United States Prevention, Pesticides EPA738-R-02-014
Environmental Protection And Toxic Substances October 2002
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
OXYFLUORFEN
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F02-013
October, 2002
R.E.D. FACTS
Pesticide
Reregistration
Oxyfluorfen
All pesticides sold or distributed in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first registered
before November 1, 1984, be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants
and children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 2490,
oxyfluorfen.
Use Profile
Regulatory
History
Oxyfluorfen is a diphenyl-ether herbicide used for broad spectrum pre- and
post-emergent control of annual broadleaf and grassy weeds in a variety of tree
fruit, nut, vine, and field crops. The largest agricultural markets in terms of total
pounds active ingedient are wine grapes and almonds. There are also non-
agricultural ornamental and forestry uses. Oxyfluorfen is also used for weed
control in landscapes, patios, driveways, and similar areas in residential sites.
Oxyfluorfen was first registered in the United States in 1979 to control pre-
emergent and post-emergent broadleaf and grassy weeds in a variety of field,
fruit, and vegetable crops, ornamentals, as well as non-crop sites. It is
manufactured by Dow AgroSciences and Makhteshim-Agan under the trade
names Goal and Galigan. Data call-ins were issued in 1991, 1993, and 1995. In
January 2002, the risk assessments were made publicly available for comment
and a close-out conference call was conducted on July 25, 2002, to discuss the
risk management decisions and resultant changes to the oxyfluorfen labels.
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Human Health Toxicity
AsS6SSm6nt Oxyfluorfen is of low acute oral, dermal, and inhalation toxicity. The
primary toxic effects are alterations in blood parameters (anemia) and in the liver.
Oxyfluorfen is classified as a possible human carcinogen based on combined
hepatocellular adenomas/carcinomas in the mouse carcinogenicity study. A
cancer potency factor (Ql *) was used to estimate human risk. The FQPA Safety
Factor for protection of infants and children was reduced to IX for all population
subgroups as there was no increased susceptibility in animals due to pre- or post-
natal exposure to Oxyfluorfen.
Dietary Exposure
No adverse effects reflecting a single dose were identified in toxicological
studies; therefore, no acute endpoint was selected and an acute dietary risk
assessment was not conducted. EPA's dietary risk analysis for Oxyfluorfen
evaluated chronic (non-cancer) and cancer risk. For these chronic food risk
assessments, anticipated residues were calculated using either USDA Pesticide
Data Program (PDF) monitoring data or field trial data. Both data sets are
consistent in that they show all non-detectable residues.
Based on this analysis, the percentage of cPAD utilized is expected to be
less than 1 percent for the U.S. population and all subpopulations. Therefore, the
chronic (non-cancer) dietary risk estimate from food alone is not of concern.
Cancer risk from food is calculated by using a linear low-dose risk model
("Qi*") to determine the lifetime cancer risk estimate. The Agency generally
considers risks greater than 1 x 10"6 (1 in 1 million) to exceed its level of concern
for cancer dietary exposure. Using the Qt* of 7.32 x 10 "2 results in a maximum
estimated lifetime cancer risk to the U.S. general population of 3.8 x 10"7.
Therefore, the cancer risk from food alone is also not of concern.
People may be exposed to residues of Oxyfluorfen through the diet.
Tolerances or maximum residue limits have been established for 33 fruits,
vegetables and nut trees as well as meat commodities (please see 40 CFR
180.381). EPA has reassessed the Oxyfluorfen tolerances and found that the
majority are acceptable. New tolerances must be proposed/established for cotton
gin byproducts, soybean forage, soybean hay, and grass forage, grass hay, and
grass seed screenings.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and applicators)
may be exposed to Oxyfluorfen during and after normal use of liquid and granular
formulations in agricultural and other settings. Oxyfluorfen is used in the
residential environment by homeowners to kill weeds on patios, driveways and
similar surfaces. Oxyfluorfen homeowner products are intended solely for spot
treatment; they are not used for broadcast treatment of lawns because they kill
grass.
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FQPA Considerations
Chronic (non-cancer) Aggregate Risk - This assessment addresses exposure
to oxyfluorfen residues in food and water only, as there are no chronic residential
scenarios identified. Comparison of the chronic DWLOCs with the
environmental concentrations of oxyfluorfen shows that estimated surface and
groundwater concentrations are substantially less than the DWLOCs for all
populations. Consequently, the Agency concludes that residues of oxyfluorfen in
food and drinking water do not result in a chronic aggregate risk of concern.
Short-term Aggregate Risk - Short-term DWLOCs were calculated based
upon average food residues, and the residential handler exposure which resulted
in the greatest risk (spot treatment of weeds using a RTU trigger pump sprayer).
DWLOC calculations are for adults only since the residential exposure is to
applicators. Surface and ground water concentrations estimated using
conservative modeling are less than the short-term DWLOCs for oxyfluorfen.
Consequently, there are no short-term aggregate risk concerns from food,
drinking water and residential exposures.
Cancer Aggregate Risk - The chronic food cancer risk estimate of 3.8 x 10"7,
combined with the highest residential cancer risk estimate of 8.7 x 10"7, results in
a food + residential cancer risk of 1.3 x 10"6. Since the Agency's level of concern
is 1.0 x 10 "6, cancer risk slightly exceeds EPA's level of concern when
considering both food and residential exposures. However, since PDF
monitoring and field trial data showed all residues on food were non-detects, the
food risk estimate is considered upper-bound. Screening-level surface water
modeling indicates that there may be a concern for oxyfluorfen in drinking water,
but this water modeling is also considered upper-bound.
Occupational and Residential Risk
Cancer risk to workers is of greater concern than non-cancer risk.
Occupational cancer risks, when calculated without personal protective
equipment or engineering controls, can range up to 1 x 10"3. With the protection
specified on several current labels, most scenarios result in cancer risks in the 10"5
range.
The residential assessment for oxyfluorfen only addresses the applicator,
because negligible postapplication exposure is anticipated from spot treatment of
weeds. None of the residential applicator scenarios are of concern because the
short-term MOEs are greater than 100 and the cancer risks are less than 1.0 x
1Q-6.
Environmental Oxyfluorfen has the potential to affect terrestrial plants and aquatic
AsSGSSITIGnt ecological systems at all levels, as it is toxic to plants, invertebrates, and fish, and
has been shown to drift from application sites to nearby areas. Birds and
mammals may also experience subchronic and chronic effects from oxyfluorfen
use.
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Environmental Fate
Oxyfluorfen is persistent and relatively immobile in soil. The most likely
route of dissipation is soil binding. Laboratory data suggest that once the soil-
bound oxyfluorfen reaches deep or turbid surface water it will persist since it is
stable to hydrolysis and since light penetration would be limited; however, it may
degrade by photolysis in clear, shallow water. Oxyfluorfen can contaminate
surface water through spray drift and runoff; however, it is unlikely to
contaminate ground water because it is relatively immobile in the soil column;
therefore, the likelihood of leaching is small. No degradates were identified, and
therefore, only the parent, oxyfluorfen, is of toxicological concern for risk
assessment.
Ecological Effects
For acute exposures, oxyfluorfen is practically non-toxic to birds, mammals,
and bees, and the Agency has no risk concerns. However, subchronic and
chronic risks to terrestrial birds and mammals do present a concern. These toxic
effects may be manifested as reproductive, developmental, and hemolytic
consequences. Assuming maximum residue values, the chronic level of concern
is exceeded when oxyfluorfen is applied to crops at application rates greater than
or equal to 0.25 Ibs ai/acre/year for birds and greater than or equal to 2.0 Ibs
ai/acre for mammals. In addition, the potential of oxyfluorfen (as a light-
dependent peroxidizing herbicide) to be more toxic in the presence of intense
light may lead to the occurrence of more serious environmental effects that are
not predicted by standard guideline toxicity tests. Oxyfluorfen is highly toxic to
very highly toxic to fish and aquatic invertebrates. However, concentrations
predicted by the Agency's surface water models from normal use are generally
not high enough to cause an acute concern for fish. Chronic risk to fish and acute
and chronic risk to aquatic invertebrates may occur from some uses of
oxyfluorfen.
There are acute concerns for freshwater algal plants for all uses of
oxyfluorfen. The risk to vascular aquatic plants cannot be assessed due to lack of
data. Oxyfluorfen is expected and has been shown to negatively impact seedling
emergence and vegetative vigor of terrestrial plants. Non-target terrestrial plants
are exposed to oxyfluorfen as a result of spray drift and runoff and most incidents
reported to the Agency are related to plants affected by spray drift. Acute levels
of concern are exceeded for all uses of oxyfluorfen for terrestrial plants and semi-
aquatic plants adjacent to treated areas.
Ecological Effects Risk Assessment
Generally, the Agency believes that oxyfluorfen presents the greatest risks
to terrestrial plants and to aquatic organisms through spray drift of liquid
formulations and runoff of dissolved and soil entrained oxyfluorfen.
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Risk Mitigation
Additional Data
Required
Product Labeling
Changes Required
Regulatory
Conclusion
To lessen the risks of cancer from drinking water, occupational risks, and
risks to wildlife posed by oxyfluorfen, EPA is requiring the following risk
mitigation measures:
N Lower the maximum rate to 1.5 Ibs ai/broadcast acre/season for food crops and
2 Ibs ai/acre/season for conifer seedlings.
N For liquid formulations and granulars applied to field-grown ornamentals,
registrants have agreed to lower this seasonal maximum rate to 4.5 Ibs ai/A (1.5
Ibs ai/A/application). For granulars applied to containerized ornamentals, the rate
will be lowered to a seasonal maximum of 6 Ibs ai/A (2 Ibs ai/A/application).
N Label language will be added to require 25 foot, no-spray, vegetative buffer
zones around surface water bodies such as rivers, lakes, streams, and ponds.
N To minimize oxyfluorfen drift, only use of a coarse, very coarse, or extremely
coarse spray will be allowed according to the ASAE 572 definitions for standard
nozzles, or a volume median diameter (VMD) of 385 microns or larger for
spinning atomizer nozzles.
N The maximum application rate on residential products will be reduced to 3 Ibs
ai/A or less unless efficacy data support the need for higher rates.
N Closed mixing/loading systems to support applications to corn, cotton,
soybeans, and aerial applications to fallow land.
N Enclosed cab for applications to corn, and closed cockpit aircraft for
applications to fallow land.
N Double layer Personal Protective Equipment (PPE) for all other mixers,
loaders, and applicators.
EPA is requiring the following additional generic studies for oxyfluorfen to
confirm its regulatory assessments and conclusions: 21-day Dermal Toxicity
Study in Rats; Crop Field Trials in Bananas and Cacao Beans; Residue data on
Soybean forage and hay, and Cotton gin byproducts; Estuarine/marine Fish
Early-life Stage; Whole Sediment Invertebrate Freshwater Acute Toxicity; Whole
Sediment Invertebrate Estuarine/marine Acute Toxicity; Daphnid Chronic
Toxicity, Seed Germination/Seedling Emergence; Vegetative Vigor; Aquatic
Plant Growth; Dislodgeable Foliar Residue Study in Conifers; Fish Phototoxicity
Study; and Edge of Field Water and Sediment Monitoring.
All oxyfluorfen end-use products must comply with EPA's current pesticide
product labeling requirements. For a comprehensive list of labeling requirements,
please see the oxyfluorfen RED document. The labeling requirements table is
available as a separate document.
The use of currently registered products containing oxyfluorfen in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products are
eligible for reregistration.
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All products will be reregistered once the required product-specific data,
revised Confidential Statements of Formula, and revised labeling are received and
accepted by EPA.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for oxyfluorfen during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-
8695.
Following the comment period, the oxyfluorfen RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
6000.
For more information about EPA's pesticide reregistration program, the
oxyfluorfen RED, or reregistration of individual products containing oxyfluorfen,
please contact the Special Review and Reregistration Division (7508C), OPP, US
EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard
Time, seven days a week. Their internet address is http://npic.orst.edu.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessment for the herbicide oxyfluorfen. The Agency
has revised the human health and environmental effects risk assessments based on the comments
received during the public comment period and additional data received from the registrant.
Based on the EPA's revised risk assessments for oxyfluorfen, EPA has identified risk mitigation
measures that the Agency believes are necessary to address the human health and environmental
risks associated with the current use of oxyfluorfen. EPA is now publishing its reregi strati on
eligibility, risk management, and tolerance reassessment decisions for the current uses of
oxyfluorfen, and its associated human health and environmental risks. The Agency's decision on
the individual chemical oxyfluorfen can be found in the attached document entitled,
"Reregistration Eligibility Decision for Oxyfluorfen" which was approved on August 2, 2002.
A Notice of Availability for the Reregistration Eligibility Decision for Oxyfluorfen is
being published in the Federal Register. To obtain copies of the RED document, please contact
the Pesticide Docket, Public Response and Program Resources Branch, Field Operations
Division (7506C), Office of Pesticide Programs (OPP), USEPA, Washington, DC 20460,
telephone (703) 305-5805. Electronic copies of the RED and all supporting documents are
available on the Internet. See http://www.epa.gov/pesticides/reregistration/status.htm.
As part of the Agency's effort to involve the public in the implementation of the Food
Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain
open public dockets and to engage the public in the reregi strati on and tolerance reassessment
processes. During the public comment period, comments on the risk assessment were submitted
by Dow AgroSciences, the technical registrant. EPA also received letters from approximately 65
growers, extension agents, and commodity organizations testifying to the importance of
oxyfluorfen to their weed control programs for commodities such as forest seedlings, wine
grapes, artichokes, raspberries, blackberries, strawberries, garbanzo beans, onions, garlic, and
almonds. The Confederated Tribes of the Warm Springs Reservation of Oregon raised concern
that the dietary risk assessment for oxyfluorfen is not protective, because estimated fish
consumption was based on an amount representative of the general public rather than
subpopulations which may consume higher levels offish. A close-out conference call with
interested stakeholders was conducted on July 25, 2002 to discuss the risk management decisions
and resultant changes to the oxyfluorfen labels.
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Please note that the oxyfluorfen risk assessment and the attached RED concern only this
particular pesticide. The Food Quality Protection Act (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, 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." Oxyfluorfen is a diphenyl ether herbicide structurally
related to lactofen, fomesafen and acifluorfen. At this time, the Agency has not made a decision
as to whether oxyfluorfen shares a common mechanism of toxicity with these other diphenyl
ethers or any other pesticide. A careful evaluation of all the available data is still needed, as
well as peer review by the FIFRA Science Advisory Panel, before a formal decision is made.
Therefore, for the purposes of this risk assessment, the Agency has assumed that oxyfluorfen
does not share a common mechanism of toxicity with other pesticides. After a decision is made
regarding common mechanism of toxicity, and if the Agency has determined that a cumulative
assessment is necessary, the Agency will address any outstanding risk concerns at that time.
This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
outline(s) further data requirements for this chemical. Note that registrants of oxyfluorfen must
respond to DCIs issued by the Agency within 90 days of receipt of this letter. This RED also
contains labeling requirements for oxyfluorfen products. End-use product labels must be revised
by the manufacturer to adopt the changes set forth in Section IV of this document. Instructions
for registrants on submitting revised labeling and the time frame established to do so can be
found in Section V of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by oxyfluorfen.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern. At that time, any affected person(s) may challenge the Agency's action.
There will be a 60-day public comment period for this document, commencing on the day
the Notice of Availability publishes in the Federal Register.
If you have questions on this document or the proposed label changes, please contact the
Special Review and Reregi strati on Division representative, John Leahy (703) 305-6703. For
questions about product reregi strati on and/or the Product DCI that accompanies this document,
please contact Bonnie Adler at (703) 308-8523.
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachment
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Reregistration Eligibility Decision
(RED)
for
Oxyfluorfen
Case No. 2490
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TABLE OF CONTENTS
Executive Summary v
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 3
C. Use Profile 3
D. Estimated Usage of Pesticide 5
III. Summary of Oxyfluorfen Risk Assessment 6
A. Human Health Risk Assessment 7
1. Dietary Risk from Food 7
a. Toxicity 7
b. FQPA Safety Factor 9
c. Population Adjusted Dose (PAD) 9
d. Endpoints and Doses for Risk Assessment 9
e. Exposure Assumptions 10
f. Dietary Risk from Food 11
2. Dietary Risk from Drinking Water 11
a. Surface Water 12
b. Ground Water 13
c. Drinking Water Levels of Comparison (DWLOCs) 13
(1) DWLOCs for Chronic (Cancer and Non-cancer) Exposure
13
(2) Chronic Dietary Risk 14
(3) Cancer 14
3. Non-dietary Risk from Residential Uses 15
a. Exposure 15
b. Residential Handler Risk Estimates 16
4. Aggregate Risk 16
a. Chronic (Non-Cancer) Aggregate Risk 17
b. Short-term Aggregate Risk 17
c. Aggregate Risk for Cancer 17
5. Occupational Risk 18
a. Toxicity 19
b. Handler Exposure 19
c. Handler (Non-cancer) Risk 21
d. Handler Cancer Risk 22
(1) Post-Application Occupational Risk 24
(2) Data Sources 24
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(3) Assumptions 25
e. Reentry Worker (Non-cancer) Risk 25
f. Reentry Worker Cancer Risk 25
6. Human Incident Data 26
B. Environmental Risk Assessment 27
1. Environmental Fate and Transport 27
2. Ecological Risk 28
3. Risk to Terrestrial Organisms 28
a. Toxicity (Hazard) Assessment 28
b. Exposure and Risk 29
4. Uncertainties in Terrestrial Risk Assessment 31
5. Risk to Aquatic Animals 32
a. Toxicity (Hazard) Assessment 32
b. Exposure and Risk 32
6. Risk to Aquatic Plants 34
a. Uncertainties in the Aquatic Assessment 34
7. Endangered Species 35
8. Ecological Incidents 36
IV. Risk Management and Reregistration Decision 37
A. Determination of Reregistration Eligibility 37
B. Public Comments and Responses 38
C. Regulatory Position 39
1. FQPA Assessment 39
a. "Risk Cup" Determination 39
b. Determination of Safety for U.S. Population 40
c. Determination of Safety for Infants and Children 40
d. Endocrine Disrupter Effects 41
e. Cumulative Risks 41
f. Tolerances Summary 42
D. Regulatory Rationale 46
1. Human Health Risk Management 46
a. Dietary (Food) Risk Mitigation 46
(1) Chronic Dietary (Food) 46
(2) Cancer Dietary (Food) 46
(3) Drinking Water 46
(4) Aggregate Risk Mitigation (short-term, chronic, and cancer)
49
b. Occupational Risk Mitigation 50
(1) Handler Risks 50
(2) Post-application Exposure 51
2. Environmental Risk Mitigation 52
a. Risk Characterization 52
(1) Aquatic Organisms 52
(2) Terrestrial Organisms 53
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(3) Endangered Species 53
(4) Mitigation Measures 54
3. Other Label Statements 54
a. Endangered Species Statement 54
b. Spray Drift Management 55
V. What Registrants Need to Do 55
A. Manufacturing Use Products 57
1. Additional Generic Data Requirements 57
2. Labeling for Manufacturing Use Products 58
B. End-Use Products 58
1. Additional Product-Specific Data Requirements 58
2. Labeling for End-Use Products 58
C. Existing Stocks 58
VI. APPENDICES 65
Appendix A: Use Patterns Eligible for Reregistration 66
Appendix B: Data Supporting the Reregistration of Oxyfluorfen 88
Appendix C: Technical Support Documents 94
Appendix D. Citations Considered to be Part of the Database 95
Appendix E. Generic Data Call-In 127
Appendix F. Product Specific Data Call-In 135
Appendix G: EPA'S Batching of Oxyfluorfen Products for Meeting Acute
Toxicity Data Requirements for Reregistration 145
Appendix H. List of Registrants Sent This Data Call-In 148
Appendix I. List of Available Related Documents and Electronically Available
Forms 150
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Oxyfluorfen Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Timothy Dole
Kit Farwell
Felecia Fort
Jose Morales
Environmental Fate Risk Assessment
Amer Al-Mudallal
Norman Birchfield
Christine Hartless
Use and Usage Analysis
Jihad Alsadek
Neil Anderson
Registration Support
Eugene Wilson
Risk Management
Deanna Scher
John Leahy
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.,
drinking water) lifetime exposure at which adverse, noncarcinogenic health effects are not
anticipated to occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, airorfeed, e.g., mg/1, mg/kgorppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
11
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LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Q! * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
ill
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TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
TRR Total Radioactive Residue
UF Uncertainty Factor
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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Executive Summary
EPA has completed its review of public comments on the preliminary risk assessments
and is issuing its risk management decision for oxyfluorfen. The revised risk assessments are
based on review of the required target data base supporting the use patterns of currently
registered products and additional information received. After considering the risks identified in
the revised risk assessment and comments and mitigation suggestions from interested parties,
EPA developed its risk management decision for uses of oxyfluorfen that pose risks of concern.
This decision is discussed fully in this document.
Oxyfluorfen is a broad spectrum pre- and postemergent herbicide used on a variety of
tree and vine crops, selected annual and perennial crops, as well as fallow bed and non-crop uses
(e.g. roadsides), to control annual broadleaf and grassy weeds. Residential homeowners may use
oxyfluorfen products for spot treatment of weeds. It was first registered in 1979. Approximately
761,000 pounds of oxyfluorfen active ingredient are applied annually. Sites on which
oxyfluorfen has the highest percent of crop treated include wine grapes, almonds, cotton,
walnuts, and table grapes.
The Food Quality Protection Act (FQPA) requires that, when considering whether to
establish, modify, or revoke a tolerance, 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." Oxyfluorfen is structurally related to other diphenyl ethers
including lactofen, acifluorfen, and fomesafen. The Agency has not determined whether or not
oxyfluorfen shares a common mechanism of toxicity with these pesticides or any other pesticide.
As a result, the Agency has not determined if it would be appropriate to include them in a
cumulative risk assessment. After a decision is made regarding common mechanism of toxicity,
and if the Agency has determined that a cumulative assessment is necessary, the Agency will
address any outstanding concerns at that time.
Overall Risk Summary
Acute risks were not evaluated for oxyfluorfen because adverse effects reflecting a single
dose were not identified in toxicological studies at the highest dose tested. EPA's human health
risk assessment for oxyfluorfen indicates that chronic food risk is not of concern (<1% of
cPAD). Oxyfluorfen is classified in group C (possible human carcinogen) based on combined
hepatocellular adenomas/carcinomas in the mouse carcinogenicity study. The cancer dietary
risk from food alone is 3.8 x 10"7 for the general U.S. population, and is not a concern for the
Agency (< 1 x 10"6). The drinking water risk estimates for chronic (non-cancer) exposures are
below EPA's level of concern for ground or surface waters. However, cancer risk estimates
from modeling for surface water sources of drinking water indicate a concern based on
conservative assumptions for model inputs. Residential risks are below EPA's level of concern,
however, there is a concern for aggregate risk when considering exposures from food, drinking
water, and residential uses. There are cancer risk concerns for workers who mix, load, and
apply oxyfluorfen to agricultural sites, as well as workers who re-enter treated sites. Finally,
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EPA has identified risks of concern to plant and aquatic species and chronic concerns to birds
and mammals.
To mitigate risks of concern posed by the uses of oxyfluorfen, EPA considered the
comments and mitigation ideas from interested parties, and has decided on a number of label
amendments to address the drinking water, aggregate, worker, and ecological concerns. Results
of the risk assessments, and required label amendments to mitigate those risks, are presented in
this RED.
Dietary Risk - Food
No adverse effects reflecting a single dose were identified in toxicological studies;
therefore, no acute endpoint was selected and an acute dietary risk assessment was not
conducted. EPA's dietary risk analysis for oxyfluorfen evaluated chronic (non-cancer) and
cancer risk. For these chronic food risk assessments, anticipated residues were calculated using
either USDA Pesticide Data Program (PDF) monitoring data or field trial data. Both data sets
are consistent in that they show all non-detectable residues.
Based on this analysis, the percentage of cPAD utilized is expected to be less than 1
percent for the U.S. population and all subpopulations. Therefore, the chronic (non-cancer)
dietary risk estimate from food alone is not of concern. Cancer risk from food is calculated by
using a linear low-dose risk model ("Qi*") to determine the lifetime cancer risk estimate. The
Agency generally considers risks greater than 1 x 10"6 (1 in 1 million) to exceed its level of
concern for cancer dietary exposure. Using the Qt* of 7.32 x 10"2 results in a maximum
estimated lifetime cancer risk to the U.S. general population of 3.8 x 10"7. Therefore, the cancer
risk from food alone is also not of concern.
Dietary Risk - Drinking Water
Drinking water exposure to pesticides can occur through groundwater and surface water
contamination. For oxyfluorfen, EPA considered chronic (lifetime) drinking water risk and used
modeling to estimate those risks. To determine the maximum allowable contribution from water
allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by
food and then determines a "drinking water level of comparison" (DWLOC) to determine
whether modeled or monitoring estimated environmental concentration (EEC) levels exceed this
level. EECs that are above the corresponding DWLOC exceed the Agency's level of concern.
Since the chronic EECs for surface water and groundwater are less than the lowest
DWLOC, chronic non-cancer dietary risk from food and drinking water is not of concern.
However, modeling does indicate a possible concern for cancer risk, as the EEC in surface water
exceeds the cancer DWLOC. To address surface water concerns, the technical registrants have
agreed to implement measures to reduce the potential for oxyfluorfen to reach surface water,
including a reduction in maximum seasonal rates and implementation of vegetative buffers
between treated areas and natural water bodies. Actual drinking water exposure to oxyfluorfen
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from surface water sources is expected to be less than the DWLOCs and the registrants have also
agreed to conduct an edge of field monitoring study to confirm that drinking water exposure will
not exceed the level of concern.
Residential Risk
Oxyfluorfen is used in the residential environment by homeowners to kill weeds on
patios, driveways and similar surfaces. Oxyfluorfen homeowner products are intended solely for
spot treatment; they are not used for broadcast treatment of lawns because they kill grass. The
residential assessment for Oxyfluorfen only addresses the applicator, because negligible
postapplication exposure is anticipated from spot treatment of weeds. None of the residential
applicator scenarios are of concern because the short-term MOEs are greater than 100 and the
cancer risks are less than 1.0 x 10"6.
Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water pathways) as well as exposures from non-occupational sources (e.g., residential
uses). Generally, all risks from these exposures must have MOEs greater than 100 to not be of
concern to the Agency.
Chronic (Non-cancer) Aggregate Risk. The chronic (non-cancer) aggregate risk assessment
addresses exposure to Oxyfluorfen residues in food and water only, as there are no chronic
residential scenarios identified. As discussed previously, comparison of the chronic DWLOCs
with the environmental concentrations of Oxyfluorfen shows that estimated surface and
groundwater concentrations are substantially less than the DWLOCs for all populations.
Consequently, the Agency concludes that residues of Oxyfluorfen in food and drinking water do
not result in a chronic aggregate risk of concern.
Short-term Aggregate Risk. Short-term DWLOCs were calculated based upon average food
residues, and the residential handler exposure which resulted in the greatest risk (spot treatment
of weeds using a RTU trigger pump sprayer). DWLOC calculations are for adults only since the
residential exposure is to applicators. Surface and ground water concentrations estimated using
conservative modeling are less than the short-term DWLOCs for Oxyfluorfen. Consequently,
there is no short-term aggregate risk concerns from food, drinking water and residential
exposures.
Cancer Aggregate Risk. The chronic food cancer risk estimate of 3.8 x 10"7, combined with the
highest residential cancer risk estimate of 8.7 x 10"7, results in a food + residential cancer risk of
1.3 x 10"6. Since the Agency's level of concern is 1.0 x 10"6, cancer risk slightly exceeds EPA's
level of concern when considering both food and residential exposures. However, since PDF
monitoring and field trial data showed all residues on food were non-detects, the food risk
estimate is considered upper-bound. Screening-level surface water modeling indicates that there
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may be a concern for oxyfluorfen in drinking water, but this water modeling is also considered
upper-bound.
Occupational Risk
Cancer risk to workers is of greater concern than non-cancer risk. Occupational cancer
risks, when calculated without personal protective equipment or engineering controls, can range
up to 1 x 10"3. With the protection specified on several current labels, most scenarios result in
cancer risks in the 10"5 range. EPA believes these risks can be mitigated to an acceptable level
with the following label restrictions: (1) requiring additional personal protective equipment or
engineering controls for certain scenarios, and (2) increasing restricted entry intervals for certain
uses.
Ecological Risk
Ecological risks are of concern to the Agency. Based on toxicity studies submitted by the
registrant, oxyfluorfen has the potential to result in adverse effects to birds, mammals, aquatic
organisms and plants. To address these ecological risks, the registrants have agreed to decrease
seasonal maximum rates for certain crops, add label statements prohibiting application of
oxyfluorfen within 25 feet of aquatic areas, and require coarse droplet size for all spray
applications. The registrants will also conduct additional ecological effects and environmental
fate studies to better characterize exposure to non-target species.
Conclusions
The Agency is issuing this Reregi strati on Eligibility Document (RED) for oxyfluorfen, as
announced in a Notice of Availability published in the Federal Register. This RED document
includes guidance and time frames for complying with any required label changes for products
containing oxyfluorfen. With the addition of the label restrictions and amendments detailed in
this document, the Agency has determined that all currently registered uses of oxyfluorfen are
eligible for reregi strati on.
The risk assessments for oxyfluorfen are based on the best scientific data currently
available to the Agency and are adequate for regulatory decision making. Registrants have
committed to provide additional data that may remove some of the uncertainties associated with
exposures and risks posed by oxyfluorfen, including studies to define the cancer mechanism and
efficacy studies to determine an appropriate rate for residential uses. If data are provided which
enable EPA to refine the exposure or risk conclusions presented in this document, EPA will
evaluate the risk mitigation measures identified above, and if appropriate, will amend this RED
to reflect any new risk conclusions.
There is a 60-day public comment period for this document.
Vlll
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on 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
reregi strati on 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"). Reregi strati on involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on health and environmental effects;
and to determine whether the pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment during reregi strati on. It also
requires that by 2006, EPA must review all tolerances in effect on the day before the date of the
enactment of the FQPA, which was August 3, 1996. FQPA also amends the FFDCA to require a
safety finding in tolerance reassessment based on factors including an assessment of cumulative
effects of chemicals with a common mechanism of toxicity.
Oxyfluorfen is a diphenyl ether herbicide structurally related to lactofen, fomesafen and
acifluorfen. At this time, the Agency has not made a decision as to whether oxyfluorfen shares a
common mechanism of toxicity with these other diphenyl ethers or any other pesticide. A
careful evaluation of all the available data is still needed, as well as peer review by the FIFRA
Science Advisory Panel, before a formal decision is made. Therefore, for the purposes of this
risk assessment, the Agency has assumed that oxyfluorfen does not share a common mechanism
of toxicity with other pesticides. After a decision is made regarding common mechanism of
toxicity, and if the Agency has determined that a cumulative assessment is necessary, the
Agency will address any outstanding risk concerns at that time.
