Reregistration Eligibility Decision
for Dikegulac sodium
March 2007
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?/EPA
United States
Environmental Protection
Agency
Prevention, Pesticides EPA 738-R-07-003
and Toxic Substances
(7508P)
Reregistration
Eligibility Decision
For Dikegulac Sodium
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Reregistration Eligibility Decision (RED) for
Dikegulac Sodium
ListC
Case No. 3061
Approved by:
Date: FI
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TABLE OF CONTENTS
I. Introduction 2
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Pesticide 5
III. Summary of Dikegulac Sodium Risk Assessments 5
A. Human Health Risk Assessment 6
1. Toxicity of Dikegulac Sodium 6
2. Human Incident Data 7
B. Environmental Risk Assessment 8
1. Environmental Fate and Transport 8
2. Toxicity and Risk Characterization 9
3. Non-target Aquatic Exposure and Risk 9
4. Non-target Terrestrial Exposure and Risk 11
5. Adverse Ecological Incidents 14
6. Endangered Species Considerations 14
IV. Risk Management and Reregistration 15
A. Determination of Reregistration Eligibility 15
B. Public Comments and Responses 16
C. Regulatory Position 15
1. Regulatory Rationale 16
2. Endocrine Disrupter Effects 17
3. Endangered Species 18
D. Labeling Requirements 18
V. What Registrants Need to Do 19
A. Generic Data Requirements 19
B. End-Use Products 19
1. Additional Product-Specific Data Requirements 19
C. Labeling Changes Summary Table 20
1. Labeling for Manufacturing-Use Products 20
2. Labeling for End-Use Products 20
Appendix A A-l
Appendix B B_l
Appendix C C-l
Appendix D D_l
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Glossary of Terms and Abbreviations
ai
CFR
CSF
DCI
DNT
EC
EEC
EPA
EUP
FIFRA
FFDCA
FQPA
GLN
LC50
LD
'50
LOG
LOAEL
mg/kg/day
mg/L
MRID
MUP
N/A
NOAEL
OPP
PHI
ppb
PPE
ppm
RED
REI
RQ
SF
SLN
TGAI
UF
WPS
Active Ingredient
Code of Federal Regulations
Confidential Statement of Formula
Data Call-in
Developmental Neurotoxicity
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Guideline Number
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
Lowest Observed Adverse Effect Level
Milligram Per Kilogram Per Day
Milligrams Per Liter
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Manufacturing-Use Product
Not Applicable
No Observed Adverse Effect Level
EPA Office of Pesticide Programs
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts per Million
Reregistration Eligibility Decision
Restricted Entry Interval
Risk Quotient
Safety Factor
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Uncertainty Factor
Worker Protection Standard
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DIKEGULAC SODIUM TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Richard Griffin
Yvonne Barnes
Judy Facey
Shanna Recore
Ecological Fate and Effects Risk Assessment
Michael Davy
William Eckel
Biological and Economics Analysis Assessment
Jenna Carter
Margaret Ervin
Andrew Lee
Sunil Ratnayake
Registration Division
Tony Kish
John Bazuin
Risk Management
Jacqueline Guerry
Kimberly Nesci
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for dikegulac sodium, a plant growth regulator, and is
issuing its risk management decision. The risk assessments, which are summarized below, are
based on the review of the required database supporting the use patterns of currently registered
products and additional data provided by the technical registrant, PBI/Gordon Corporation. No
toxicological endpoints were identified for the human health risk assessment; thus, only a
qualitative assessment was conducted. Based on this assessment, there are no human health risks
of concern (i.e., drinking water, occupational, residential). However, because of its acute
toxicity level (eye irritation) additional personal protective equipment and restricted-entry
interval measures are required. When completing the risk assessment, essential ecological fate
studies were not yet submitted to the Agency and, therefore, the ecological fate characteristics of
dikegulac sodium were based on upper-end assumptions and open literature. Despite these
uncertainties, all potential risks to aquatic organisms and plants were below the Agency's level
of concern (LOG). All potential risks to terrestrial organisms were also below the Agency's
LOG, except for semi-aquatic non-listed and listed plants.
After considering the acute toxicity of dikegulac sodium identified in the human health
assessment and the potential risks identified in the ecological risk assessment, the Agency
developed its risk management decision for uses of dikegulac sodium. As a result of this review,
EPA has determined that products containing dikegulac sodium are eligible for reregistration,
provided that all protective measures are adopted and labels are amended accordingly. That
decision is discussed fully in this document.
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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 a review of all submitted data by
the U.S. Environmental Protection Agency (referred to as EPA or "the Agency").
Reregistration involves a thorough review of the scientific database underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential risks arising
from the currently registered uses of the pesticide; to determine the need for additional data
on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents EPA's human health and ecological risk assessments, and the
reregistration eligibility decision for dikegulac sodium. The document consists of six
sections. Section I contains the regulatory framework for reregistration. Section II provides
a profile of the use and usage of the chemical. Section III gives an overview of the human
health and environmental effects risk assessments based on data and other information
received. Section IV presents the Agency's reregistration eligibility and risk management
decisions. Section V summarizes label changes necessary outlined in Section IV. Section VI
provides information on how to access related documents. Finally, the Appendices list
related information and supporting documents. The risk assessments and other supporting
documents for dikegulac sodium are available in the Public Docket, under docket number
EPA-HQ-OPP-2006-0954, and on the Agency's web page, http://www.reuLilations.iiov.
II. Chemical Overview
A. Regulatory History
Dikegulac sodium was first registered in the United States in 1978 to Maag
Agrochemical. The first Generic Data Call-In (GDCI) was issued in January 1989 for
product chemistry, ecological toxicology and fate, and acute and chronic toxicity data. In
January 1992, PBI/Gordon Corporation acquired the label from Maag Agrochemical. As part
of its phase 2 response to the GDCI, PBI/Gordon requested the Agency waive a number of
data requirements due its limited productions and to the "low volume/minor use" of the
chemical. "Minor use" is defined in part as the use of a pesticide on a commercial
agricultural crop or site where the total United States production is fewer than 300,000 acres
(see also FIFRA 2(11)). The registrant provided the Agency projected sales and use data for
1992 and previous years, and anticipated sales of the formulated product would stay within
the projected volume. As a result, the Agency accepted the low volume minor use waivers,
contingent upon continued low production of dikegulac sodium. In order to retain the data
waivers, the registrant was required to submit, and submitted, yearly sales data to the Agency
demonstrating that dikegulac sodium production remained below specified levels.
In October 2005, at a meeting with the Agency, the registrant petitioned the Agency
to remove this condition, based on the low toxicity of the chemical. The Agency agreed to
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consider the registrant's request during the reregistration process, and any additional data
needs to support the removal of the production cap would be determined and identified in the
RED.
There is no technical dikegulac sodium product registered in the United States.
FBI/Gordon's formulated product, Atrinal Plant Growth Regulation (EPA registration
number 2217-776), contains 18.5% active ingredient. There is also a Ready-to-Use (RTU)
tree injection product, which also contains 18.5% active ingredient (EPA registration number
69117-7).
B. Chemical Identification
DIKEGULAC SODIUM:
H,C
OH
CH,
Dikegulac sodium is structurally similar to natural products involved in synthesis, or
biosynthesis, of L-ascorbic acid (vitamin C) and structurally similar to naturally occurring
plant cell wall components.
Common Name:
Trade Names:
Chemical Name:
Case Number:
CAS Registry Number:
OPP Chemical Code:
Molecular Weight:
Empirical Formula:
Dikegulac Sodium
Atrinal®, Pincher®
Sodium salt of 2,3:4,6-bis-O-(l-methylethylidene)-a-L-
xylo-2-hexulofurano-sonic acid
3061
52508-35-7
109601
296.25 grams
C12H17NaO7
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Basic End Use Producer: FBI/Gordon Corporation
C. Use Profile
The following information on the currently registered uses includes an overview of
use sites and application methods. A detailed table of the uses of dikegulac sodium eligible
for reregistration is contained in Appendix A.
