. 83 p.
40315502 Haefele, L. comp. (1987) Drexel Dodine Technical: Analysis and Cer- tification
of Product Ingredients. Unpublished compilation. 238 p.
40315503 Haefele, L. comp. (1987) Drexel Dodine Technical: Physical and Che- mical
Characteristics. Unpublished compilation. 74 p.
40315504 Willems, M. (1981) Evaluation of Dodine Tech. 95% for Mutagenic Ac- tivity in
the Ames Test: Report No. V. 81.102/210064-7. Unpub- lished study prepared
by Netherlands Org. for Appl. Sci. Res. (TNO). 21 p.
40315505 Van Beek, L. 1984. Acute Dermal Toxicity and Oral Toxicity Studies with
Dodine in Honey Bees. Unpublished Study Conducted by the Netherlands
Organization for Applied Scientific Research for Drexel Chemical Co.
40756805 Forbis, A. (1988) Acute Toxicity of CT-334-87 to Daphnia magna: Final Rept.
#36746. Unpublished study prepared by Analytical Bio-Chemistry Laboratories,
Inc. 63 p.
40940801 Meyer, M. (1988) Dodecylguanidine Hydrochloride: Product Chemistry:
Volume 17 of 19: Physical and Chemical Characteristics. Unpu- blished study
prepared by Calgon Corp. 5 p.
40940802 Roberts, S.; Wineholt, R. (1976) Report: 96-Hour LC50 Determination of
Calgon Dodecylguanidine Hydrochloride 40.6% in Oyster Straight-Hine Larvae:
Lab No. 6E-3281. Unpublished study pre- pared by Cannon Laboratories, Inc.
12 p.
40975701 Haefele, L. (1988) Supplement to Drexel Dodine Technical: Physical and
Chemical Characteristics. Unpublished study prepared by Drexel Chemical Co.
4 p.
41316901 Auletta, Carol S., (1989). A 21-day dermal toxicity study in rats with CT-334-
Pase69of80
-------
87. Bio/Dynamics, Inc., East Millstone, NJ. Project No. 4932-88. July 7, 1989.
41316902 Schroeder, R. (1989) A Teratogenecity Study in Rats with CT-334-87: Lab
Project Number: 88/3309. Unpublished study prepared by Bio/Dynamics, Inc.
428 p.
41316903 Auletta, Carol S. (1989) A sub-chronic (3 month) oral toxicity study in the dog
with CT-334-87 via capsule administration. Bio/dynamics, Inc., East Millstone,
NJ. Study No. 88-3311. October 16, 1989.
41418901 Ivett, J. (1989) Single Acute Exposure Dose Selection Study on CT- 334-87: Lab
Project Number: 11071-0-459-PO: 20996. Unpublished study prepared by
Hazleton Laboratories America, Inc. 12 p.
41418902 Ivett, J. (1990) Mutagenicity Test on CT-334-87 in vivo Mouse Mi- cronucleus
Assay: Lab Project Number: 11071-0-455: 20996. Unpublished study prepared
by Hazleton Laboratories America, Inc. 22 p.
41418903 Cifone, Maria A. (1990). Mutagenicity Test on CT-334-87 in the In Vitro Rat
Primary Hepatocyte Unscheduled DNA Synthesis Assay. Hazleton Laboratories
America, Inc.
41671001 Hakin, B. (1988) The Acute Oral Toxicity (LD50) of Dodine to the Bobwhite
Quail: Lab Project Number: CMK 41/881123. Unpublished study prepared by
Huntingdon Research Centre Ltd. 33 p.
41671002 Hakin, B. (1988) The Dietary Toxicity (LC50) of Dodine to the Bob- white
Quail: Lab Project Number: CMK 39/881199. Unpublished study prepared by
Huntingdon Research Centre. 74 p.
41671003 Hakin, B. (1988) The Acute Oral Toxicity (LD50) of Dodine to the Mallard
Duck: Lab Project Number: CMK 40/881487. Unpublished study prepared by
Huntingdon Research Centre Ltd. 33 p.