The implementation of FQPA has required the Agency to revisit some of its existing
policies relating to the determination and regulation of dietary risk, and has also raised a number
of new issues for which policies need to be created. These issues were refined and developed
through collaboration between the Agency and the Tolerance Reassessment Advisory Committee
(TRAC), which was composed of representatives from industry, environmental groups, and other
interested parties. The TRAC identified the following science policy issues it believed were key
to the implementation of FQPA and tolerance reassessment:
Applying the FQPA 10-fold safety factor
• Whether and how to use probabilistic analyses in dietary exposure assessments
• How to interpret "no detectable residues" in dietary exposure assessments
• Refining dietary (food) exposure estimates
Refining dietary (drinking water) exposure estimates
Assessing residential exposure
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• Aggregating exposure from all non-occupational sources
• How to conduct a cumulative risk assessment for organophosphate or other pesticides
with a common mechanism of toxicity
Selection of appropriate toxicity endpoints for risk assessments of organophosphates
Whether and how to use data derived from human studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving
and in a different stage of refinement. Some issue papers have already been published for
comment in the Federal Register and others will be published shortly.
This document consists of six sections. Section I contains the regulatory framework for
reregi strati on/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section III gives an overview of the revised human health and environmental effects
risk assessments resulting from public comments and other information. Section IV presents the
Agency's reregi strati on eligibility and risk management decisions. Section V summarizes
required label changes based on the risk mitigation measures outlined in Section IV. Section VI
provides information on how to access related documents. Finally, the Appendices list Data
Call-In (DCI) information. The revised risk assessments and related addenda are not included in
this document, but are available on the Agency's web page www.epa.gov/pesticides, and in the
Public Docket.
II. Chemical Overview
A. Regulatory History
Oxyfluorfen was first registered in the United States in 1979 to control pre-emergent and
post-emergent broadleaf and grassy weeds in the culture of a variety of field, fruit, and vegetable
crops, ornamentals, as well as non-crop sites. It is manufactured by Dow AgroSciences and
Makhteshim-Agan under the trade names Goal and Galigan. Data call-ins were issued in 1991,
1993, and 1995.
In an effort to promote transparency of the reregi strati on process and public
understanding of regulatory decisions, the Agency, in cooperation with the U.S. Department of
Agriculture (USDA) modified the reregi strati on and tolerance reassessment process in 1998.
This modified process provides opportunities for stakeholders to ask questions about and provide
input to the risk assessment and risk mitigation strategies, via conference calls and other formats.
Consistent with this process, the January 2002 risk assessments were made publicly available
for comment and a close-out conference call was conducted on July 25, 2002 to discuss the risk
management decisions and resultant changes to the oxyfluorfen labels.
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B. Chemical Identification
ci
/"\ /O. ,CH,
~^ NO,
Common Name:
Chemical Name:
Chemical family:
Case number:
CAS registry number:
OPP chemical code:
Empirical formula:
Molecular weight:
Trade and other names:
Basic manufacturer:
Oxyfluorfen
2-chloro-l-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene
Diphenyl ether herbicide
2490
42874-03-3
111601
C15HnClF3NO4
361.72g/mole
Goal, Galigan
Dow AgroSciences
Oxyfluorfen is an orange to deep red brown crystalline solid with a melting point of 65-
84° C, density of 1.49 g/mL, octanol/water partition coefficient of >20, and vapor pressure of
2.5 x 10"7 Torr at 25° C. Oxyfluorfen is practically insoluble in water (0.1 ppm), but is readily
soluble in most organic solvents.
C.
Use Profile
The following information is based on the currently registered uses of Oxyfluorfen:
Type of Pesticide: Contact herbicide used for pre- or post-emergence control of
monocotyledenous and broad-leaved weeds.
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Mode of Action: Oxyfluorfen targets a specific enzyme, protoporphyrinogen oxidase, in the
chlorophyll biosynthetic pathway. Inhibiting protoporphyringen oxidase in plants leads to an
accumulation of phototoxic chlorophyll precursors which, in the presence of light, produce
activated oxygen species which rapidly disrupt cell membrane integrity. Oxyfluorfen must
contact plant foliage to cause effects. Plants that are actively growing are most susceptible to
Oxyfluorfen. By forming a chemical barrier on the soil surface, Oxyfluorfen affects plants at
emergence. This barrier is formed with adequate spray coverage or irrigation following granule
application (to partially dissolve granules and promote dispersion of Oxyfluorfen over the soil
surface). Because of the length of Oxyfluorfen soil half-life, this barrier may last up to three
months. All plants attempting to emerge through the soil surface will be affected through
contact. Oxyfluorfen also affects plants through direct contact of spray or granules to exposed
tissues.
Summary of Use Sites:
Food:
Treefruit/Nut/Vine Crops:
Almonds, apple, apricot, avocado, banana, beechnut, brazil nut, butternut, cashew, cherry,
chestnut, chinquapin, citrus (non-bearing), crab apple, dates, feijoa, fig, filbert, grapes, hickory
nut, kiwi, loquat, macadamia nut, mango, mayhaw, nectarine, olives, papaya, peach, pear, pecan,
persimmon, pistachio, plum, pomegranates, prune, quince, and walnut.
Field Crops:
Artichokes (globe), blackberries, broccoli, cabbage, cacao, cauliflower, clary sage, clover,
coffee, corn, cotton, garbanzo beans, garlic, guava, horseradish, jojoba, mint, onions, raspberries,
soybeans and taro.
Fallow Bed:
Broccoli, cabbage, cauliflower, cotton, garlic, grapes, kiwi, onion, potato, soybeans, tree
fruit/nut/citrus, dry beans.
Fallow Bed (non-food, no tolerance):
Cantaloupe, carrot, cereal grains, celery, conifers, dry beans, peanut (other legumes), pepper,
safflower, squash, strawberries, sugarbeet (other root/tuber crops), tomato (other fruiting
vegetables), watermelon (other cucurbits).
Non-food Uses:
Ornamental plants/trees/shrubs, conifer seed beds and transplants, cut flowers, forest trees,
Christmas tree plantations, rights-of-way/fencerows and non-crop areas (nonagricultural
uncultivated areas, roadsides, industrial areas, storage yards, non-grazed meadows and
farmsteads.)
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Residential Uses: Landscape, curbs/gutters, patios, brick walls, sidewalks/walkways and
driveways.
Formulation Types Registered: Oxyfluorfen is formulated for agricultural uses as an
emulsifiable liquid concentrate containing 0.2 to 4 pounds active ingredient (ai) per gallon and as
a granular product containing 2% oxyfluorfen by weight. Oxyfluorfen is most frequently used in
a liquid formulation for food crops and as a granular formulation for ornamental nursery crops.
There are also several ready-to-use products and a liquid concentrate available for residential
use. Residential formulations contain 0.25% to 0.70% oxyfluorfen by volume and are packaged
in a ready-to-use (RTU) sprinkler jug, a RTU trigger sprayer or as a liquid to be mixed in a
sprinkler can or tank sprayer.
Application Methods and Equipment: Agricultural liquid formulations of oxyfluorfen are
applied using large, small or ATV groundboom rigs. Aerial application is used mainly for
fallow fields and bulb vegetables. Backpack sprayers can be used in Christmas tree plantations
and right-of-way areas. Chemigation is used for over the top application to bulb vegetables and
for drip application to some orchard trees, however, chemigation is often prohibited per the
product labels. Right-of-way sprayers are used in right-of-way areas. Granular oxyfluorfen is
applied to field- and container-grown ornamentals with broadcast spreaders.
Application Rates and Frequency: 0.25 - 2.0 Ibs ai/acre/application. Typically one or two
applications are made in the growing season to prevent weed growth (pre emergent) and/or to
kill small weeds (post emergent). Some crops allow a greater number of applications/season,
including tropical commodities (e.g. guava, coffee, macadamia nut) in Hawaii and ornamentals.
Use Classification: General use pesticide
D. Estimated Usage of Pesticide
A full listing of all uses of oxyfluorfen, with the corresponding use and usage data for
each site, has been completed and is in the "Quantitative Use Analysis" document, which is
available in the public docket. The data, reported on an aggregate and site (crop) basis, reflect
annual fluctuations in use patterns as well as the variability in using data from various
information sources.
Based on available pesticide survey usage information for the years 1990 through 1999,
an annual estimate of oxyfluorfen's total domestic usage averaged approximately 761,000
pounds a..i. for 1,167,000 acres treated. Use of oxyfluorfen is increasing. From 1992 to 1997
the use of oxyfluorfen increased by 54%, from an estimated 458,000 pounds active ingredient in
1992 to an estimated 705,000 Ibs active ingredient in 1997. The largest markets in terms of total
pounds active ingredient are wine grapes (32%), almonds (23%), cotton (7%), walnuts (6%), and
table grapes (4%). The remaining usage is primarily on apples, corn, raisin grapes, mint, dry
onion, ornamentals, peaches, pistachios, prunes, and artichokes. Crops with a high percentage of
the total U.S. planted acres treated include wine grapes (54%), artichokes (53%), pistachios
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(44%), almonds (43%), table grapes and nectarines (35% each), and figs (33%). Most of the
usage is in CA, OR, WA and the cotton growing regions along the Mississippi River.
Table 1. Oxyfluorfen Estimated Usage for Representative Sites1
Crop
Almonds
Artichokes
Blackberries
Corn
Cotton
Figs
Table grapes
Wine grapes
Kiwifruit
Mint
Nectarines
Olives
Onions, dry
Peaches
Pistachios
Plums
Pomegranates
Raspberries
Walnuts
Total non-agricultural (pasture, ornamentals,
right-of-way, rangeland, etc.)
Lbs. Active Ingredient
Applied (Wt. Avg.)2
170,000
4,000
1,000
7,000
54,000
3,000
30,000
240,000
1,000
10,000
5,000
5,000
15,000
24,000
26,000
6,000
1,000
1,000
48,000
41,000
Percent Crop
Treated (Wt. Avg.)
43%
53%
18%
.02%
1%
33%
35%
54%
9%
18%
35%
13%
29%
14%
44%
24%
26%
28%
28%
N/A
Percent Crop Treated
(Likely Maximum)
86%
78%
29%
0.1%
3%
69%
61%
84%
29%
26%
61%
21%
57%
23%
76%
52%
54%
56%
42%
N/A
1 Uses with more than 5,000 Ibs applied (weighted average) and/or over 20% crop treated were selected as
representative sites.
2 Weighted Average is based on data for 1990 through 1999; the most recent years and more reliable data are
weighted more heavily.
III. Summary of Oxyfluorfen Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the herbicide Oxyfluorfen, as fully presented in the documents, "Oxyfluorfen.
Revised Human Health Risk Assessment" dated April 29, 2002, and "Environmental Fate and
Effects Division Science Chapter for Reregi strati on Eligibility Document for Oxyfluorfen,"
dated May 2, 2002. The purpose of this summary is to assist readers by identifying the key
features and findings of these risk assessments, so that they may better understand the
conclusions reached in the assessments.
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The original risk assessments for oxyfluorfen were made available in the public docket
and on the Internet on January 30, 2002. The Agency reviewed and addressed all comments on
the risk assessment documents. There is a discussion of these comments in Section IV, later in
this document.
A. Human Health Risk Assessment
In response to comments and studies submitted, the risk assessments were updated and
refined. The conclusions of the risk assessment are summarized below.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database is sufficiently complete, and that it supports a reregi strati on eligibility
determination for all currently registered uses. The Agency Metabolism Assessment Review
Committee has concluded that the residue of concern in plants and animals is oxyfluorfen/?er se
and not its metabolites or degradate products.
It should be noted that older toxicity studies with oxyfluorfen used technical material of
approximately 71% or 85% purity. The newer toxicity studies used a technical material of
approximately 98% purity, which is the basis for the current registrations of oxyfluorfen. The
newer technical material has similar impurities to the older technical material, but in reduced
concentrations. Toxicity was less severe for studies with the 98% product than for the 71%
product; however, one mammal developmental study with the 98% technical was submitted in
which animals experienced the most severe anemia and related hematologic effects of any of the
mammalian studies. When there were studies with both the new and old technical material,
preference for an endpoint for risk assessment purposes was generally given to the newer, 98%
technical material (current registrations).
Oxyfluorfen is of low acute toxicity and is in toxicity category IV for acute oral, dermal,
and inhalation toxicity. It is a slight eye and dermal irritant and is not a dermal sensitizer.
Toxicity was similar for subchronic and chronic rat, mouse, and dog studies in both
sexes. Oxyfluorfen inhibits heme production, which results in a variety of anemias. Heme is the
part of the hemoglobin molecule that contains iron and binds oxygen. In the 1997 subchronic rat
study which used the current 98% a.i. formulation, the red blood cell count was normal, but the
red blood cell mass was decreased due to the small size of the red blood cells, presumably
because of inhibition of the protoporphyrinogen oxidase enzyme. The anemia was generally
mild in other studies, with varying hematologic abnormalities described in the rat, mouse, and
dog studies.
Mild liver toxicity was described in the 1997 subchronic rat study which used the current
98% formulation. Increased liver weight was accompanied by very slight increases in liver
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enzyme activities and minimal histopathologic changes. Similar effects also occurred in the
other subchronic and chronic rat, mouse, and dog studies. There were typically few
histopathological lesions seen in the liver, although hepatocyte necrosis did occur in the mouse
and dog studies. Renal toxicity was most severe in the 2-generation reproduction study in rats,
in which pelvic mineralization occurred.
Developmental studies using the current 98% technical material found no developmental
toxicity in rats whereas an increase in late resorptions occurred in the rabbit study (principally in
1 litter). A developmental study in rats using the older 71% technical material found increased
early resorptions, decreased fetal weight, and increased incidence of fetal visceral and skeletal
variations and malformations. A developmental study in rabbits with formulation manufactured
from the older technical material found increased early resorptions and decreased litter size. A
reproduction study with 71% technical material reported decreased live pups per litter and
decreased pup body weights.
The newer technical material (96-99% a.i.) was tested in 12 genetic toxicology studies,
which included assessments of gene mutation, chromosomal aberrations, and DNA damage. All
assays were negative, except for one Ames assay which was positive only at high, insoluble
levels. A subsequent Ames assay with 96% material was negative. The older 72% technical
material and a polar fraction were tested in eight genetic toxicology studies. Both Ames assays
and a mouse lymphoma study were positive for the 72% technical material. The polar fraction of
the 72% technical material was also positive in an Ames assay.
Oxyfluorfen is classified as a category C, possible human carcinogen based upon
combined hepatocellular adenomas/carcinomas in the mouse carcinogenicity study. The Cancer
Peer Review Committee recommended a linear, low dose extrapolation for human risk
assessments, with a Qt* of 7.32 x 10"2 (mg/kg/day)"1 in human equivalents.
Lactofen, a compound that is structurally related to oxyfluorfen, has recently been
identified as a non-genotoxic hepatocarcinogen with a mechanism of action due to peroxisome
proliferation. Peroxisome proliferator compounds are known to cause an increased number of
peroxisomes in rodent liver cells. Peroxisomes are membrane-bound vesicles of enzymes in liver
cells which produce hydrogen peroxide. The increased peroxisomes leak hydrogen peroxide
which cause DNA effects and act as promoters for cancer in rodent livers. Dow AgroSciences
has committed to undertake mechanistic studies to determine whether or not oxyfluorfen acts via
a mechanism involving peroxisome proliferation. If oxyfluorfen is shown to be a peroxisome
proliferator, an MOE approach (indicative of a non-linear dose response), rather than a Q*
approach would be more appropriate to quantify cancer risks. If oxyfluorfen is determined to be
a peroxisome proliferator, EPA will re-evaluate cancer risks and risk mitigation decisions for
oxyfluorfen.
Further details on the toxicity of oxyfluorfen can be found in the April 29, 2002, Human
Health Risk Assessment, and the August 8, 2001 memo entitled, "Oxyfluorfen: Toxicology
Chapter for the RED". A brief overview of the studies used for the human health risk
assessment and other relevant information is outlined in Table 2 .
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b. FQPA Safety Factor
The FQPA Safety Factor was removed (i.e. reduced to IX) based on the following
factors: 1) There does not appear to be any increased susceptibility in animals due to pre- or
postnatal exposure to oxyfluorfen based upon the developmental and reproductive toxicity
studies reviewed. Although two doses in the high-dose group of the 98% ai rabbit
developmental study aborted, these abortions were considered secondary to the debilitating
condition (generalized, systemic toxicity) of the mothers and occurred at the same dose that
cause maternal toxicity; 2) Although neurotoxicity studies were not performed, there was no
indication of neurotoxicity in the submitted developmental and reproductive studies or in the
published literature. A developmental neurotoxicity study was not required; and 3) The dietary
(food and drinking water) and non-dietary (residential) exposure assessments will not
underestimate the potential exposures for infants and children. The FQPA safety factor is
applicable to the dietary and residential risk assessments for all population subgroups.
c. Population Adjusted Dose (PAD)
Dietary exposure estimates are expressed in mg/kg body weight/day and as a percent of
the acute/chronic Population Adjusted Dose (a/cPAD) which is the RfD taking into account the
FQPA safety factor. This procedure is performed for each population subgroup. There are no
aPADs for oxyfluorfen because an appropriate acute endpoint was not identified. Resorptions
seen in the rabbit developmental study were not used as an acute endpoint because they were not
considered indicative of a one-time exposure; rather, they were considered secondary to the
debilitating condition of the mothers.
The cPAD is a risk expression reflecting the Reference Dose that has been adjusted to
account for the FQPA safety factor (i.e., RfD/FQPA safety factor). In the case of oxyfluorfen,
the FQPA safety factor is 1; therefore, the chronic RfD equals the chronic PAD. A risk estimate
that is less than 100% of the chronic PAD does not exceed the Agency's risk concern.
d. Endpoints and Doses for Risk Assessment
All doses for risk assessment purposes were assessed along with the uncertainty factors
of 10X for interspecies extrapolation and 10X for intraspecies variability. An additional
uncertainty factor of 3X was applied to intermediate-term exposures because the dose was
derived from the LOAEL. No short- or immediate-term oral endpoints are necessary due to
negligible postapplication residential exposure. Long-term endpoints are also not needed, as all
exposures are expected to be of short- or intermediate-term duration.
-------
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human
Health Risk Assessment for Oxyfluorfen
Assessment
Chronic Dietary
Cancer
Dermal,
Short-Term3
Dermal,
Intermediate-Term8
Inhalation, Short-
Termb
Inhalation,
Intermediate-Term15
Dose
(mg/kg/day)
NOAEL = 3.0
Q!* = 7.32xlO-2
(mg/kg/day)-1
NOAEL= 30
LOAEL = 32
NOAEL = 30
LOAEL = 32
Endpoint
Liver toxicity occurring in dogs and
mice at the LOAEL of 33 mg/kg/day
(cf ) and 42 mg/kg/day ( ? ) mice.
Combined hepatocellular adenomas
and carcinomas.
Clinical signs seen at the maternal
LOAEL of 90 mg/kg/day
Liver toxicity and anemia seen at the
LOAEL of 32 mg/kg/day.
Clinical signs seen at the maternal
LOAEL of 90 mg/kg/day.
Liver toxicity and anemia seen at the
LOAEL of 32 mg/kg/day.
UFC
100
n/a
100
300
100
300
Study
Chronic dog and mouse
carcinogenicity studies
Mouse carcinogenicity
study
Developmental rabbit
study (1998)
90-day mouse
Developmental rabbit
study (1998)
90-day mouse
NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; UF=uncertainty factor; RfD = reference dose.
a. An oral endpoint was used for dermal exposure: a dermal absorption factor of 18% of oral exposure was selected from a dermal absorption
study in rats.
b. An oral endpoint was used for inhalation exposure: inhalation exposure is assumed equivalent to oral exposure.
c. Uncertainty factors of lOx for intraspecies variability, lOx for interspecies extrapolation and 3x for lack of a NOAEL
e. Exposure Assumptions
Oxyfluorfen chronic dietary exposure assessments were conducted using the Dietary
Exposure Evaluation Model (DEEM™) software Version 7.73, which incorporates consumption
data from USDA's Continuing Surveys of Food Intake by Individuals (CSFII), 1989-1992. The
1989-92 data are based on the reported consumption of more than 10,000 individuals over three
consecutive days, and therefore represent more than 30,000 unique "person days" of data. Foods
"as consumed" (e.g., apple pie) are linked to raw agricultural commodities and their food forms
(e.g., apples-cooked/canned or wheat-flour) by recipe translation files internal to the DEEM
software. Consumption data are averaged for the entire US population and within population
subgroups for chronic exposure assessment.
For chronic exposure and risk assessment, an estimate of the residue level in each food or
food-form (e.g., orange or orange-juice) on the commodity residue list is multiplied by the
average daily consumption estimate for that food/food form. The resulting residue consumption
estimate for each food/food form is summed with the residue consumption estimates for all other
food/food forms on the commodity residue list to arrive at the total estimated exposure.
Exposure estimates are expressed in mg/kg body weight/day and as a percent of the cPAD. This
procedure is performed for each population subgroup.
Anticipated residues were calculated using either USDA Pesticide Data Program (PDF)
monitoring data or field trial data. Both data sets are consistent in that they show essentially all
non-detectable residues, with the same limit of detection (0.01 ppm). Monitoring data for
10
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oxyfluorfen generated through the USD A PDF were from the years 1996 to 1999 (total of 3,720
samples analyzed). These data were used for the following crops: apple juice, apples, carrots,
grapes, green beans (canned and fresh), high fructose corn syrup, oranges, peaches, spinach (
fresh and canned), sweet corn, sweet peas, tomatoes (fresh and canned), sweet potatoes, orange
juice, pears, winter squash (fresh and canned), cantaloupe, grape juice, strawberries (fresh and
frozen) and sweet bell peppers. There were no residues detected on these commodities. In
addition, estimates of percent crop treated (% CT) generated by the Biological and Economic
Analysis Division (BEAD), Office of Pesticide Programs, were used to refine the assessment.
Although a Tier 2/3 dietary risk assessment was conducted and is the most refined
assessment to date for oxyfluorfen, there are some uncertainties associated with the exposure
estimates as follows: (i) the use of 1A LOQs instead of 1A LODs for field trial residue values will
tend to overestimate the residue values from the field trial studies (all of the field trial studies
were non-detects; therefore, this assessment is an upper bound and the real residues are
somewhere between this estimate and zero); (ii) no cooking studies were used; (iii) tolerance
level residues for bananas and cacao beans and 100% crop treated for cacao beans were used;
and (iv) DEEM default processing factors were used in the assessment.
f. Dietary Risk from Food
In general, a non-cancer chronic dietary (food) risk estimate of less than 100% of the
chronic PAD is not of concern to the Agency. Cancer risks less than 1 x 10"6 are also not of
concern to the Agency. Oxyfluorfen is classified as a category C, possible human carcinogen
based upon combined hepatocellular adenomas/carcinomas in the mouse carcinogenicity study.
A cancer dietary (food) risk assessment using a low-dose linear extrapolation was conducted. As
shown in Table 3, chronic dietary risk is <1% of the chronic PAD for the U.S. general population
and all population subgroups. Using the Qx* of 7.32 x 10 "2 results in a maximum estimated
lifetime cancer risk to the U.S. general population of 3.8 x 10"7. Neither the non-cancer or the
cancer risk estimates pose a dietary risk concern for food for any population subgroup.
Table 3. Summary of Dietary Exposure and Risk for Oxyfluorfen
Population Subgroup
U.S. Population
Infants (<1 year old)
Children 1-6 years
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.000005
0.000011
0.000012
% cPAD
<1
<1
<1
Cancer
Risk
3.8 xlO'7
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. For oxyfluorfen, EPA considered chronic (lifetime) drinking water risks and
used modeling to estimate those risks. The PRZM-EXAMS/IR model was used to estimate
11
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surface water concentrations, and SCI-GROW was used to estimate groundwater concentrations.
Both of these models are considered to be screening tools, with the PRZM-EXAMS model being
somewhat more refined than SCI-GROW.
Oxyfluorfen in the environment is expected to be very persistent with low mobility. In
general, oxyfluorfen degrades very slowly in both soil and water and binds strongly to soil
containing organic matter. Oxyfluorfen contaminates surface water through spray drift and
runoff; the latter is considered a much larger contributor to surface water contamination.
Oxyfluorfen is unlikely to contaminate ground water because it is relatively immobile in the soil
column; therefore, the likelihood of leaching is small.
Some samples have been collected and analyzed for oxyfluorfen in water and sediments
in the Columbia River basin of Oregon and Washington as a result of an August, 2000
oxyfluorfen (Goal 2XL) spill into the Fifteen Mile Creek near its mouth into the Columbia River.
Of 35 background sediment measurements made in nearby rivers and streams which were
reportedly unaffected by the spill, 2 detections of oxyfluorfen in sediment were noted. The
higher detection, 541 ppb, was downstream of orchards.
Except for the data collected near the spill site in Fifteen Mile Creek (near the Columbia
River), no targeted water monitoring data are available for dissolved phase oxyfluorfen. The
U.S. Geological Survey (USGS) monitored oxyfluorfen concentrations in suspended sediment at
one site in the San Joaquin River in central California during several years in the 1990's. The
highest average concentration of oxyfluorfen in sediment was 27.2 ppb. Assuming partitioning
between water and sediment is reversible and at equilibrium, the dissolved oxyfluorfen
concentration was estimated to by 0.27 |ig/L (calculated using the average Kd partitioning
coefficient of 100.) Additionally, the USGS-EPA pilot reservoir monitoring program did not
detect oxyfluorfen concentrations in raw and finished drinking water. However, due to the
limited geographic range of these data and the uncertainties in estimating the dissolved
concentration, these data are insufficient for use in the drinking water assessment.
The monitoring data are not adequate to perform a quantitative drinking water assessment
for the following reasons: 1) The majority of the data are limited to sediment levels, whereas
dissolved phase concentrations are more useful for estimating drinking water exposure; and 2)
Oxyfluorfen use is widespread but the monitoring data are limited to a few locations. The
monitoring data are temporally limited.
a. Surface Water
PRZM/ EXAMS, a Tier II model with index reservoir (IR) scenarios and a percent
cropped area (PCA) adjustment factor, was used. For Tier II surface water screening
assessments, OPP uses the PRZM-EXAMS model which accommodates the specific
characteristics of the chemical and which include site-specific information regarding the
application method and impact of daily weather on the treated field over a period of 30 more
years. The PRZM-EXAMS model was developed to provide 'best estimates' of chemical
concentrations in the modeled water bodies based on the fate characteristics of the chemical. The
12
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input values specific to each of the modeled cropping scenarios and the fate parameter inputs for
a given chemical are intended to be conservative.
Apples in Oregon (2 Ibs ai/acre, IX/season) was chosen to estimate the concentration of
oxyfluorfen in surface drinking water. This scenario was selected after evaluating results from
additional scenarios chosen to represent areas where oxyfluorfen is heavily used or has the
potential for heavy use.
b. Ground Water
The SCI-GROW model, a Tier I model, was used to estimate the concentration of
oxyfluorfen in drinking water from shallow ground water sources. Currently, there is no Tier II
assessment tool for groundwater. Since SCI-GROW, unlike the PRZM/EXAMS surface water
model, does not require a specific crop scenario, EFED used the highest use rate of four
applications at 2.0 Ibs ai/acre as allowed for ornamentals to estimate the concentration of
oxyfluorfen in drinking water from shallow groundwater sources.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of pesticide residues in water, EPA
first looks at how much of the overall allowable risk is contributed by food and then determines
a "drinking water level of comparison"(DWLOC) to determine whether modeled or monitoring
levels exceed this level. The Agency uses the DWLOC as a surrogate to capture risk associated
with exposure from pesticides in drinking water. The DWLOC is the maximum concentration in
drinking water which, when considered together with dietary exposure, does not exceed a level
of concern.
The results of the Agency's drinking water analysis are summarized here. Details of the
drinking water analysis are found in the Revised Human Health Risk Assessment for
Oxyfluorfen, dated April 29, 2002.
(1) DWLOCs for Chronic (Cancer and Non-cancer)
Exposure
Chronic and cancer DWLOCs for oxyfluorfen were calculated based on anticipated
residues in food only; DWLOCs calculated from food + residential exposure are presented in the
aggregate risk section of this document. Comparisons made between DWLOCs and the
estimated concentrations of oxyfluorfen in surface water and ground water are presented in
Table 4. If model estimates are less than the DWLOC, there is generally no dietary (food +
water) concern.
13
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Table 4. Oxyfluorfen Summary of Chronic (Non-cancer) DWLOC Calculations
Population Subgroup
U.S. Population
All Infants (< lYear)
Children (1-6 years)
Females (13-50 years)
DWLOCs (ppb)1
Chronic
1050
900
300
300
Cancer
0.315
N/A
N/A
N/A
EECs (ppb)
Surface Water
(PRZM/EXAMS)
Chronic 2
7.1
Cancer 3
5.7
Ground Water
(SCI-GROW)
Chronic and Cancer
0.08
1 DWLOCs based on food exposure only.
2 Chronic risk based on the 1 in 10 yearly concentration
3 Cancer risk based on the 36 year annual mean concentration
(2) Chronic Dietary Risk
As shown in Table 4, the chronic DWLOCs, ranging from 300 - 1050 for all populations,
are substantially higher than the estimated environmental concentrations (EECs) of oxyfluorfen
in surface and groundwater (7.1 ppb and 0.08 ppb respectively) based on conservative modeling.
Consequently, chronic drinking water risk from surface or groundwater sources is below EPA's
level of concern.
(3) Cancer Dietary Risk
The cancer DWLOC is the concentration of a pesticide in drinking water that results in a
negligible cancer risk when considered together with estimated food exposure (1 x 10"6 or less).
Upon comparison of the cancer DWLOC with the environmental concentrations of oxyfluorfen
estimated using conservative modeling, the surface water concentration (5.7 ppb) is greater than
the cancer DWLOC (0.315 ppb). Thus, there appears to be a potential concern for oxyfluorfen
residues in surface water.
However, the estimated drinking water concentrations are considered to be conservative.
First, the 2 Ib ai/broadcast acre/season maximum labeled rate used in the drinking water
modeling assessment is not typically applied as a broadcast spray but rather as a banded
application between rows of perennial crops such as fruit/nut trees and artichokes, which leaves
approximately 50-75% of the actual land area untreated. Careful targeting of the spray is
required because oxyfluorfen is non-selective and will damage crops. The use rate for the
perennial crops per acre of total land area is generally around 0.5 to 1.0 Ibs ai/acre. Although
there are oxyfluorfen use sites that are broadcast treated, such as bulb vegetables or fallow land,
these sites have a lower maximum rate, typically 0.5 Ibs ai/acre.
The drinking water assessment also assumes that the maximum labeled rate of 2 Ibs
ai/acre is applied every year for 70 years when it is known that the average reported use rate
(regardless of application method) is less than Va of the maximum labeled rate (< 1 Ib ai/acre).
Based on information provided by growers, extension service, and industry, the higher 2 Ib rate
14
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is used more during the first couple of establishment years or when a poorly managed
orchard/field is purchased; after which lower rates are generally used to manage weeds at a
maintenance level.
3. Non-dietary Risk from Residential Uses
Oxyfluorfen is used in the residential environment by homeowners to kill weeds on
patios, driveways and similar surfaces. Oxyfluorfen homeowner products are intended solely for
spot treatment; they are not used for broadcast treatment of lawns because they kill grass.
Residential formulations contain 0.25% to 0.70% Oxyfluorfen by weight and are
packaged in a RTU sprinkler jug, a RTU trigger sprayer or as a liquid to be mixed in a sprinkler
can or tank sprayer.
Table 5. Residential Use Product Information for Oxyfluorfen
Product/Registrant
Kleenup Super Edger/Platte
Chemical Corp
Ortho GroundClear SuperEdger/
Scotts Company
Ortho GroundClear Triox Total
Vegetation Killer A /Scotts
Company
Formulation and Application Method
Contains 0.25% Oxyfluorfen in pre-mixed one pint to one
gallon containers. Applied from a RTU trigger sprayer, a
RTU sprinkler jug or from a tank sprayer.