Type of Pesticide: Plant Growth Regulator
Target Organism: Trees, plants, and shrubs
Mode of Action:
Use Sites:
Use Classification:
Dikegulac sodium interferes with terminal growth areas by inhibiting
DNA synthesis, which is required for new growth. The dominant
growth points (apexes) of treated plants are suppressed, resulting in the
breaking of "apical dominance" and the enhancing of the growth of
lateral shoots.
Dikegulac sodium is used in greenhouses, nurseries, and on landscape
trees, ornamentals, and plants. Landscape use sites include parks,
school campuses, city streets, and similar recreational, institutional, or
industrial areas. Although the labeled use sites do not preclude
treatment of residential areas, residential applications made by
homeowners are unlikely due to the high cost of the product, and
according to the registrant, dikegulac sodium is not sold in the
homeowner market.
Both dikegulac sodium products are designated as general use;
however, the RTU product specifies use by professional arborists only.
Formulation Types: Soluble Concentrate/Liquid
Ready-to-Use (RTU)
A technical formulation of dikegulac sodium active ingredient is not registered in the
United States. Therefore, Table 1 lists the current end-use formulations.
Table 1. Formulations of Dikegulac Sodium
Formulation
Soluble
Concentrate/Liquid
RTU
Registration No.
2217-776
69117-7
% Active Ingredient
18.5%
18.5%
% Acid Equivalent1
17%
17%
Acid equivalent (ae) is defined as that portion of a formulation that can be converted back to the
corresponding parent acid. The percentage ae is specified on the product labels, and the application
rates are given in ae.
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Application Methods: Dikegulac sodium is applied either as a foliar spray or by pressure
injection.
Application Rates: As a sodium salt, dikegulac sodium will rapidly dissociate into
dikegulac acid and sodium ions in water. Therefore, the rates on the dikegulac sodium
product labels are expressed as acid equivalent (ae). The product contains 1.67 pounds of ae
per gallon (Ibs ae/gal). The maximum application rates (Ibs ae/gal) per use are as follows.
• Greenhouse and Nursery Ornamentals (chemical pinching): 0.048 Ib ae/gal
• Landscape Ornamentals (growth control): 0.07 Ib ae/gal
• Broadleaf Trees (plant growth retardant): 0.77 Ib ae/gal
• Fruiting Landscape Trees and Shrubs (suppression of flower and fruit formation)-
0.060 Ib ae/gal
The label does not specify the application rate per acre because, according to the
registrant, the applications are to individual trees or plants with a hand held spray wand and
not a broadcast type application. Therefore, the applicator will usually only be spraying one
tree in a residential setting and possibly multiple trees in a park or street setting. However,
for the purpose of this risk assessment, the Agency calculated the maximum application rate
of 5.68 Ibs ae/acre1. This is based on the landscape ornamental (growth control) application
rate.
D. Estimated Usage of Pesticide
Dikegulac sodium has been designated a low volume/minor use pesticide (< 300,000
acres of crop treated per year) by EPA. However, since there is a single manufacturer,
identification of the amount produced or used per year would disclose the amount that
manufacturer produces per year - information the manufacturer considers to be confidential
business information (CBI). However, the manufacturer has provided the Agency with
annual sales information to support the low volume/minor use designation and the use
assumptions used in risk assessments.
III. Summary of Dikegulac Sodium Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments, and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents,
and supporting information listed in Appendix C, were used to formulate the safety finding
and regulatory decision for dikegulac sodium.
While the risk assessments and related addenda are not included in this document,
they are available from the OPP Public Docket, docket number OPP-2006-0954, and may
Based on directions for use specified on the label, the Agency used the following calculation to determine the
Ibs ae/A: 1.67 Ibs ae/gal * 4 fl oz/128 fl oz * 1 gal/400 sq ft * 43,560 sq ft/acre = 5.68 Ibs ae/acre.
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also be accessed through the Agency's website at https://www.reuulations.gov. Hard copies
of these documents may be found in the OPP public docket under this same docket number.
• Dikegulac Sodium. Human Health Considerations for the Reregistration Eligibility
Decision, October 31, 2006
• Drinking Water Assessment for Dikegulac sodium Reregistration Eligibility Decision
(RED), February 9, 2007
• EFED Risk Assessment for the Reregistration of Dikegulac sodium, October 6, 2006
A. Human Health Risk Assessment
The human health risk assessment incorporates potential exposure and risk from all
sources, which for dikegulac sodium are limited. The growth regulator uses of dikegulac
sodium do not involve use on food commodities. Further, given the extremely limited annual
production of dikegulac sodium currently permissible, any drinking water exposure as a
result of the use of dikegulac sodium is expected to be infrequent and not significant on a
national scale. Additionally, based on the available toxicity data for dikegulac sodium, a low
hazard concern is indicated via the oral, dermal, and inhalation routes of exposures (i.e., there
is very low systemic toxicity). Therefore, the Agency has concluded that a qualitative human
health risk assessment to evaluate potential drinking water, occupational, and non-
occupational (residential) exposures is appropriate for dikegulac sodium and will be
protective of all U.S. populations, including infants and young children. For the complete
health risk assessment, refer to Dikegulac Sodium. Human Health Considerations for the
Reregistration Eligibility Decision, October 31, 2006, which is available in the public docket.
1. Toxicity of Dikegulac Sodium
The available toxicological data for dikegulac sodium are sufficient for hazard
assessment. The database consists of acute toxicity, irritation, inhalation, and sensitization
studies. In addition, there are developmental rat and rabbit (oral) toxicity studies, subchronic
dog and rat (oral) toxicity studies, and a 21-day (dermal) rabbit study. Mutagenicity studies
available include Salmonella typhimurium, micronucleus, and gene mutation assays. The
available combination of published literature and submitted toxicity studies are sufficient to
assess the toxicity of dikegulac sodium. Based on the very low hazard concern via the oral,
dermal, and inhalation routes of exposure, a qualitative hazard assessment is appropriate for
dikegulac sodium.
The available acute toxicity studies indicate that dikegulac sodium is of low oral,
dermal and inhalation toxicity (all Toxicity Categories IV). A primary eye irritation study
resulted in moderate ocular irritation and iridial changes, subsiding in all test animal eyes by
7 days, and conjunctival changes subsiding by 10 days (Toxicity Category II). Dikegulac
sodium did not produce dermal sensitization in tests with guinea pigs. Table 2 summarizes
the acute toxicity profile of dikegulac sodium.
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Table 2. Acute Toxicity Profile for Dikegulac Sodium
Study
81-1 Acute Oral - Rat
870.1000
8 1 -2 Acute Dermal - Rabbit
870.1200
81-3 Acute Inhalation - Rat
870.1300
8 1 -4 Eye Irritation - Rabbit
870.2400
8 1 -5 Skin Irritation - Rabbit
870.2500
81-6 Dermal Sensitization
870.2600
MRID
44093901
43064604
43064605
43064606
43064608
44093902
44093903
44093904
44093905
43064616
44093906
Results
No death, no clinical signs
LD50>5000 mg/kg
No deaths, no clinical signs
LD50 >5000 mg/kg
No deaths.
LC50>2.09 mg/L
No corneal effects were observed.
Iridial changes subsided in all eyes by
7 days and conjunctival changes
subsided by 1 0 days
Slight erythema and edema observed.
All animals survived. No adverse
clinical signs. Not a dermal sensitizer
Toxicity
Category
IV
IV
IV
II
IV
N/A
There is currently no long-term rodent information regarding the carcinogenic
potential of dikegulac sodium. However, limited usage and use patterns preclude the need
for such long-term chronic studies. Also, neurotoxicity information is currently not
available. However, there were no clinical signs in any of the acute, subchronic, or
developmental toxicity studies to suggest that dikegulac sodium elicits a neurotoxic effect.