41671004 Hakin, B. (1988) The Dietary Toxicity (LC50) of Dodine to the Mallard Duck:
Lab Project Number: CMK 38/881122. Unpublished study prepared by
Huntingdon Research Centre Ltd. 77 p.
41711001 Wilmer, J. (1985) Chromosome Analysis of Cultured Human Lymphocytes
Treated in vitro with Dodine: Lab Project Number: V85.164/250- 209.
Unpublished study prepared by Civo Institutes TNO. 24 p.
41711002 Davis, P. (1985) An Investigation into the Possible Induction of Point Mutation
at the HGPRT Locus of Chinese Hamster Ovary Cells by Dodine: Lab Project
Number: R85/105. Unpublished study prepared by Div. of Tech. for Society
TNO. 24 p.
41900301 Caley, C.; Cameron, B.; Chapleo, S. (1984) Dodine: Determination of Acute
Toxicity (Lc50) to Bluegill Sunfish (96 h, Semi-Static): Re-Issued Final Report:
Lab Project Number: IRI 138020. Unpub- lished study prepared by Inveresk
Research International. 62 p.
41900302 Caley, C.; Cameron, B.; Chapleo, S. (1984) Dodine: Determination of Acute
Toxicity (LC50) to Rainbow Trout (96 h, Semi-Static): Lab Project Number: IRI
138015. Unpublished study prepared by Inveresk Research International. 62 p.
41900303 McCay, C.; Hazelden, K. (1989) Dodine: Teratogenicity Study in Rabbits: Lab
Project Number: IRI 437745. Unpublished study pre- pared by Inveresk
Research International. 101 p.
41900304 Wilson, J.; Hazelden, K. (1989) Dodine: Teratogenicity Study in Rats: Lab
Project Number: IRI 437766. Unpublished study pre- pared by Inveresk
Page 70 of 80
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Research International. 97 p.
42148901 Williams, M.; Hargadine, S. (1991) Soil/Sediment Adsorption/ Desorption of
DGH: Final Report: Lab Project Number: 38683. Unpublished study prepared by
Analytical Bio-Chemistry Labs., 381 p.
42242601 Daly, D.; Kabler, K.; Williamson, K. (1991) Hydrolysis of Dodecylguanidine
HCL as a Function of pH at 25(degree)C: Final Report: Lab Project Number:
38680. Unpublished study prepared by ABC Laboratories, Inc.
42311601 Murli, H. (1992) Mutagenicity Test on Dodecylguanidine Acetate Technical in
vivo Mammalian Micronucleus Assay: Final Report: Lab Project Number:
14710-0-455. Unpublished study prepared by Hazleton Washington, Inc. 42 p.
42327401 Cady, C.; Cranor, W. (1992) Aerobic Aquatic Metabolism of Metasol DGH:
Final Report: Lab Project Number: 38682. Unpublished study prepared by ABC
Laboratories, Inc. 48 p.
42339601 Putt, A.E. 1992. (Dodine Technical) - Acute Toxicity to Daphnids (Daphnia
magna) Under Flow-Through Conditions. Unpublished Study Conducted by
Springborn Laboratories for Rhone-Poulenc Ag Company.
42414601 Cady, C.; Cranor, W. (1992) Aerobic Aquatic Metabolism of Metasol DGH:
Final Raw Data Report: Lab Project Number: 38682R. Unpublished study
prepared by ABC Laboratories, Inc. 953 p.
42419001 Daly, D.; Kabler, K. (1991) Determination of the Photolysis Rate of ?carbon 14|-
Dodecylguanidine Hydrochloride in pH 5 Buffered Solution at 25 degrees
celsius: Final Report: Lab Project Number: 38681: 900016: 8170. Unpublished
study prepared by ABC Laboratories, Inc. 748 p.