Ready to use liquid containing 0.25% Oxyfluorfen. Applied
directly from the jug which has an applicator spout.
Concentrate containing 0.70% Oxyfluorfen. Mixed with
water and applied from a sprinkler can.
Application Rate
(Ibs ai/acre)
4.8
4.8
8.9
a. Exposure
The assessment evaluated four methods of application: 1) low pressure tank sprayer, 2)
"mix your own" sprinkler can, 3) ready-to-use (RTU) invert sprayer, and 4) RTU trigger sprayer.
The residential assessment for Oxyfluorfen only addresses the applicator, because negligible
postapplication exposure is anticipated from spot treatment of weeds.
Exposure data for scenarios 1 and 4 were taken from an Outdoor Residential Exposure
Task Force (ORETF) mixer/loader/applicator exposure study with carbaryl. Exposure data for
scenarios 2 and 3 were derived from an ORETF proprietary study that was conducted during the
application of diazinon to lawns using "Mix Your Own" and "Ready to Use" hose end sprayers.
Dermal and inhalation exposures are combined in this assessment. MOEs were
calculated for short-term (1-30 day) exposure scenarios only based on the use pattern.
General assumptions used in the residential handler risk assessment are as follows:
Clothing consisted of a short-sleeved shirt, short pants and no gloves.
15
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An area of 200 sq ft per application was treated with one gallon of the "ready to use"
product or 2.67 quarts of the "mix your own" product in an invert jug or sprinkler can.
An area of 300 sq ft per application was treated with one gallon of product in a low
pressure hand carried tank sprayer.
Two applications are made per year.
Applicators are assumed to have 50 years of potential exposure over a 70 year life span.
b.
Residential Handler Risk Estimates
Residential handler non-cancer risk is measured as a Margin of Exposure (MOE), which
determines how closely the exposure comes to a NOAEL. Since the FQPA safety factor was
reduced to IX, the Agency's level of concern (i.e., target MOE) is 100. As with dietary risk,
residential cancer risk estimates less than l.QxlO"6 do not exceed the Agency's level of concern.
As shown in Table 6, none of the residential applicator scenarios alone are of concern because
the MOEs for non-cancer effects are greater than 100 and the cancer risks are less than l.OxlO"6.
The highest residential applicator cancer risk is 8.7x 10"7 for the trigger pump sprayer scenario;
however, this risk estimate is considered conservative because it is not anticipated that
homeowners would use two gallons of product/year if applying with a trigger sprayer. Assuming
one gallon/year, the cancer risk estimate for the trigger pump sprayer is 4.4x 10"7.
Table 6. Residential Risk Estimates for Non-cancer and Cancer Effects
Spot Treatment Scenarios
Low Pressure Tank Sprayer
"Mix Your Own" Sprinkler Can
RTU Invert Sprayer
RTU Trigger Pump Sprayer
Combined Absorbed
Daily Dose
(mg/kg/day)
2.5 x ID'3
1.4 x ID'3
l.SxlO'4
3.5 x 10'3
Non-Cancer
Short-term Risk
(MOE)
12,000
22,000
170,000
8,500
Lifetime Absorbed
Daily Dose
(mg/kg/day)
8.5 x 10-6
4.6 x 10-6
5.9 x 10-7
1.2xlO'5
Cancer Risk
6.2 x 10-7
3.3 x 10-7
4.3 x 10-8
8.7 x 10'7
4. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require that for establishing a pesticide tolerance, "that
there is reasonable certainty that no harm will result from aggregate exposure to pesticide
chemical residue, including all anticipated dietary exposures and other exposures for which there
are reliable information." Aggregate exposure will typically include exposures from food,
drinking water, residential uses of a pesticide, and other non-occupational sources of exposure.
For oxyfluorfen, aggregate risk assessments were conducted for short-term (one to thirty days)
and chronic (cancer/non-cancer) exposure. Occupational exposure is not considered in any
aggregate exposure assessment. As noted previously, no acute dietary/aggregate risks were
assessed for oxyfluorfen because no adverse effects reflecting a single dose were identified.
16
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a. Chronic (Non-Cancer) Aggregate Risk
The chronic aggregate risk assessment addresses exposure to oxyfluorfen residues in
food and water only, as there are no chronic residential scenarios identified. As shown
previously in Table 4, comparison of the chronic DWLOCs with the estimated environmental
concentrations of oxyfluorfen shows that estimated surface and groundwater concentrations are
substantially less than the DWLOCs for all populations. Consequently, the Agency concludes
that residues of oxyfluorfen in food and drinking water do not result in a chronic aggregate risk
of concern.
b. Short-term Aggregate Risk
Short-term DWLOCs were calculated based upon average food residues, and the
residential handler exposure which resulted in the greatest risk estimate (spot treatment of weeds
using a RTU trigger pump sprayer). DWLOC calculations are for adults only since the
residential exposure is to adult handlers. The DWLOC calculation was done using standard
body weight and daily water consumption, i.e., 70 kg/2L (adult male) and 60 kg/2L (adult
female).
As shown in Table 7, surface and ground water concentrations (7.1 ppb and 0.08 ppb
respectively), estimated using modeling, are below the short-term DWLOCs of 8900 ppb
(females) and 10400 ppb (males). Consequently, there are no short-term aggregate risk concerns
from food, drinking water and residential exposures.
Table 7. Short-Term Aggregate Risk and DWLOC Calculations
Population
Adult Male
Adult Female
Aggregate Risk MOE
(food + residential)
8600
8600
Surface Water EEC
(ppb)
7.1
7.1
Ground Water
EEC (ppb)
0.08
0.08
Short-Term
DWLOC1 (ppb)
10400
8900
c. Aggregate Risk for Cancer
Cancer DWLOCs were calculated using average food residues together with residential
exposure estimates. The handler exposure scenario which resulted in the greatest risk estimate
(spot treatment of weeds using a RTU Trigger Pump Sprayer) was used in the calculation.
DWLOC calculations were done for adults only using standard body weight and daily water
consumption, i.e., 70 kg/2L (adult male). The chronic food cancer risk estimate of 3.8 x 10"7,
combined with the residential cancer risk estimate of 8.7 x 10"7, results in a food + residential
cancer risk of 1.3 x 10"6. Since the Agency's level of concern is 1.0 x 10"6, the DWLOC is
effectively zero and any additional water exposure will further contribute to potential risks of
concern.
17
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Table 8. Cancer Aggregate Risk ( Food and Residential) and DWLOC Calculations
Population
U.S. Pop
Chronic
Food Risk
3.8 xlO'7
Residential
Risk
8.7 x lO'7
Aggregate Cancer Risk
(food and residential)
1.3 x lO'6
Surface Water
EEC (ppb)
5.7
Ground Water
EEC (ppb)
0.08
Cancer
DWLOC (ppb)
0
The estimated food risk is considered highly conservative. First, PDF analyzed 3,700
samples on approximately 20 different commodities from 1996-1999 and found zero detects.
This is not surprising considering the fact that, except for bulb vegetables, oxyfluorfen is not
directly applied to crops due to damage to the foliage. Secondly, field trial data also showed all
residues were non-detects at an LOD of 0.01 ppm. Third, 1A LOQ (0.01 ppm) was used in the
dietary assessment instead of 1A LOD (0.003 ppm), which over-estimates the residue values.
EPA used !/2 LOQ rather than 1A LOD for field trial residue values because of the possibility of
an occasional residue of oxyfluorfen greater than 0.01 ppm, and the registrant's intention to
propose a new single analyte enforcement method for oxyfluorfen with a quantitation limit of
0.02 ppm. Actual residues are expected to be somewhere in between the calculated estimates
and zero.
In addition, the residential cancer risk estimate of 8.7 x 10"7 is believed to be an over-
estimate since residential applicators are not likely to apply two gallons/year of a ready-to-use
product with a trigger sprayer. Assuming one gallon/year, the cancer risk estimate for the trigger
pump sprayer is 4.4 x 10"7. Therefore, the cancer risk of 6.2 x 10"7 from use of the low pressure
tank sprayer can be considered "worst-case".
Regardless of food and residential exposure, estimated cancer risk from drinking water
alone is of concern based on the surface water EEC of 5.7 ppb. As noted previously, the Agency
believes that the surface water modeling overestimates the concentration of oxyfluorfen that may
be present in drinking water. Targeted drinking water monitoring data would allow refinement
of the EECs.
5. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of oxyfluorfen include:
individual farmers or growers who mix, load, and/or apply pesticides, and professional or custom
agricultural applicators. Non-cancer risk for all of these potentially exposed populations is
measured by a Margin of Exposure (MOE) which determines how close the occupational
exposure comes to a No Observed Adverse Effect Level (NOAEL). In the case of oxyfluorfen,
dermal/inhalation MOEs greater than 100 for short-term and 300 for intermediate-term do not
exceed the Agency's level of concern. Cancer risks greater than 1.0 X 10"4 (one in ten thousand)
for the occupational population exceeds the Agency's level of concern. EPA closely examines
occupational cancer risks in the 1 x 10"4 to 1 x 10"6 range and seeks cost effective ways to reduce
occupational cancer risks to the greatest extent feasible, preferably 10"6 or less.
18
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a. Toxicity
The toxicological endpoints, and other factors used in the occupational risk assessment
for oxyfluorfen are listed previously in Table 2. The acute toxicity profile for technical
oxyfluorfen is listed below in Table 9. Oxyfluorfen is of low acute toxicity and is in toxicity
category IV for acute oral and inhalation toxicity and is category III for acute dermal toxicity.
Oxyfluorfen is a slight eye and dermal irritant and is not a dermal sensitizer.
Table 9. Acute Toxicity of Technical Oxyfluorfen
Study Type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye
Irritation
Primary Skin
Irritation
Dermal Sensitization
Test Material
96%
97.1%
96%
97.1%
96%
96%
96%
96%
96%
96%
23%
MRID
44712010
44828903
44712011
44828904
44712012
44712013
44828906
44712014
44828905
44712015
44814901
Results
LD50>5000 mg/kg
LD50>5000 mg/kg
LD50>2000 mg/kg
LD50>5000 mg/kg
LC50>3.71 mg/L
slight irritant
negative
slight irritant
negative
negative
negative
Toxicity
Category
IV
IV
III
IV
IV
IV
IV
IV
IV
—
—
b. Handler Exposure
EPA has determined that there are potential exposures to mixers, loaders, applicators, or
other handlers during usual use-patterns associated with oxyfluorfen. Agricultural liquid
formulations of oxyfluorfen are applied using large, average or all-terrain vehicle (ATV)
groundboom rigs. Aerial application is generally used only for fallow fields and bulb vegetables.
Chemigation is mainly used for over-the-top application to bulb vegetables and for drip
application to some orchard trees, however, chemigation is often prohibited on product labels.
Granular oxyfluorfen is applied to field and container grown ornamentals with broadcast
spreaders. Based upon the application methods, the following exposure scenarios were
developed:
Application Method
1. Large Groundboom
(can treat 200 acres/day)
2. Average Groundboom
(can treat 80 acres/day)
3. ATV Groundboom
Exposure Scenario
1A - Mix/Load Liquids - Large Groundboom
IB - Spray Application - Large Groundboom
2A - Mix/Load Liquids - Average Groundboom
2B - Spray Application - Average Groundboom
3 A - Mix/Load Liquids - ATV Groundboom
3B - Spray Application - ATV Groundboom
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4. Fixed Wing Aircraft 4A - Mix/Load Liquids for Aerial Application
4B - Spray Application - Fixed-Wing Aircraft
4C - Flag Aerial Applications
5. Chemigation 5 - Mix/Load Liquids - Chemigation
6. Right-of- Way (ROW) Sprayer 6A - Mix/Load Liquids - ROW Sprayer
6B - Spray Application - ROW Sprayer
7. Backpack Sprayer 7 - Mix/Load/Apply Liquids - Backpack
8. Tractor Drawn Broadcast Spreader 8A - Load Granules into Broadcast Spreader
8B - Apply Granules with Broadcast Spreader
9. Push Type Broadcast Spreader 9 - Broadcast Spreader (Load/Apply)
EPA has adopted a methodology to present the risks separately for some scenarios and
combine others. Most of the hand-held equipment such as backpack sprayers and push type
granular spreaders are assessed as a combined function. With these types of small operations the
mixing, loading, and applying are almost always carried out by the same individual and there are
data available to estimate exposure from these activities. For equipment such as fixed-wing-
aircraft or groundboom tractors, the applicators are assessed separately from the individual who
mixes and loads the formulated product. EPA assumes that the pilots are rarely involved in
mixing/loading procedures. By separating the two job functions, EPA can determine the most
appropriate PPE or engineering controls without requiring the handler to wear PPE throughout
the entire workday or to use engineering controls that are not needed.
Handler Data Sources
With the exception of the push-type broadcast spreader scenario, which relied upon a
high-quality Outdoor Residential Exposure Task Force (ORETF) study with DCPA, exposure
analyses were performed with The Pesticide Handlers Exposure Database (PHED). PHED was
designed by a task force of representatives from the US EPA, Health Canada, the California
Department of Pesticide Regulation, and member companies of the American Crop Protection
Association. It is a software system consisting of two parts - a database of measured exposure
values for workers involved in the handling of pesticides under actual field conditions and a set
of computer algorithms used to subset and statistically summarize the selected data. Currently,
the database contains values for over 1,700 monitored individuals (i.e., replicates). The quality
of the data and exposure factors represents the best sources of data currently available to the
Agency for completing these kinds of assessments.
Handler Exposure Assumptions
The following assumptions and factors were used in order to complete the exposure and
risk assessments for occupational handlers/applicators:
• The average work day was 8 hours.
20
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• Maximum application rates and daily acreage were used to evaluate non-cancer
occupational risk.
• Average application rates and daily acreage were used to evaluate cancer occupational
risk.
A body weight of 60 kg was assumed for short term exposures because the short term
endpoint relates to females 13-50 years of age.
A body weight of 70 kg was assumed for intermediate term exposures because the
intermediate term endpoint is not gender specific.
• A body weight of 70 kg was assumed for cancer scenarios.
• A private grower is assumed to mix, load and apply liquid formulation of oxyfluorfen 5
days per year. This is based upon the 90th to 95th percentile farm size (taken from the
1997 Census of Agriculture) divided by the assumed acres treated per day. It is also
assumed that approximately one or two applications are made per year as listed in the
National Agricultural Statistics Service (NASS) data.
A private grower is assumed to load and apply granular formulations of oxyfluorfen 10
days per year because the granular labels allow up to 4 applications of 2 Ib/ai per year.
• A custom applicator mixes, loads and applies oxyfluorfen 30 days per year.
• Baseline PPE includes long sleeve shirts, long pants and no gloves or respirator.
• Single Layer PPE includes baseline PPE with gloves.
• Double Layer PPE includes coveralls over single layer PPE .
Double Layer PPE PF5 includes a dust/mist respirator.
Double Layer PPE PF10 includes a cartridge respirator.
Anticipated use patterns and application methods, range of application rates, and daily
amount of acres treated were derived from current product labeling. With the exception of some
tropical commodities, application rates specified on oxyfluorfen labels range from 0.5 to 2.0
pounds of active ingredient per acre in agricultural settings. The Agency typically uses acres
treated per day values that are thought to represent 8 hours of application work for specific types
of application equipment.
c. Handler (Non-cancer) Risk
Since the endpoint of concern was the same for dermal and inhalation, the exposures and
risks were combined. The target MOEs are 100 for short term exposures and 300 for
intermediate term exposures. Scenarios with MOEs greater than the target MOEs are not of
concern for the occupational population.
Table 10 summarizes the ranges of the combined MOEs for the various exposure
scenarios. A brief summary of the specific exposure scenarios with risks of concern (i.e.
combined MOEs less than 100 or 300) is presented in Table 11.
21
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Table 10. Non-Cancer Combined MOEs for Occupational Exposure to Oxyfluorfen
Endpoint
Short Term
Intermediate Term
Baseline MOEs
6 - 14000
7 - 17000
Single Layer MOEs1
490 - 14000
520 - 15000
1 Single layer = baseline clothing + gloves
Table 11. Oxyfluorfen Handler Exposure Scenarios of Concern"
Mitigation Level
Baseline PPE
Single layer PPE (without respirators)
Scenarios of Concern (MOE = Short Term, Intermediate Term)
1A - Mix/load liquids - Large Groundboom (MOE =23 to 34, 29
2A - Mix/load liquids - Average Groundboom (MOE = 22 to 85,
3A - Mix/load liquids - ATV Groundboom (MOE = 43, 54)
4A - Mix/load liquids - Aerial (MOE = 6, 7)
5 - Mix/load liquids - Chemigation (MOE =20, 24)
6A - Mix/load liquids - Right-of-Way Sprayer (MOE = 69, 86)
6B - Spray Application - Right-of- Way (MOE = 150, 190)
to 43)
27 to 110)
None
a' Scenarios are of concern when the MOE <100 for short term exposures or the MOE <300 for intermediate term
exposures
The calculations of occupational handler/applicator non-cancer risk indicate that, at the
single layer PPE level (which includes baseline PPE + chemical resistant gloves) none of the
scenarios are of concern for short or intermediate term non-cancer risks. Currently, PPE
requirements on labels ranges from baseline to double layer with most of the labels requiring
waterproof or chemical-resistant gloves.
d.
Handler Cancer Risk
For occupational risks between 1 x 10"6 and 1 x 10"4, the Agency will pursue risk
mitigation where feasible and cost effective to manage the risks to 1 x 10"6. The cancer risks
were calculated starting with the PPE level (single layer) that achieved acceptable MOEs for
non-cancer risks. As shown in Table 12, the cancer risks for all of the custom applicator
scenarios are less than 1 x 10"4 at the single layer PPE level and some of the applicator scenarios
are less than 1 x 10"6. At the highest level of mitigation (engineering controls) the risks for most
of the custom applicator scenarios are reduced to less than 1 x 10"5 and some are reduced to less
than 1 x 10"6. In general, cancer risks to private growers were three to six times less than those
for custom applicators due to the assumption that they handle Oxyfluorfen fewer number of days
per year (30 days/year = custom applicators, 10 days/year = private grower [granular], 5
days/year = private grower [liquid]). Cancer risk estimates for private growers can be found in
the May 1, 2002 Revised Occupational and Residential Exposure and Risk Assessment for
Oxyfluorfen.
22
-------
Table 12. Summary of Oxyfluorfen Cancer Risks for Custom Applicators (30 Exposure Days per Year)
Exposure Scenario
1 A - Mix/Load Liquids - Large Groundboom
IB - Spray Application - Large Groundboom
1 A - Mix/Load Liquids - Large Groundboom
IB - Spray Application - Large Groundboom
2A - Mix/Load Liquids - Average Groundboom
2B - Spray Application - Average Groundboom
2A - Mix/Load Liquids - Average Groundboom
2B - Spray Application - Average Groundboom
3A - Mix/Load Liquids - ATV Groundboom
3B - Spray Application - ATV Groundboom
4A - Mix/Load Liquids for Aerial Application
4B - Spray Application - Aerial
4C - Flag Aerial Applications
5 - Chemigation
6A - Mix/Load Liquids - Right of Way Sprayer
6B - Spray Application - Right of Way Sprayer
7 - Mix/Load/Apply Liquids - Backpack
7 - Mix/Load/Apply Liquids - Backpack
8A - Tractor Drawn Broadcast Spreader - Load
8B - Tractor Drawn Broadcast Spreader - Apply
9 - Load and Apply Using Broadcast Spreader
Crops
Com
Cotton, Soybeans
Orchards/ Vineyards
Nursery Trees, Mint
Onions, Brassica
Artichokes
Fallow Fields
Onions, Garlic, Horseradish
Right of Ways
Conifers
Conifers
Ornamentals
Ornamentals
Ornamentals
Average
Application Rate
(Ib ai/Acre)
0.5
0.25
1.0
0.25
1.0
0.25
0.25
1.0
1.0
0.375
1.0
1.0
1.0
Treated Area
(Acres/day)
200
200
80
80
40
350
350
50
2
2
40
40
5
Single Layer
Cancer Risk
2.3e-05
1.4e-05
l.le-05
7.0e-06
1.8e-05
l.le-05
4.6e-06
2.8e-06
9.2e-06
5.6e-06
2.0e-05
Not applicable
(N/A)
9.4e-06
2.0e-05
5.7e-05
8.0e-05
4.1e-05
1.5e-05
5.1e-06
4.3e-06
l.Oe-05
Double Layer
Cancer Risk
1.9e-05
1.2e-05
9.3e-06
5.8e-06
1.5e-05
9.4e-06
3.7e-06
2.3e-06
7.5e-06
4.7e-06
1.6e-05
N/A
8.8e-06
1.6e-05
4.7e-06
6.0e-05
2.7e-05
l.Oe-05
4.0e-06
3.4e-06
5.9e-06
Double Layer
PF5
Cancer Risk
1.5e-05
9.2e-06
7.3e-05
4.6e-06
1.2e-05
7.3e-06
2.9e-06
1.8e-06
5.8e-06
3.7e-06
1.3e-05
N/A
7.7e-06
1.3e-05
3.6e-06
5.7e-05
2.5e-05
9.5e-06
1.6e-06
1.7e-06
4.6e-06
Double Layer
PF10
Cancer Risk
1.4e-05
8.8e-06
7.2e-06
4.4e-06
l.le-05
7.1e-06
2.8e-06
1.8e-06
5.6e-06
3.5e-06
1.2e-05
N/A
7.6e-06
1.2e-05
3.5e-06
5.7e-05
2.5e-05
9.4e-06
1.3e-06
1.5e-06
4.4e-06
Engineering
Controls
Cancer Risk
7.0e-06
4.1e-06
3.5e-06
2.0e-06
5.6e-06
3.2e-06
1.4e-06
8.1e-07
2.8e-06
1.6e-06
6.1e-06
3.6e-06
1.8e-07
6.1e-06
1.8e-06
N/A
N/Aa
N/A
l.le-07
l.Oe-06
N/A
23
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(1) Post-Application Occupational Risk
The post-application occupational risk assessment considered exposures to workers
entering treated sites. Oxyfluorfen is a non-selective herbicide that can cause leaf damage to
most of the labeled crops. With the exception of bulb vegetables and conifers, which have more
tolerance to oxyfluorfen, over the top applications are not recommended. Therefore, it was
determined that significant postapplication exposure is only anticipated following applications of
oxyfluorfen to conifer seedlings, conifer trees and bulb vegetables.
Only dermal exposures were evaluated in the postapplication worker assessment;
inhalation exposures are not anticipated due to the low vapor pressure of oxyfluorfen (2.0 x 10"7
torr at 20 C). Because oxyfluorfen is typically applied only a few times per season and because
the agricultural scenarios generally occur for only a few months per year, it was determined that
oxyfluorfen exposures would be in the range covered by the short and intermediate term
toxicological endpoints.
In the Worker Protection Standard (WPS), a restricted entry interval (REI) is defined as
the duration of time which must elapse before residues decline to a level so entry into a
previously treated area and engaging in any task or activity would not result in exposures which
are of concern. Typically, the activity with the highest risk will drive the selection of the
appropriate REI for the crop. The restricted entry interval for oxyfluorfen is currently set at 24
hours.
(2) Data Sources
The registrant submitted a chemical specific Dislodgeable Foliar Residue (DFR) study
for postapplication worker exposure. This study measured dislodgeable foliar residues
following groundboom application of oxyfluorfen (Goal) to control weeds in conifer seedling
beds at a nursery in Oregon. This study is of marginally sufficient quality for use in risk
assessment. The lack of validation data, high fortification levels and low recovery during the
study are the most significant deficiencies. In the absence of acceptable chemical-specific DFR
data, standard Agency assumptions were also used for comparative purposes: the initial percent
of application rate assumed to be available as DFR was 20% for bulb vegetables and conifers,
and the dissipation rate per day was assumed to be 10%.
The transfer coefficients are based on proprietary data from the Agricultural Re-entry
Task Force (ARTF). These coefficients range from 300 for low contact activities such as
scouting, irrigating and thinning fields of bulb vegetables to 3000 for higher contact activities
such as shearing Christmas trees. The exact transfer coefficient for a given scenario also
depends upon the crop height and foliage development. Currently there are no transfer
coefficients for conifer seedlings and a value of-1000 cm /hr was chosen for conifer seedling
irrigation/scouting based upon professional judgement, transfer coefficients for similar activities
on other low crops, and preliminary ARTF data that is being collected for a variety of related
crops.
24
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(3) Assumptions
The following assumptions were made regarding post application occupational exposure:
Occupational post application cancer risks were calculated using a 30 day rolling average
DFR that was predicted using the default dissipation rate of 10 percent per day. These
calculations are based upon the assumption that post application exposure would only
occur on one particular farm. This assumption is considered valid for conifer seedling
nurseries and Christmas tree farms, because these industries are less likely to employ
migrant labor that would move from one farm to the next. This assumption is less valid
for bulb vegetable farms that use migrant labor.
• Non-Cancer short term risks were assessed using the maximum label rates. Intermediate
term and cancer risks were assessed using average application rates. Risks for conifer
trees were also assessed at the rate of 0.375 Ibs ai/acre, which can be used for "chemical
mowing1" around Christmas trees.
• It was assumed that a private grower has ten days of post application exposure per year
and a commercial re-entry worker has thirty days of post application exposure per year.
e. Reentry Worker (Non-cancer) Risk
The length of time for non-cancer risks to decline to levels that are not of concern (i.e.,
MOEs > 300) was shorter than the current REI of 24 hours for all activities except for Christmas
tree shearing, which required 3 days.
f. Reentry Worker Cancer Risk
A summary of the cancer risks for commercial re-entry workers is presented in Table 13.
Risks for conifer tree activities exceed l.OxlO"4 on day of treatment. These risks decline to less
than l.OxlO"4 in 3 days for all activities. All of the scenarios have cancer risks in excess of
l.OxlO"6 on day zero and the time for these risks to decline to l.OxlO"6 ranges from 12 to 47 days.
Cancer risks for private growers are three times less than commercial workers due to the
assumption that they work fewer days per year.
Chemical mowing is a term used to describe the practice of applying post-emergent herbicides at low rates to stunt or
suppress weeds, which is cost-effective and promotes soil conservation. Chemical mowing can be used as a broadcast
application or as a treatment for row middles.
25
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Table 13. Post Application Cancer Risks for Commercial Workers (Default Data)
Crops
Bulb Vegetables
Tree Seedlings,
Conifer
Trees, Conifer
Trees, Conifer
Average
Application Rate
(Ibs ai/acre)
0.25
0.5
1.0
0.375
(chemical mowing)
Activities
Irrigating, scouting, hand
weeding
Irrigation, Scouting, Hand
Weeding
Irrigation, Scouting
Shearing
Irrigation, Scouting
Shearing
Cancer Risk on
Day Zero After
Treatment
3.3e-06
2.2e-05
4.5e-05
1.3e-04
1.7e-05
5.0e-05
Day After Treatment When
Cancer Risk is Less Than:
LOxlO'4
0
0
0
3
0
0
LOxlO'5
0
8
15
25
5
16
l.OxlO'6
12
30
37
47
27
38
Although the chemical-specific study data on conifer seedlings has serious
deficiencies, the study is useful for characterizing oxyfluorfen-specific DFR levels on conifers,
as the study suggests dissipation is faster than default assumptions. Cancer risk using a 30-day
rolling average could not be calculated using the conifer DFR data because the conifer DFR
dissipated to the LOD by DAT 5. When using the study data, reentry risks for conifer tree
activities decline to less than 1 .OxlO"4 in one day and the time for these risks to decline to
l.OxlO"6 ranges from 6 to 11 days.
Table 14. Postapplication Cancer Risks for Commercial Workers (Conifer Study Data)
Crops
Tree Seedlings,
Conifer
Trees, Conifer
Trees, Conifer
Application
Rate
(Ibs ai/acre)
0.5
1.0
0.375
Activities
Irrigation, Scouting, Hand Weeding
Irrigation, Scouting
Shearing
Irrigation, Scouting
Shearing
Cancer Risk on
Day Zero After
Treatment
6.9e-05
1.4e-04
4.2e-04
5.2e-05
1.6e-04
Day After Treatment When
Cancer Risk is Less Than:
l.OxlO'4
0
1
1
0
1
l.OxlO'6
6
8
11
6
8
6.
Human Incident Data
The Agency consulted and reviewed sources of information on health incidents involving
human exposure. Oxyfluorfen cases mostly relate to handler and worker exposure. The four
sources of information are OPP's Incident Data System (IDS), American Association of Poison
Control Centers (PCC), California Department of Pesticide Regulation (CDPR), and the National
Pesticides Telecommunication Network. CDPR and OPP data tend to provide the most insight
into oxyfluorfen's association with human health incidents. A total of 66 incidents connected
with oxyfluorfen were reported in the OPP Incident Data System (IDS) from 1994 to 2000.
Most of these incidents involved irritant effects to the eyes, skin and occasionally respiratory
26
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passages. There were 25 cases reported in the California Pesticide Illness Surveillance Program
and the majority of these cases involved minor symptoms of systemic illness such as headache,
dizziness and nausea. During one of these incidents, nine of 15 field workers developed
symptoms while transplanting cauliflower plants in a field that was sprayed about 30 minutes
earlier. The reentry interval required on the label was 24 hours. These illnesses included
symptoms of chemical conjunctivitis, eye irritation, tingling and itching of the skin, nausea,
dizziness, headache, and vomiting. The incident report recommends that measures be taken to
enforce the reentry interval and that skin and eye protection be worn by handlers and those who
are likely to have substantial contact with oxyfluorfen products. Both PCC and CDPR data
indicate that incidents rarely result in hospitalization or prolonged absences from work, which is
expected due to the low acute toxicity profile for oxyfluorfen. However, in the case of
oxyfluorfen, the Agency does not have as great a concern for acute poisoning as for cancer risk,
which is not covered by incident data.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For
detailed discussions of all aspects of the environmental risk assessment, see the Environmental
Fate and Effects Division Science Chapter for the Oxyfluorfen Reregi strati on Eligibility
Decision, dated May 2, 2002, available in the public docket.
1. Environmental Fate and Transport
Except for the photolysis in water study (which indicates relatively rapid degradation),
laboratory data indicate that oxyfluorfen is persistent (aerobic soil metabolism half-lives of 291
and 294 days in a clay loam soil and 556 and 596 days in a sandy loam soil; and anaerobic soil
metabolism half-lives between 554 and 603 days). Adsorption/desorption studies suggest
oxyfluorfen is relatively immobile, except perhaps when used on very sandy soils. The most
likely route of dissipation is soil binding. Laboratory data suggest that once the soil-bound
oxyfluorfen reaches deep or turbid surface water it will persist since it is stable to hydrolysis and
since light penetration would be limited; however, it may degrade by photolysis in clear, shallow
water. Oxyfluorfen can contaminate surface water through spray drift and runoff; however, it is
unlikely to contaminate ground water because it is relatively immobile in the soil column;
therefore, the likelihood of leaching is small.
The major degradate found in the environmental fate studies was 2-chloro-l-(3-ethoxy-4-
hydroxyphenol)-4-(trifluoromethyl) benzene, which was identified in the aqueous photolysis
study at > 10 % of the applied radioactivity. Other degradates were identified in the aqueous
photolysis study but not quantified. In the hydrolysis study, 2-chloro-l-(3-hydroxy-4-
nitrophenoxy)-4-(trifluoromethyl) benzene was identified at a maximum concentration of 1.2-
1.7% of the applied radioactivity. There were no degradates identified in the anaerobic soil
metabolism, leaching adsorption/desorption and soil photolysis studies. The Health Effects
Division has determined that only parent oxyfluorfen is of toxicological concern for human
health risk assessment.