Furthermore, based on the low hazard concern from the available studies, no
endpoints of toxicological concern have been identified for risk assessment purposes.
Finally, given the extremely limited annual production of dikegulac sodium currently
allowed, and that it is unlikely to be used in a significant portion of any given watershed, the
Agency concludes that human drinking water exposure to this compound is negligible. For
more detail on the toxicological data base and Agency's drinking water determination, refer
to the Dikegulac Sodium. Human Health Considerations for the Reregis (ration Eligibility
Decision, October 31, 2006, and the Drinking Water Assessment for Dikegulac sodium
Reregistration Eligibility Decision (RED), February 9, 2007.
2.
Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from the National
Poison Control Centers (PCC), the Agency's Office of Pesticide Program's Incident Data
System (IDS), the California Pesticide Illness Surveillance Program, National Pesticide
Information Center, and the National Institute for Occupational Safety and Health's (NIOSH)
Sentinel Event Notification System for Occupational Risk (SENSOR) program. There are no
reported cases of reactions or illness to workers or others, due to dikegulac sodium, in any of
the databases.
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B. Environmental Risk Assessment
On a nationwide basis, dikegulac sodium use is relatively limited. Therefore,
ecological exposure and risks will be relatively localized to specific use sites. Dikegulac
sodium application methods include spraying of foliage (nursery, greenhouse and landscape
plants), tree injection to retard growth, spray banding of tree trunks to suppress flowering and
fruiting, and spraying of individual tree crowns. Based on these use patterns, the Agency
believes the most likely exposure scenario involves spray drift or runoff from a large outdoor
nursery or landscape maintenance to nearby terrestrial or aquatic habitats. Tree injection is
not considered to be a major route of environmental exposure and, therefore, was not
assessed in the ecological risk assessment. For the complete ecological risk assessment, refer
to EFED Risk Assessment for the Reregistration of Dikegulac Sodium, October 6, 2006,
which is available in the public docket.
1. Environmental Fate and Transport
As of this writing, no guideline environmental fate studies for dikegulac sodium had
been submitted. However, dikegulac sodium is a sugar derivative, and its intermediate
breakdown products include ascorbic acid (vitamin C). Therefore, it is expected that
dikegulac sodium will be fully mineralized to carbon dioxide and water, with no persistent
degradates. An unreviewed soil metabolism study suggests that the soil metabolism half-life
of dikegulac sodium is 15 days. Once the epoxide bridges are removed, the remaining
molecule should be metabolized by natural pathways. As a sodium salt, dikegulac sodium
will dissociate into dikegulac-acid and sodium ions in water. Thus, dikegulac-acid is the
form that organisms will be exposed to in water. As a free acid, dikegulac is semi-volatile;
however, the very low Henry's Law constant makes exposure by volatilization unlikely.
On site, liquid formulations of dikegulac sodium applied using spray banding of
trunks, and spray application to foliage (hand applicator) will be directly applied to target
plants with the potential for incidental exposure to invertebrates inhabiting the foliage at the
time of application. Applied as foliar spray, dikegulac sodium is also expected to result in
residues on the soil, non-target ground foliage, and invertebrates on the soil. Dikegulac
sodium residues on vegetation will be absorbed through the leaves and translocated to the
shoot tips. After dikegulac sodium reaches the soil, it is available for uptake by vegetation
and soil invertebrates. Terrestrial wildlife exposure could result from the following actions
or behaviours: incidental inhalation of spray; ingestion of residues on or in food items (i.e.,
plants and insects); deliberate or incidental ingestion of pesticide-treated soil when foraging
or preening; dermal uptake via direct contact of skin with treated vegetation; soil or spray;
contaminated puddles or surface water; and ingestion of water from contaminated surface
water, puddles, or dew.
Dikegulac sodium may also reach offsite soil, terrestrial vegetation, and insects from
spray drift, or it may reach offsite soils via runoff and erosion. Dikegulac sodium applied to
trees in urban/suburban parking lots and similar areas will tend to run off from impervious
surfaces with rainfall and be transported to surface water bodies. Direct aquatic organism
exposure could result from direct contact with contaminated water or pore water.
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2. Toxicity and Risk Characterization
The pesticide use profile, exposure data, and toxicity information are used to
determine risk estimates to non-target aquatic and terrestrial organisms. Estimated
Environmental Concentrations (EECs) are used to calculate risk quotients (RQs). An RQ is
the estimated ratio of exposure concentration to the toxicity endpoint. The calculated RQs
use the EECs that are based on the maximum single application rate of dikegulac sodium,
which would yield the maximum exposure estimates. The RQ is then compared to the level
of concern (LOG) to determine if exposure to dikegulac sodium would pose a risk to non-
target organisms. Table 3 outlines the Agency's LOCs and the corresponding risk
presumptions.
Table 3. Agency's LOCs and Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk;
regulatory action may be warranted in addition to
restricted use classification.
Acute Endangered Species - endangered species
may be adversely affected; regulatory action may
be warranted.
Chronic Risk - there is potential for chronic risk;
regulatory action may be warranted.
LOC
Terrestrial Animals
0.5
0.1
1
LOC
Aquatic Animals
0.5
0.05
1
LOC
Plants
1
1
N/A
3. Non-target Aquatic Exposure and Risk
Fish and aquatic invertebrates in surface water or sediment adjacent to treated
ornamentals and fruiting trees (nurseries and/or urban use sites) may be exposed to dikegulac
sodium residues through spray drift alone or in concert with run-off from labeled use of the
pesticide. For exposure to fish and aquatic invertebrates, EPA generally considers residues
in both surface water and sediment. However, based on environmental fate data on dikegulac
sodium, the Agency believes that dikegulac sodium will be predominantly in the water
column in an aquatic system; therefore, exposure estimates for aquatic organisms used in the
ecological risk assessment focused on surface water, not sediment. Aquatic plants in surface
water adjacent to treated ornamentals and fruiting trees (nurseries and/or urban use sites) may
also be exposed to dikegulac sodium residues through spray drift alone or in concert with
run-off from labeled use of the pesticide.
Further, as explained in the environmental fate and transport section above,
dikegulac-acid is the form that organisms will be exposed to in water. Therefore, the Tier 1
aquatic model GENEEC was used to estimate surface water concentrations of dikegulac-acid.
This model was also used to derive EECs to measure potential exposures to freshwater
organisms in surface water. The maximum single application rate of 5.68 Ib acid equivalent
(ae)/acre to fruiting trees and ornamentals in nurseries, greenhouses, urban and suburban
Based on the use directions on the label, the Agency used the following calculation to establish the maximum
rate of 5.68 Ibs ae/A: 1.67 Ibs/gal * 4 fl oz/128 fl oz * 1 gal/400 sq ft * 43,560 sq ft/acre.
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areas is the highest application rate that would yield the maximum EECs. Table 4 lists the
EECs for dikegulac acid in surface water using the GENEEC model.
Table 4. Dissolved dikegulac-acid surface water EECs using the GENEEC model
EECs (ug ae/L) in a small surface water body
Average Peak
Average 21-day
Average 60-day
663
663
662
Due to the lack of complete dikegulac sodium or dikegulac acid environmental fate
data, the exposure assessment is based partly on literature data, quantitative structure-activity
relationship (QSAR) estimates, and conservative assumptions. The Agency made the very
conservative assumption that the dikegulac acid is highly stable in the environment and does
not degrade in the soil, water, or when exposed to light. The effect of this is that exposure
estimates are likely to be higher than they would be with data on fate properties.
a. Fish and Aquatic Invertebrates
Dikegulac sodium has little to no toxic effect on freshwater fish and invertebrates. For
these taxa, there was no mortality at the highest concentrations tested in the laboratory, and
the EECs were all well below these concentrations. Therefore, the Agency determined that
there is no acute risk (listed or non-listed) to freshwater fish or invertebrates; the RQs are
below the Agency's LOG.