42479001 Reddy, V.; Litle, L.; Murrill, E. (1992) Disposition and Metabolism of ?carbon
14|-labeled Dodine in Rats (Preliminary and Definitive Study): Final Report:
Lab Project Number: 9938-F. Unpublished study prepared by Midwest Research
Institute. 97 p.
42501501 Bettencourt, M. (1992) Dodine Technical: Acute Toxicity to Sheepshead
Minnow (Cyprinodon variegatus) under Flow-through Conditions: Final Report:
Lab Project Number: 92-9-4416: 10566.0191.6183.505. Unpublished study
prepared by Springborn Labs, Inc. 66 p.
42501502 Dionne, E. (1992) Dodine Technical: Acute Toxicity to Eastern Oyster
(Crassostrea virginica) under Flow-through Conditions: Final Report: Lab
Project Number: 92-9-4404: 10566.0191.6184.504. Unpublished study prepared
by Springborn Labs, Inc. 68 p.
42501503 Bettencourt, M. (1992) Dodine Technical: Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) under Flow-through Conditions: Final Report: Lab Project
Number: 92-9-4401: 10566.0191.6182.515. Unpublished study prepared by
Springborn Labs, Inc. 65 p.
42553201 Mohseni, R.; Ewing, A.; Kimmel, E.; et. al (1992) A Metabolism Study with
?carbon 14|-Dodine on Apples: Lab Project Number: 286W-1: 286W.
Unpublished study prepared by PTRL-West, Inc. 114 p.
42653501 Putt, A.E. 1992. Dodine 65W - Acute Toxicity to Daphnids (Daphnia magna)
Under Flow-Through Conditions. Unpublished Study Conducted by Springborn
Laboratories for Rhone-Poulenc Ag Company.
42653502 Bettencourt, MJ. 1993. Dodine 65W - Acute Toxicity to Sheepshead Minnow
(Cyprinodon variegatus) Under Flow-Through Conditions. Unpublished Study
Page 71 of 80
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Conducted by Springborn Laboratories, Inc. for Rhone-Poulenc Ag Company.
42653503 Dionne, E. 1992. Dodine 65W - Acute Toxicity to Eastern Oyster (Crassostrea
virginica) Under Flow-Through Conditions. Unpublished Study Conducted by
Springborn Laboratories for Rhone Poulenc Ag Company.
42653503 Dionne, E. (1992) Dodine 65W--Acute Toxicity to Eastern Oyster (Crassostrea
virginica) under Flow-through Conditions: Final Report: Lab Project Number:
92-11-4493: 10566.0191.6189.504. Unpublished study prepared by Springborn
Labs, Inc. 77 p.
42653504 Bettencourt, MJ. 1992. Dodine 65W - Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) Under Flow-Through Conditions. Unpublished Study
Conducted by Springborn Laboratories, Inc. for Rhone-Poulenc Ag Company.
42653504 Bettencourt, M. (1992) Dodine 65W--Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) under Flow-through Conditions: Final Report: Lab Project
Number: 92-11-4492: 10566.0191.6187.515. Unpublished study prepared by
Springborn Labs, Inc. 72 p.
42695101 Hoberg, J. (1993) Dodine--Toxicity to the Freshwater Green Alga, Selenastrum
capricornutum: Final Report: Lab Project Number: 92-12-4550:
10566.0792.6247.430: 090392/FIFRA ALG. SEL. Unpublished study prepared
by Springborn Labs., Inc. 70 p.
42695102 Maggi, V.L. 1993. Tier I: Determination of the Phytotoxic Effects of Dodine
Fungicide on Seedling Emergence of Nontarget Plants. Unpublished Study
Conducted by California Agricultural Research, Inc. for Rhone-Poulenc Ag
Company.
42695103 Maggi, V.L. 1993. Tier I: Determination of the Phytotoxic Effects of Dodine
Fungicide on Vegetative Vigor of Nontarget Plants. Unpublished Study
Conducted by California Agricultural Research, Inc. for Rhone-Poulenc Ag
Company.