27
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2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics, pesticide use, and/or monitoring data. To evaluate the potential risk to nontarget
organisms from the use of oxyfluorfen products, EPA calculates a Risk Quotient (RQ), which is
the ratio of the estimated exposure concentration to the toxicity endpoint values, such as the LC50
(the concentration of a substance which causes death to 50% of the test animals). The RQ is
simply a means of integrating the results of ecological exposure and ecological toxicity. These
RQ values are compared to levels of concern (LOCs), given in Table 15 which provide an
indication of the relative risk the particular pesticide and/or use may pose for nontarget
organisms. If the RQ does not exceed the LOG, it is unlikely that the pesticide will pose a
significant risk. Similarly, when RQs are equal to or greater than the LOG, then the Agency
does have concerns. These concerns may be addressed by further refinements of the risk
assessment or by mitigation. Use, toxicity, fate, and exposure are considered to characterize the
risk as well as the level of certainty and uncertainty in the assessment. EPA further characterizes
ecological risk based on any reported aquatic or terrestrial incidents to nontarget organisms in
the field (e.g., fish or bird kills).
Table 15. Risk Presumptions for Terrestrial and Aquatic Animals
Risk Presumption
Acute Risk there is potential for acute risk; regulatory action may be warranted in
addition to restricted use classification,
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;
regulatory action may be warranted,
Chronic Risk -there is potential for chronic risk; regulatory action may be warranted.
LOG
terrestrial animals
0.5
0.2
0.1
1
LOG
aquatic animals
0.5
0.1
0.05
1
Specific uses chosen for modeling include non-bearing citrus, apples, grapes, walnuts,
cotton, and cole crops. Although this only represents a portion of the crops for which
oxyfluorfen has a labeled use, it does represent crops with higher application rates and crops
which have a large percentage of their total acreage treated with oxyfluorfen. By encompassing
crops with large percentages of acreage treated with oxyfluorfen and a large geographic area,
some crops with lower maximum application rates were also included in the set of scenarios.
3. Risk to Terrestrial Organisms
a. Toxicity (Hazard) Assessment
Toxicity values for risk calculations for all terrestrial assessments are given in Table 16.
Toxicity tests with terrestrial species show that oxyfluorfen is "practically non-toxic" to birds
and mammals exposed for short periods; however, adverse effects were demonstrated in one of
28
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the two avian reproduction toxicity studies and in the mammalian sub-chronic, chronic,
developmental, and 2-generation toxicity studies. Guideline toxicity tests show oxyfluorfen is
"practically non-toxic" to honeybees; however, a non-guideline study demonstrated that an
oxyfluorfen end-use product caused almost 100% mortality of predaceous mites at an application
rate of 1.28 Ibs ai/acre/application. In general, toxicity tests demonstrate that oxyfluorfen
negatively impacts seedling emergence and vegetative vigor of terrestrial plants.
Table 16. Summary of toxicity values for terrestrial risk assessments
Test Species
% a.i.
Endpoint
Toxicity Category and/or Most
Sensitive Endpoint
MRID
Acute Avian and Mammalian
Bobwhite quail (oral)
Bobwhite quail (dietary)
Laboratory rat (dietary)
70.1
70.2
97.1
LD50 > 2150 mg ai/kg-bw
LC50 > 5000 mg ai/kg-diet
LD50 > 5000 mg ai/kg-bw
practically nontoxic
practically nontoxic
practically nontoxic
921361-02a
921361-03
447120-10
Chronic (reproductive) Avian and Mammalian
Bobwhite quail
Laboratory rat
72.5
71.4
NOAEC <50 mg ai/kg-diet
LOAEC = 50 mg ai/kg-diet
NOAEC = 400 mg ai/kg-diet
LOAEC = 1600 mg ai/kg-diet
Reduced body weight of 14-
day chicks
Parental = mortality, decreased
BW and liver and kidney
histopathology Reproductive =
decreased BW and decreased
number of live pups/litter
4153012-06
420149-01
Non-Target Insects
Honey bee
71.4
LD50 > 100 |ag/bee
practically non-toxic
423681-01
Terrestrial Plants
Seedling Emergence-
Monocot
Seedling Emergence -
Dicot
Vegetative Vigor -
Monocot
Vegetative Vigor - Dicot
71.5
71.5
71.5
71.5
EC25 = 0.0058 Ibs ai/acre
EC25 = 0.0026 Ibs ai/acre
EC25 = 0.0062 Ibs ai/acre
EC25 = 0.00043 Ibs ai/acre
shoot length (ryegrass)
shoot length (cabbage)
shoot weight (onion)
shoot weight (tomato)
416440-01
416440-01
416440-01
416440-01
a Also reviewed under MRID 422559-01.
b. Exposure and Risk
For pesticides applied as liquids, the estimated environmental concentrations (EECs) on
food items following product application are compared to LC50 values to assess risk with a Risk
Quotient (RQ) method. For birds and mammals, estimates of maximum residue levels of
oxyfluorfen on wildlife food was based on the model of Hoerger and Kenega (1972), as modified
by Fletcher et al. (1994). EECs resulting from multiple applications are calculated from the
maximum number of applications, minimum application interval, and foliar half-life data. The
Agency does not calculate assess chronic risk from granular applications. For terrestrial and
semi-aquatic plants, the exposure model incorporates runoff and spray drift.
29
-------
RQs were not calculated to evaluate the potential acute risks to birds and mammals
because no adverse effects reflecting a single dose were identified at the highest dose. For the
current labeled application rates, minimal acute risks to birds and mammals are anticipated.
Subchronic and chronic risks to terrestrial birds and mammals do present a concern.
Assuming maximum residue values, the chronic LOG of 1.0 is exceeded for birds consuming
short grass when oxyfluorfen is applied to crops at application rates greater than or equal to 0.25
Ibs ai/acre/year. The chronic RQs are lower for birds consuming other food stuffs, but there are
chronic exceedences at higher application rates. Since the NOEC in the chronic avian toxicity
study was not determined (< 50 mg ai/kg-diet), the RQs represent a lower bound. Consumption
of short grass leads to the highest chronic risk estimates for birds.
Table 17. Summarized Chronic Avian Risk Quotients for Spray Applications
Crop (Site)
Citrus (Florida)
Apples (Oregon)
Walnut (California)
Grapes (New York)
Cotton (Mississippi)
Cole crops (California)
Cole crops (California)
Max Single
App. Rate
( Ibs ai/A)
2.0
2.0
0.5
0.25
Max No.
of Apps.
2
1
1
1
Chronic RQs for Predicted Max Residue Levels
Fruits, pods, seeds,
large insects
>0.9
>0.6
>0.2
>0.1
Broadleaf forage,
small insects
>8.4+
>5.4+
>1.4+
>0.7
Tall grass
>6.8+
>4.4+
>!.!+
>0.6
Short grass
>14.9+
>9.6+
>2.4+
>1.2+
+ indicates an exceedence of Chronic LOG
a Chronic toxicity threshold (NOEC) was <50 mg ai/kg-diet; Chronic LOC = 1.0.
For mammals, chronic risk quotients are estimated to exceed the Chronic LOC of 1.0 for
the citrus scenario with the highest application rate (2 Ibs ai/acre, 2 applications/season) and for
all scenarios with a 2 Ib ai/acre/year application rate (chronic RQs <2). Multiple applications of
a pesticide may raise the risk to an organism by increasing the concentration of residues on food
items and by extending the period during which these residues may be present.
Table 18. Summarized Chronic Mammalian Risk Quotients for Spray Applications
Crop (Site)
Citrus (Florida)
Apples (Oregon)
Walnut (California)
Grapes (New York)
Cotton (Mississippi)
Cole crops (California)
Cole crops (California)
Max Single App.
Rate
( Ibs ai/A)
2.0
2.0
0.5
0.25
Max No. of
Apps.
2
1
1
1
Chronic RQs
for Predicted Max Residue Levels
Seeds
0.12
0.08
0.02
0.01
Broadleaf forage,
small insects
1.05
0.68
0.17
0.09
Short grass
1.86+
1.20+
0.30
0.15
+ indicates an exceedence of the Chronic Risk LOC.
a Chronic toxicity threshold (NOEC) was 400 mg ai/kg-diet.
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The Agency currently does not quantify risks to terrestrial non-target insects; therefore,
risk quotients are not calculated for these organisms.
As a herbicide, oxyfluorfen is expected and has been shown to negatively impact
seedling emergence and vegetative vigor of terrestrial plants. For nearly all modeled scenarios,
the acute risk LOG of 1.0 for terrestrial plants adjacent to treated areas and plants in semi-aquatic
areas is exceeded. The RQs range from 1 to 169. The risk assessment for terrestrial plants was
based on RQs calculated from toxicity studies using the technical grade of oxyfluorfen instead of
a typical end-use product (TEP). Often the TEPs include surfactants or adjuvants to increase the
herbicide's adsorption into the plant, thereby increasing its efficacy. If the toxicity tests were
conducted using a TEP of oxyfluorfen (e.g., Goal 2XL) at the same rates as the technical grade,
the toxicity endpoints may be much lower. Furthermore, if the toxicity endpoints were reduced
with the TEP, the RQs and the risks would be higher than currently estimated.
Table 19. Summarized Acute Non-endangered Terrestrial Plant Risk Quotients
Crop
Citrus
Apples, Walnuts, Grapes
Cotton (aerial)
Cole crops (aerial)
Application Rate (Ibs ai/acre)
2 Ibs ai/acre, 2 applications/year
2 Ibs ai/acre, 1 application/year
0.5 Ibs ai/acre, 1 application/year
0.25 Ibs ai/acre, 1 application/year
Acute RQs
Adjacent to treated
sites
6-93
3-47
4-58
2-30
Semi-aquatic areas
6-169
3-85
4-58
2-30
4.
Uncertainties in Terrestrial Risk Assessment
There are a number of areas of uncertainty in the terrestrial risk assessment. Sensitivity
differences between species can be considerable (even up to two orders of magnitude) for some
chemicals. The rank of the tested species relative to the distribution of all species' sensitivities to
oxyfluorfen is unknown. In addition, the toxicity of oxyfluorfen to wild (non-laboratory) species
relative to laboratory species is unknown.
The risk assessment only considered a subset of possible use scenarios. It is possible that
some of the labeled uses that were not modeled will have a greater risk to the environment than
those included in this risk assessment. For example, coffee, cacao, and ornamentals have a
higher seasonal maximum application rate than those modeled. There is uncertainty in the
Chronic RQ estimates for birds because a NOEC was not established in the study used for risk
assessment. The true magnitude of the RQs for chronic avian toxicity is unknown, as these
represent lower bound estimates. Only dietary exposure is included in the exposure assessment.
Other exposure routes are possible for animals in treated areas. These routes include ingestion of
contaminated drinking water, ingestion of contaminated soils, preening/grooming, dermal
contact, and inhalation.
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5. Risk to Aquatic Animals
a. Toxicity (Hazard) Assessment
Toxicity values for risk calculations for all aquatic assessments are given in Table 20.
Based on toxicity studies with aquatic species submitted by the registrant, oxyfluorfen is "highly
toxic" to fish exposed for short or extended periods of time, "very highly toxic" to "moderately
toxic" to aquatic invertebrates exposed for short or extended periods of time, and "highly toxic"
to aquatic plants.
Table 20. Summary of toxicity values for aquatic risk assessments.
Test Species
% a.i.
Endpoint
Toxicity Category and/or Most
Sensitive Endpoint
MRID
Acute Freshwater
Bluegill Sunfish
Daphnia magna
94.0
23.2
96-hr LC50 = 200 ug/L
48-hr EC50 = 80 ug/L
Highly toxic
Very highly toxic
Ace. 95583
Ace. 96881
Acute Estuarine/Marine
Sheepshead Minnow
Grass shrimp
71.4
74.0
96-hr LC50> 170 ug/L
96-hr LC50 = 32 ug/L
Highly toxic
Very highly toxic
416988-01
309701-17
Chronic Freshwater
Fathead Minnow
Daphnia magna
71
71.8
NOAEC = 38 ug/L
LOAEC = 74 ug/L
NOAEC = 13 ug/L
LOAEC = 28 ug/L
Survival, larval length and weight
growth (length), reproduction
921360-57a
421423-05b
Aquatic Plants
Selenastrum capricornutum
23.2
96-hr EC50 = 0.29 ug/L
reduction in growth
452713-02
a Also reviewed under Ace. 99270.
b Raw data submitted under MRID 455502-01.
b. Exposure and Risk
For exposure to aquatic animals, EPA considers surface water only since most organisms
are not found in ground water. Surface water models are used to estimate exposure to freshwater
aquatic animals since monitoring data are generally not targeted studies on small water bodies
and primary streams where many aquatic animals are found. The modeling results used in risk
calculations are detailed in the EFED chapter.
The Agency used PRZM-EXAMS to calculate refined EECs. The Pesticide Root Zone
Model (PRZM, version 3.12) simulates pesticides in field runoff and erosion, while the Exposure
Analysis Modeling System (EXAMS, version 2.7.95) simulates pesticide fate and transport in an
aquatic environment (one hectare body of water, two meters deep). EECs were calculated for
surface water using the highest application rate on non-bearing citrus, apples, grapes, walnuts,
cotton, and cole crops. Although this only represents a portion of the crops for which
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oxyfluorfen has a labeled use, it does represent crops with higher application rates and crops
which have a large percentage of their total acreage treated with oxyfluorfen. By encompassing
crops with large percentages of acreage treated with oxyfluorfen and a large geographic area,
some crops with lower maximum application rates were also included in the set of scenarios.
For freshwater and estuarine fish, the acute and chronic risk LOCs are not exceeded. For
freshwater invertebrates, the acute risk LOG of 0.5 is exceeded for two citrus scenarios with
higher application rates (RQs <0.62). For estuarine invertebrates, the acute risk LOG of 0.5 is
exceeded for all citrus scenarios (RQs < 1.56). Though oxyfluorfen is highly toxic to all fish and
invertebrate species tested, the RQs calculated from EECs derived from Tier II simulations
suggest little potential for acute risk to fish or invertebrates.
Of the scenarios modeled, there were no Chronic Risk LOG exceedences for freshwater
fish. For freshwater invertebrates, the Chronic LOG was exceeded in all Florida citrus scenarios
and for the maximum application rate on New York grapes.
Table 21. Acute/Chronic Risk Quotients for Aquatic Species
Crop
(Site)
Citrus (Florida)
Apples (Oregon)
Grapes (New York)
Walnut (California)
Cotton (Mississippi)
Cole crops
(California)
Max Single
App. Rate
( Ibs ai/A)
2.0
2.0
2.0
2.0
0.5
0.25
Max No. of
Apps./
Method Type
2/ground
I/ground
I/ground
I/ground
I/aerial
I/ground
I/aerial
I/ground
Freshwater
Acute RQ
Fish
0.25**
0.04
0.10**
0.02
0.02
0.01
Invert.
0.62***
0.10**
0.25**
0.04
0.06*
0.06*
0.02
Chronic RQ
Fish
0.67
0.10
0.33
0.11
0.08
0.09
0.02
Invert.
2.35+
0.38
1.11+
0.82
0.29
0.27
0.08
0.06
Estuarine/
Marine
Acute RQ
Invert.
1.56***
0.25**
0.61***
0.10*
0.15**
0.14**
0.05*
0.04
* indicates an exceedence of Endangered Species LOG
** indicates an exceedence of Acute Restricted Use LOG
*** indicates an exceedence of Acute Risk LOG
+ indicates an exceedence of Chronic LOG
Limited monitoring data provide further information for the evaluation of environmental
risk to aquatic organisms. Based on sampling during February 1992 in the San Joaquin River,
oxyfluorfen concentrations in water were estimated to be between 0.1 and 1.0 |lg/L. Using 1.0
|ig/L as an EEC, the Acute Risk LOG was exceeded for aquatic plants (RQ = 3.45), but there
were no acute LOG exceedences for freshwater fish (RQ < 0.01) and invertebrates (RQ = 0.01),
and estuarine fish (RQ < 0.01) and invertebrates (RQ = 0.03). Long term sampling at four sites
had estimated average concentrations of oxyfluorfen in water ranging from 0.01 to 0.27 |lg/L,
indicating a lower risk to aquatic organisms; however, localized high concentrations of
oxyfluorfen have been observed. As a result of the Goal 2XL spill in the Columbia River Basin
(Fifteen Mile Creek) on August 24, 2000, focused sediment and water sampling was conducted.
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Water and sediment samples were collected as background measures from areas thought not to
be impacted by the spill. The few background water samples did not have detectable amounts of
oxyfluorfen, but 2 of the 35 background sediment samples did have detectible amounts of
oxyfluorfen (the highest was 541 ppb). It is important to note that these background samples
were collected seven months after most oxyfluorfen applications would have occurred
(oxyfluorfen is primarily applied during the dormant winter season).
6. Risk to Aquatic Plants
The RQs for all modeled scenarios currently exceed the acute risk LOG of 1.0 for
freshwater algal plants, and range from 5 to 172. Risks to aquatic vascular plants cannot be
assessed at this time since no data have been submitted.
Table 22. Acute Risk Quotients for Aquatic Plants*
Crop
(Site)
Citrus (Florida)
Apples (Oregon)
Grapes (New York)
Walnut (California)
Cotton (Mississippi)
Cole crops (California)
Max Single App. Rate
( Ibs ai/A)
2.0
2.0
2.0
2.0
0.5
0.25
Max No. of Apps./
Method Type
2/ground
I/ground
I/ground
I/ground
I/aerial
I/ground
I/aerial
I/ground
Freshwater algae (Nonvascular)
Acute RQ
171.59
28.38
67.59
44.72
16.72
15.31
5.45
4.59
* Acute toxicity for Aquatic Plants (The plant growth study on Selenastrum capricornutum (MRID 452713-02J with
Goal 2XL indicated a 96-hr EC50 of 0.29 ppb at 23.2 % ai, classifying oxyfluorfen as "highly toxic")
a. Uncertainties in the Aquatic Assessment
There are a number of areas of uncertainty in the aquatic organism risk assessment. The
risk assessment only considers the most sensitive species tested. The position of the tested
species relative to the distribution of all species' sensitivities to oxyfluorfen is unknown. The
aquatic plant risk assessment is based on only one species, a freshwater algae. There is a large
uncertainty because the response of non-vascular plants to oxyfluorfen may be different than the
response of the vascular plants to oxyfluorfen. The risk assessment only considered a subset of
possible use scenarios. Some of the labeled uses that were not modeled may have a greater risk
to the environment than those included in this risk assessment. No chronic toxicity studies for
estuarine fish or invertebrates were submitted to the Agency, so the toxicity of oxyfluorfen to
these organisms is unknown.
Aquatic risks have not been assessed for a myriad of aquatic habitats (e.g., marshes,
streams, intermittent aquatic areas) which are more extensive and are frequently more productive
than 2-meter deep ponds. The benthic environment (aquatic soil environment) provides habitat
to many invertebrates that provide important food sources to fish and other aquatic organisms.
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Based on toxicity data to invertebrates, oxyfluorfen may pose long term effects to benthic
organisms. Because of oxyfluorfen's high affinity to soil, soil eroding from application areas is
likely to carry bound oxyfluorfen to aquatic areas. Guideline studies for aerobic and anaerobic
soil metabolism suggest oxyfluorfen is highly persistent on soil and would likely accumulate in
depositing sediments. This information, combined with oxyfluorfen measurements in river
suspended sediment and aquatic toxicity data, suggests benthic organisms may be impacted and
aquatic habitat degraded as a result of oxyfluorfen usage. EPA is requesting a 10-day survival
and growth toxicity test for sediments using freshwater sediment toxicity organisms.
Oxyfluorfen may pose risks to animals not conveyed by standard guideline toxicity
studies because oxyfluorfen's mode of action suggests it may be more toxic in the presence of
light (phototoxic). Oxyfluorfen, and other light-dependent peroxidizing herbicides, act in plants
by producing phototoxic compounds. Toxicity studies with oxyfluorfen and other similar
herbicides suggest the same phototoxic compounds may occur in animals as a result of herbicide
exposure. Because guideline toxicity studies are normally conducted under relatively low,
artificial light conditions, the effects of being exposed simultaneously to oxyfluorfen and
sunlight are not known. To provide information on the magnitude of this effect, EPA is
requesting fish phototoxicity studies be conducted for oxyfluorfen.
7. Endangered Species
The preliminary risk assessment for endangered species indicates that oxyfluorfen
exceeds the endangered species LOCs for the following combinations of analyzed uses and
species:
• terrestrial plants for all uses;
avian chronic for non-bearing citrus and all applications with rates greater than 0.5 Ib
ai/acre/application (such as rights-of-way, apples, walnuts and grapes) based on both
maximum and mean residue levels;
mammalian chronic for non-bearing citrus, and applications with rates of 2 Ibs ai/acre
(such as rights-of-way, apples, walnuts and grapes) based on maximum residues;
• freshwater fish for non-bearing citrus and grapes (of those scenarios modeled); and
• estuarine fish for non-bearing citrus, apples and grapes (of those scenarios modeled); and
• freshwater invertebrates for non-bearing citrus, apples, grapes and cotton (of those
scenarios modeled).
Although the endangered species LOG for estuarine invertebrates has been exceeded,
there are no federally listed species in this group. Risks to endangered aquatic vascular plants
cannot be assessed at this time since no acceptable toxicity test for Lemna gibba has been
submitted to the Agency. Further analysis regarding the overlap of individual species and their
behavior with each use site is required prior to determining the likelihood of potential impact to
listed species.
The Agency had a consultation in 1985 (amended in 1986) with the US Fish and Wildlife
Service (FWS or the Service) on oxyfluorfen (Goal 1.6E and Goal 2E) regarding its use on
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noncrop areas including rights-of ways, fence rows, roadsides, and levee banks. The Service
found jeopardy to 76 species of endangered plants, 54 species of endangered fish, 23 species of
endangered mussels (clams), two species of snails, eleven species of endangered insects, four
endangered amphibians and one endangered bird (piping plover). The Service proposed a
Reasonable and Prudent Alternatives (RPA) to avoid jeopardy to these species. The RPA
prohibited the application of Goal within a quarter mile of the habitat of the listed plants and
terrestrial invertebrates and within a quarter mile of the streams or bodies of water where the
aquatic species occur.
Oxyfluorfen was included in the corn cluster consultation in 1983, and it's uses on crops
and forests were also included in the "reinitiation" of clusters in 1988. The resulting 1989
opinion found jeopardy to one amphibian (the Wyoming toad which is extirpated in the wild
except on FWS refuges), five fish species, two species of crustaceans and one bird species (the
wood stork). The Service proposed Reasonable and Prudent Alternatives (RPA) for each of these
jeopardized species. In addition, the Service had Reasonable and Prudent Measures (RPM) to
reduce incidental take of 34 aquatic and three bird species. The details of the RPM
recommendations are provided in the FWS 1989 biological opinion.
Acute risks to endangered birds is no longer a concern for oxyfluorfen, as the study used
as the basis for the earlier findings of jeopardy to birds has since been determined to be invalid.
However, many additional species, especially aquatic species, have been federally listed as
endangered/threatened since the biological opinion of 1989 was written, and determination of
potential effect to these species has not been assessed for oxyfluorfen. In addition, endangered
plants, which were considered in the 1985 and 1986 biological opinions for the rights-of-way
uses, were not considered in the 1989 opinion and need to be addressed. Finally, not only are
more refined methods to define ecological risks of pesticides being used but also new data, such
as that for spray drift, are now available that did not exist in 1989. The RPAs and RPMs in the
1989 opinion may need to be reassessed and modified based on these new approaches.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(l) of the Endangered Species Act to clarify
and develop consistent processes for endangered species risk assessments and consultations.
Subsequent to the completion of this process, the Agency will reassess both those species listed
since the completion of the biological opinion and those not considered in the opinion. The
Agency will also consider regulatory changes implemented in this RED when the reassessment is
undertaken.
8. Ecological Incidents
There is one reported incident in the EIIS database with an aquatic organism effect. On
August 22, 2000, Fifteen Mile Creek near the Dalles Dam in Oregon was the site of an
oxyfluorfen spill. A truck carrying formulated oxyfluorfen (Goal 2XL) crashed on a bridge
spilling approximately 20,000 gallons of herbicide into the creek yards from where the creek
enters the Columbia River. Two weeks after the spill, samples of filtered and unfiltered water
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near the spill site contained an average of 32 |ig/L and 340 |ig/L, respectively. This spill was
estimated to cause a 35% decrease in the numbers of adult chinook salmon and a 26% decrease
in the numbers of steelhead passing over the Dalles Dam the day immediately following the
spill, relative to the day prior to the spill. The spill was also reported to kill thousands of young
lampreys. An extensive cleanup operation (removal of water and sediment) removed a majority
of the chemical, and the estimated quantity of oxyfluorfen not recovered was less than 1000
gallons.
There are several reported plant incidents in the Environmental Incident Information
System (EIIS) database. One incident occurred on March 7, 1996, when a pest control operator
in Madera County, California, applied Roundup (glyphosate) and Goal (oxyfluorfen) to an
unspecified site. These herbicides drifted to 40 acres of plums and 90-100 acres of almonds with
total damage estimated at $520,000 to $760,000. A similar incident occurred in 1996 in
Arkansas. A grower stated that aerial drift of Roundup Ultra and Goal damaged 160 acres of
rice, and 80 acres had to be replanted. Another aerial drift incident occurred in 1996 in
California. A grower stated that aerial drift of Roundup Ultra and Goal damaged 10 acres of
oranges. Investigation by Monsanto representatives revealed that adequate buffer zones had not
been employed. In these cases, either of these compounds may have contributed to the damage of
these crops. There are 2 reported incidents of damage attributed to a home use product (Ortho
GroundClear Triox). Both incidents involved damage and death to small numbers of ornamentals
and juniper trees. The damage may have been caused by oxyfluorfen and/or the other active
ingredient in Triox, isopropylamine salt.
The lack of reported incidents to birds, mammals, and aquatic species cannot be
considered as evidence of lack of risk. For example, the major concerns for risks to birds and
mammals are chronic effects. If oxyfluorfen is having a chronic impact to bird and mammal
populations in the wild, observance of these effects is much less likely than if the risks of
concern were acute effects (e.g., mortality).
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of
relevant data concerning an active ingredient, whether products containing the active ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of the generic (i.e., an active ingredient specific) data required to support reregistration of
products containing the active ingredient oxyfluorfen.
The Agency has completed its assessment of the occupational, non-occupational, and
ecological risks associated with the use of pesticide products the active ingredient oxyfluorfen,
as well as an oxyfluorfen-specific dietary risk assessment. Based on a review of these data and
on public comments on the Agency's assessments for the active ingredient oxyfluorfen, EPA has
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sufficient information on the human health and ecological effects of oxyfluorfen 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 oxyfluorfen products are
eligible for reregi strati on provided that: (i) current data gaps and additional confirmatory data
needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted, and
(iii) label amendments are made to reflect these measures. Label changes are described in
Section V. Appendix A summarizes the uses of oxyfluorfen 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 of oxyfluorfen, and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of oxyfluorfen, the Agency has determined that oxyfluorfen
products, unless labeled and used as specified in this document, would present risks inconsistent
with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory action to address the risk
concerns from use of oxyfluorfen. If all changes outlined in this document are incorporated into
the product labels, then all current risks for oxyfluorfen will be adequately mitigated for the
purposes of this determination.
B. Public Comments and Responses
When making its reregi strati on decision, the Agency took into account all comments
received after opening of the public docket. These comments in their entirety are available in the
docket (OPP #34252). Comments on the risk assessment were submitted by two registrants,
Dow AgroSciences and the Scotts Company. EPA also received letters from approximately 65
growers, extension agents, and commodity organizations attesting to the importance of
oxyfluorfen to their weed control programs for commodities such as forest seedlings, grapes,
artichokes, various brassica and crucifer crops, Christmas trees, raspberries, blackberries,
garbanzo beans, onions, ornamentals, various orchard crops, garlic, walnuts, and almonds. The
majority of comments were submitted by the forestry and nursery industries, which point out that
oxyfluorfen is one of the most important, if not the most important, pesticides used for weed
control based on its cost effectiveness and efficacy. The Oregon Strawberry Commission
submitted a comment regarding their pending Section 3 petition for use of oxyfluorfen on
strawberries. Strawberry growers have used oxyfluorfen (Goal 2XL) under the Section 18
Emergency Exemption Program from 1997-2001.
The Confederated Tribes of the Warm Springs Reservation of Oregon raised concern that
the dietary risk assessment for oxyfluorfen is not protective, because estimated fish consumption
was based on an amount representative of the general public rather than subpopulations which
may consume higher levels offish. EPA did not address this comment in the Response to
Comments documents, so this comment is being addressed here. The fish bioconcentration study
suggests that accumulation would occur, but residues would depurate rapidly when fish move to
clean water. In contrast, the fish monitoring data from the Columbia river (gathered as a part of
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the oxyfluorfen spill incident) suggests a slower depuration period. The fish in the Columbia
River were not sediment dwelling but frequently contained residues greater than 10 ppb and a
couple of instances over 100 ppb. It is uncertain whether or not residues were caused by the spill
because the fish were collected either upstream or many miles downstream. These
measurements in the Columbia River are useful in defining bioaccumulation potential since they
were collected in the field and represent a variety offish (including those eaten by tribes and
recreational anglers). The Columbia River results do suggest that oxyfluorfen has the potential
to accumulate in fish in the environment to a certain extent. The Office of Pesticide Programs
has provided the information relevant to potential oxyfluorfen accumulation in fish to the Office
of Water who will determine if state advisory actions and/or additional monitoring programs are
needed. The Office of Pesticide Programs will continue to work with the Office of Water to
ensure that potential exposures and risks are appropriately assessed.
Formal Agency responses to comments related to the risk assessments can be found in
the following documents, which are available in the public docket: "Oxyfluorfen: Response to
Public Comments to the Human Health Risk Assessment" dated May 1, 2002; "Oxyfluorfen:
Response to the Occupational/Residential Exposure (ORE) Comments Submitted in Response to
the 60 Day Public Comment Period" dated May 2, 2002; and "Environmental Fate and Effects
Division Response to Public Comments Made by Dow AgroSciences and the California Almond
Board on EFED's Risk Assessment for Oxyfluorfen" dated May 2, 2002.
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks
associated with this pesticide. EPA has determined that risk from dietary (food sources
only) exposure to oxyfluorfen is within its own "risk cup." In other words, EPA has
concluded that the tolerances for oxyfluorfen meet the FQPA safety standards. In reaching
this determination EPA has considered the available information on the special sensitivity of
infants and children, as well as the acute and chronic food exposure. An aggregate
assessment was conducted for exposures through food, drinking water, and residential uses.
The Agency has determines that the human health risks from these combined exposures are
within acceptable levels.