Acute toxicity data was only submitted for one marine/estuarine species, which is the
brown shrimp. The test was conducted only for 48 hours rather than the guideline 96 hours.
This value was selected for calculating RQs for marine/estuarine invertebrates. Acute risk
may potentially be underestimated because it is only a 48-h LC50 and not the guideline 96-h
LC50. No 96-h LC50 study was submitted by the registrant or found in the literature for
marine/estuarine fish. Based on similar sensitivity between freshwater fish and invertebrates
for the range tested, it is assumed that marine/estuarine fish would be at least as sensitive as
the brown shrimp. However, the 48-hr EC50 for brown shrimp, representing estuarine/marine
invertebrates and fish is 9,129,000 ppb which results in an acute RQ of O.0001. Therefore,
there are no listed or non-listed LOG exceedances for marine/estuarine fish and invertebrates.
Chronic toxicity data were not submitted for any aquatic animals; the Agency is
unable to quantitatively assess possible chronic effects to aquatic animals. However, chronic
risks are considered unlikely for the given labeled uses, based on consideration of the
magnitude of the acute-to-chronic ratio. Based on the acute fish and invertebrate data, the
Agency determined that the chronic toxicity would have to be between 7,000 to 15,000 times
greater than the acute toxicity to result in an chronic RQ > 1, which is the chronic LOG. This
is highly unlikely, based on the Agency's experience interpreting ecotoxicology data for
many other pesticide chemicals. For more detailed information, refer to the EFED Risk
Assessment for the Reregistration of Dikegulac Sodium, October 6, 2006, which is available
in the public docket.
10
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b. Aquatic Plants
Despite the use of dikegulac sodium as a plant growth regulator, no risks to aquatic
plants (listed or non-listed) have been identified. Average peak EECs for dikegulac-acid are
compared to the acute EC50 toxicity endpoints for duckweed (a vascular plant), green alga
(non-vascular plant), freshwater diatom, and marine diatom to calculate RQs to non-listed
aquatic plant species. There are no exceedances of LOCs for non-listed or listed aquatic
plants.
4. Non-target Terrestrial Exposure and Risk
Terrestrial vertebrates (birds, mammals, reptiles, terrestrial phase amphibians) may be
exposed to dikegulac sodium residues on seeds, insects, and foliage on treated ornamentals
and fruiting trees due to direct deposition or overspray from labeled use of the pesticide on
these media. Spray drift and long-range aerial transport would result in lower residue levels
for these media than on target plants; therefore, this risk hypothesis provides an upper bound
for risks to terrestrial vertebrates from dietary exposure.
Upland plants adjacent to treated ornamentals and fruiting trees (nurseries and/or
urban use sites) may be exposed to dikegulac sodium residues in soil or on foliage due to
spray drift from labeled use of the pesticide. Furthermore, riparian/wetland plants adjacent to
treated ornamentals and fruiting trees (nurseries and/or urban use sites) may be exposed to
dikegulac sodium residues on foliage due to spray drift from labeled use of pesticide.
The Agency used the maximum single application rate of 5.68 Ibs ae/acre3 to fruiting
trees and ornamentals in nurseries, greenhouses, urban and suburban areas, which is the
highest application rate that would yield the maximum EECs for terrestrial organisms in
tables 5 and 6 below.
Table 5. Upper Kenaga dietary and dose-based EECs of dikegulac acid equivalents (ae) for
avian food items
Use Site
Nurseries,
greenhouses,
urban and
suburban areas
with fruiting trees
and ornamentals
Food Item
short grass
tall grass
broadleaf plants/sm insects
fruits/pods/seeds/lg insects
Dietary
EECs
(ppm ae)
2481.48
1137.35
1395.83
155.09
Dose-based EECs (mg ae/kg-bw) by
Avian Body Weight
Small (20g)
2826.16
1295.32
1589.71
176.63
Medium
(lOOg)
1611.60
738.65
906.52
100.72
Large
(lOOOg)
721.53
330.70
405.86
45.10
' Based on the use directions on the label, the Agency used the following calculation to establish the maximum
rate of 5.68 Ibs ae/A: 1.67 Ibs/gal * 4 fl oz/128 fl oz * 1 gal/400 sq ft * 43,560 sq ft/acre.
11
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Table 6. Dikegulac-acid
lowland areas using up
Use Site
Nurseries, greenhouses,
urban and suburban
areas with fruiting trees
and ornamentals
1 EECs for non-target vascular plants in off-site upland and semi-aquatic
per and lower bound label application rates
Application Rate
(Ibs ae/acre)
5.68 (lower bound)
Application
Method
Ground
EECs (Ibs ae/acre)
Adjacent
upland
0.3408
Semi-
aquatic
lowland
2.8968
Drift
0.0568
As stated above, due to a lack of available environmental fate data for dikegulac
sodium, the exposure assessment is based on literature, quantitative structure-activity
relationship (QSAR) estimates, and conservative assumptions. Therefore, the exposure
estimates above are likely to be higher than they would be with data on fate properties.
a.
Birds
Dikegulac-sodium is classified as being practically non-toxic to avian species.
The Agency's avian acute LOCs (listed or non-listed) were not exceeded for any proposed
use. Therefore, no acute risks to birds (or reptiles) are expected. In addition, since dikegulac
sodium is not acutely toxic to birds at doses many times higher than expected exposure, and
is not chronically toxic to mammals (see section below), the Agency does not expect a
chronic risk to birds, and will not require chronic avian toxicity studies.
b.
Mammals
Dikegulac sodium has little to no toxic effect on mammals; there were no mortalities
at the highest level tested (5000 ppm). Considering estimated exposures are below this level,
the Agency determined there is no acute risk to mammals. No mammalian reproductive data
are available. However, a rabbit development toxicity study was reviewed in which no fetal
parameters such as litter size, litter weight or viability were significantly affected compared
with the controls. Therefore, the Agency determined there were no chronic risks of concern
to non-listed or listed mammals.
c.
Beneficial Insects
Dikegulac sodium is non-toxic to honey bees (no mortality at 81 ug/bee). Therefore,
the Agency determined there are no risks to beneficial insects.
d. Non-target Terrestrial Plants
The TERR-PLANT model was used to estimate risk to terrestrial plants in areas
adjacent to the treated field (sheet runoff), wetland areas (channelized runoff), and from
spray drift. Table 7 contains the acute RQs for terrestrial plants using the TERR-PLANT
exposure model for the maximum application rate of 5.68 Ib ae/A.
12
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Table 7. Acute RQs for terrestrial plants
Application
Rate
Application
Method
Runoff Plus Drift
RQs
Adjacent Areas
Non listed
Listed
Runoff Plus Drift
RQs
Semi-Aquatic Areas
Non listed
Listed
Spray Drift RQs
Vegetative Vigor
Non listed
USE SITE: NURSERIES, GREENHOUSES, URBAN & SUBURBAN AREAS
5.68 Ibs ae/A
Ground
0.09
0.1
0.8
1.2
<0.1
Listed
03
The TERR-PLANT exposure model calculates RQs for terrestrial plants for a single
pesticide application only. Since dikegulac sodium labels allow for up to two foliar
applications per year to several plants, the magnitude of the risk to plants is uncertain, and
potentially underestimated. In order to compensate for this uncertainty, the Agency
considered the upper bound to the magnitude of the RQs for terrestrial plants, which would
be to sum the exposures from each application as if the effect to non-target plants were
additive. The resulting RQs for two applications, or a maximum yearly application rate of
11.36 Ibs ae/A indicate a potential risk to both non-endangered and endangered semi-aquatic
plants. However, the Agency believes that this is an upper bound and highly conservative
exposure scenario; thus, these risk estimates were not presented in Table 7 above. The RQs
for a single application of dikegulac sodium (5.68 Ibs ae/A) do not indicate a potential risk
for non-endangered terrestrial plants.