42703001 Mohseni, R.; Kimmel, E.; Toia, R. (1993) A Metabolism Study with (carbon
14)-Dodine on Strawberries: Lab Project Number: 287W-1: 287W. Unpublished
study prepared by PTRL West Inc. 142 p.
42763002 Cady, C. (1993) Anaerobic Aquatic Metabolism of Metasol DGH: Final Raw
Data Report: Lab Project Number: 38684R. Unpublished study prepared by
ABC Labs, Inc. 981 p.
42763100 DuPont Agricultural Products (1993) Submission of Exposure Data in Support
of FIFRA 6(a)2 Requirements for Benomyl 50 WP. Transmittal of 1 Study.
43274601 Pederson, C.A. 1994. Dodecylguanidine Acetate (Dodine) Technical Grade:
Toxicity and Reproduction Study in Bobwhite Quail. Unpublished Study
Conducted by Bio-life Associates, Ltd. for Rhone-Poulenc Ag Company.
43274602 Pederson, C.A. 1994. Dodecylguanidine Acetate (Dodine) Technical Grade:
Toxicity and Reproduction Study in Mallard Ducks. Unpublished Study
Conducted by Bio-life Associates, Ltd. for Rhone-Poulenc Ag Company.
43485505 Davis, J.; Youngerman, D. (1994) CT-334-87-Dodecylguanidine Hydrochloride
(DGH): Acute Toxicity To Rainbow Trout (Oncorhynchus mykiss) Under Flow-
Through Test Conditions: Lab Project Number: J9401002E. Unpublished study
prepared by Toxikon Environmental Science. 51 p.
43485506 Youngerman, D., and J.W. Davis. 1994. CT-334-87 - Dodecylguanidine
Hydrochloride (DGH): Acute Toxicity to the Sheepshead Minnow, Cyrpinodon
Page 72 of 80
-------
variegatus, Under Continuous Flow-through Conditions. Unpublished Study
Conducted by Toxikon Environmental Sciences for Cytec Industries.
43485507 Jones, F., and J. W. Davis. 1994. CT-334-87 - Dodecylguanidine
Hydrochloride (DGH): Acute Toxicity to the Mysid, Mysidopsis bahia, Under
Continuous Flow-through Conditions. Unpublished Study. Conducted by
Toxikon Environmental Sciences for Cytec Industries.
43485508 Youngerman, D., and J.W. Davis. 1994. CT-334-87 - Dodecylguanidine
Hydrochloride (DGH): Acute Effect on New Shell Growth of the Eastern Oyster,
Crassostrea virginica. Unpublished Study. Conducted by Toxikon
Environmental Sciences for Cytec Industries.
43485510 Helsten, B.R., and A. M. Solatycki. 1994. 8-Day Acute Dietay LC50 Study
with CT-334-87 (DGH) in Mallard Ducklings. Unpublished Study. Conducted
by Bio-Life Associates, Ltd., for Cytec Industries.
43876501 Putt, A.E. 1995. Dodine Technical - The Chronic Toxicity to Daphnia magna
Under Flow-Through Conditions. Unpublished Study Conducted by Springborn
Laboratories, Inc. for Rhone-Poulenc Ag Company.
43876502 Sousa, J.V. 1995. Dodine Technical: The Toxicity to Fathead Minnow
(Pimephales promelas) During an Early Life-Stage Exposure. Unpublished
Study Conducted by Springborn Laboratories, Inc. for Rhone-Poulenc Ag
Company.
43945201 Cooper, J.; Jones, M.; Lowden, P. (1996) (Carbon 14)-Dodine: Aerobic Soil
Metabolism in Two Soils at 25 (degrees) C: Lab Project Number: P 94/162:
201088: 95/18. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd.
156 p.