Therefore, there are no changes in oxyfluorfen tolerances due to risk concerns and most
tolerances will remain in effect; however, the following tolerance changes and data are
necessary:
Tolerances for field corn fodder and forage are not warranted because oxyfluorfen's
registered use on field corn is limited to the states of NC and SC in conjunction with a USDA
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program to eradicate "witchweed" (Striga asiaticci); the treated forage and fodder of field corn
are not fed to livestock to avoid the spread of the weed. With respect to animal commodities, the
established oxyfluorfen tolerances for milk, fat, meat, and meat by-products of cattle, goats,
hogs, horses, and sheep should be lowered from 0.05 to 0.01 ppm based on the reviewed cattle
feeding study. Similarly, adjustments in the tolerance levels of the following poultry
commodities are required based on the results of the poultry feeding study: eggs (from 0.05 to
0.03 ppm); meat and meat by-products (from 0.05 to 0.01 ppm); and fat (from 0.05 to 0.2 ppm).
The registrant may impose label restrictions on the feeding of oxyfluorfen-treated soybean
forage and hay in lieu of submitting field residue data and proposing tolerances for these
soybean commodities. The Agency will establish tolerances for cotton gin byproducts, and
citrus oil. Tolerances with regional registration for grass forage, grass hay, and grass seed
screenings at 0.05 ppm each should also be established. The need to modify tolerances for
bananas and cacao beans will be determined upon receipt of confirmatory data.
b. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for oxyfluorfen, 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, that there is a reasonable certainty of no
harm for the general population. In reaching this determination, EPA has considered all
available information on the toxicity, use practices, and scenarios, and the environmental
behavior of oxyfluorfen. As discussed in chapter 3, the chronic dietary (food alone) risk is
below the level of concern, as is the cancer dietary risk from food alone. Risks from residential
exposures alone are also below the level of concern. Regarding risks from drinking water
exposures, chronic risks from drinking water are not of concern for surface or groundwater
supplies. Although the projected surface water concentrations exceed the Agency's cancer
concern level, the Agency believes that those projections are conservative and over-estimate the
human exposure to oxyfluorfen that will result from drinking water sources from surface water
(See Regulatory Rationale under Drinking Water in section IV.D. 1 .a.iv.).
c. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for oxyfluorfen, 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 the
factors 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 oxyfluorfen residues in
this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from oxyfluorfen residues, EPA considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other
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information. An FQPA safety factor is not required for oxyfluorfen because: 1) There does not
appear to be any increased susceptibility in animals due to pre- or postnatal exposure to
oxyfluorfen based upon the developmental and reproductive toxicity studies reviewed. Although
two does in the high-dose group of the rabbit developmental study aborted, these abortions are
considered secondary to the debilitating condition (generalized, systemic toxicity) of the
mothers; 2) Although neurotoxicity studies were not performed, there was no indication of
neurotoxicity in the submitted developmental and reproductive studies or in the published
literature. A developmental neurotoxicity study was not required; and 3) the dietary (food and
drinking water) and non-dietary (residential) exposure assessments will not underestimate the
potential exposures for infants and children.
d. 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 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 effects in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allows, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, oxyfluorfen may be subject to additional screening and/or testing to
better characterize effects related to endocrine disruption.
e. Cumulative Risks
The Food Quality Protection Act (FQPA) requires that, when considering whether to
establish, modify, or revoke a tolerance, 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." Oxyfluorfen is a diphenyl ether herbicide structurally related
to lactofen, fomesafen and acifluorfen. Although chemical class is not necessarily synonymous
with a common mechanism of toxicity, structurally similar chemical substances do frequently
exhibit common modes of toxicity. At this time, the Agency has not made a decision as to
whether oxyfluorfen shares a common mechanism of toxicity with these other diphenyl ethers or
any other pesticide. A careful evaluation of all the available data, as well as additional data on
the cancer mechanism of the diphenyl ether herbicides are still needed. A peer review by the
FIFRA Science Advisory Panel is also necessary before a formal decision is made. Therefore,
for the purposes of this risk assessment, the Agency has assumed that oxyfluorfen does not share
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a common mechanism of toxicity with other pesticides. After a decision is made regarding
common mechanism of toxicity, and if the Agency has determined that a cumulative assessment
is necessary, the Agency will address any outstanding risk concerns at that time.
f. Tolerances Summary
A summary of the oxyfluorfen tolerance reassessments is presented in Table 23. In the
assessment, tolerances for residues of oxyfluorfen in/on plant commodities [40 CFR §180.381]
are presently expressed in terms of the parent only.
No Codex MRLs have been established for oxyfluorfen; therefore, issues of compatibility
between Codex MRLs and U.S. tolerances do not exist.
The majority of data indicate that oxyfluorfen residues in/on most plant commodities
were below the LOQ (<0.01 ppm) of the data-collection method following application of
oxyfluorfen formulation(s) according to maximum registered uses. At this time, EPA is
reassessing most plant commodity tolerances at the established level of 0.05 ppm until an
adequate single analyte enforcement method becomes available.
The need to modify tolerances for bananas and cacao beans will be determined upon
receipt of confirmatory data. The reassessed tolerance for broccoli is based on residue data
translated from cabbage and cauliflower. As per 40 CFR §180.1 a separate tolerance for garlic is
not needed because the established tolerance for dry bulb onions will apply to garlic.
Tolerances for field corn fodder and forage are not warranted because oxyfluorfen's
registered use on field corn is limited to the states of NC and SC in conjunction with a USDA
program to eradicate "witchweed" (Striga asiatica); the treated forage and fodder of field corn
are not fed to livestock to avoid the spread of the weed.
With respect to animal commodities, the established oxyfluorfen tolerances for milk, fat,
meat, and meat by-products of cattle, goats, hogs, horses, and sheep should be lowered from 0.05
to 0.01 ppm based on the reviewed cattle feeding study. Similarly, adjustments in the tolerance
levels of the following poultry commodities are required based on the results of the poultry
feeding study: eggs (from 0.05 to 0.03 ppm); meat and meat by-products (from 0.05 to 0.01
ppm); and fat (from 0.05 to 0.2 ppm).
An oxyfluorfen tolerance for cotton gin byproducts must be proposed once adequate field
residue data, reflecting the maximum registered use pattern, have been submitted and evaluated.
The registrant may impose label restrictions on the feeding of oxyfluorfen-treated soybean
forage and hay in lieu of submitting field residue data and proposing tolerances for these
soybean commodities.
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Adequate data are available to reassess the established tolerances with regional
registrations for the following commodities, as defined: blackberry, garbanzo beans, guava,
papaya, raspberry, and taro (corms and leaves).
Table 23. Tolerance Reassessment Summary for Oxyfluorfen.
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment (ppm)
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.381 (a):
Almond hulls
Artichokes
Avocados
Bananas (including
plantain)
Broccoli
Cabbage
Cauliflower
Cattle, fat
Cattle, mbyp
Cattle, meat
Cocoa beans
Coffee
Corn, grain
Cottonseed
Dates
Eggs
Feijoa
Figs
Garlic
Goat, fat
Goat, mbyp
Goat, meat
Grapes
Hogs, fat
Hogs, mbyp
Hogs, meat
Horseradish
Horses, fat
Horses, mbyp
Horses, meat
Kiwifruit
Olives
0.1
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
-
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.1
0.05
0.05
TBD1
0.05
0.05
0.05
0.01
0.01
0.01
TBD1
0.05
0.05
0.05
0.05
0.03
0.05
0.05
0.05
0.01
0.01
0.01
0.05
0.01
0.01
0.01
0.05
0.01
0.01
0.01
0.05
0.05
[Almond, hulls]
[Artichoke, globe]
[Avocado]
[Banana (including plantain)]
The registrant may wish to propose a crop group
tolerance of 0.05 ppm for Head and stem Brassica
subgroup.
[Cacao bean]
[Coffee bean, green]
[Corn, field, grain]
[Cotton, undelinted seed]
[Date]
[Feijoa (pineapple guava)]
[Fig]
[Grape]
[Olive]
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Commodity
Onions (dry bulb)
Milk
Mint hay (peppermint
and spearmint)
Persimmons
Pistachios
Pome fruits group
Pomegranates
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
Soybeans
Stone fruits group
Tree nuts group
(except almond hulls)
Current
Tolerance (ppm)
0.05
0.05
0.1
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
Tolerance
Reassessment (ppm)
0.05
0.01
0.05
0.05
0.05
0.05
0.05
0.2
0.01
0.01
0.01
0.01
0.01
0.05
0.05
0.05
Comment/
[Correct Commodity Definition]
[Onion, dry bulb (only)]
Separate tolerances should be established, each at
0.05 ppm for: [Peppermint, tops] [Spearmint, tops]
[Persimmon]
[Pistachio]
[Fruit, Pome, Group]
[Pomegranate]
[Soybean]
[Fruits, Stone, Group]
[Nuts, Tree, Group] For tolerance reassessment
counting purposes walnut was counted separately
because it had been listed separately in the
Tolerance Index System .
Tolerances To Be Proposed Under 40 CFR §180.381 (a):
Cotton, gin
byproducts
Soybean forage
Soybean hay
None
None
None
TBD1
TBD1
TBD1
New RAC according to Table 1 (OPPTS 860.1000).
A feeding restriction may be established in lieu of
proposing tolerances.
Tolerances Listed Under 40 CFR §180.381 (c):
Blackberry
Garbanzo beans
Guava
Papaya
Raspberry
Taro (corms and
leaves)
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
Recently established under PP#5E04429 (60 FR
62330, 12/6/95)
[Chickpea (bean, garbanzo)]
Recently established under PP#5E04429
(60 FR 62330, 12/6/95)
Separate tolerances should be established, each at
0.05 ppm for: [Taro, corm], [Taro, foliage]
Tolerances To Be Proposed Under 40 CFR §180.381 (c)
Grass Forage, Grass
Hay, and Grass Seed
Screenings
None
0.05
Separate tolerances should be established, each at
0.05 ppm for grass forage, grass hay and grass seed
screenings
TBD = To be determined.
data are needed to be able
This term means the tolerance to be set will be safe. However, additional confirmatory
to set the tolerance level.
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Residue Analytical Methods
The Pesticide Analytical Manual (PAM) Vol. II lists two GLC/electron capture detector
(BCD) methods, designated as Methods I and II, for the enforcement of tolerances for
oxyfluorfen residues in/on plant and animal commodities, respectively. Both methods determine
levels of oxyfluorfen and its reduced metabolites by a common moiety (as heptafluorobutyryl
derivatives of oxyfluorfen). The tolerance expression for oxyfluorfen was amended (60 FR
62330, 12/6/95) to delete the metabolites of oxyfluorfen containing the diphenyl ether linkage.
The established tolerances for plant and animal commodities [40 CFR §180.381 (a), (b), and (c)]
are now expressed in terms of oxyfluorfen per se [2-chloro-l-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene]. Because oxyfluorfen/>er se is now the residue of concern, the PAM
Vol. II methods are no longer suitable for enforcement purposes.
EPA recommends that FDA's Multiresidue Methods for oxyfluorfen per se be utilized as
the primary enforcement method for plant commodities until the registrant submits a proposed
enforcement method for plants to determine oxyfluorfen per se. An enforcement method for the
determination of oxyfluorfen per se in animal commodities is required as FDA's Multiresidue
Methods are not suitable for animal commodities.
New single analyte methods are being proposed for determination of residues of
oxyfluorfen/>er se for enforcement and data collection purposes. In conjunction with a pending
tolerance petition (PP#3F4229/FAP#3H5674) on peanut, the registrant proposed a GC/ECD
method (Method TR 34-94-150, renamed as Method TR-34-95-111) including a confirmatory
GC/MS method for the enforcement of oxyfluorfen tolerances on plant commodities. The stated
limits of quantitation (LOQ) and detection (LOD) for Method TR-34-95-111 are 0.01 ppm and
0.003 ppm, respectively, except on peanut vine, shell, and hay for which the reported LOQ and
LOD are 0.02 ppm and 0.007 ppm, respectively. Method TR 34-95-111 was adequately
validated by the registrant using a wide array of plant matrices and by an independent laboratory
using peanut nutmeat. The method will be forwarded to the Biological and Economic Analysis
Division's Analytical Chemical Laboratory for a petition method validation trial to ensure that
the procedures are appropriate for tolerance enforcement.
Also in conjunction with PP#3F4229/FAP#3H5674, the registrant proposed a GC/ECD
method (Method TR 34-95-110) including a confirmatory GC/MS method for the enforcement of
oxyfluorfen tolerances on animal commodities. The stated LOQ and LOD for Method TR-34-
95-110 are 0.01 ppm and 0.003 ppm, respectively, for all animal commodities. Method TR 34-
95-110 was adequately validated by the registrant using a variety of animal matrices and by an
independent laboratory using milk and chicken fat. The method was also successfully
radiovalidated using aged samples from the hen and goat metabolism studies. EPA will forward
Method TR 34-95-110 to the Biological and Economic Analysis Division's Analytical Chemical
Laboratory (ACL) for a petition method validation trial.
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D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the
current use of oxyfluorfen. Where labeling revisions are warranted, specific language is set forth
in the summary tables of Section V of this document.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
No adverse effects reflecting a single dose were identified; therefore, no acute endpoint
was selected and an acute dietary risk assessment was not conducted. A refined Tier 3 dietary
risk assessment using the Dietary Exposure Evaluation Model (DEEM™) was completed for
chronic food exposure. The DEEM™ analysis evaluated the individual food consumption as
reported by respondents in the USD A 1989-91 Continuing Surveys for Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each commodity. For all
analyses, anticipated residues and percent of crop treated data were used.
(1) Chronic Dietary (Food)
The chronic dietary analysis utilized USDA Pesticide Data Program (PDF) monitoring
data, field trial data, and percent crop treated information. Based on that analysis, the percentage
of cPAD utilized is expected to be less than 1 percent for the U.S. population and all
subpopulations. Therefore, the chronic dietary (food) risk estimate is not of concern, and no
mitigation measures are needed.
(2) Cancer Dietary (Food)
A cancer dietary exposure and risk analysis was performed based upon revised cancer
Qj* of 7.32 x 10"2 derived from a mouse carcinogenicity study and upon Agency analyses of
anticipated residues in food. Based on that analysis, which yielded a cancer risk of 3.8 x 10"7, the
Agency has concluded that the cancer dietary risk from food alone is not of concern (< 1 x 10"6),
and that no mitigation measures are needed to address the cancer food risk.
(3) Drinking Water
As previously mentioned, acute endpoints were not established for oxyfluorfen and an
acute drinking water assessment was not performed. The Agency has determined that there are
no chronic (non-cancer) drinking water concerns, as the chronic EECs are substantially less than
the DWLOCs for all populations (see Section III. A.2). However, the Agency risk assessment
shows potential dietary cancer risks of concern for drinking water derived from surface waters.
This assessment was based on modeling simulations which predict that oxyfluorfen residues in
surface waters have a 36-year annual mean concentration of 5.7 ppb. In comparison, the cancer
DWLOC based on food exposure is 0.315 ppb.
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EPA believes that the DWLOC based on food exposure is upper-bound because PDF
and field trial residue data show all non-detectable residues, and /^ the LOQ was used in the
dietary (food) assessment which overestimates residue values. EPA used /^ LOQ rather than /^
LOD for field trial residue values because of the possibility of an occasional residue of
oxyfluorfen greater than 0.01 ppm, and the registrant's intention to propose a new single analyte
enforcement method for oxyfluorfen with a quantitation limit of 0.02 ppm. Actual residues are
expected to be somewhere in between the calculated estimates and zero.
The Agency also believes that the modeling simulations over-estimate exposures through
drinking water. First, the model input variables assumed maximum use rates and frequencies.
Usage data indicate that typical use rates are below maximum use rates by approximately 50%.
Secondly, the modeling assumed that the 2 Ib ai/acre application rate was being applied as a
broadcast treatment; however, oxyfluorfen is typically applied as a banded application between
rows of crops. Careful targeting of the spray is required because oxyfluorfen is non-selective
and will damage crops. The maximum use rate for crops per acre of total land area treated is
generally around 1.0 Ib ai/acre. There are oxyfluorfen use sites that are broadcast treated rather
than banded, such as bulb vegetables or fallow land, but these sites have a lower maximum rate,
typically 0.5 Ibs ai/acre/season. Nut trees may also require broadcast treatment to clear the
orchard floor before harvest, but typically at a rate of 0.5 Ibs ai/acre.
Monitoring data also indicate that concentrations may be lower than what was estimated
with the PRZM/EXAMS model. For example, USGS conducted monitoring of oxyfluorfen
bound to suspended sediment for several years in central California, within an area of high
usage. The highest average concentration of oxyfluorfen associated with the suspended
sediment was 27.2 ppb. From this monitoring, it is estimated that approximately 0.27 ppb of
oxyfluorfen may be available in the water, assuming reversible partitioning with an average Kd
partitioning coefficient of 100.
These water monitoring results are useful, but do not negate the need for targeted water
monitoring. The monitoring data available are not adequate because the data are mainly limited
to sediment levels, they are limited to only a few locations, and the data are temporally limited;
samples were often taken outside the major use season. Also, the samples collected as a result of
the August 24, 2000 spill in Oregon indicated that a sediment detection of 541 ppb was found in
a nearby creek believed to be unaffected by the spill and downstream from orchards. EPA needs
additional information to ascertain whether this detection was actually related to the spill or due
to the presence of the upstream orchards.
In response to potential dietary cancer risks from drinking water derived from surface
waters, the registrants have agreed to several measures which are expected to decrease the
amount of oxyfluorfen reaching surface water:
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• The maximum seasonal application rate for oxyfluorfen use on food crops is currently 2
Ibs ai/broadcast acre/season2. Registrants have agreed to lower this maximum rate to 1.5
Ibs ai/broadcast acre/season and 2 Ibs ai/acre/season for conifer seedlings. The time
interval of the total chemical applied is inconsistent and unclear on some labels, and for
some uses the maximum poundage to be applied per year or the maximum number of
applications per year is not specified (e.g. right-of-way). The maximum poundage of the
chemical applied per acre must be given on a calendar year basis for all uses, or the terms
"season" and "growing season" must be clearly defined on the labels.
• The maximum seasonal application rate for oxyfluorfen use on ornamentals is currently 8
Ibs ai/A. For liquid formulations and granulars applied to field-grown ornamentals,
registrants have agreed to lower this seasonal maximum rate to 4.5 Ibs ai/A (1.5 Ibs
ai/A/application). For granulars applied to containerized ornamentals, the rate will be
lowered to a seasonal maximum of 6 Ibs ai/A (2 Ibs ai/A/application).
• Labeling will clearly limit the seasonal maximum rate for conifer seedlings to 2 Ibs
ai/acre. Information provide by conifer seedling growers indicate the need for greater
than 1.5 Ibs ai/acre, particularly in the South. Since conifer seedling nurseries tend to be
relatively small operations (20 to 40 acres) and only about 2,500 acres are in U.S.
production, EPA concludes that the 2 Ib ai/acre/season rate is appropriate and will add
negligible risk.
Label language will be added to require 25 foot, no-spray, vegetative buffer zones around
surface water bodies such as rivers, lakes, streams, and ponds.
• Spray requirements will be added to labels to minimize oxyfluorfen drift. Only use of a
coarse, very coarse, or extremely coarse spray will be allowed according to the ASAE
572 definitions for standard nozzles, or a volume median diameter (VMD) of 385
microns or larger for spinning atomizer nozzles.
The registrant (Dow AgroSciences) has further agreed to conduct a tiered surface water
monitoring study to provide additional information on potential drinking water contamination.
The initial tier consists of an edge-of-field water and sediment monitoring in a limited number of
vulnerable sites around the country. Vulnerability would be based on soil types, historical
precipitation levels, and/or other relevant factors. Study sites as well as the monitoring study
protocol would be agreed upon by the registrant and the Agency in advance of study initiation.
Higher tiers (e.g., full scale monitoring study at drinking water treatment plants) would be
initiated based on the results of the initial monitoring.
Use rates are higher (up to 6 Ibs ai/broadcast acre/season) for some Hawaiian commodities such as guava,
coffee, and macadamia nuts because high humidity, heat, and rain require a higher single application rate and more
frequent applications. EPA is not concerned with surface water contamination for drinking water risk purposes
because drinking water sources are predominately groundwater in Hawaii. The higher rates are addressed in more
detail in the ecological risk mitigation section.
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(4) Aggregate Risk Mitigation (short-term, chronic, and
cancer)
The short-term aggregate risk assessment considers exposures from food, drinking water,
and residential exposures. As shown in Section III. A.4, surface and ground water concentrations
(7.1 ppb and 0.08 ppb respectively), estimated using modeling, are below the short-term
DWLOCs of 8900 ppb (females) and 10400 ppb (males). Consequently, there are no short-term
aggregate risks of concern.
The chronic (non-cancer) aggregate risk assessment addresses exposure to oxyfluorfen
residues in food and water only, as there are no chronic residential scenarios identified. The
lowest DWLOC of 300 is substantially higher than the estimated environmental concentrations
of oxyfluorfen in surface and groundwater (7.1 ppb and 0.08 ppb respectively). Consequently,
the Agency concludes that residues of oxyfluorfen in food and drinking water do not result in a
chronic aggregate risk of concern.
To evaluate cancer aggregate risk, the chronic food cancer risk estimate combined with
the highest residential cancer risk estimate results in a food + residential cancer risk of 1.3 x 10"6.
Since the Agency's level of concern is 1.0 x 10 "6, this cancer risk exceeds EPA's level of
concern when considering just food and residential exposures combined. As stated previously,
the exposure and risk estimate from food is upper-bound as all field trial and PDF samples
contained non-detectable residues of oxyfluorfen. Therefore, no mitigation measures are
necessary to address dietary risk from food due to aggregate risk concerns.
Although residential cancer risk alone is not of concern (< 1.0 x 10"6), it contributes to
aggregate risk. It is realistic to assume that residential applicators are only applying 1
gallon/year with a trigger sprayer; therefore, the highest residential cancer risk is 6 x 10"7 for spot
treatment of weeds using a low pressure tank sprayer. Currently, residential rates (4.5 to 8.9 Ibs
ai/acre) are considerably higher than agricultural rates (2 Ibs ai/acre). The Scotts Company, a
registrant of two oxyfluorfen residential products, has stated that a 4.5 Ib ai/acre rate is necessary
to control perennial grassy weeds and for effective residual control. The registrant is conducting
efficacy trials to support appropriate residential use rates. In response to the
residential/aggregate cancer risks, the registrants have agreed to several measures which are
expected to decrease the amount of oxyfluorfen used in residential settings:
• The maximum application rate on residential products will be reduced to 3 Ibs ai/A or
less unless efficacy data support the need for higher rates. This measure will bring the
residential rates in line with the highest rate (2 Ib ai/A/season) needed for efficacy in
agricultural use scenarios. EPA will consider the results of the efficacy studies to
determine whether the data support a different rate.
Notwithstanding the food + residential risk estimate, aggregate cancer risk is still of
concern because surface water modeling indicates that there may be a risk exceedence from
oxyfluorfen in drinking water alone. The Agency believes this risk can be reduced by
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implementing the risk mitigation actions previously mentioned under drinking water risk
management. The modeled drinking water concentrations are believed to be high-end estimates
that may not represent levels that people actually consume in finished drinking water (for
reasons discussed earlier in the drinking water sections of this document). However, the extent
to which the modeling may overestimate surface water concentrations is not known and
additional information is necessary. The registrants of oxyfluorfen must submit edge-of-field
water and sediment monitoring. Pending review of these studies, no additional mitigation
measures are necessary to address drinking water concerns at this time.
b. Occupational Risk Mitigation
(1) Handler Risks
Handler exposure assessments are completed by EPA using a baseline exposure scenario
and, if required, increasing levels of mitigation (PPE and engineering controls) to achieve an
adequate margin of exposure (MOE). For oxyfluorfen the target MOE is 100 or greater for
short-term risks and 300 or greater for intermediate-term risks. Analyses for handler/applicator
exposures were performed using PHED. These calculations indicate that the MOEs for most
mixing/loading scenarios and the Right-of-Way application scenario are below 100 at the
baseline level and exceed EPA's level of concern. At the single layer PPE level (which includes
chemical resistant gloves), all of the scenarios have MOEs of 490 or greater. Cancer risks to
handlers are of greater concern than non-cancer risks; therefore, risk mitigation measures will be
determined based on the cancer risk assessment for occupational handlers.
Occupational cancer risks greater than 1 x 10"4are of concern. For risks between 10"6 and
10"4, EPA carefully evaluates exposure scenarios to seek cost effective ways to reduce cancer
risks to the greatest extent feasible, preferably to a risk of 1 x 10"6 or less.
At baseline and single-layer PPE, cancer risks for all handler scenarios are greater than 1
x 10"6, but less than 1 x 10"4. Assuming the use of double layer protective clothing currently on
some oxyfluorfen labels, most cancer risks are in the 10"5 range.
To address cancer risks to agricultural handlers, EPA has determined that the following
mitigation measures are necessary, reasonable, and cost-effective:
• closed mixing/loading systems to support applications to corn, cotton, soybeans, and
aerial applications to fallow land;
• enclosed cab for applications to corn, and closed cockpit aircraft for applications to
fallow land; and
double layer PPE for all other mixers, loaders, and applicators.
For high-acreage crops such as corn, cotton, and soybeans, engineering controls for
mixing and loading, and closed cabs are increasingly common for exposure reduction as well as
for comfort and increased efficiency of mixing and transferring high volumes of chemicals
necessary to treat large fields. Also, EPA understands that virtually all agricultural aviators
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currently use closed-cockpit aircraft. As such, EPA believes that these requirements are cost
effective and appropriate.
Likewise, EPA has determined that the use of engineering controls for additional handler
scenarios would further reduce exposure to handlers, but for some scenarios, such as
mixing/loading and applying with handheld (backpack) equipment and applying with Right-of-
Way spray equipment, engineering controls are not currently available. For other scenarios, such
as mixing/loading to support applications to perennials including tree fruit, nut, and vine crops,
while some engineering controls may be available they are not common with the equipment
typically used to make ground-directed herbicide applications in these crops. Such equipment
tends to be smaller and less sophisticated than the equipment used for foliar sprays of fungicides
and insecticides. EPA encourages the use of engineering controls in all settings where practical
and feasible, and allows for handlers to reduce PPE when engineering controls are used. But
EPA concludes that the risk-reduction potential of requiring engineering controls for additional
scenarios would not be commensurate with the costs and difficulties associated with
implementing the requirement.
(2) Post-application Exposure
Oxyfluorfen is a non-selective herbicide that can cause leaf damage to most of the
labeled crops. For this reason, the liquid product labels specify that it should be applied to the
ground in such a manner as to minimize crop damage and the granular product labels specify that
it should be watered in to rinse the granules off of the foliage. With the exceptions of bulb
vegetables and conifers, which have more tolerance to oxyfluorfen, over the top applications are
not recommended. Based upon these factors it was determined that re-entry workers would only
have significant post-application exposure following applications of oxyfluorfen to conifer
seedlings, conifer trees and bulb vegetables.
The Restricted Entry Interval (REI) represents the amount of time required for residues to
dissipate in treated areas prior to beginning a job or task in that area such that the resulting
exposures do not exceed the Agency's level of risk concern. In order to determine the REI for a
crop, EPA calculates the number of days that must elapse after pesticide application until
residues dissipate and risk to a worker falls below the target risk estimate. For a specific
crop/pesticide combination, the duration required to achieve the target risk estimate can vary
depending on the activity assessed.
To address potential risks to post-application workers, the Agency is modifying the REIs
for oxyfluorfen as described in Table 24 below. Since the conifer REIs are based on the
chemical-specific DFR study which has serious deficiencies, a confirmatory DFR study on
conifers is necessary.
For all post-application commercial worker exposure scenarios, the proposed REIs
provide estimated dermal MOEs greater than the target MOE of 300. Although the estimated
cancer risks for some of the scenarios are slightly above the 1 x 10"6 target value, they are still in
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the 10"6 range, and the Agency believes these REIs provide an acceptable level of protection
without disruption to needed cultural practices.
Table 24. Restricted Entry Intervals (REIs) for Oxyfluorfen
Crop
Bulb vegetables
Conifer
seedlings
Conifer trees
All other crops
Pre-harvest Interval (days)
45 (dry bulb onion)
60 (onions grown for seed)
60 (dry bulb garlic)
6 months (taro)
N/A
N/A
N/A
REI (days)
2
3
6
24 hours
Comments
A two day REI results in a cancer risk estimate of 2.7
x 10'6.
A three day REI results in a cancer risk estimate of 3 . 1
x 10-6.
An REI of 6 days results in a cancer risk estimate of
1.8 x 10"6 for low exposure activities (e.g. irrigation,
scouting, hand weeding) and 5.4 x 10"6 for medium
exposure activities (shearing). Since oxyfluorfen is
applied to weeds in Christmas tree plantations in a
semi-directed manner to reduce tree contact, only the
lower branches typically receive overspray. Therefore,
the risk estimates for Christmas tree shearing are
probably conservative.
Current Labeling
Scouting is a handler activity under the WPS, so anyone performing this activity may
legally enter the treated field during the REI provided they use the handler personal protective
equipment (PPE) specified on the label. In addition, if the scout is a certified crop advisor as
defined in the WPS [40 CFR 170.204(b)], the individual can determine the appropriate PPE to be
used. For many of these crops, irrigation equipment is not routinely moved by hand. For these
methods, the primary activity involves entering the field to turn the watering equipment on and
off. This activity is allowed during the REI under the no contact exception to WPS [40 CFR
170.112(b)]. Should irrigation equipment need unexpected repairs during the REI, WPS allows
workers to enter a treated field provided early entry PPE is used [40 CFR 170.112(c)]. This
exception also usually applies to mechanical harvesting and tree shaking for nut crops in
enclosed cabs.
2. Environmental Risk Mitigation
a. Risk Characterization
(1) Aquatic Organisms
Oxyfluorfen has the potential to affect aquatic ecological systems at all levels, as it is
toxic to plants, invertebrates, and fish, and exceeds the LOCs based on modeled EECs. For
freshwater invertebrates, the chronic level of concern was exceeded in all Florida citrus
scenarios, as well as for the maximum application rate on New York grapes. For estuarine
invertebrates, the acute risk level of concern is exceeded for all citrus scenarios. Based on
toxicity data to invertebrates, oxyfluorfen may pose long term effects to benthic (sediment
52
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dwelling) aquatic organisms; however, data on persistence and toxicity in the benthic
environment is limited. Dissolved oxyfluorfen concentrations are expected to be relatively low
in runoff water. However, because of oxyfluorfen's high affinity to soil, soil eroding from
application areas is likely to carry bound oxyfluorfen to aquatic areas.
The RQs for all modeled scenarios exceed the acute risk level of concern for freshwater
algal plants. The risk to vascular aquatic plants cannot be assessed due to lack of data.
(2) Terrestrial Organisms
For acute exposures, oxyfluorfen is practically non-toxic to birds, mammals, and bees,
and the Agency has no risk concerns. However, subchronic and chronic risks to terrestrial birds
and mammals do present a concern. These toxic effects may be manifested as reproductive,
developmental, and hemolytic consequences. Assuming maximum residue values, the chronic
level of concern is exceeded when oxyfluorfen is applied to crops at application rates greater
than or equal to 0.25 Ibs ai/acre/year for birds and greater than or equal to 2.0 Ibs ai/acre for
mammals.
Oxyfluorfen is expected and has been shown to negatively impact seedling emergence
and vegetative vigor of terrestrial plants. Non-target terrestrial plants are exposed to oxyfluorfen
as a result of spray drift and runoff and most incidents reported to the Agency are related to
plants affected by spray drift. Acute levels of concern are exceeded for all uses of oxyfluorfen
for terrestrial plants and semi-aquatic plants adjacent to treated areas.