However, additional information on the effect of dikegulac sodium on terrestrial
plants would be needed to evaluate the uncertainty in multiple application terrestrial plant
RQs. The effects of multiple applications could only be additive if the affected plants could
not recover from the effects of successive applications. If the plants could recover over time,
the effect of multiple applications could be greater for plants which are treated at the shortest
application intervals.
The magnitude of effect of dikegulac sodium on terrestrial plants from multiple
applications is uncertain. The effects of multiple applications could only be additive if the
affected plants could not recover from the effects of successive applications. If the plants
could recover over time, the effect of multiple applications could be greater for plants which
are treated at the shortest application intervals.
The uncertainty in the magnitude of exposure to multiple applications of dikegulac
sodium is even greater. The RQs for terrestrial plants assume exposure both through spray
drift and runoff from a treated site after a heavy rain event. The likelihood of co-occurrence
of such events is uncertain, especially for multiple applications, and as a result the estimated
exposure values are conservative. In addition, while the likelihood of exposure to non-target
plants through drift alone is significantly higher, the same plants may not be exposed to spray
drift from each application since wind speed and direction could be different at the time of
each application.
13
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5. Adverse Ecological Incidents
There are currently no adverse ecological incidents listed in the Ecological Incident
Information System (EIIS) that are associated with the dikegulac sodium.
6. Endangered Species Considerations
Based upon the screening-level assessment conducted on dikegulac sodium, the RQ
for non-target semi-aquatic terrestrial plants exceeds the endangered species LOG. Acute
RQs did not exceed endangered species LOCs for birds, mammals, aquatic plants, freshwater
fish and invertebrates, or estuarine/marine fish and invertebrates. Chronic data were not
available for any aquatic species or birds. Additionally, no mammalian reproductive study
was available, although a developmental study was available.
As described above, the Agency believes that the low toxicity in available acute
toxicity studies for freshwater and marine/estuarine animals suggests that chronic risk to
freshwater and estuarine/marine animals is unlikely. Similarly, since dikegulac sodium is not
acutely toxic to birds at doses many times higher than expected exposure, and is not
chronically toxic to mammals, the Agency does not expect a chronic risk to birds. However,
because the toxicity data are not available, the Agency cannot completely preclude chronic
risks to birds, terrestrial phase amphibians, reptiles, freshwater fish and crustaceans, and
estuarine/marine fish, invertebrates, and crustaceans at this time.
Additionally, because the screening-level assessment identified exceedences of the
endangered species LOG for listed semi-aquatic terrestrial plants, the Agency cannot
preclude indirect effects on listed species which rely on a specific or multiple plant species.
However, as stated above, the Agency believes the RQs used in this assessment were
conservative because 1) the use scenario assumes application of a full acre of tress, shrubs,
and/or ornamental plants, which the registrant stated is a highly unlikely to occur due to the
intended use of the product, as well as the high cost of the product, and 2) the model used to
generate the RQs assumes co-exposure from spray drift and a large run-off event.
Table 8 provides a matrix that depicts the potential for direct and indirect effects to
listed species resulting from the use of dikegulac sodium. Details regarding these effects are
provided in the sections below.
Table 8. Listed species potential risk associated with direct or indirect effects due to
applications of dikegulac sodium
Listed Taxon
Terrestrial plants
Terrestrial invertebrates
Birds
Terrestrial phase amphibians
Reptiles
Direct Effects
Acute
Yes
No
No
No
No
Chronic
N/A
N/A
No available data
No available data
No available data
Indirect Effects
No
Yes
Yes
Yes
Yes
14
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Listed Taxon
Mammals
Aquatic non- vascular plants
Aquatic vascular plants
Freshwater fish
Aquatic phase amphibians
Freshwater crustaceans
Mollusks
Marine/estuarine fish
Marine/Estuarine invertebrates
Marine/estuarine crustaceans
Direct Effects
Acute
No
No
No
No
No
No
No
No available data
No
No
Chronic
No
N/A
N/A
No available data
N/A
No available data
N/A
No available data
No available data
No available data
Indirect Effects
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
N/A is not applicable since guidelines for these studies do not exist
IV. Risk Management and Reregistration
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregistration. The Agency has completed its review of available
generic data (i.e., active ingredient-specific), and has determined that the data are sufficient
to support reregistration of all products containing dikegulac sodium.
The Agency has completed its assessment of the occupational, residential, drinking
water, and ecological risk associated with the use of pesticide products containing the active
ingredient dikegulac sodium. The Agency has determined that dikegulac sodium-containing
products are eligible for reregistration provided that label amendments are made as outlined
in Chapter V. Appendix A summarizes the uses of dikegulac sodium that are eligible for
reregistration. Appendix B identifies the generic data requirements that the Agency reviewed
as part of its determination of reregistration eligibility of dikegulac sodium, and lists the
submitted studies that the Agency found acceptable.
Based on its evaluation of dikegulac sodium, the Agency has determined that
dikegulac sodium does not present risks to human health or the environment. However, in
order to comply with the Worker Protection Standards, the Agency is requiring additional
PPE for tree injection applications, as well as for early entry, and an increased REI for
agricultural uses. Additionally, to mitigate potential ecological risks to semi-aquatic plants,
the Agency is requiring the implementation of spray drift language on all end use labels with
foliar applications. Should a registrant fail to implement any of the reregistration
requirements identified in this document, or should the Agency identify any risks
inconsistent with FIFRA at a later date, the Agency may take regulatory action.
15
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B. Public Comments and Responses
Because the risks associated with the use of dikegulac sodium were low and did not
warrant significant mitigation measures, the Agency determined an expedited one phase RED
process was appropriate for dikegulac sodium. Therefore, a public comment period was not
conducted. However, a 60-day public comment period will be conducted after the RED is
issued, and will be announced in the Federal Register. Comments may be submitted under
Docket number EPA-HQ-OPP-2006-0954 at http://www.regulations.aov. The RED
document and technical supporting documents for dikegulac sodium are also available to the
public through EPA's electronic public docket and comment system, at
http://www.reuulations.gov under docket identification (ID) number EPA-HQ-OPP-2006-
0954. In addition, the dikegulac sodium RED document may be downloaded or viewed
through the Agency's website at http://www.epa.TOV/pcsticides/reregistration/status.hti-n.
C. Regulatory Position
1. Regulatory Rationale
The Agency has determined that dikegulac sodium is eligible for reregistration
provided that specified label amendments are made. The following is a summary of the
rationale for managing risks associated with the use of dikegulac sodium.
a. Human Health Risk Management
There are no human health risks of concern for dikegulac sodium. However, the
Agency is updating the Restricted Entry Interval (REI) and Personal Protective Equipment
(PPE) requirements for dikegulac sodium. Dikegulac sodium is an acute toxicity category II
eye irritant; therefore, pursuant to the Worker Protection Standard (WPS) and according to
the OPPTS Label Review Manual 3rd Edition, products with agricultural uses must require a
24 hour REI and the following PPE for early entry: coveralls, chemical-resistant gloves made
of any water proof material, shoes plus socks, and protective eyewear. The RTU product is
registered for tree injection only; therefore, there would be little to no post-application
exposure and a REI and early entry PPE are unnecessary.
Protective eye equipment must also be worn by occupational handlers making direct
injection applications to trees due to the nature of the application and the possibility of
backsplash. Further, additional personal protective equipment may be required, if
appropriate based on the acute toxicity categories of each end-use product.
b. Ecological Risk Management
All ecological risks are below the Agency's LOG, except for potential risks to non-
endangered and listed semi-aquatic plants as a result of two applications of dikegulac sodium
on an acre of trees, plants, and/or shrubs, and exposure from both run-off and spray drift. As
stated in Section III, the Agency believes the RQs are overly conservative because: 1) the
EECs are based on conservative assumptions of stability, and not chemical specific fate data,
16
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2) the use scenario assumes an application on an acre of trees, shrubs, and/or ornamental
plants, which the registrant stated is highly unlikely to occur due to the intended use of the
product, as well as the high cost of the product, and 3) the model assumes exposure both
through spray drift and run-off from a treated site after a heavy rain event, the Agency
believes the likelihood of co-occurrence for multiple applications is unlikely.