43945202 Simonin, B. (1996) Dodine: Analytical Method for the Determination of
Residues in Fruits: AR 116-95: Lab Project Number: R&D/CRLD/AN-9561518:
AR 116-95. Unpublished study prepared by Rhone-Poulenc Secteur Agro. 51 p.
44146401 Langford-Pollard, A. (1996) (Carbon 14)-Dodine: Metabolism in the Goat: Lab
Project Number: RNP 477/961299: RNP 477. Unpublished study prepared by
Huntingdon Life Sciences Ltd. 116 p.
44146402 Herzig, R. (1996) Independent Laboratory Confirmation of the Tolerance
Enforcement Method by EPA PR Notice 88-5 for Dodine: Method of Analysis
for Dodine in Fruit: Final Report: Lab Project Number: RES9608: RES-9608-
ILV: 45140. Unpublished study prepared by Agvise Labs., Inc. 147 p.
44171801 Andrawes, N. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
Acetate) in/on Peaches after Ground Treatment with Syllit 65W: Final Report:
Lab Project Number: US95X06R: 45172: 95-0100. Unpublished study prepared
by Rhone-Poulenc Ag Co. and American Agricultural Services, Inc. 526 p.
44171802 Wargo, J. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
Acetate) in/on Cherries after Ground Treatment with Syllit 65W: Final Report:
Lab Project Number: US95X02R: 45174: 95-0081. Unpublished study prepared
by Rhone-Poulenc Ag Co. and American Agricultural Services, Inc. 451 p.
44176401 Wargo, J. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
Acetate) in/on Apple Processeed Fractions after Ground Treatment with Syllit
65W: Final Report: Lab Project Number: US95X05R: 45177: 95-0099.
Unpublished study prepared by American Agricultural Services, Inc. 531 p.
44176402 Pittman, J. (1996) Dodine-Validation of Method of Analysis for Dodine in
Page 73 of 80
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Fruit: Final Report: Lab Project Number: EC-96-342: 45154. Unpublished study
prepared by Rhone-Poulenc Ag Co. 190 p.
44182801 Wargo, J. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
Acetate) in/on Apples after Ground Treatment with SYLLIT 65W: Final Report:
Lab Project Number: US95X01R/45173: US95X01R: 95-0069. Unpublished
study prepared by American Ag Services, Inc. and Rhone-Poulenc Ag Co. 587 p.
44182802 Wargo, J. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
acetate) in/on Pears after Ground Treatment with SYLLIT 65W: Final Report:
Lab Project Number: PLT-136: US95X03R/45175: US95XO3R. Unpublished
study prepared by American Ag Services, Inc. and Rhone-Poulenc Ag Co. 447 p.
44246001 1996. Mammalian reproduction and fertility effects (rat).
44246001 Kenwood, S. (1996) Two-Generation Reproduction Study with Dodine in Rats:
Final Report: Lab Project Number: HWI 6224-218: TP4560: CHW 6224218A.
Unpublished study prepared by Corning Hazleton Inc. 1530 p.
44246101 1996. Mammalian chronic oral toxicity (dog).
44246101 Trutter, J. (1996) 52-Week Toxicity Study in Dogs with Dodine: Final Report:
Lab Project Number: CHV 656-192: 656-192: MP-R186-MA. Unpublished
study prepared by Corning Hazleton Inc. 365 p.
44703201 Williams, K. (1998) 78-Week Dietary Oncogenicity Study with Dodine in Mice:
Final Report: Lab Project Number: COVANCE 6224-220: T94485: HWI 6224-
220. Unpublished study prepared by Covance Laboratories, Inc. 1935 p.
44704401 Dange, M. (1998) Chronic Toxicity and Carcinogenicity Study of
Dodecylguanidine Acetate (Dodine) in the Sprague-Dawley Rat by Dietary
Administration: Lab Project Number: SA 95083: 603263. Unpublished study
prepared by Rhone-Poulenc Agro. 2600 p.