(3) Endangered Species
The preliminary risk assessment for endangered species indicates that oxyfluorfen
exceeds the endangered species LOCs for the following combinations of analyzed uses and
species:
• terrestrial plants for all uses;
• avian chronic for non-bearing citrus and all applications with rates greater than 0.5 Ib
ai/acre/application (such as rights-of-way, apples, walnuts and grapes) based on both
maximum and mean residue levels;
mammalian chronic for non-bearing citrus, and applications with rates of 2 Ibs ai/acre
such as rights-of-way, apples, walnuts and grapes) based on maximum residues;
freshwater fish for non-bearing citrus and grapes (of those scenarios modeled); and
• freshwater invertebrates for non-bearing citrus, apples, grapes and cotton (of
thosescenarios modeled).
Based on the available data, oxyfluorfen acute toxicity, RQs, and LOG exceedences for
estuarine/marine fish were assumed to be similar to that of freshwater fish. Although the
endangered species LOG for estuarine invertebrates has been exceeded, there are no federally
listed species in this group. Risks to endangered aquatic vascular plants cannot be assessed at
this time since no acceptable toxicity test for Lemna gibba has been submitted to the Agency.
53
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(4) Mitigation Measures
Those same mitigation measures that will reduce drinking water exposure will also
reduce exposure to non-target organisms. A reduction in maximum seasonal rates from 2.0 Ibs
ai/broadcast acre to 1.5 Ibs ai/broadcast acre will protect both aquatic and terrestrial organisms.
The maintained 25 foot vegetative buffer strip is designed to reduce the potential for oxyfluorfen
to contaminate water through runoff. The buffer strips in combination with use of only coarse,
very coarse, or extremely coarse spray will also reduce exposure to aquatic organisms through
spray drift. The water and sediment monitoring will further refine the exposure potential for
aquatic and sediment-dwelling species.
3. Other Label Statements
In order to be eligible for reregi strati on, various use and safety information must also be
placed on the labeling of all end-use products containing oxyfluorfen. For the specific labeling
statements, refer to Section V of this document.
a. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide
uses to affect any particular species, EPA puts basic toxicity and exposure data developed for
REDs into context for individual listed species and their locations by evaluating important
ecological parameters, pesticide use information, the geographic relationship between specific
pesticides uses and species locations, and biological requirements and behavioral aspects of the
particular species. This analysis will take into consideration any regulatory changes
recommended in this RED that are being implemented at that time. A determination that there is
a likelihood of potential impact to a listed species may result in limitations on use of the
pesticide, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice
(54 FR 27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part
of the interim program, the Agency has developed County Specific Pamphlets that articulate
many of the specific measures outlined in the Biological Opinions issued to date. These
Pamphlets are available for voluntary use by pesticide applicators, on EPA's web site at
www.EPA. gov/espp . A final Endangered Species Protection Program, which may be altered
from the interim program, is scheduled to be proposed for public comment in the Federal
Register in 2002.
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b. Spray Drift Management
The Agency is in the process of developing more appropriate label statements for spray,
and dust drift control to ensure that public health, and the environment is protected from
unreasonable adverse effects. In August 2001, EPA published draft guidance for label
statements in a pesticide registration (PR) notice ("Draft PR Notice 2001-X"
http://www.epa.gov/ PR_Notices/#2001). A Federal Register notice was published on August
22, 2001, 66 FR 44141 (http://www.epa.gov/fedrgstr) announcing the availability of this draft
guidance for a 90-day public comment period. After receipt, and review of the comments, the
Agency will publish final guidance in a PR notice for registrants to use when labeling their
products.
Until EPA decides upon, and publishes the final label guidance for spray, and dust drift,
the registrant for oxyfluorfen has agreed to add the following spray drift related language, in part
to address concerns of surface water runoff of oxyfluorfen.
A 25 ft. vegetative buffer strip must be maintained between all areas treated with this
product and lakes, reservoirs, rivers, permanent streams, marshes or natural ponds,
estuaries and commercial fish farm ponds.
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas, non-
target crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.
For groundboom applications, apply with nozzle height no more than 4 feet above the
ground or crop canopy and when wind speed is 10 mph or less at the application site as
measured by an anemometer.
Use coarse spray according to ASAE 572 definition for standard nozzles or VMD of 475
microns for spinning atomizer nozzles.
The applicator also must use all other measures necessary to control drift."
V. What Registrants Need to Do
The Agency has determined that oxyfluorfen is eligible for reregi strati on provided that:
(i) additional data that the Agency intends to require confirm this interim decision; and (ii) 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 must
amend their product labeling to incorporate the label statements set forth in the Label Summary
Table in Section V.D below. The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
A. For oxyfluorfen technical grade active ingredient products, registrants need
to submit the following items.
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Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact John Leahy at (703) 305-6703 with questions regarding generic
reregi strati on and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
By US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
John Leahy John Leahy
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient oxyfluorfen registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregi strati on (EPA Form 8570-1).
Indicate on the form that it is an "application for reregi strati on";
(3) five copies of the draft label incorporating all label amendments outlined
in Table 25 of this document;
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(4) a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please contact Bonnie Adler at (703) 308-8523 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By US mail:
Document Processing Desk (PDCI/PRB)
Bonnie Adler
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service only:
Document Processing Desk (PDCI/PRB)
Bonnie Adler
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of oxyfluorfen for the above eligible
uses has been reviewed and determined to be substantially complete. However the following
data requirements are necessary to confirm the reregi strati on eligibility decision documented in
this RED.
OPPTS GLN 870.3200:
OPPTSGLN 860.1200:
OPPTS GLN 860.1500:
OPPTS GLN 850.1400:
OPPTS GLN 850.1735:
OPPTS GLN 850.1740:
OPPTS GLN 850.1350:
OPPTS GLN 850.2300:
OPPTS GLN 850.4225:
OPPTS GLN 850.4250:
OPPTS GLN 850.4400:
OPPTS GLN 875.2100:
Non-Guideline Studies:
21-day Dermal Toxicity Study in Rats
(Directions for Use ) - Label revisions are required
Crop Field Trials in Bananas, Cacao Beans, Soybean forage and hay,
and Cotton gin byproducts.
Estuarine/marine Fish Early-life Stage
Whole sediment acute toxicity invertebrates, Fresh Water
Whole sediment acute toxicity invertebrates, Estuarine/marine
Daphnid Chronic Toxicity
Avian Reproduction Studies, Quail and Duck
Seed Germination/seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Foliar Dislodgeable Residue Dissipation on Conifers
Fish Phototoxicity Study. Oxyfluorfen has a light dependent peroxidase and may be
more toxic to fish in clear natural waters than the guideline fish acute toxicity study
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would indicate. This study should quantify any additional toxicity which is light
induced.
Edge of Field Water and Sediment Monitoring. Simple initial tier study to determine
oxyfluorfen residues in drinking water. Monitoring of drinking water is reserved pending
the results of this study.
Ten-day survival and growth toxicity test for sediments, fresh water and estuarine. There
is potential for exposure of sediment-dwelling organisms to oxyfluorfen.
2. Labeling for Manufacturing Use Products
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices and applicable policies. The MP
labeling should bear the labeling contained in Table 25 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product.
A product-specific data call-in, outlining specific data requirements, accompanies this
RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in Table 25.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12
months from the date of the issuance of this Reregi strati on Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 24 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
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D. Required Labeling Changes Summary Table
Table 25 Summary of Required Labeling Changes for Oxyfluorfen
Description
I
Required Labeling
Placement on Label
Manufacturing Use Products
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
"Only for formulation into an herbicide for the following use(s): artichokes (globe), broccoli, cabbage,
cauliflower, cacao, citrus (non-bearing), coffee, conifers (seedbeds, transplants, container stock) and
selected deciduous trees, corn, cotton, cottonwood, eucalyptus, fallow bed (cotton/soybeans), fallow land,
garbanzo beans, garlic, guava (Hawaii only), horseradish, jojoba, mint, onions, onions grown for seed,
papayas (Hawaii only), soybeans, taro, and tree fruit, nuts, and vines (which includes almond, apple,
avocado, beechnut, brazil nut, butternut, cashew, cherry, chestnut, chinquapin, crabapple, date, feijoa, fig,
filbert, grapes, hickory nut, kiwi, loquat, macadamia nut, mayhaw, nectarines, olives, peach, pear, pecan,
persimmon, pistachio, plum, pomegranates, prune, quince, walnut).
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support
of suchuse(s)."
Directions for Use
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
This pesticide is toxic to fish. Do not discharge effluent into lakes, streams, ponds, estuaries, oceans, or
public waters unless in accordance with the requirements of a National Pollutant Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously notifying the sewage
treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.
Directions for Use
Handler PPE Guidelines (all
formulations)
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain oxyfluorfen, the product label must be revised to
adopt the handler personal protective equipment (PPE)/engineering control requirements set forth in this
section. Any conflicting PPE requirements on the current label must be removed.
For multiple-active-ingredient end-use products that contain oxyfluorfen, the handler PPE/engineering
control requirements set forth in this section must be compared with the requirements on the current label,
and the more protective language must be retained. For guidance on which requirements are considered to
be more protective, see PR Notice 93-7.
PPE that will be established on the basis of Acute Toxicity testing on end-use products undergoing product
reregistration must be compared with the active ingredient PPE specified below by the RED. 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.
Handler PPE Statements
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Description
Required Labeling
Placement on Label
End Use Products Intended for Occupational Use (WPS and Non-WPS Uses)
PPE Requirements Established
by the RED
for liquid products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant
material). "If you want more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart."
Mixers, loaders and applicators using engineering controls (see engineering controls requirements below),
must wear:
Long-sleeved shirt and long pants
Shoes plus socks
Chemical-resistant gloves when mixing and loading
Chemical-resistant apron when mixing and loading
All other mixers, loaders, applicators and other handlers must wear:
Coveralls over long-sleeved shirt and long pants
Chemical-resistant footwear plus socks
Chemical-resistant gloves
Chemical-resistant headgear when exposed overhead
Chemical-resistant apron when exposed to the concentrate
Immediately following^elow
Precautionary Statements:
Hazards to Humans and Domestic
Animals
PPE Requirements Established
by the RED
for Granular product
formulations.
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant
material). "If you want more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart."
Mixers, loaders, applicators and other handlers must wear:
Coveralls over long-sleeved shirt and long pants
Chemical-resistant footwear plus socks
Chemical-resistant gloves
Chemical-resistant apron for mixers and loaders.
Immediately following^elow
Precautionary Statements:
Hazards to Humans and Domestic
Animals
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Description
Required Labeling
Placement on Label
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
Precautionary Statements:
Hazards to Humans and Domestic
Animals immediately following
the PPE requirements
Engineering Controls
Established by the RED
for liquid products
"Engineering Controls
"Mixers and loaders supporting aerial applications to fallow land or ground applications to corn, cotton, or
soybeans must use a closed system that meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides [40 CFR 170.240(d)(4)], and must:
~ wear the personal protective equipment required above for mixers/loaders using engineering
controls,
~ wear protective eyewear if the system operates under pressure, and
~ be provided and have immediately available for use in an emergency, such as a broken package,
spill, or equipment breakdown: coveralls, and chemical-resistant footwear."
"Handlers performing applications to corn must use an enclosed cab that meets the definition in the Worker
Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition,
such applicators must:
wear the personal protective equipment required above for applicators using engineering
controls,
be provided and must have immediately available for use in an emergency when they must exit
the cab in the treated area: coveralls, chemical-resistant gloves, chemical-resistant footwear,
and chemical-resistant headgear, if overhead exposure,
take off any PPE that was worn in the treated area before reentering the cab, and
store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent
contamination of the inside of the cab."
"Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];
"When handlers use closed systems or enclosed cabs in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary Statements:
Hazards to Humans and Domestic
Animals (Immediately following
PPE and User Safety
Requirements.)
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Description
Required Labeling
Placement on Label
Engineering Controls
Established by the RED
for Granular Formulations.
'Engineering controls"
"When handlers use closed systems or enclosed cabs in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary Statements:
Hazards to Humans and Domestic
Animals (Immediately following
PPE and User Safety
Requirements.)
User Safety Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on
clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"This product is toxic to aquatic invertebrates and wildlife. Do not apply directly to water, or areas where
surface water is present or to intertidal areas below the mean high water mark. Runoff from treated areas
may be hazardous to aquatic organisms in neighboring areas. See Directions for Use for additional
restrictions. Do not contaminate water when disposing of equipment wash water."
Precautionary Statements
immediately following the User
Safety Recommendations
Restricted-Entry Interval
In the Agricultural Use Requirements box, place the following statements:
"Do not enter or allow workers to enter during the restricted-entry interval (REI).
In the Directions for Use under Application Instructions for each crop, specify the following REIs:
The REI is 24 hours for all crops except for the following:
Onions, garlic and horseradish: The REI is 48 hours.
Conifer seedlings: The REI is three days.
Conifer trees: The REI is six days.
Directions for Use, Agricultural
Use Requirements Box and
Application Instructions for
Appropriate Crop
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Description
Required Labeling
Placement on Label
Early Re-entry Personal
Protective Equipment
established by the RED.
" PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
coveralls,
chemical-resistant gloves made of any waterproof material,
shoes plus socks
Directions for Use, Agricultural
Use Requirements Box
REI Statements required if non-
WPS uses are on the label
Liquid Formulations:
"Do not enter or allow others to enter until sprays have dried.'
Granular formulations:
"Do not enter or allow others to enter until dusts have settled."
Directions for Use
Non-Agricultural Use
Requirements Box
General Application
Restrictions
Do not apply this product in a way that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application."
Place in the Direction for Use
directly above the Agricultural
Use Box.
Other Application Restrictions
The following risk mitigation measures must be reflected in the directions for use:
New Maximum Annual Application Rates Restrictions:
All Food/Feed Crops (except tropical commodities grown in HI): 1.5 Ibs ai/A
All ornamentals: liquid application rate of 1.5 Ibs/ai/application (4.5 Ibs ai/season)
Container-grown ornamentals: granular application rate of 2 Ibs ai/A/application (6 Ibs ai/season).
Conifer seedlings: 2 Ibs/ai/A.
Directions for Use
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Description
Spray Drift Buffer Restrictions
Required Labeling
The following spray drift statement is required.
"A 25 ft. vegetative buffer strip must be maintained between all areas treated with this product and lakes,
reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries and commercial fish farm ponds."
"Do not allow spray to drift from the application site and contact people, structures people occupy at any
time and the associated property, parks and recreation areas, non-target crops, aquatic and wetland areas,
woodlands, pastures, rangelands, or animals.
For groundboom applications, apply with nozzle height no more than 4 feet above the ground or crop
canopy and when wind speed is 10 mph or less at the application site as measured by an anemometer.
Use coarse spray according to ASAE 572 definition for standard nozzles or VMD of 475 microns for
spinning atomizer nozzles.
The applicator also must use all other measures necessary to control drift."
Placement on Label
Directions for Use under General
Application Instructions and/or
Restrictions
End Use Products Intended for Residential Consumer Use
Environmental Hazards
Entry Restrictions
General Application
Restrictions
Other Application
Restrictions/Risk Mitigation
"Environmental Hazards"
"Do not apply directly to water. Do not contaminate water when disposing of equipment washwaters or
rinsate."
"Do not allow people or pets to enter treated area until spays have dried."
"Do not apply this product in a way that will contact people or pets"
The application instructions must be revised to reflect the maximum consumer product (residential) rate of
3 Ibs ai/A.
Precautionary Statements
Directions for Use
Directions for Use
Directions for Use
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.
Instructions in the Labeling Required section not in quotes represent actions that the registrant must take to amend their labels or product registrations.
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VI. APPENDICES
This Reregi strati on Eligibility Document is supported by documents that are presently
maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal
holidays from 8:30 am to 4 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/oxvfluorfen.
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Appendix A: Use Patterns Eligible for Reregistration
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Almonds (See also "Tree nuts")
Directed spray application
Nondormant
Ground equipment
Chemigation
Nondormant
Flood (basin) irrigation, low-
volume sprinkler
(microsprinkler) or drip
trickle irrigation
1.6 Ib/gal EC
[CA890012]
2 Ib/gal EC
[CA960020]
2 Ib/gal EC
[CA960020]
1.5 Ib/A
1.5 Ib/A
Not specified
(NS)
NS
1.5 Ib/A
(nondormant
season)
1 5 Ib/A
(nondormant
season)
30
30
Use limited to CA. Application may be made in a
minimum of 20 gal of water/A (minimum of 10 gal/A for
certain tank mix applications). Application may be made
alone or as a tank mix with other herbicides.
Use limited to CA.
Apples (See "Pome fruits")
Apricots (See "Stone fruits")
Artichokes, Globe
Directed spray application
Postemergence
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1 5 Ib/A
l.Olb/A
I
2
1 5 Ib/A
1.5 Ib/A
5
5
Applications may be made in a minimum of 40 gal of
water/A. The use of any treated plants for feed or forage
and the feeding or grazing of any treated area are
prohibited for the 1.6 Ib/gal EC formulation only.
The first application is made to susceptible weed
seedlings and the second application is made 8-10 weeks
later. Applications may be made in a minimum of 40 gal
of water/A. The use of any treated plants for feed or
forage and the feeding or grazing of any treated area are
prohibited for the 1.6 Ib/sal EC formulation only.
66
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Avocados
Directed spray application
Dormant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Beech nut (See "Tree nuts")
Blackberries
Directed spray application
Early season (primocane
growth 4 to 6 inches) or
dormant
Ground equipment
1.61b/galEC
[OR960005]
2 Ib/gal EC
[OR960036]
[OR000028]
0.8 Ib/A
(early season)
1.0 Ib/A
(dormant)
4
1.5 Ib/A
15
Use limited to OR. Applications may be made in a
minimum of 50 gal water/A.
Brazil nut (See "Tree nuts")
Broccoli
Broadcast application
Pretransplant (preplant)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
NS
Applications may be made in a minimum of 20 gal of
water/A.
Butternut (See "Tree nuts")
Cabbage
Broadcast application
Pretransplant (preplant)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
NS
See "Broccoli."
67
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Cacao beans (bearing and nonbearing)
Directed spray application
Postemergence
Ground equipment
Directed spray application
Pretransplant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
2.0 Ib/A
1.0 Ib/A
NS
NS
6.0 Ib/A
6.0 Ib/A
1
1
Applications may be made in a minimum of 15 gal of
water/A.
Cashew (See "Tree nuts")
Cauliflower
Broadcast application
Pretransplant (preplant)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
NS
See "Broccoli."
Cherries (See "Stone fruits")
Chestnut (See "Tree nuts")
Chickpea (Garbanzo bean)
Broadcast application
Preemergence
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-4241
0.25 Ib/A
NS
NS
NS
Use limited to CA. Applications may be made in a
minimum of 25 gal of water/A. Feeding of bean, vines,
or hay is prohibited.
68
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Chickpea (Garbanzo bean) (continued)
Broadcast application
Preemergence
Ground equipment
1.61b/galEC
[CA920029]
2 Ib/gal EC
[AZ000001]
[CA960022]
0.25 Ib/A
NS
NS
NS
Use limited to AZ and CA. Applications may be made
in a minimum of 20 gal of water/A.
Chinquapin (See "Tree nuts")
Coffee (bearing and nonbearing)
Broadcast application (over
the top)
Dormant transplants
Ground equipment
Directed spray application
Postemergence
Ground equipment
Directed spray application
Pretransplant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
2.0 Ib/A
2.0 Ib/A
1.0 Ib/A
NS
NS
NS
6.0 Ib/A
6.0 Ib/A
6.0 Ib/A
1
1
1
Use limited to HI. Applications may be made in a
minimum of 30 gal of water/A. Applications may be
made alone or as a tank mix with other herbicides.
69
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Corn, field
Directed spray application
Foliar/postemergence
Ground equipment
Broadcast application
Fallow bed
Ground or aerial equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
[NC990007]
[SC000002]
1.6 Ib/gal EC
FT A m r\r\ i i n
[LA930011J
2 Ib/gal EC
[AR960009]
[LA960012]
FA /FO c\£ r\r\ i en
[MS960015J
0.75 Ib/A
(first application)
0.5 Ib/A
(subsequent
applications)
0.5 Ib/A
NS
NS
1.25 Ib/A
0.5 Ib/A
(per fallow
season)
30
[62719-395]
[62719-400]
60
[62719-424]
[NC990007]
[SC000002]
Not applicable
/'MA ^
(NA)
Use in conjunction with the USDA "witchweed"
eradication program in NC and SC. Applications may be
made in a minimum of 10 gal of water/A. The use of any
plants from a treated field for green chop, ensilage,
forage, or fodder is prohibited. PHI is 60 days.
Use limited to AR, LA, and MS. Application may be
made in a minimum of 20 gal of water/A using ground
equipment or 5 gal/A by air. Applications may be made
alone or as a tank mix with other herbicides. A 7-day
interval from treatment to planting is specified. The use
of any plants from a treated field for green chop,
ensilage, forage or fodder or the feeding or grazing of
animals on any treated area is prohibited. PHI is 60
days.
Cotton
Directed spray application
Postemergence
Ground equipment
1.6 Ib/gal EC
[62719-400]
[VA930010]
2 Ib/gal EC
[62719-395]
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
(single or
multiple
applications)
l.Olb/A
(multiple
applications)
0.5 Ib/A
(single
V1-^ o
application)
90
[62719-400]
[62719-424]
[VA930010]
NS
[62719-395]
75
[62719-400]
[62719-424]
NS
[62719-395]
Use limited to AL, AR, GA, LA, MS, MO, MM, NC,
OK, SC, TN, TX, and VA (Southern cotton).
Applications may be made in a minimum of 20 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. Application after initiation of
bloom is prohibited.
Use limited to AZ and CA (Western cotton).
Applications may be made in a minimum of 20 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. Application after initiation of
bloom is prohibited.
70
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Cotton (continued)
Broadcast application
Fallow bed
Aerial equipment
Broadcast application
Fallow bed
Ground equipment
Broadcast application
Fallow bed
Ground or aerial equipment
2 Ib/gal EC
[62719-395]
2 Ib/gal EC
[62719-395]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
NS
NS
NS
0.5 Ib/A
(per fallow
season)
0.5 Ib/A
(per fallow
season)
0.5 Ib/A
(per fallow
season)
NA
NA
NA
Use limited to AZ and CA. Applications may be made
in a minimum of 10 gal of water/A (minimum of 5 gal/A
for certain tank mix applications). Applications may be
made alone or as a tank mix with other herbicides. A 14-
day interval from treatment to incorporation and planting
is specified.
Applications may be made in a minimum of 20 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. A 14-day interval from
treatment to incorporation and planting is specified.
Applications may be made in a minimum of 20 gal of
water/A using ground equipment or 5 gal/A by air
(minimum of 10 gal/A by air in CA). Applications may
be made alone or as a tank mix with other herbicides. A
7-day interval from treatment to planting is specified.
Crabapples (See "Pome fruits")
Dates
Directed spray application
Dormant
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Fallow land
Broadcast application
Fallow bed
Ground or aerial equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
NA
Applications may be made in a minimum of 20 gal of
water/A using ground equipment or 10 gal/A by air.
Applications may be made alone or as a tank mix with
other herbicides.
71
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Fallow land (continued)
Broadcast application
Fallow bed
Ground equipment
1 6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
0.5 Ib/A
NS
NS
NA
Use limited to ID, OR, and WA. Use is restricted to
summer fallow land that will be planted back the
following year to barley, oats, or winter wheat.
Applications may be made in a minimum of 20 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides.
Feijoa
Directed spray application
Dormant
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Figs
Directed spray application
Dormant
Ground equipment
1 6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Filberts (See "Tree Nuts")
Garbanzo bean (see "Chickpea")
Garlic
Broadcast or band application
Postemergence to seeded
garlic (at least 2 true leaves)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.25 Ib/A
NS
0.5 Ib/A
60
Use limited to direct-seeded garlic in Western states of
AZ, CA, CO, ID, NV, MM, OR, TX, UT, and WA.
Applications may be made in a minimum of 40 gal of
water/A. For use on dry bulb garlic only; use on garlic
grown for seed is prohibited.
72
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Garlic (continued)
Broadcast or band application
Postemergence to seeded
garlic (at least 3 true leaves)
Ground equipment
Broadcast or band application
Postemergence to seeded
garlic (at least 2 true leaves)
Ground equipment
Broadcast or band application
After transplanting
Ground equipment
Broadcast application
Preemergence
Ground or aerial equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[CA920018]
2 Ib/gal EC
[CA960021]
0.06 Ib/A
0 12 Ib/A
0.5 Ib/A
0.06 Ib/A
0.25 Ib/A
NS
NS
NS
NS
NS
0.5 Ib/A
0 5 Ib/A
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
60
60
60
60
60
Use limited to direct-seeded garlic in Northeastern states
of CT, ME, MA, NH, NJ, NY, RI, and VT. Applications
may be made in a minimum of 40 gal of water/A. For
use on dry bulb garlic only; use on garlic grown for seed
is prohibited.
Use limited to direct-seeded garlic in all other states not
listed above. Applications may be made in a minimum
of 40 gal of water/A. For use on dry bulb garlic only;
use on garlic grown for seed is prohibited.
Use limited to transplanted garlic for all states except the
Northeastern states listed above. Applications may be
made in a minimum of 40 gal of water/A. For use on dry
bulb garlic only; use on garlic grown for seed is
prohibited.
Use limited to transplanted garlic in the Northeastern
states listed above. Applications may be made in a
minimum of 40 gal of water/A. For use on dry bulb
garlic only; use on garlic grown for seed is prohibited.
Use limited to CA. Applications may be made in a
minimum of 20 gal of water/A using ground equipment
or 10 gal/A by air. For use on dry bulb garlic only.
73
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Garlic (continued)
Directed spray application
Postemergence
Ground equipment
Chemigation
Preemergence or
postemergence
Sprinkler irrigation
1.6 Ib/gal EC
[CA920018]
1 IK/rrol T7f^
Z ID/ gal E:^
[CA960021]
[NV990001]
1.6 Ib/gal EC
[CA920018]
2 Ib/gal EC
[CA960021]
0.25 Ib/A
0.25 Ib/A
NS
NS
0.5 Ib/A
0.5 Ib/A
60
60
Use limited to CA and NV. Applications may be made
in a minimum of 20 gal of water/A. For use on dry bulb
garlic only.
Use limited to CA. For use on dry bulb garlic only.
Grapes
Directed spray application
Dormant
Ground equipment
Directed spray or broadcast
(over the top) application
Dormant (nonbearing)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.6 Ib/gal EC
[CA950008]
2 Ib/gal EC
[CA960023]
[WA970023]
1.5 Ib/A
1.5 Ib/A
NS
NS
1.5 Ib/A
NS
NS
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Use limited to CA and WA. Applications may be made
in a minimum of 40 gal of water/A. Application after
buds start to swell is prohibited.
74
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Grapes (continued)
Directed spray application
Nondormant
Ground equipment
Chemigation
Nondormant
Low-volume sprinkler
(microsprinkler) or drip
trickle irrigation
2 Ib/gal EC
[CA970026]
2 Ib/gal EC
[OR000001]
[WA970013]
2 Ib/gal EC
[CA970026]
[WA970024]
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
NS
NS
NS
1.5 Ib/A
1.5 Ib/A
1.5 Ib/A
14
60
14
Use limited to CA as a nondormant application to wine
grapes and raisin grapes only. Applications may be
made in a minimum of 20 gal of water/A (minimum of
10 gal/A for certain tank mix applications). Application
may be made alone or as a tank mix with other
herbicides.
Use limited to OR and WA as a nondormant application
to wine and processing grapes only. Applications may
be made in a minimum o f 50 gal of water/A.
Application may be made alone or as a tank mix with
other herbicides.
Use limited to CA and WA as a nondormant application
to grapes grown for processing (includes juice, wine, and
raisin grapes only).
Grasses grown for seed
Broadcast application
Ground equipment
2 Ib/gal EC
[OR990006]
[WA990035]
2 Ib/gal EC
[OR990006]
0. 125-0.375 Ib/A
0.121b/A
2
1
0.375 Ib/A
0.121b/A
150
150
Use limited to OR and WA for grass grown for seed
(including Kentucky bluegrass, tall fescue, orchardgrass,
bentgrass, and perennial ryegrass). Applications may be
made in a minimum of 20 gal of water/A. Applications
may be made alone or as a tank mix with other
herbicides. A 150-day pregrazing interval (PGI) has
been established.
Use limited to OR for grass grown for seed (including
fine fescues: chewing, creeping red, and hard types).
Applications may be made in a minimum of 20 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. A 150-day pregrazing
interval (PGI) has been established.
75
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
2 Ib/gal EC
[OR990036]
Maximum Single
Application Rate
(ai)
0.0375 Ib/A
Maximum No.
of Applications
Per Season
1
Maximum
Seasonal Rate
(ai)
NS
Preharvest
Interval (Days)
150
Use Limitations '
Use limited to OR for grass grown for seed (including
perennial ryegrass and tall fescue). Applications may be
made in a minimum of 20 gal of water/A. Applications
may be made alone or as a tank mix with other
herbicides. A 150-day pregrazing interval (PGI) has
been established.
Guavas (bearing and nonbearing)
Directed spray application
Postemergence (after new
foliage has hardened off)
Ground equipment
1.61b/galEC
[62719-400]
2 Ih/eal PC
[62719-424]
2.0 Ib/A
NS
4.0 Ib/A
1
Use limited to HI. Applications may be made in a
minimum of 15 gal of water/A. Applications may be
made alone or as a tank mix with other herbicides.
Hickory Nut (See "Tree Nuts")
Horseradish
Broadcast application
Preemergence
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 20 gal of
water/A.
Kiwifruit
Directed spray application
Dormant
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Loquat (See "Pome fruits")
76
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Macadamia Nut (bearing and nonbearing; see also "Tree nuts")
Directed spray application
Postemergence (after new
foliage has hardened off)
Ground equipment
2 Ib/gal EC
[HI960010]
2.0 Ib/A
1.0 Ib/A
(lava soil)
NS
4.0 Ib/A
7
Use limited to HI. Applications may be made in a
minimum of 15 gal of water/A. Applications may be
made alone or as a tank mix with other herbicides.
Feeding or grazing of animals on any treated area is
prohibited.
Mayhaws (See "Pome fruits")
Nectarines (See "Stone fruits")
Olive
Directed spray application
Dormant
Ground equipment
1 6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Onions, bulb
Broadcast or band application
Postemergence to seeded
onions (at least 2 true leaves)
Ground equipment
Broadcast or band application
Postemergence to seeded
onions (at least 3 true leaves)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.25 Ib/A
0.06 Ib/A
NS
NS
0.5 Ib/A
0.5 Ib/A
45
45
Use limited to direct-seeded onions in Western states of
AZ, CA, CO, ID, NV, MM, OR, TX, UT, and WA.
Applications may be made in a minimum of 40 gal of
water/A.
Use limited to direct-seeded onions in Northeastern
states of CT, ME, MA, NH, NJ, NY, RI, and VT.
Applications may be made in a minimum of 40 gal of
water/A.