Additionally, while the likelihood of exposure to non-target plants through drift alone
is significantly higher than simultaneous exposure from spray drift and run-off from a heavy
rain event, the same plants may not be exposed to spray drift from each application since
wind speed and direction could be different at the time of each application. However, in
order to mitigate the potential for exposure through drift, the Agency is requiring the addition
of spray drift language on all labels with foliar applications. Section V, Table 9 contains the
required spray drift language.
c. Data Waivers Based Upon Low-Volume Minor-Use Status
As stated in the Regulatory History in Section I above, the Agency agreed to waive
certain data requirements in light of the low volume of production of dikegulac sodium.
FBI/Gordon has recently requested that the Agency remove the linkage between production
and the data waivers based upon the low toxicity and low potential for human health or
ecological risk associated with the use of dikegulac sodium. The Agency has considered this
request and has determined that an increase in the production and use of dikegulac sodium
would not impact either the human health or ecological risk assessments. The Agency
determined that the maximum production amount estimated by the registrant, which is
considered by the registrant to be CBI, would not be great enough to be used in a significant
portion of a single watershed and, therefore, the increase in production would not impact the
drinking water assessment. Finally, the Agency determined that an increase in production
would not require any additional data, other than the product chemistry data listed in Section
V of this document. Therefore, the requirement to report annual sales information and the
linkage between such information and the data waivers will no longer be required for these
registrations, provided that the Agency receives acceptable generic product chemistry data.
2. Endocrine Disrupter Effects
Following recommendations of its Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for
including, as part of the program, the androgen and thyroid hormone systems, in addition to
the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a substance may have an
effect in humans, FFDCA authority to require the wildlife evaluations. As the science
develops and resources allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or
testing protocols being considered under the EDSP have been developed, dikegulac sodium
may be subject to additional screening and/or testing.
17
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3. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions are
not likely to jeopardize listed species or adversely modify designated critical habitat. The
Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on federally listed endangered and threatened species,
and to implement mitigation measures that address these impacts. To assess the potential of
registered pesticide uses that may affect any particular species, EPA puts basic toxicity and
exposure data developed for the REDs into context for individual listed species and considers
ecological parameters, pesticide use information, the geographic relationship between
specific pesticide uses and species locations and biological requirements and behavioral
aspects of the particular species. When conducted, these analyses take into consideration any
regulatory changes recommended in this RED being implemented at that time. A
determination that there is a likelihood of potential effects to a listed species may result in
limitations on the use of the pesticide, other measures to mitigate any potential effects, and/or
consultations with the Fish and Wildlife Service or National Marine Fisheries Service, as
necessary. If the Agency determines use of dikegulac sodium "may affect" listed species or
their designated critical habitat, EPA will employ the provisions in the Services regulations
(50 CFR Part 402).
The ecological assessment that EPA conducted for this RED does not, in itself,
constitute a determination as to whether specific species or critical habitat may be harmed by
the pesticide. Rather, this assessment serves as a screen to determine the need for any
species specific assessment that will evaluate whether exposure may be at levels that could
cause harm to specific listed species and their critical habitat. That assessment refines the
screening-level assessment to take into account such things as the geographic area of
pesticide use in relation to the listed species, the habits and habitat requirements of the listed
species, etc. If the Agency's specific assessments for dikegulac sodium result in the need to
modify use of the pesticide, any geographically specific changes to the pesticide's
registration will be implemented through the process described in the Agency's Federal
Register Notice (54 FR 27984) regarding implementation of the Endangered Species
Protection Program.
D. Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be
included in the labeling of all end-use products containing dikegulac sodium. For the
specific labeling statements and a list of outstanding data, refer to Section V of this RED
document.
Because of the potential risks to non-listed and listed semi-aquatic plants, as
summarized in this document, the Agency is requiring spray drift mitigation as part of the
reregistration eligibility determination. Section V, Table 9 contains the required spray drift
label language.
18
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The Agency has been working closely with stakeholders to develop improved
approaches for mitigating risks to human health and the environment from pesticide spray.
As part of the reregistration process, the EPA will continue to work with all interested parties
on this important issue.
V. What Registrants Need to Do
The Agency has determined that dikegulac sodium is eligible for reregistration
provided that the risk mitigation measures outlined in this document are adopted, and label
amendments are made to reflect these measures. To implement the risk mitigation measures,
the registrants will be required to amend their product labeling to incorporate the label
statements set forth in the Label Changes Summary Table (Table 9) below. The Agency
intends to issue Data Call-In Notices (DCIs) requiring product-specific data and additional
generic (technical grade) data. Generally, registrants will have 90 days from receipt of a DCI
to complete and submit response forms or request time extension and/or waiver requests with
a full written justification. For product-specific data, the registrant will have eight months to
submit data. For generic data, due dates can vary depending on the specific studies being
required. Below are the additional generic data and label amendments that the Agency
intends to require for dikegulac sodium to be eligible for reregistration.
A. Generic Data Requirements
The generic data base supporting the reregistration of dikegulac sodium has been
reviewed and determined to be substantially complete. However, there are a few data gaps
remaining, and these are listed below. In addition, updated Confidential Statements of
Formula (CSFs) are required.
Product Chemistry
830.1750 Certified Limits
830.1800 Enforcement Analytical Methods
830.1900 Submittal of Samples
830.7050 UV/VIS Absorption
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made. The
registrant must review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product. The Agency intends to issue a separate product-
specific Data Call-In (PDCI) outlining specific data requirements.
19
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C. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to comply with
Table 9, which describes how language on the labels should be amended.
1. Labeling for Manufacturing-Use Products
There are currently no Manufacturing-Use Products of dikegulac sodium registered
with in the United States. However, should any MUP products be registered at a later date,
labeling must comply with all current EPA regulations, PR Notices, and applicable policies.
The MUP labeling should bear the labeling contained in Table 9.
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 9. 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.