44717601 Baker, F.; McKemie, D.; Kimmel, E. (1998) A Metabolism Study with (carbon-
14)-Dodine on Pecans: Lab Project Number: 643W: 643W-1. Unpublished study
prepared by PTRL West, Inc. and Excel Research Services, Inc. 145 p. (OPPTS
860.1300}
44985701 Norris, F. (1999) Terrestrial Soil Dissipation After Application of SYLLIT
Brand 65W Fruit Fungicide to Bare Ground Plots Simulating an Orchard or
Grove: Lab Project Number: 45751: 96X10342: 10342-02. Unpublished study
prepared by Quails Agricultural, Labs, and Excel Research Services, Inc. 1408 p.
44985704 Yang, J. (1998) Storage Stability of the Residue of Dodine (n-Dodecylguanidine
acetate) in/on Fruits and Their Processed Fractions: Lab Project Number: EC-96-
357: 45671. Unpublished study prepared by Rhone-Poulenc Ag Co. 153 p.
44985705 Pederson, C.A. 1999. Avian Reproductive Toxicity Study with
Dodecylguanidine Acetate (Dodine) Technical in Bobwhite Quail. Unpublished
Study Conducted by Bio-life Associates, Ltd. for Rhone-Poulenc Ag Company.
45192201 Macy, L. (2000) DODINE: Dissipation of Dislodgeable Foliar Dodine Residue
from Peaches Treated with SYLLIT 65W: Lab Project Number: 17415-01:
17415-02: 99X17415. Unpublished study prepared by ABC Laboratories and
Southeastern Ag Research, Inc. 327 p. {OPPTS 875.2100}.
45322701 Stephan, D. (1998) Dodine: Product Identity and Composition: Series 61: Lab
Project Number: 98-03. Unpublished study prepared by Aventis CropScience. 48
p. {OPPTS 830.1550 830.1600, 830.1620, 830.1670}
45322702 Cousin, J. (1998) Technical Dodine: Analysis of Product Ingredients: Lab
Page 74 of 80
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Project Number: 96-59: R&D/CRLD/AN/9716190. Unpublished study prepared
by Rhone-Poulenc Agro. 64 p. (OPPTS 830.1700 and 830.1800}
45322703 Emeric, G. (1999) Technical Dodine: Certification of Ingredient Limits: Lab
Project Number: 99-08: R&D/CRLD/AN/9915029. Unpublished study prepared
by Rhone-Poulenc Agro. 10 p. {OPPTS 830.1750}
45322704 Bascou, J. (1998) Dodine: Physical Characteristics: Lab Project Number: 97-57:
R&D/CRLD/AN/9816880. Unpublished study prepared by Rhone-Poulenc
Agro. 22 p.
45322705 Bascou, J. (1999) Dodine: pH and Dissociation Constant: Lab Project Number:
97-57: R&D/CRLD/AN/9915061. Unpublished study prepared by Rhone-
Poulenc Agro. 21 p. {OPPTS 830.7000 and 830.7370}
45322705 Bascou, J. (1999) Dodine: pH and Dissociation Constant: Lab Project Number:
97-57: R&D/CRLD/AN/9915061. Unpublished study prepared by Rhone-
Poulenc Agro. 21 p. {OPPTS 830.7000 and 830.7370}
45322706 Bascou, J. (1999) Dodine: Water and Solvent Solubility: Lab Project Number:
97-57: R&D/CRLD/AN/9816934. Unpublished study prepared by Rhone-
Poulenc Agro. 33 p. {OPPTS 830.7840}
45322707 Bascou, J. (1999) Dodine: n-Octanol/Water Partition Coefficient: Lab Project
Number: 97-57: R&D/CRLD/AN/9915132. Unpublished study prepared by
Rhone-Poulenc Agro. 35 p. {OPPTS 830.7570}
45322708 Bascou, J. (1999) Dodine: Stability: Lab Project Number: 97-57:
R&D/CRLD/AN/9915325. Unpublished study prepared by Rhone-Poulenc
Agro. 28 p. {OPPTS 830.6313, 830.6314, 830.6317}
45322709 Bascou, J. (1999) Dodine: Vapor Pressure: Lab Project Number: 97-57:
R&D/CRLD/AN/9915350. Unpublished study prepared by Rhone-Poulenc
Agro. 29 p. {OPPTS 830.7950}
46146501 Fox, O. (2003) Dodine Technical: HPLC Product Analysis for
Decylguanidinium-Acetate: Preliminary Analysis of 5 Batches. Project Number:
CHI/030407, CHI/002, CHI/030422. Unpublished study prepared by Life
Scientific Ltd. 50 p.