77
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Onions, bulb (continued)
Broadcast or band application
Postemergence to seeded
onions (at least 2 true leaves)
Ground equipment
Broadcast or band application
After transplanting
Ground equipment
Broadcast or band application
Pre-transplanting
Ground equipment
Broadcast application
Pre-transplanting
Ground equipment
Chemigation
Postemergence (at least 2 true
leaves) or after transplanting
Sprinkler irrigation
1.61b/galEC
[62719-400]
7 1h/cra1 FC
[62719-424]
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[GA890006]
1.6 Ib/gal EC
[CA880034]
[OR9 10026]
2 Ib/gal EC
[OR970008]
0.121b/A
0.5 Ib/A
0.06 Ib/A
0.5 Ib/A
0.5 Ib/A
0.25 Ib/A
NS
NS
NS
NS
NS
NS
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
0.5 Ib/A
45
45
45
45
NS
45 (OR)
60 (CA)
Use limited to direct-seeded onions in all other states not
listed above. Applications may be made in a minimum
of 40 gal of water/A.
Use limited to transplanted onions for all states except
the Northeastern states listed above. Applications may
be made in a minimum of 40 gal of water/A.
Use limited to transplanted onions in the Northeastern
states listed above. Applications may be made in a
minimum of 40 gal of water/ A.
Use prohibited in Northeastern and Western states listed
above, except if specifically directed on other approved
supplemental labeling. Applications may be made in a
minimum of 40 gal of water/ A.
Use limited to GA. Applications may be made in a
minimum of 40 gal of water/A. The use of any treated
plants for feed or forage and the feeding or grazing of
any treated area are prohibited.
Use limited to CA and OR.
78
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Onions, bulb (continued)
Chemigation
Postemergence (at least 2 true
leaves)
Sprinkler irrigation
Chemigation
After transplanting
Sprinkler irrigation
2 Ib/gal EC
[CA960026]
[WA960033]
2 Ib/gal EC
[WA960033]
0.25 Ib/A
0.5 Ib/A
NS
NS
0.5 Ib/A
0.5 Ib/A
45
45
Use limited to CA and WA.
Use limited to WA.
Onions Grown for Seed
Broadcast application
Postemergence (at least 4 true
leaves)
Ground equipment
Broadcast application
Postemergence (at least 3 true
leaves)
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.03 Ib/A
0.121b/A
NS
NS
0.5 Ib/A
0.5 Ib/A
60
60
Use limited to onions grown for seed in Northeastern
states of CT, ME, MA, NH, NJ, NY, RI, & VT.
Applications may be made in a minimum of 40 gal/A.
Use limited to onions grown for seed in all other states
not listed above. Applications may be made in a
minimum of 40 gal/A.
Ornamental Plants
Field grown ornamentals and
Containerized ornamentals
Broadcast application
Postemergence (at least 4 true
leaves)
Ground equipment
2% Granular
[538-172]
2 Ib/gal EC
[62719-424]
1.5 Ib/A
NS
4.5 Ib/A
NA
79
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Ornamental Plants (continued)
Containerized ornamentals
Broadcast application
Postemergence (at least 4 true
leaves)
Ground equipment
Residential ornamentals
Broadcast application
Ground equipment
2% Granular
[538-172]
0.25% Solution
[239-2356]
2.0 Ib/A
1.5 Ib/A
NS
NS
6.0 Ib/A
3.01b/A
NA
NA
Papayas
Directed spray application
Postemergence
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
1.0 Ib/A
NS
3.01b/A
1
Use limited to HI. Initial application should occur no
earlier than 4 months after transplanting or 6 months
after direct seeding. Applications may be made in
minimum of 15 gal of water/A and repeated at 4-month
intervals.
Peaches (See "Stone fruits")
Pears (See "Pome fruits")
Pecans (See "Tree nuts")
80
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Peppermint
Broadcast or band application
Dormant
Ground equipment
Broadcast application
Dormant
Ground equipment
Broadcast application
Dormant
Ground equipment
1.6 Ib/gal EC
[62719-400]
9 Ib/pal FC
[62719-395]
1.6 Ib/gal EC
[CA930014]
[NV930002]
[SD940001]
2 Ib/gal EC
[MT960003]
[ND980001]
2 Ib/gal EC
[62719-424]
2 Ib/gal EC
[SD960007]
1.5 Ib/A
0.75 Ib/A
1.5 Ib/A
1.5 Ib/A
0.75 Ib/A
1.5 Ib/A
1
1
NS
1
1
1
NS
NS
1.5 Ib/A
NS
NS
NS
NA
NA
NA
NA
NA
NA
Use limited to OR and WA (East of Cascades) and
western ID. Application may be made in a minimum of
20 gal of water/A.
Use limited to western OR (Willamette Valley).
Application may be made in a minimum of 20 gal of
water/A.
Use limited to CA, MT, ND, NV, and SD. Applications
may be made in a minimum of 20 gal of water/A.
Use limited to OR and WA (East of Cascades) and CA,
ID, MT, NV, SD, and UT. Application may be made in
a minimum of 20 gal of water/A.
Use limited to western OR (Willamette Valley).
Application may be made in a minimum of 20 gal of
water/A.
Use limited to SD. Application may be made in a
minimum of 20 gal of water/ A.
81
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Peppermint (continued)
Broadcast application
Preemergence (dormant)
Ground equipment
1.6 Ib/gal EC
[IN840003]
[WI950001]
Ib/gal EC
[IN960004]
[MI970002]
[WI960009]
1.5 Ib/A
NS
NS
NA
Use limited to IN, MI, and WI for mint grown in muck
soil (>20% organic matter). Applications may be made
in a minimum of 20 gal of water/A. The use of any
treated plants for feed or forage and the feeding or
grazing of any treated area are prohibited.
Persimmons
Directed spray application
Dormant
Ground equipment
Pistachios (See also "Tree Nuts"
Directed spray application
Nondormant
Ground equipment
Chemigation
Nondormant
Flood (basin) irrigation
Chemigation
Nondormant
Flood (basin) irrigation, low-
volume sprinkler
(microsprinkler) or drip
trickle irrigation
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.5 Ib/A
NS
2.0 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
1.6 Ib/gal EC
[CA950007]
2 Ib/gal EC
[CA960019]
1 6 Ib/gal EC
[CA950007]
2 Ib/gal EC
[CA960019]
1.5 Ib/A
1.5 Ib/A
NS
NS
1.5 Ib/A
(nondormant
season)
1.5 Ib/A
(nondormant
season)
7
7
Use limited to CA. Application may be made in a
minimum of 20 gal of water/A (minimum of 10 gal/A for
certain tank mix applications). Application may be made
alone or as a tank mix with other herbicides.
Use limited to CA.
82
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg No ]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Plums (See "Stone fruits")
Pome fruits (including apple, crabapple, loquat, mayhaws, pear, and quince)
Directed spray application
Dormant
Ground equipment
1 6 Ib/eal FC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Pomegranates
Directed spray application
Dormant
Ground equipment
1 6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Prunes (See "Stone fruits")
Quince (See "Pome fruits")
Raspberries
Directed spray application
Early season (primocane
growth 4 to 6 inches)
Ground equipment
1.6 Ib/gal EC
[OR960006]
2 Ib/gal EC
[OR960037]
[WA960034]
0.8 Ib/A
0.75 Ib/A
2
2
1.2 Ib/A
1.25 Ib/A
50
50
Use limited to OR and WA. Applications may be made
in a minimum of 50 gal water/A.
83
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Soybeans
Broadcast application
(Conservation tillage)
Early preplant
Ground equipment
Broadcast application
(No-till)
Preemergence
Ground equipment
Broadcast application
(Conventional till)
Preemergence
Ground equipment
Directed spray application
(Conventional-till)
Postemergence
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
0.75 Ib/A
0.5 Ib/A
0.38 Ib/A
0.25 Ib/A
2
2
2
2
0.75 Ib/A
(all uses)
0.75 Ib/A
(all uses)
0.5 Ib/A
(preemergent
uses)
0.75 Ib/A
(all uses)
0.5 Ib/A
(preemergent
uses)
0.75 Ib/A
(all uses)
0.5 Ib/A
(preemergent
uses)
NS
NS
NS
NS
Use prohibited in CA. Application should be made
approximately 14 days prior to planting.
Use prohibited in CA. Application should be made
within 1 day of planting. Application may be made in a
minimum of 20 gal of water/A. Application may be
made alone or as a tank mix with other herbicides.
Use prohibited in CA. Application should be made when
soybean plants are a minimum of 8 inches tall and before
blooms appear. Application may be made in a minimum
of 20 gal of water/A. Application may be made alone or
as a tank mix with other herbicides.
84
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Soybeans (continued)
Broadcast application
Fallow bed
Ground or aerial equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
NS
0.5 Ib/A
(per fallow
season)
NA
Use prohibited in CA. Applications may be made in a
minimum of 20 gal of water/A using ground equipment
or 5 gal/A by air. Applications may be made alone or as
a tank mix with other herbicides. A 7-day interval from
treatment to planting is specified.
Spearmint
Broadcast or band application
Dormant
Ground equipment
Broadcast application
Dormant
Ground equipment
Broadcast or band application
Dormant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
2 Ib/gal EC
[62719-424]
[SD960007]
1.6 Ib/gal EC
[CA930014]
[NV930002]
[SD940001]
2 Ib/gal EC
[MT960003]
[ND980001]
1.5 Ib/A
1.5 Ib/A
1.5 Ib/A
1
1
NS
NS
NS
NS
NA
NA
NA
See "Peppermint."
See "Peppermint."
See "Peppermint."
85
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Spearmint (continued)
Broadcast application
Preemergence (dormant)
Ground equipment
1.61b/galEC
[IN840003]
[WI950001]
2 Ib/gal EC
[IN960004]
[MI970002]
[WI960009]
1.5 Ib/A
NS
NS
NA
See "Peppermint."
Stone fruits (including apricot, cherry, nectarine, peach, plum, and prune)
Directed spray application
Dormant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Taro
Broadcast or band application
Preemergence (within one
week after transplanting)
Ground equipment
Directed spray application
Postemergence
Ground equipment
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
1.6 Ib/gal EC
[62719-400]
2 Ib/gal EC
[62719-424]
0.5 Ib/A
0.25 Ib/A
NS
NS
1.0 Ib/A
(all uses)
1.0 Ib/A
(all uses)
0.5 Ib/A
(multiple
post-direct
applications)
0.5 Ib/A
(preemergent
uses)
6
(months)
6
(months)
Use limited to HI. Applications may be made in a
minimum of 15 gal of water/A.
Use limited to dryland taro grown in HI. Applications
may be made in a minimum of 20 gal of water/A.
86
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Example
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum No.
of Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval (Days)
Use Limitations '
Tree nurseries and plantations, right of ways, irrigation systems, uncultivated non-agricultural land, industrial sites
Directed spray application
Postemergence
Ground equipment
2 Ib/gal EC
[62719-424]
2.0 Ib/A
NS
2.0 Ib/A
NA
Tree nuts (including almond, beech nut, Brazil nut, butternut, cashew, chestnut, chinquapin, filbert, hickory nut, macadamia nut, pecan, pistachio, and walnut)
Directed spray application
Dormant
Ground equipment
1.61b/galEC
[62719-400]
2 Ib/gal EC
[62719-395]
[62719-424]
1.5 Ib/A
NS
1.5 Ib/A
NS
Applications may be made in a minimum of 40 gal of
water/A. Applications may be made alone or as a tank
mix with other herbicides. The use of any treated plants
for feed or forage, the feeding or grazing of any treated
area, and application after buds start to swell or when
foliage or fruit are present are prohibited.
Walnuts (See also "Tree nuts")
Directed spray application
Nondormant
Ground equipment
Chemigation
Nondormant
Flood (basin) irrigation, low-
volume sprinkler
(microsprinkler) or drip
trickle irrigation
1.6 Ib/gal EC
[CA890012]
2 Ib/gal EC
[CA960020]
2 Ib/gal EC
[CA960020]
1.5 Ib/A
1.5 Ib/A
NS
NS
1.5 Ib/A
(nondormant
season)
1.5 Ib/A
(nondormant
season)
7
7
Use limited to CA. Application may be made in a
minimum of 20 gal of water/A (minimum of 10 gal/A for
certain tank mix applications). Application may be made
alone or as a tank mix with other herbicides.
Use limited to CA.
87
-------
Appendix B:Data Supporting the Reregistration of Oxyfluorfen
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
New Guideline
Number
Old Guideline
Number
Description
PATTERN CITATION(S)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1200
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7300
830.7840
830.7860
830.7950
830.7550
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-7
63-8
63-9
63-11
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
Melting Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition Coefficient
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
44828901, CSF 11/17/99
44720201, CSF 12/4/98
44828901, 44720201
44828901, 44720201
44828901, 44720201, 44720202
44828901, CSF 11/17/99,
44712001, 44712002,
CSF 12/4/98
44828901, 44720201, 44720202
44828902, 44720203
44828902, 44720203
44828902, 44720203
44828902, 44720203
44828902, 44720203
44828902, 44720203
44828902, 44712004, 44712005
44828902, 44712006
44828902, 44712007
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
71-1
71-2A
71-2B
71-4A
71-4B
72-1A
72- 1C
72-2A
72-3A
72-3B
72-3 C
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
All
All
All
All
All
All
All
All
All
All
All
92136102
92136103
92136104
Data Gap
Data Gap
42129801
42129802
45271301
41698801
42378901
30970117
850.1400
72-4A
Fish- Early Life Stage
All
92136057 (99270), Data Gap
88
-------
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
New Guideline
Number
850.1300
850.1350
850.1735
850.1740
850.1500
850.4225
850.4250
850.4400
Old Guideline
Number
72-4B
None
None
72-5
123-1A
123-1B
123-2
Description
Estuarine/Marine Invertebrate Life Cycle
Fresh Water Whole Sediment Acute
Toxicity
Estruarine/marine Whole Sediment
Acute Toxicity
Life Cycle Fish
Seed Germ./ Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
PATTERN CITATION(S)
All
All
All
All
All
All
All
Data Gap
Data Gap
Data Gap
Reserved
4 1644001, Data Gap
4 1644001, Data Gap
45271302, Data Gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3200
870.3465
870.4100
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
870.5375
None
870.7485
870.7600
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-2
82-4
83-1B
83-2B
83-3A
83-3B
83-4
83-5
84-2A
84-2B
84-4
85-1
85-2
Acute Oral Toxicity -Rat
Acute Dermal Toxicity -Rabbit/Rat
Acute Inhalation Toxicity -Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
44712010, 44828903
44712011,44828904
44712012
44712013, 44828906
44712014, 44828905
44712015, 44814901
44933101, 00117601, 92136011,
42142317, 00117603, 0017602,
92136012,42142316
Data Gap
Waived
00078767, 92136062, 92136016
00037939, 92136017
44933103
44933102, 00094052, 00094051,
92136018, 92136019
42014901
00083445, 00135072, 92136061
00098421, 44942801, 44933104,
40992201, 00098420, 00098422,
44947205
00098419, 44933105, 44933106,
44947204, 44947203, 41873801,
00098418, 00109283, 00098423
44947201, 00098424
42374201, 42652401
42142306, 92136095
89
-------
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
PATTERN CITATION(S)
New Guideline
Number
875.2100
875.2400
None
Old Guideline
Number
Description
860.1200
860.1300
860.1300
860.1340
860.1340
860.1380
860.1480
860.1500
860.1500
860.1500
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A
133-3
231
Foliar Residue Dissipation
Dermal Passive Dosimetry Exposure
Estimation of Dermal Exposure at
Outdoor Sites
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.1240
835.6100
None
None
840.1200
161-1
161-2
161-3
162-1
162-2
163-1
164-1
164-4-SS
165-4
202-1
RESIDUE
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Drinking Water Monitoring
Bioaccumulation in Fish
Drift Field Evaluation
CHEMISTRY
171-3 Chemical Identity
171-4A
171-4B
171-4C
171-4D
171-4E
171-4J
171-4K
171-4K
171-4K
ABC 42098301, Data Gap
ABC 42098301
ABC 44972201,444598-01
All 96882
All 42142307,42129101
All 41999901
All 42142309
All 42142310
All 94336,42142311
All 43840101
All Data Gap
All 96883
ABC 144894
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animals
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Root and Tuber Vegetables Group
Crop Field Trials (Horseradish)
Crop Field Trials (Taro Corm)
Leaves of Root and Tuber Vegetables Group
Crop Field Trials (Taro Foliage)
AB Data Gap1
00160143, 42865001, 42873301,
AB 42913201, 92136027, 92136101,
92136114,92136121
AB 42634701 , 42670601, 43317701
00149622, 40223201, 92136028,
AB 92136029, 92136065, 44400202,
44400203
00135077, 43307502 , 43307503,
AB 43346401,92136030, 92136060,
44400204, 44407801, 44506601
43424201, 43424202, 43813201,
43859801
AB 43152201,43152202
AB 43973701
AB 40940301
AB 40940301
90
-------
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
PATTERN CITATION(S)
New Guideline Old Guideline
Number Number
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
860.1500 171-4K
860.1500 171-4K
171-4K
171-4K
171-4K
Description
Bulb Vegetables Group
Crop Field Trials (Garlic) AB
Crop Field Trials (Onions, dry bulb) AB
Brassica Leafy Vegetables Group
Crop Field Trials (Broccoli) AB
Crop Field Trials (Cabbage) AB
Crop Field Trials (Cauliflower) AB
Legume Vegetables (Succulent or Dried) Group
Crop Field Trials (Chickpea) AB
Crop Field Trials (Soybean seed and
aspirated grain fractions)
Foliage of Legume Vegetables Group
Crop Field Trials (Soybean forage and
hay)
Pome Fruits Group
Crop Field Trials (All)
Stone Fruits Group
Crop Field Trials (All)
Berries Group
Crop Field Trials (Blackberries)
Crop Field Trials (Raspberries)
Tree Nuts Group
Crop Field Trials (All)
Crop Field Trials (Pistachios)
Cereal Grains Group
Crop Field Trials (Corn, field, grain and
aspirated grain fractions)
AB
AB
AB
AB
AB
AB
AB
AB
No additional data required
00126583, 43965501, 92136049,
92136083
00148291, 40007203, 92136034,
92136070
00148291, 40007201, 43986301,
92136035,92136071
00148291, 40007202, 43986302,
92136036, 92136072
41622701
00125632, 00136873, 92136053,
92136086
AB Data Gap
00079475, 00141092, 40223206,
43794001, 44575901, 92136050,
92136051,92136084
00036704, 00036705, 00036708,
00079475, 00110745, 00146340,
43794008, 44025401, 92136054,
92136087
43424201
43424202 , 43424203
00036707, 00071290, 00071291,
00071292, 00071293, 00110745,
00141093, 40223206, 92136055,
92136088
00071290, 00071291, 00071292,
00071293,92136056, 92136089
00135077, 43944801, 92136038,
92136074
91
-------
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
New Guideline
Number
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1520
860.1520
Old Guideline
Number
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4L
171-4L
Description
Forase, Fodder, Hav, and Straw of Cereal
Crop Field Trials (Corn, field, forage and
fodder)
Miscellaneous Commodities
Crop Field Trials (Artichokes)
Crop Field Trials (Avocado)
Crop Field Trials (Bananas)
Crop Field Trials (Cacao beans)
Crop Field Trials (Coffee)
Crop Field Trials (Cotton, seed, and gin
byproducts)
Crop Field Trials (Dates)
Crop Field Trials (Fallow land)
Crop Field Trials (Feijoa)
Crop Field Trials (Figs)
Crop Field Trials (Grapes)
Crop Field Trials (Guavas)
Crop Field Trials (Kiwifruits)
Crop Field Trials (Mint, tops)
Crop Field Trials (Olives)
Crop Field Trials (Papayas)
Crop Field Trials (Persimmons)
Crop Field Trials (Pomegranates)
Crop Field Trials (Strawberries)
Processed Commodities
Processed Food (Apples)
Processed Food (Coffee)
USE
PATTERN
Grains Group
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
CITATION(S)
00135077, 92136038, 92136074
00145973, 43794007, 92136031,
92136067
00145972, 40223202, 43794002,
92136032, 92136068
00102529, 92136033, 92136069,
Data Gap
PP#OE3898
00102529, 92136037, 92136073
00071290, 00071291, 00071292,
00071293, 00110747, 92136039,
92136040, 92136075, Data Gap
00145972, 40223205, 92136041,
92136076
40567001
PP#9E3779
00079475, 43794003 , 92136042,
92136077
00036703, 00110745, 00146340,
92136043, 92136078, 44385401,
44385402
00158014, 92136044, 92136079
00145972, 40223203, 43794005,
92136045, 92136080
00071290, 00071291, 00071292,
00071293, 92136046, 92136047,
92136081
00145972, 40223204, 43794006,
92136048, 92136082
40783201
PP#9E3718
00145972, 43794004 , 92136052,
92136085
IR-4 Project PR-3443
00141092,92136051
44172301
92
-------
Data Supporting Guideline Requirements for the Reregistration of Oxyfluorfen
REQUIREMENT
PATTERN CITATION(S)
New Guideline Old Guideline
Number Number
860.1520 171-4L
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
860.1850
171-4L
171-4L
171-4L
171-4L
171-4L
171-4L
171-4L
165-1
Description
Processed Food (Corn, field, grain)
Processed Food (Cottonseed)
Processed Food (Figs)
Processed Food (Grapes)
Processed Food (Mint)
Processed Food (Olives)
Processed Food (Plums)
Processed Food (Soybeans)
Rotational Crops (Confined)
AB 43944801
00071290, 00071291, 00071292,
AB 00071293,00110747,92136040,
92136075
AB No additional data required
AB No additional data required
00071290, 00071291, 00071292,
00071293,92136046, 92136047
AB No additional data required
AB No additional data required
AB 43764901
AB 40567001
Label amendments are required.
93
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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, 1921 Jefferson Davis Highway, Arlington, VA. It is open
Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
August 10, 1998. Sixty days later the first public comment period closed. The EPA then
considered comments, revised the risk assessment, and added the formal "Response to
Comments" document and the revised risk assessment to the docket on June 16, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
www.epa.gov/pesticides/op
These documents include:
HED Documents:
1. Revised Human Health Risk Assessment for Oxyfluorfen, 4-29-02, Felicia
Fort, OPP/HED
2. Second Revised Occupational and Residential Risk Assessment for
Oxyfluorfen, 5-01-02, Timothy Dole, OPP/HED
3. Report of the HIARC for Oxyfluorfen, Kit Farwell, OPP/HED
4.Toxicity Chapter for Oxyfluorfen, 4-08-02, Kit Farwell, OPP/HED
5. FQPA Safety Factor Report, 4-30-01, Kit Farwell, OPP/HED
6. Product and Residue Chemistry Chapter for Oxyfluorfen, 6-06-01, Jose
Morales, OPP/HED
7. Dietary Risk Assessment for Oxyfluorfen, 7-12-01, Jose Morales, OPP/HED
EFED Documents:
1. Water Estimates for Oxyfluorfen, 8-30-01, Amer Al-Mudallal, OPP/EFED
2. Revised EFED Risk Assessment, 5-02-02, Christine Hartless, OPP/EFED
94
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Appendix D. Citations Considered to be Part of the Database Supporting the Interim Reregistration
Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
95
-------
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
96
-------
BIBLIOGRAPHY
MRID CITATION
Toxicology Chapter Bibliography
00037939 Goldenthal, E. and Wazeter, F. (1977). RH-2915 Technical - Twenty month
dietary feeding study in mice. Final reports. International Research and
Development Corporation, Mattawan, MI. Laboratory Project Identification:
None given. Unpublished.
00071915 Cruzan, G.(1978) RH 2915, Twenty day repeat percutaneous toxicity in rabbits.
Toxicology Department, Rohm and Haas Company, Spring House, PA. Protocol
No. TD-77P-35. February, 1978. Unpublished.
00071916 Goldenthal, E. 1978. One month inhalation toxicity study in rats. International
Research and Development Corporation Toxicology Department (address not
given). Study No. 285-018, June 21, 1978. Unpublished.
00078767 Weatherholtz W.W. (1981) 104-Week Toxicity Study in Dogs RH 2915.
Hazleton Laboratories of America, Inc. Project No. 417-367, April 9, 1981.
Unpublished.
00083445,
00096872,
92136061
Auletta, C. and W. Rinehart (1990) Goal® technical Herbicide (RH-2915
technical): twenty -four month oral toxicity/carcinogenicity study in rats.
Bio/dynamics, Inc. Mettler Rd., East Millstone, NJ 08873, Laboratory project ID
75-1 1 1 1 A, May 16, 1990. (This study was completed in 1977.)
00094051 Hoberman, A.M.; Christian, M.S. (1981) Goal herbicide-oral rangefinding study
in pregnant rabbits: Argus Project 018-006P; Rohm and Haas Company Study
81P-86. Prepared by Argus Research Laboratories, Inc., submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL: 246694-B). Unpublished.
00094052 Hoberman, A.M., M.S. Christian, and G.D. Christian (1981) Goal herbicide -
teratogenicity study in rabbits. Argus Research Laboratories, Inc.. Argus Project
018-006, November 26, 1981. Unpublished.
00098418 McCarthy, K.L.; O'Neill, P.J. (1982) Goal Technical Cytogenetic Study in Rats:
Report No. 81R-261. (Unpublished study received Apr 8, 1982 under 707-145;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:247206-B)
97
-------
BIBLIOGRAPHY
MRID CITATION
00098419 Cifone, M.A.; Fisher, J. (1982) Mutagenicity Evaluation of RH-2915, Pure,
TD-81-308 in the Mouse Lymphoma Forward Mutation Assay: LBI Project No.
20989; Report No. 81RC-165. Final rept. (Unpublished study, including letter
dated Mar 10, 1982 from K.L. McCarthy to S.S. Burke, received Apr 8, 1982
under 707-145; prepared by Litton Bionetics, Inc., submitted by Rohm & Haas
Co.; Philadelphia, Pa.; CDL:247206-C)
00098420 Scribner, H.E.; Melly, J.G.; O'Neill, P.J.; et al. (1982) Goal RH-2915: Microbial
Mutagen Assay: Report No. 80R-247. (Unpublished study, including letter dated
Mar 10, 1982 from M.F. Cochran and S.S. Burke to C. Swithenbank, received
Apr 8, 1982 under 707-145; submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL: 247206-D)
00098421 Scribner, H.E.; Melly, J.G.; O'Neill, P.J.; et al. (1980) Goal Tech, Purified:
Microbial Mutagen Assay: Report No. 81R-28. (Unpublished study, including
letter dated Oct 28, 1981 from M.F. Cochran and W.T. Lynch to C. Swithenbank,
received Apr 8, 1982 under 707-145; submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:247206-E)
00098422 Scribner, H.E.; Melly, J.G; Lohse, K.; et al. (1982) Goal (Polar Fraction):
Microbial Mutagen Assay: Report No. 82R-80. (Unpublished study received Apr
8, 1982 under 707-145; submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:247206-F)
00098423 Myhr, B.C.; McKeon, M. (1982) Evaluation of RH-2915 (TD 81-561, Lot No.
7530) in the Primary Rat Hepatocyte: Unscheduled DNA Synthesis Assay: LBI
Project No. 20991; No. 82RC-20. Final rept. (Unpublished study, including
letter dated Mar 23, 1982 from K.L. McCarthy to S.S. Burke, received Apr 8,
1982 under 707-145; prepared by Litton Bionetics, Inc., submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL:247206-G)
00098424 Myhr, B.C.; McKeon, M. (1982) Evaluation of Polar Fraction from Lot 2-3985
(TD 81-562, WJZ 1861) in the Primary Rat Hepatocyte: Unscheduled DNA
Synthesis Assay: LBI Project No. 20991; No. 82RC-21. Final rept. (Unpublished
study, including letter dated Mar 23, 1982 from K.L. McCarthy to S.S. Burke,
received Apr 8, 1982 under 707-145; prepared by Litton Bionetics, Inc.,
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:247206-H)
98
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BIBLIOGRAPHY
MRID CITATION
00109283 Cifone, M.; Fisher, J. (1982) Mutagenicity Evaluation of RH 2915 Technical in
the Mouse Lymphoma Forward Mutation Assay: LBI Project No. 20989; Rohm
and Haas Report No. 82RC-37. Final rept. (Unpublished study received Jul 22,
1982 under 707-145; prepared by Litton Bionetics, Inc., submitted by Rohm &
Haas Co., Philadelphia, PA; CDL:247900-A)
00117601 Harris, J.C. and O'Hara, G.P. (1982). RH-2915 Three month dietary toxicity
study in rats. Rohm and Haas Company, Toxicology Department, Spring House,
PA. Report No. 82R-62. 10/26/82. Unpublished.
00117602 DiDonato, LJ. and O'Hara, G.P. (1982). Goal-Three month mouse dietary study.
Rohm and Haas Company, Toxicology Department, Spring House, PA. Report
No. 82R-12. 10/26/82. Unpublished.
00117603 Burke, S.S. (review, translated from Japanese, original author not provided,
1982). Goal: thirteen week subacute toxicity study by dietary administration in
rats. Nomura Research Institute (Japan). Report No. 81RC1008. Unpublished.
00135072 Tornaben, J.; Barthel, C.; Brown, W. (1977) A Twenty-four Month Oral Toxicity/
Carcinogenicity Study of RH 2512 and RH 2915 in Rats: Project No. 75-1111.
(Unpublished study received Mar 8, 1978 under 707-142; prepared in cooperation
with Research Pathology Services, Inc., submitted by Rohm & Haas Co.,
Philadelphia, PA; CDL:096872-A)
40992201 Sanies, J.; Frank, J. (1988) Goal Herbicide (Technical): Salmonella typhimurium
Gene Mutation Assay: Report No. 88R-191. Unpublished study prepared by
Rohm and Haas Co. 25 p.
41873801 Gudi, R. (1990) Acute Test for Chemical Induction of Chromosome Aberration in
Mouse Bone Marrow Cells in Vivo: Lab Project Number 0158-1541: 90RC-006.
Unpublished study prepared by Sitek Research Laboratories. 49 p.
41806501 Solomon, H.M. and Romanello, A.S. (1991) Goal: oral (gavage) developmental
toxicity study in rats. Rohm and Haas Company, Spring House, PA. Study
Number: 90R-008. Unpublished. 2/15/91. Unpublished.
42014901
Solomon, H.M., W.R. Brown, R.E. Swenson, and T.L. Thomas (1991) Goal®
Technical Herbicide: Two generation reproduction study in rats. Rohm and Haas
99
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BIBLIOGRAPHY
MRID CITATION
Company, Toxicology Department, Spring House, PA 19477. Report No. 90P-
007. August 26, 1991. Unpublished.
42142316 Spinnler, J.F. and Towson, A. J. (1990) Goal® technical herbicide: analytical
report on Goal® content in mouse feed. 5/15/90. Unpublished. (In support of
MRID 00117602, Goal—Three month mouse dietary study, Rohm and Haas
Company, 1982.)
42142317 Spinnler, J.F. and Towson, A. J. (1990). Goal® technical herbicide: analytical
report on Goal® content in rat feed. Report Supplement No. 82R-062A. 5/15/90.
Unpublished, (in support of MRID 00117601, Three month dietary toxicity study
in rats. Rohm and Haas Company, 1982)
42142318 Spinnler, J.; Towson, A. (1990) Goal Technical Herbicide: Analytical Report on
Goal Content in Rabbit Gavage Dose Samples: Supplement to MRID 94051:
Project ID: SC-81-0258: 81RC-142A. Prepared by Rohm and Haas.
Unpublished.
42142319 Spinnler, J.; Towson, A. (1990) Goal Technical Herbicide: Analytical Report on
Goal Content in Rabbit Gavage Dose Samples: Supplement to MRID 94052:
Project ID: SC-81-0259: 81RC-173A. Prepared and submitted by Rohm & Haas.