20
-------
ium Labeling Changes Summary Table
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-------
Appendix B
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 2510 covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to 2510 in all products, including
data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1 • Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. The reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are 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 if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
B-l
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Dikegulac Sodium
REQUIREMENT
Use
Patterns
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.1900
830.6302
830.6303
830.6304
830.6313
830.7000
830.7050
830.7200
Old
Guideline
Number
61-1
6 1-2 A
61-2B
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-12
None
63-5
Study Description
Product Identity and
Composition
Description of materials
used to produce the
product
Description of production
process
Description of Formulation
Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Submission of Samples
Color
Physical State
Odor
Stability to normal and
elevated temperatures,
metals, and metal ions
pH
UV/Visible Absorption
Melting Point
Use
Patterns
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
CITATION(S)
43225901
43225902
43225903
43225901
43225902
43225903
43225901
43225902
43225903
43225901
43225902
43225903
43225901
43225902
43225903
43225901
43225902
43225903
Data Gap
Data Gap
Data Gap
Waived/
Material Safety Data
Sheet (MSDS)
Waived/Farm Chemical
Handbook (FCH)
Waived/MSDS
Waived/MSDS
Waived/MSDS
Data Gap
Waived/FCH
B-2
-------
830.7220
830.7300
830.7840
830.7950
830.7370
830.7550
63-6
63-7
63-8
63-9
63-10
63-11
Boiling Point/Boiling Point
Range
Density
Solubility
Vapor Pressure
Dissociation constants in
water
Partition coefficient, shake
flask method
All
All
All
All
All
All
Waived/MSDS
Waived/MSDS
Waived/FCH
Waived/MSDS
Waived
Waived/MSDS
ECOLOGICAL DATA
850.2100
850.2200
850.2200
850.1075
850.1075
850.1010
850.1075
850.4100
850.4150
850.4400
850.3020
71-1A
71-2A
71-2B
72-1A
72- 1C
72-2A
72-3A
122-1A
122-1B
122-2
141-1
Avian Acute Oral Toxicity
Avian Dietary Toxicity -
Quail
Avian Dietary Toxicity -
Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow
Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity
-Fish
Terrestrial Plant Toxicity,
Seedling Emergence
Terrestrial Plant Toxicity,
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
C,I
C,I
c,i
c,i
c,i
c,i
c,i
C,I
c,i
c,i
c,i
Waived/
46547302
Waived/
46547303
4563 1 702
Waived
Waived/
45631702
Waived/
46547301
Waived/
45631702
45631702
46547305
46547306
46547307
44093910
ACUTE AND CHRONIC TOXICITY
870.1100
870.1200
870.1300
870.2400
81-1
81-2
81-3
81-4
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-
Rabbit/Rat
Acute Inhalation Toxicity-
Rat
Primary Eye Irritation-
Rabbit
C,I
c,i
c,i
C,I
44093901
43064604
43064605
43064606
43064607
43064608
43064612
43064610
44093902
43064613
44093903
43064614
44093904
B-3
-------
870.2500
870.2600
870.3100
870.3150
870.3200
870.3700
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.5100
870. 5300
870.5395
870.7485
870.7600
81-5
81-6
81-7
82-1A
82-1B
82-2
82-3
82-4
82-5A
82-5B
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-2
84-4
85-1
85-2
Primary Skin Irritation
Dermal Sensitization
Acute Delayed
Neurotoxicity
Subchronic Oral Toxicity:
90-Day Study Rodent
Subchronic Oral Toxicity:
90-Day Study Non-rodent
2 1 -Day Dermal -
Rabbit/Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotox - Hen
90-Day Neurotox -
Mammal
Chronic Feeding Toxicity -
Rat
Chronic Feeding Toxicity -
Non-Rodent
Carcinogenicity - Rat
Carcinogenicity - Mouse
Developmental Toxicity -
Rat
Developmental Toxicity -
Rabbit
2-Generation Reproduction
-Rat
Bacterial Reverse Gene
Mutation
HGPRT Forward Mutation
Assay/V79 Cell Line
Micronucleus
Other geno toxic effect
General Metabolism
Dermal Penetration and
Absorption
C,I
c,i
c,i
c,i
C,I
c,i
C,I
c, i
C, I
c,i
c,i
c,i
C, I
C, I
C,I
c,i
c,i
c,i
c,i
C,I
c, i
c,i
c,i
43064615
44093905
43064616
44093906
Waived
Waived/
42957701
Waived/
42957702
Waived/
42957703
Waived
Waived
Waived
Waived
Waived/
43064617
43064618
Waived
Waived
Waived
43064618
43612801
43064601
Waived
44093907
44093908
44093909
44093909
Waived
Waived
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2400
875.2500
133-3
133-4
Dermal Passive Dosimetry
Exposure
Inhalation Passive
Dosimetry Exposure
c,i
C,I
Waived
Waived
ENVIRONMENTAL FATE
B-4
-------
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.1240
835.1410
835.8100
835.6100
850.1730
161-1
161-2
161-3
162-1
162-2
162-3
163-1
163-2
163-3
164-1
165-1
165-2
165-4
165-5
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic
Metabolism
Leaching/Adsorption/Deso
rption
Laboratory Volatilization
Field Volatilization
Terrestrial Field
Dissipation
Confined Rotational Crop
Field Rotational Crop
Bioaccumulation in Fish
c,i
C, I
C, I
c,i
C, I
C,I
c,i
C,I
C, I
c,i
C, I
C, I
C, I
Waived/
46932401
Waived
Waived
Waived/
46932402
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
B-5
-------
Appendix C
Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard (South Building), 1777 S. Crystal Drive,
Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to
4pm.
The risk assessments and other supporting documents for dikegulac sodium are
available in the Public Docket, under docket number EPA-HQ-OPP-2006-0954, and on the
Agency's web page, http://www.regulations.gov. The docket contains risk assessments and
related documents as of February 2007.
Technical support documents for the Dikegulac Sodium RED include the following:
Health Effects Documents
1. Dikegulac Sodium. Human Health Consideration for the Reregistration Eligibility
Decision. October 31, 2006.
2. Dikegulac Sodium. Addendum to the HED Risk Assessment. February 6, 2007.
Ecological Fate and Effects Documents
3. EFED Risk Assessment for the Reregistration of Dikegulac Sodium. October 6, 2006.
4. Drinking Water Assessment for Dikegulac-Sodium Reregistration Eligibility Decision
(RED). February 9, 2007.
C-l
-------
Appendix D
Bibliography
MRID
42957701
42957702
42957703
43064601
43064604
43064605
43064606
43064607
43064608
Citation
Hummler, H. (1975) Tolerance Experiment on Rats with Oral
Administration of Ro 07-6145/001 (DAG) for 13 Weeks: Lab Project
Number: B-85 589. Unpublished study prepared by Roche Corporate
Laboratory. 195 p.
Hummler, H. (1975) Tolerance Experiment on Dogs with Oral
Administration of Ro 07-6145/001 (DAG) for 13 Weeks: Lab Project
Number: B-85 589. Unpublished study prepared by Roche Corporate
Laboratory. 140 p.
Davies, R.; et al. (1975) The Effect of Repeated Applications of ACR
1139A to the Skin of Rabbits for Twenty-One Days: Lab Project
Number: HLR27/75185. Unpublished study prepared by Huntingdon
Research Centre. 56 p.
Wipf, H. (1974) Na-DAG (Ro 07-6145/001): Stability in Aqueous
Solution. Unpublished study prepared by Roche Corporate Lab. 8 p.
Bachtold (1973) Ro 07-6145/001: Single Oral Dose Toxicity to Rats:
Translated by A. Rix: Lab Project Number: IM 4899. Unpublished
study prepared by F. Hoffmann La-Roche Co. 5 p.
Bachtold (1974) Ro 07-6145/001: Single Oral Dose Toxicity to Male
and Female Rats: Translated by A. Rix: Lab Project Number: IM 5313.
Unpublished study prepared by F. Hoffmann La-Roche Co. 5 p.
Bachtold (1974) Ro 07-6145/001: Single Oral Dose Toxicity to Male
and Female Rats: translated by A. Rix: Lab Project Number: IM 5393.
Unpublished study prepared by F. Hoffmann La-Roche Co. 5 p.
Bachtold (1973) Ro 07-6145/001: 5-Day Repeated Oral Dose Toxicity
to Rats: Translated by A. Rix: Lab Project Number: IM 4899.
Unpublished study prepared by F. Hoffmann La-Roche Co. 5 p.
Hane, D.; Tarabour, B.; Dairman, W. (1977) Acute Oral Toxicity in
Rats of ATRINAL Formulation ACR-1139B and the Active Ingredient
Ro 07-6145/001. Unpublished study prepared by Roche Corporate Lab.
6 p.
D-l
-------
43064610
43064612
43064613
43064614
43064615
43064616
43064617
43064618
43225901
43225902
43225903
FBI/Gordon Corp. (1978) Dikegulac Sodium (Ro 07-6145/001) and
ATRINAL Formulation ACR-1139B: Summary of Acute Toxicity in
Rats and Mice. Unpublished study. 4 p.
Hane, D.; Pool, W. (1973) 5-Day Skin Absorption Toxicity (in mice) of
Ro 07-6145/001 (Plant Growth Control Agent). Unpublished study
prepared by Roche Corporate Lab. 5 p.
Thackara, J.; Rinehart, W. (1977) An acute Inhalation Toxicity Study
of Ro 07-6145/001 in the Rat: Lab Project Number: 77-1928.
Unpublished study prepared by Bio/Dynamics Inc. 19 p.