46165601 Gorman, C. (2003) Dodine Technical: Product Identity and Composition:
Description of Materials Used: Description of Manufacturing Process:
Discussion of the Formation of Impurities: Certified Limits: Enforcement
Analytical Method. Project Number: DOD/111203, 6056. Unpublished study
prepared by Chimac-Agriphar S.A. 57 p.
46165602 Duff, S. (2003) Analytical Profile of Dodine Technical: (Prelimary Analysis of 5
Batches). Project Number: CHI/020709, CHI/001. Unpublished study prepared
by Life Scientific Ltd. 141 p.
46420701 Kern, T. (1998) A 28-Day Dermal Toxicity Study of Dodine Technical Material
in Rats. Project Number: WIL/21140. Unpublished study prepared by WIL
Research Laboratories, Inc. 433 p.
46438201 Desmares-Koopmans, M.J.E. 2002. Sediment-Water Chironomid Toxicity Test
Using Water Spiked with Dodine Technical. Unpublished Study Conducted by
Notox for Chimac-Agriphar S.A.
46438202 Slangen, D. (2004) The Fate of Dodine in Two Water/Sediment Systems. Project
Number: 344677. Unpublished study prepared by Notox V.O.F. 86 p.
46438203 Slangen, D.; Noorloos, B. (2004) Photodegradation of Dodine in Water
Page 75 of 80
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Including Amendment (Attachment I). Project Number: 327061. Unpublished
study prepared by Notox V.O.F. 117 p.
46438204 Mislankar, S. (2004) Photodegradation of Dodine in Soil. Project Number:
2000X18609. Unpublished study prepared by Aventis CropScience. Ill p.
46438205 Wargo, J. (1996) Magnitude of the Residue of Dodine (n-Dodecylguanidine
acetate) in/on Plums after Ground Treatment with Syllit 65W. Project Number:
US95X04R, 45176. Unpublished study prepared by Notox V.O.F. 413 p.
46621303 Bound, S. (1995) Dodine Formulation: Absorption Study in the Male Rat after
Topical Application. Submitted by Ceres International LLC for Chimac-
Agriphar S.A. Study Report No. 95/RHA552/0850. Study prepared by Pharmaco
LSR.
46621304 Esdaile, D. (1999) In Vivo Absorption and Skin Distribution Study of a Dodine
Formulation after Topical Exposure in the Rat. Submitted by Ceres International
LLC for Chimac-Agriphar S.A. Study Report No. SA 99254. Study prepared by
Phone-Poulenc Agro.
46621305 Caley, C.; Cameron, B.; Chapleo, S. (1989) Determination of Acute Toxicity
(LC50) to Daphnia (48 Hours Semi-Static). Project Number: 7069, HU/138036,
138036. Unpublished study prepared by Inveresk Research International. 57 p.
46621306 Migchielsen, M. (2002) Acute Toxicity Study in Daphnia Magna with Dodine in
Water-Sediment System (Static). Project Number: 354825. Unpublished study
prepared by Notox B.V. 30 p.
46621307 Migchielsen, M. (2004) Acute Toxicity Study in Daphnia Magna with Dodine
400 SC (Semi-Static). Project Number: 413213. Unpublished study prepared by
Notox B.V. 35 p.
46621308 Migchielson, M. (2004) Fresh Water Algal Growth Inhibition Test with Dodine
400 SC. Project Number: 413224. Unpublished study prepared by Notox B.V.
47 p.
46621309 Hoberg, J. (1995) Dodine: Toxicity to the Freshwater Green Alga, Selenastrum
capricornutum, During a 15-Day Partial Renewal Test. Project Number:
95/10/6147, 10566/0895/6372/430. Unpublished study prepared by Springborn
Laboratories Inc. 108 p.
Accession Citation
Number
130888 Howard, D.J. and C.D. Johnston. 1971. CYTOX 2160 - Safety Evaluation by
Single Oral Administration to Bobwhite Quail. Unpublished Study Conducted by
Woodard Research Corporation for American Cyanamid Co.
131455 Johnston, C.D. 1971. CYTOX 2160 - Safety Evaluation by Single Oral
Administration to Mallard Ducks. Unpublished Study Conducted by Woodard
Research Corporation for American Cyanamid Co.
132149 Sleight, Bevier Hasbrouck. 1971. The Acute Toxicity of CYTOX 2160 (ST
45093) to Bluegill (Lepomis macrochirus) and Rainbow Trout (Onchirynchus
mykiss formerly Salmo gairdneri). Unpublished Study Conducted by Bionomics,
Inc. for American Cyanamid Co.
226855 Fink, R. 1976. Eight-Day Dietary LC50 - Bobwhite quail - CYTOX 2160.
Unpublished Study Conducted by Wildlife International for Union Carbide Corp.
Submitted by American Cyanamid Company.
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Appendix E. EPA's Batching of Dodine Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In deciding how to meet the product-specific data requirements, registrants must follow
the directions given in the Data Call-in notice (DCI) and its attachments appended to the dodine
RED document. 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. End-use product batching was not
performed for dodine; therefore, acute toxicity data requirements should be addressed for each
product individually.
EPA Reg. No.
241-51
55260-4
55260-6
% Active Ingredient
65
98
39.6
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Appendix F. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available via the Agency's website at
http://www. epa. gov/opprdOOl/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 hard copy 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(a),epa. gov.
The following Agency Pesticide Registration Forms are currently available via the Internet at the following
locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution
of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (PR
Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice 98-1)
http://www. eva. eov/ovvrdOOl /forms/8 5 70-l.pdf
http://www.epa.sov/opprd001/forms/S570-4.pdf
http://www. eva. sov/opprdOOl /forms/8 5 70-5. vdf
http://www. eva. sov/opprdOOl /forms/8 5 70-1 7. vdf
http://www. eva. sov/opprdOOl /forms/8 5 70-25. vdf
http://www. eva. sov/opprdOOl /forms/8 5 70-27. vdf
http://www. eva. sov/opprdOOl /forms/8 5 70-28. vdf
http://wmv. eva. sov/opprdOOl /forms/8 5 70-30. vdf
http://wmv. epa.sov/opprdOOl /forms/8 5 70-32. vdf
http://www.epa.sov/opppmsdl/PR Notices/vr98-5.vdf
http://www. eva. sov/opppmsdl/PR Notices/vr98-5. vdf
http://www.epa.sov/opppmsdl/PR Notices/vr98-l.vdf
http://www.epa.sov/opppmsdl/PR Notices/vr98-l.vdf
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Pesticide Registration Kit http://www.epa.sov/pesticides/resistrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www. epa.sov/opppmsdl/PR Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR § 156, Labeling Requirements for Pesticides and Devices (PDF format)
f 40 CFR § 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.
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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 22161-0002
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
for Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their website.
4. The National Pesticide Information Center (NPIC) can provide information on active
ingredients, uses, toxicology and chemistry of pesticides. You can contact NPIC by telephone
at (800) 858-7378 or through their website at http://www.nets.orst. edu.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
• Date of receipt;
• EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the
EPA identifying file symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application for registration,
experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities). Please
provide a chemical abstract system (CAS) number if one has been assigned.
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