Tarabour, B.; Hane, D.; Dairman, W. (1977) Eye Irritation Testing in
Rabbits of ATRINAL Formulation ACR-1139B, Full Strength and
Diluted and the Active Ingredient Ro 07-6145/001 (Plant Growth
Regulator). Unpublished study prepared by Roche Corporate Lab. 9 p.
Hane, D.; Tarabour, B.; Dairman, W. (1977) Skin Irritation Testing in
Rabbits of ATRINAL Formulation ACR-1139B, Full Strength and
Diluted and the Active Ingredient Ro 07-6145/001 (Plant Growth
Regulator). Unpublished study prepared by Roche Corporate Lab. 7 p.
Hane, D.; Somma-Tarabour, B.; Barbo, E.; et al. (1977) Guinea Pig
Skin Sensitization Test with ATRINAL and the Active Ingredient, Ro
07-6145/001 (Plant Growth Regulator). Unpublished study prepared by
Roche Corporate Lab. 12 p.
Backes, G. (1977) Embryotoxicity Studies in the Rat Following Oral
Administration of Ro 07-6145/001. Unpublished study prepared by
Roche Corporate Lab. 177 p.
Backes, G. (1977) Embryotoxicity Studies in the Rabbit Following
Oral Administration of Ro 07-6145/001. Unpublished study prepared
by Roche Corporate Lab. 96 p.
Sharp, J.; Armbruster, J. (1994) Structural Similarity of Dikegulac
Sodium to Natural Products. Unpublished study. 14 p.
Szkrybalo, W., inventor; Hoffman-La Roche Inc., assignee (1982) Plant
Growth Regulants. US patent 4,337,080. Int. Cl A01N 43/14. Jun 29.
17 p.
March, J. (1977) Advanced Organic Chemistry: Atrinal Plant Growth
Regulator. Unpublished study prepared by PBI/Gordon Corp. 4 p.
D-2
-------
43612801
44093901
44093902
44093903
44093904
44093905
44093906
44093907
44093908
44093909
Armbruster, J. (1995) Supplemental Test Substance Purity Information
for Embryotoxicity Studies in the Rabbit Following Oral
Administration of Ro 07-6145/001: (Supplements MRID 43064618).
Unpublished study prepared by Roche Corporate Lab. 13 p.
Douds, D. (1995) An Acute Oral Toxicity Study (Limit Test) in Rats
with Dikegulac Sodium: Final Report: Lab Project Number: 3229.102:
EPA/AO-1-2/94. Unpublished study prepared by Springborn Labs, Inc.
37 p.
Douds, D. (1996) An Acute Dermal Toxicity Study (Limit Test) in
Rabbits with Dikegulac Sodium: Final Report: Lab Project Number:
3229.103: EPA/AD-1-2/94. Unpublished study prepared by Springborn
Labs, Inc. 51 p.
Douds, D. (1995) An Acute Whole-Body Inhalation Toxicity Study
(Limit Test) in Rats with Dikegulac Sodium: Final Report: Lab Project
Number: 3229.104: EPA/AI-1-2/94. Unpublished study prepared by
Springborn Labs, Inc. 59 p.
Douds, D. (1995) A Primary Eye Irritation Study in Rabbits with
Dikegulac Sodium: Final Report: Lab Project Number: 3229.105:
EPA/El-1-2/94. Unpublished study prepared by Springborn Labs, Inc.
45 p.
Douds, D. (1995) A Primary Skin Irritation Study in Rabbits with
Dikegulac Sodium: Final Report: Lab Project Number: 3229.106:
EPA/PSI-1-2/94. Unpublished study prepared by Springborn Labs, Inc.
42 p.
Douds, D. (1995) A Dermal Sensitization Study in Guinea Pigs with
Dikegulac Sodium: Modified Buehler Design: Final Report: Lab
Project Number: 3229.107: EPA/MB-2-2/94: 999.49. Unpublished
study prepared by Springborn Labs, Inc. 63 p.
Lawlor, T. (1995) Mutagenicity Test with Dikegulac Sodium Technical
in the Salmonella-Escherichia coli/Mammalian-Microsome Reverse
Mutation Assay: Final Report: Lab Project Number: 17008-2-409: 409.
Unpublished study prepared by Corning Hazleton, Inc. (CHV). 72 p.
Cifone, M. (1995) Mutagenicity Test on Dikegulac Sodium Technical
in the L5178Y TK+/-Mouse Lymphoma Forward Mutation Assay:
Final Report: Lab Project Number: 17008-0-431: 431: 20989.
Unpublished study prepared by Corning Hazleton, Inc. (CHV). 61 p
Murli, H. (1995) Mutagenicity Test on Dikegulac Sodium Technical in
D-3
-------
44093910
45631702
46547301
46547302
46547303
46547305
46547306
46547307
46932401
an in vivo Mouse Micronucleus Assay: Final Report: Lab Project
Number: 17008-0-455: 455: 20996. Unpublished study prepared by
Corning Hazleton, Inc. (CHV). 55 p.
Palmer, S.; Beavers, J. (1996) Dikegulac Sodium: An Acute Contact
Toxicity Study with the Honey Bee: Final Report: Lab Project Number:
281-113: 281/030895/BLD.NC/CHP86. Unpublished study prepared
by Wildlife International Ltd. 29 p.
Mileson, B. (2002) Dikegulac Ecotoxicity Overview: Lab Project
Number: DK-02-02. Unpublished study prepared by Technology
Sciences Group, Inc. 52 p.
Palmer, S.; Kendall, T.; Krueger, H. (2004) Dikegulac: A 96-Hour
Static-Renewal Acute Toxicity Test with the Rainbow Trout
(Oncorhynchus mykiss): Final Report. Project Number: 281A/127A.
Unpublished study prepared by Wildlife International, Ltd. 56 p.
Gallagher, S.; Beavers, J. (2004) Dikegulac: An Acute Oral Toxicity
Study with the Northern Bobwhite. Project Number: 281/114.
Unpublished study prepared by Wildlife International, Ltd. 38 p.
Gallagher, S.; Martin, K.; Beavers, J. (2004) Dikegulac: A Dietary
LC50 Study with the Northern Bobwhite. Project Number: 281/115.
Unpublished study prepared by Wildlife International, Ltd. 47 p.
Brignole, A.; Porch, J.; Krueger, H.; et. al. (2004) Dikegulac: A
Toxicity Test to Determine the Effects of the Test Substance on
Seedling Emergence of Ten Species of Plants: Final Report. Project
Number: 281/116. Unpublished study prepared by Wildlife
International, Ltd. 99 p.
Brignole, A.; Porch, J.; Krueger, H.; et. al. (2004) Dikegulac: A
Toxicity Test to Determine the Effects of the Test Substance on
Vegetative Vigor of Ten Species of Plants: Final Report. Project
Number: 281/117. Unpublished study prepared by Wildlife
International, Ltd. 167 p.
Desjardins, D.; Kendall, T.; Krueger, H. (2004) Dikegulac: A 7-Day
Toxicity Test with Duckweed (lemna gibba G3): Final Report. Project
Number: 281 A/132. Unpublished study prepared by Wildlife
International, Ltd. 59 p.
Wisocky, M. (2006) Hydrolysis of [14-Carbon] Dikegulac in Buffered
Water at pH 5, 6, 7 and 9. Project Number: XBL/03002, RPT01447.
Unpublished study prepared by Xenobiotic, Inc. 261 p.
D-4
-------
46932402 Wisocky, M. (2006) Aerobic Soil Metabolism of [ 14-Carbon]
Dikegulac. Project Number: XBL/03001, RPT01572. Unpublished
study prepared by Xenobiotic, Inc. 309 p.
Arnold, C. E., Aldrich, J. H., and Martin, F. G. (1983). Peach
Responses to Dikegulac. Hortscience 18: 474-476.
Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature
review and evaluation of the EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants. Environ. Tox.
Chem. 13:1383-1391.
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants:
Correlation of representative data as a basis for estimation of their
magnitude in the environment. In F. Coulston and F. Korte, eds.,
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