Unpublished.
42374201 DiDonato, L; Hazelton, G. (1992) Oxyfluorfen (carbon 14) (Goal Herbicide):
Pharmacokinetic Study in Rats: Lab Project Number: 90P-193: 90R-193.
Unpublished study prepared by Rohm & Haas Co. 133 p.
42652401 Zhang, Q. (1993) Final Report: Pharmacokinetic Study in Rats: (carbon 14)-
Oxyfluorfen: Supplemental Report A: Metabolism of (carbon 14)-Oxyfluorfen in
Rats: Lab Project Number: 90R-193: 34-92-97. Unpublished study prepared by
Rohm and Haas Co. 251 p.
44712010 Dreher, D. (1995) AG 510: Acute Oral Toxicity (Limit) Test in the Rat: Lab
Project Number: 008.297. Unpublished study prepared by Safepharm
Laboratories, Ltd. 18 p.
100
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BIBLIOGRAPHY
MRID CITATION
44712011 Dreher, D. (1995) AG 510: Acute Dermal Toxicity (Limit Test) in the Rat: Lab
Project Number: 008.298. Unpublished study prepared by Safepharm
Laboratories, Ltd. 19 p.
44712012 Blagden, S. (1995) AG 510: Acute Inhalation Toxicity (Nose Only) in the Rat:
Lab Project Number: 008.299. Unpublished study prepared by Safepharm
Laboratories, Ltd. 34 p.
44712013 Dreher, D. (1995) AG 510: Acute Eye Irritation Test in the Rabbit: Lab Project
Number: 008.301. Unpublished study prepared by Safepharm Laboratories, Ltd.
20 p.
44712014 Dreher, D. (1995) AG 510: Acute Dermal Irritation Test in the Rabbit: Lab
Project Number: 008.300. Unpublished study prepared by Safepharm
Laboratories, Ltd. 15 p.
44712015 Dreher, D. (1995) AG 510: Magnusson and Kligman Maximization Study in the
Guinea Pig: Lab Project Number: 008.302. Unpublished study prepared by
Safepharm Laboratories, Ltd. 33 p.
44814901 Glaza, S. (1996) Dermal Sensitization Study of Goal 2XL(P) in Guinea
Pigs-Maximization Test: Final Report: Lab Project Number: CHW 6228-123:
96P-102: 96RC-102. Unpublished study prepared by Corning Hazleton Inc. 104
P-
44828903 Lampe, K.; Morrison, R.; Baldwin, R. (1988) Acute Oral Toxicity Study in Male
and Female Rats: Goal Technical 95 Herbicide: Lab Project Number: 87P-245:
87R-142. Unpublished study prepared by Rohm and Haas Co. 13 p.
44828904 Lampe, K.; Morrison, R.; Baldwin, R. (1988) Acute Dermal Toxicity Study in
Male Rabbits: Goal Technical 95 Herbicide: Lab Project Number: 87P-246:
87R-144. Unpublished study prepared by Rohm and Haas Co. lip.
44828905 Lampe, K.; Morrison, R.; Baldwin, R. (1988) Skin Irritation Study in Rabbits:
Goal Technical 95 Herbicide: Lab Project Number: 87P-231: 87R-145.
Unpublished study prepared by Rohm and Haas Co. 10 p.
101
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BIBLIOGRAPHY
MRID CITATION
44828906 Lampe, K.; Morrison, R.; Baldwin, R. (1988) Eye Irritation Study in Rabbits:
Goal Technical 95 Herbicide: Lab Project Number: 87P-233: 87R-143.
Unpublished study prepared by Rohm and Haas Co. 14 p.
44933101 Steward, J. S., (1997) Oxyfluorfen Technical: Toxicity Study by Dietary
Administration to CD Rats for 13 Weeks. Huntingdon Life Sciences Ltd.,
Suffolk, England. Laboratory Report No. 96/AGN077/1128, March 3, 1997.
Unpublished.
44933102 Burns, L.M. (1997). Oxyfluorfen Technical: Study of Embryo-Fetal Toxicity in
the Rabbit by Oral Gavage Administration. Huntingdon Life Sciences Ltd.,
Suffolk, England. Laboratory Report # 96/AGN074/1147, February 5, 1997.
Unpublished.
44933103 Burns, L.M. (1997). Oxyfluorfen Tech: Study of Embryo-Fetal Toxicity in the
CD Rat by Oral Gavage Administration. Huntingdon Life Sciences Ltd., Suffolk,
England. Laboratory Report # 96//AGN075/1054, January 30, 1997.
Unpublished.
44933104 Everich, R. (1995) AG 510 Technical: Bacterial Mutation Assay: Lab Project
Number: AGM35/951066. Unpublished study prepared by Huntingdon Research
Centre, Ltd. 23 p.
44933105 Everich, R. (1995) AG 510 Technical: Mouse Micronucleus Test: Lab Project
Number: AGM/952067. Unpublished study prepared by Huntingdon Research
Centre, Ltd. 23 p.
44933106 Everich, R. (1995) AG 510 Technical: In Vivo Rat Liver DNA Repair Test: Lab
Project Number: AGM37/951849. Unpublished study prepared by Huntingdon
Research Centre, Ltd. 25 p.
44942801 Willington, S. (1999) AG 510: Testing for Mutagenic Activity with Salmonella
typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100: Lab Project
Number: 757039: 12096. Unpublished study prepared by Inveresk Research
International. 37 p.
44947201 Jagannath, D. (1987) Mutagenicity Test on Goal Technical 95 Herbicide in the
Bacterial DNA Damage Test (Rec-Assay): Revised Final Report: Lab Project
102
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BIBLIOGRAPHY
MRID CITATION
Number: 1002. Unpublished study prepared by Hazleton Laboratories America,
Inc. 20 p.
44947203 Sames, 1; Frank, J. (1989) Goal Herbicide (Technical 95): In Vivo Cytogenetics
Study in Mice: Lab Project Number: 88P-149:88R-163. Unpublished study
prepared by Rohm and Haas Company. 29 p.
44947204 Murli, H. (1999) Mutagenicity Test on Goal Technical Purified Herbicide
(TD98-0115) Measuring Chromosomal Aberrations in Chinese Hamster Ovary
(CHO) Cells: Final Report: Lab Project Number: 20155-0-437OECD: 98RC-191.
Unpublished study prepared by Covance Laboratories Inc. 83 p.
92136101,
42142306,
92136095
Cheng, T. (1989) 14C-Oxyfluorfen: Dermal absorption study in male rats.
Hazleton Laboratories America, Inc., Madison, WI. Laboratory Project No. HLA
6228-105, May 8, 1989. Unpublished.
92136011 Nave, V.A.; Longacre, S.L. (1990). Phase 3 summary of MRID 00117601. Goal
herbicide (oxyfluorfen) three month dietary toxicity study in rats. Unpublished
92136012 Nave, V.A. and Longacre, S.L. (1990). Phase 3 summary of MRID 00117602
Goal® herbicide (oxyfluorfen) three month dietary toxicity study in mice. 5/8/90.
92136015 Nave, V.; Longacre, S. (1990). Phase 3 Summary of MRID 00083445. Goal
Herbicide (Oxyfluorfen) Twenty-Four Month Oral Toxicity/ Carcinogenicity
Study in Rats: Rohm and Haas Report 77RC-904; Project 75-1111 A. Prepared by
Rohm and Haas Co.
92136016 Nave, V.; Longacre, L. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 00078767. Goal Herbicide (Oxyfluorfen) 104-Week Dietary Toxicity
Study in Dogs: Rohm and Haas Report 81RC-055; Project No. 417-367.
Prepared by Hazleton Laboratories America, Inc. 12 p.
92136017 Longacre, S. (1990). Rohm & Haas Company Phase 3 Summary of MRID
00037939. Goal Herbicide (Oxyfluorfen) Oncogenicity Study in Mice: Rohm and
Haas Report No. 77RC-1110; Project 285-012. Prepared by Rohm and Haas Co.
March 20, 1990.
92136018 Nave, V.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 00094051 and Related MRIDs 00094052. Goal Herbicide (Oxyfluorfen)
103
-------
BIBLIOGRAPHY
MRID CITATION
Oral-range-finding Study in Pregnant Rabbits: Rohm and Haas Report 81RC-142;
Project No. 018-006P. Prepared by Argus Research Labs. Inc. 15 p.
Unpublished.
92136019 Nave, V.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 00094052 and Related MRIDs 00094051. Goal Herbicide (Oxyfluorfen)
Teratogenicity Study in Rabbits: Rohm and Haas Report 8IRC-173; Project No.
018-006. Prepared by Argus Research Labs. Inc., submitted by Rohm & Haas.
5/15/90. Unpublished.
92136062 Weatherholtz, W.W. (1990) Goal® Technical Herbicide (RH-2915 Technical):
104-Week Dietary Toxicity study in Dogs. Phase 3 Reformat of MRID 00078767.
Hazleton Laboratories America, Inc., Vienna, VA. Report 81RC-055. May 16,
1990. Unpublished.
104
-------
BIBLIOGRAPHY
MRID CITATION
Chemistry Chapter References
44712001 Wells, D. (1997) Galigan - Characterization of the Pure Active Ingredient (AI):
Final Report: Lab Project Number: 97-1-6852: 11742.0896.6108.210.
Unpublished study prepared by Springborn Laboratories, Inc. 61 p.
44712002 Guzikevich, G. (1996) Analysis of 5 Lots of Oxyfluorfen Technical: Lab Project
Number: 96-08: 9000849B. Unpublished study prepared by Agan Chemical
Manufacturers Ltd. 120 p.
44712003 Wells, D. (1997) Galigan TGAI - Determining the Product Chemistry: Final
Report: Lab Project Number: 97.1.6831: 11742.0896.6109.885. Unpublished
study prepared by Springborn Laboratories, Inc. 66 p.
44712004 Harley, D. (1997) Galigan TGAI - Determination of Solubility in Water and Six
Organic Solvents: Final Report: Lab Project Number: 97.1.6861:
11742.0896.6110.700. Unpublished study prepared by Springborn Laboratories,
Inc. 51 p.
44712005 Wells, D. (1998) Galigan (Oxyfluorfen) TGAI - Determination of Water
Solubility: Final Report: Lab Project Number: 98.4.7297: 11742.0997.6137.702.
Unpublished study prepared by Springborn Laboratories, Inc. 33 p.
44712006 Wells, D. (1997) Galigan (Oxyfluorfen) TGAI - Determination of Vapor Pressure
Using a Gas Saturation Method: Final Report: Lab Project Number: 97.1.6853:
11742.0896.6111.740. Unpublished study prepared by Springborn Laboratories,
Inc. 57 p.
44712007 Hartley, D. (1997) Oxyfluorfen (Galigan PAI) - Determination of the
n-Octanol/Water Partition Coefficient: Final Report: Lab Project Number:
97.1.6856: 11742.0896.6112.705. Unpublished study prepared by Springborn
Laboratories, Inc. 42 p.
44712008 Wells, D. (1997) Galigan TGAI - Determination of Stability: Final Report: Lab
Project Number: 97.1.6837: 11742.0896. 6113.863. Unpublished study prepared
by Springborn Laboratories, Inc. 43 p.
105
-------
BIBLIOGRAPHY
MRID CITATION
44712009 Wells, D. (1998) Galigan (Oxyfluorfen) TGAI - Determination of the Storage
Stability Under Controlled Conditions: Final Report: Lab Project Number:
97.1.6862: 11742.0986.6114.865. Unpublished study prepared by Springborn
Laboratories, Inc. 50 p.
44720201 Guzikevich, G. (1997) Oxyfluorfen Technical - Product Properties: Lab Project
Number: 97-05. Unpublished study prepared by Agan Chemical Manufacturers,
LTD. 156 p.
44712002 Guzikevich, G. (1996) Analysis of 5 Lots of Oxyfluorfen Technical: Lab Project
Number: 96-08: 9000849B. Unpublished study prepared by Agan Chemical
Manufacturers Ltd. 120 p.
44828901 Crawford, J. (1999) Product Chemistry Series 830 Group A: Product Identity,
Composition, and Analysis for Goal High Purity Technical Active Ingredient:
Lab Project Number: APR-99-060: 13-99-013TR. Unpublished study prepared
by Lancaster Laboratories. 425 p.
44828902 Crawford, J. (1999) Product Chemistry Series 830 Group B: Physical and
Chemical Characteristics of Goal High Purity Technical Active Ingredient: Lab
Project Number: APR-99-061:RAS 133/992443: 18862P. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 447 p.
Residue Chapter References
00036703 Adler, I.L.; Jones, B.M. (1975) A Summary of RH-2915 Residue Data for Grapes:
Technical Report No. 3923-75-40. (Unpublished study received Oct 14, 1975
under 6G1690; prepared by Bristol Dev. Ag. Chem. Research, submitted by
Rohm & Haas Co., Philadelphia, Pa., CDL:094687-D)
00036704 Rohm and Haas Company (1975) Detailed Analytical Reports for Peaches.
(Unpublished study received Oct 14, 1975 under 6G1690; CDL:094687-F)
00036705 Rohm and Haas Company (1975) Analytical Results for RH-2915
Residues: Apricots. (Unpublished study received Oct 14, 1975 under 6G1690;
CDL:094687-G)
106
-------
BIBLIOGRAPHY
MRID CITATION
00036706 Rohm and Haas Company (1975) Analytical Results for RH-2915 Residues:
Nectarines. (Unpublished study received Oct 14, 1975 under 6G1690; CDL:094687-H)
00036707 Rohm and Haas Company (1975) Detailed Analytical Reports for Almonds.
(Unpublished study received Oct 14, 1975 under 6G1690; CDL:094687-I)
00036708 Rohm and Haas Company (1975) Analytical Results for RH-2915 Residues:
Prunes. (Unpublished study received Oct 14, 1975 under 6G1690;
CDL: 094687-J)
00071290 Rohm & Haas Company (1980) Summary and Discussion: 6Goa\V4(R)[i\.
(Unpublished study received Mar 20, 1981 under 707-145; CDL: 099954-C)
00071291 Adler, I.L.; Haines, L.D.; Jones, B.M. (1978) Gas-liquid chromatographic
determination of residues from the herbicide 2-Chloro-l- (3-ethoxy-4-
nitrophenoxy)-4-(trifluoromethyl) Benzene. Journal of the Association of Official
Analytical Chemists 61(3):636-639. (Also~In~unpublished submission received
Mar 20, 1981 under 707-145; submitted by Rohm & Haas Co., Philadelphia,
Pa.;CDL:099954-D)
00071292 Rohm & Haas Company (1979) Discussion: Goal1/4(R)|l|. (Unpublished
study received Mar 20, 1981 under 707-145; CDL:099954-E) 00071293 Rohm &
Haas Company (1979) Results and Discussion: Goal 2E. (Unpublished study
received Mar 20, 1981 under 707-145; CDL:099954-G)
00079475 Rohm & Haas Company (1981) GoaP/^R))! 2E Herbicide: 2-Chloro-l-(3-
ethoxy-4-nitrophenoxy)-4-(trifluoromethyl) Benzene: Residue Chemistry.
(Compilation; unpublished study, including published data, received Aug 6, 1981
under 1F2549; CDL:070261-A)
00102529 Rohm & Haas Co. (1982) Residue Chemistry: oGoal 2E Herbicide.
(Compilation; unpublished study received May 21, 1982 under 707-145;
CDL:070878-A)
00110745 Rohm & Haas Co. (1979) Goal 2E Herbicide (Formerly RH-2915) ...: Residue
Chemistry. (Compilation; unpublished study received Mar 12, 1979 under
707-142; CDL:098209-A)
107
-------
BIBLIOGRAPHY
MRID CITATION
00110747 Fisher, J. (1978) Goal Residue Analysis of Cottonseed Oil: Technical Report No.
34H-78-21. (Unpublished study received Oct 19,1978 under 707-EX-91;
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:235349-A)
00125632 Rohm & Haas Co. (1975) RH-2915: Residue Data. (Compilation; unpublished
study received Dec 23, 1975 under 707-EX-83; CDL:095071-A)
00126583 Rohm & Haas Co. (1983) Goal 1.6E Herbicide: Residue Chemistry: Onion.
(Compilation; unpublished study received Mar 23, 1983 under 707-174;
CDL:071493-A)
00135077 Rohm & Haas Co. (1978) GOAL 2E Herbicide (Formerly RH-2915): Residue
Reports and Methods (Residue Chemistry 12.03). (Compilation; unpublished
study received Mar 8, 1978 under 707-142; CDL:096873-A; 096874)
00136873 Rohm & Haas Co. (1978) Goal 2E Herbicide (Formerly RH-2915) ...: Residue
Reports and Methods: Soybeans and Other Food Crops. (Compilation;
unpublished study received Mar 8, 1978 under 707-142; CDL:096875-A; 096876)
00141092 Rohm & Haas Co. (1984) Residue Chemistry: Goal l.GE; Goal 2E. Unpublished
compilation. 99 p.
00141093 Rohm & Haas Co. (1984) Residue Chemistry: Goal l.GE. Unpublished
compilation. 322 p.
00145972 Rohm & Haas Co (1984) Residue Chemistry: Goal l.GE; Goal 2E. Unpublished
compilation. 127 p.
00145973 Rohm & Haas Co. (1984) Residue Chemistry: Goal 1.6E. Unpublished
compilation. 50 p.
00146340 Rohm and Haas Co. (1984) Residue Chemistry: Goal 1.6E and Goal 2E
Herbicides in Fruits. Unpublished compilation. 216 p.
00148291 Interregional Research Project No. 4 (1985) Residue of Oxyfluoren in Broccoli,
Cabbage & Cauliflower^. Unpublished compilation. 275 p.
108
-------
BIBLIOGRAPHY
MRID CITATION
00149622 Haines, L. (1975) Residue Chemistry: Goal Herbicide: Technical Report No.
3923-75-22. Unpublished study prepared by Rohm and Haas Company. 145 p.
00158014 Interregional Research Project No. 4 (1984?) The Results of Tests on the Amount
of Oxyfluorfen Residues Remaining in or on Guava Including a Description of
the Analytical Method Used. Unpublished compilation. 99 p.
00160143 Zogorski, W.; Lafferty, J. (1986) Translocation Studies on Mature Apple Trees
from Soil Treated with Carbon 14 Goal Herbicide: Technical Report No.
310-86-06. Unpublished study prepared by Rohm and Haas Co. 275 p.
40007201 Baron, J. (1986) Oxyfluorfen - Magnitude of Residue on Cabbage: Additional
Data: Project ID: 86-0076. Unpublished compilation prepared by Interregional
Research Project No. 4 in cooperation with Craven Laboratories. 41 p.
40007202 Baron, J. (1986) Oxyfluorfen - Magnitude of Residue on Cauliflower: Additional
Data: Project ID: 86-0077. Unpublished compilation prepared by Interregional
Research Project No. 4 in cooperation with Craven Laboratories. 54 p.
40007203 Baron, J. (1986) Oxyfluorfen - Magnitude of Residue on Broccoli: Additional
Data: Project ID: 84-0089. Unpublished compilation prepared by Interregional
Re search Project
40223201 Zogorski, W.; Craven, D. (1987) An Improved Terminal Residue Analytical
Method for Determining Residues Due to Oxyfluorfen, Its Major Isomers, and
Reduced Metabolites in a Variety of Crops and Soils: Rohm & Haas Technical
Report No.: 31C-87-16. Unpublished study prepared by Rohm & Haas Co. in
cooperation with Craven Labs, Inc. 66 p.
40223202 Zogorski, W. (1987) Magnitude of Residues Due to Oxyfluorfen in Avocado:
Rohm & Haas Analytical Report No. 31A-87-29. Unpublished study prepared by
Rohm & Haas Co. in cooperation with Craven Labs, Inc. 101 p.
40223204 Zogorski, W. (1987) Magnitude of Residues Due to Oxyfluorfen in Olives: Rohm
& Haas Analytical Report No. 31A-87-28. Unpublished study prepared by Rohm
& Haas Co. in cooperation with Craven Labs, Inc. 106 p.
109
-------
BIBLIOGRAPHY
MRID CITATION
40223205 Zogorski, W. (1987) Magnitude of Residues Due to Oxyfluorfen in Dates: Rohm
& Haas Analytical Report No. 31A-87-30. Unpublished study prepared by Rohm
& Haas Co. in cooperation with Craven Labs, Inc. 144 p.
40223206 Holmdal, J. (1987) Harvest and Storage Information on Nut and Pome Fruit
Crops (Supplement to Residue Data in PP4F3115 and 4F3119): Rohm & Haas
Memorandum No. JAH-85-59 and JAH-84-233. Unpubished compilation
prepared by Rohm & Haas Co. 6 p.
40567001 Zogorski, W. (1988) Carbon 14-Oxyfluorfen Confined Rotation Crop Study:
Rohm and Haas Technical Report No. 34C-88-11. Unpublished study prepared by
Rohm and Haas. 153 p.
40783201 Baron, J. (1988) Oxyfluorfen-Magnitude of Residue on Papaya: Project ID: IR-4
PR 2062. Unpublished study prepared by Univ., of Hawaii, Pesticide Laboratory.
95 p.
40940301 Baron, J. (1988) Oxyfluorfen: Magnitude of Residue on Taro (Dryland): IR-4 PR
No. 3527. Unpublished study prepared by University of Hawaii. 66 p.
41622701 Choban, R. (1989) Oxyfluorfen: Magnitude of Residue on Garbanzo Beans: Lab
Project Number: IR/4/4041. Unpublished study prepared by University of
Hawaii. 82 p.
42634701 Kim-Kang, H. (1993) Metabolism of (carbon 14)-Oxyfluorfen in the Laying
Hen—Analytical Phase: Identification and Quantitation of Metabolites in Eggs
and Tissues: Lab Project Number: XBL 92002: RPT00111: 3107.13.
Unpublished study prepared by Xenobiotic Labs Inc. 299 p
42670601 Reibach, P. (1993) Metabolism of (carbon 14)-Oxyfluorfen in Lactating Dairy
Goats: Lab Project Number: 34-93-4. Unpublished study prepared by Rohm and
Haas Co. and ABC Labs., Inc. 332 p.
42865001 Sun, Y. (1993) Oxyfluorfen: Nature of the Residue in Tomato: Lab Project
Number: 34-93-49. Unpublished study prepared by Rohm and Haas Company.
115 p.
110
-------
BIBLIOGRAPHY
MRID CITATION
42873301 Sun, Y. (1993) Oxyfluorfen: Nature of the Residue in Stone Fruit: Lab Project
Number: 34-93-50. Unpublished study prepared by Rohm and Haas Co. 129 p.
42913201 Sun, Y. (1993) Oxyfluorfen: Nature of the Residue in Onion: Lab Project
Number: 34-93-65: 34P-92-35. Unpublished study prepared by Rohm and Haas
Co. 138 p.
43152201 Zhang, Q.; Martin, D. (1994) Oxyfluorfen (Goal Herbicide) Cow Feeding Study;
Magnitude of Residue in Lactating Diary Cows: Lab Project Number: 34P/92/61:
34/93/114. Unpublished study prepared by Biodevelopment Labs, Inc., Centre
Analytical Labs, Inc., Bio-Life Associates, Ltd., and Enviro-Bio-Tech Ltd. 715 p.
43152202 Zhang, Q. (1994) Oxyfluorfen (Goal Herbicide) Hen Feeding Study; Magnitude
of Residue in Chickens in Full Lay: Lab Project Number: 34P/92/62: 34/93/115.
Unpublished study prepared by Centre Analytical Labs, Inc., Bio-Life Associates,
Ltd., and Enviro-Bio-Tech Ltd. 587 p.
43307502 Zhang, Q.; Martin, D.; Chen, J. et al. (1993) Oxyfluorfen (Goal) Meat and Fat
Analytical Method: Lab Project Number: 34-93-72. Unpublished study prepared
by Rohm and Haas Co. and Centre Analytical Laboratories, Inc. 88 p.
43307503 Li, Z.; Arjmand, M. (1993) Analytical Method for Goal (Oxyfluorfen and its
Isomers) Residues in Egg: Lab Project Number: 34-93-46. Unpublished study
prepared by Centre Analytical Laboratories, Inc. 33 p.
43317701 Kim-Kang, H. (1994) Supplemental Analyses of Liver Samples from Dairy Goats
Dosed with (carbon 14)-Oxyfluorfen: Supplement to Rohm and Haas Technical
Report No. 34-93-4 (MRID No. 42670601): Lab Project Number: XBL 93101:
RPT00145: 34-94-79. Unpublished study prepared by XenoBiotic Labs, Inc. 98 p.
43346401 Zhang, Q.; Stavinski, S. (1993) Oxyfluorfen (Goal): Milk Residue Analytical
Method: Lab Project Number: 34-93-17: TR 34-93-17. Unpublished study
prepared by Rohm and Haas Co. 33 p.
43424201 Biehn, W. (1994) Oxyfluorfen: Magnitude of Residue on Blackberry, 1988-1989
Trials: Lab Project Number: 3485: 88-OR-001: 89-OR-001. Unpublished study
prepared by Oregon State University. 75 p.
Ill
-------
BIBLIOGRAPHY
MRID CITATION
43424202 Biehn, W. (1994) Oxyfluorfen: Magnitude of Residue on Raspberry, 1988-1989
Trials: Lab Project Number: 3486: 88-OR-002: 89-OR-002. Unpublished study
prepared by Oregon State University. 64 p.
43424203 Biehn, W. (1994) Oxyfluorfen: Magnitude of Residue on Raspberry, 1992 Trial:
Lab Project Number: A3486: 3486.92-RHR 08: 3486.92-WA37. Unpublished
study prepared by Arthur D. Little, Inc., Washington State University. 263 p.
43764901 Holmdal, J. (1995) Levels of Residues in Soybeans and its Processed
Components: Oxyfluorfen Residues in Soybean Seed: Lab Project Number:
34A-94-36: RAR 92-0107: 94-0136. Unpublished study prepared by Rohm and
Haas Co. 79 p.
43794001 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Apples: RAR 94-0129,
94-0130, 94-0152: Lab Project Number: 94365: 34P-95-28A: 34-95-113.
Unpublished study prepared by McKenzie Labs and Rohm and Haas Co. 108 p.
43794002 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Avocado: RAR 94-0141:
Lab Project Number: 94366: 34P-95-29A: 34-95-115. Unpublished study
prepared by Centre Analytical Labs. 75 p.
43794003 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Fig: RAR 94-0142: Lab
Project Number: 94367: 34P-95-30A: 34-95-116. Unpublished study prepared by
Centre Analytical Labs. 74 p.
43794004 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Pomegranate: RAR
94-0143: Lab Project Number: 94368: 34P-95-31A: 34-95-117. Unpublished
study prepared by Centre Analytical Labs. 72 p.
43794005 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Kiwi: RAR 94-0146: Lab
Project Number: 94369: 34P-95-32A: 34-95-118. Unpublished study prepared by
Centre Analytical Labs. 79 p.
43794006 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Olive: RAR 94-0172: Lab
Project Number: 94369: 34P-95-33A: 34-95-119. Unpublished study prepared by
Centre Analytical Labs. 78 p.
43794007 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Artichoke: RAR 94-0060,
94-0061: Lab Project Number: 94374: 34P-95-36A: 34-95-120. Unpublished
study prepared by Centre Analytical Labs. 95 p.
112
-------
BIBLIOGRAPHY
MRID CITATION
43794008 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Cherry: RAR 94-0041,
94-0042: Lab Project Number: 92302: 34P-95-37A: 34-95-121. Unpublished
study prepared by Centre Analytical Lab. 90 p.
43813201 Martin, D.; Zhang, Q. (1995) Storage Stability of Cow Muscle, Cow Liver, Milk,
and Egg Treated With Goal Herbicide: Lab Project Number: 34-95-83:
TR-34-95-83: RAR-93-0160. Unpublished study prepared by Centre Analytical
Labs and Biodevelopment Labs, Inc. 488 p.
43859801 Martin, D.; Zhang, Q. (1995) Storage Stability Study: Oxyfluorfen in Apples,
Alfalfa, Almond Nuts and Hulls, Banana Pulp, Cabbage, Cottonseeds, Onions,
Oranges, Peaches, Strawberries, Wheat Grain, and Soil: Lab Project Number:
34-95-82: 34P-92-09: 3107-04. Unpublished study prepared by Biodevelopment
Labs, Inc. 731 p.
43944801 Leppert, B. (1996) Nature and Levels of Residues in Field Corn and Its Processed
Commodities When Goal Herbicide is Applied as a Post Directed Spray: Lab
Project Number: TR 34-95-175: SARS-94-86: 94376. Unpublished study
prepared by Stewart Agricultural Research Services, Inc. and Centre Analytical
Labs. 221 p.
43965501 Biehn, W.; Kunkel, D. (1996) Oxyfluorfen: Magnitude of Residue on Onion: Lab
Project Number: PR-5739: 05739: 5739.95-IDR06. Unpublished study prepared
by University of Idaho. 456 p.
43973701 Biehn, W.; Kunkel, D. (1996) Oxyfluorfen: Magnitude of Residue on
Horseradish: Lab Project Number: 05738: PR 5738: 05738.94-IDR07.
Unpublished study prepared by Interregional Research Project No. 4. 174 p.
43986301 Biehn, W.; Kunkel, D. (1996) Oxyfluorfen: Magnitude of Residue on Cabbage:
Lab Project Number: 5105: 5105.91-RHR03: 5105.95-IDR05. Unpublished study
prepared by Biodevelopment Labs, Inc. and University of Idaho. 637 p.
43986302 Biehn, W.; Kunkel, D. (1996) Oxyfluorfen: Magnitude of Residue on
Cauliflower: Lab Project Number: 4013: 4013.92-RHE05: 4013.95-IDR10.
Unpublished study prepared by Biodevelopment Labs, Inc. and University of
Idaho. 384 p.
113
-------
BIBLIOGRAPHY
MRID CITATION
44025401 Martin, D.; Zhang, Q. (1996) Oxyfluorfen Residues in Peach: RAR 94-0117,
95-0196: Lab Project Number: 34-95-114: 34P-95-35A: 34P-95-51A.
Unpublished study prepared by Mckenzie Labs, and Rohm and Haas Co. 122 p.
44172301 Kunkel, D. (1996) Oxyfluorfen: Magnitude of Residue on Coffee: Lab Project
Number: 5154: 5154.93-HSR01: 5154.93-HI05. Unpublished study prepared by
Hawaiian Sugar Planters Assoc. and Univ. of Hawaii Manoa. 151 p.
44385401 Martin, D.; Zhang, Q. (1996) Oxyfluorfen Residues in Non-Dormant Grape
(Non-CA Trials); Supplemental to TR 34-95-104: Lab Project Number: 92308:
92308A: 34P-95-65A. Unpublished study prepared by Rohm and Haas Company
and Centre Analytical Labs, Inc. 168 p.
44385402 Martin, D.; Zhang, Q. (1995) Oxyfluorfen Residues in Grape RARs 92-0069,
92-0070, 92-0080, 92-0132, 93-0012: Lab Project Number: 92308: 92308A:
34P-95-65A. Unpublished study prepared by Rohm and Haas Company and
Centre Analytical Labs, Inc. 168 p.
44400202 Martin, D.; Zhang, Q. (1996) Enforcement Residue Analytical Method for GOAL
Herbicide (Oxyfluorfen) in Crop Commodities with GC/MS Confirmation: Lab
Project Number: 34P-95-92: 34-95-111: TR 34 95 111. Unpublished study
prepared by Rohm and Haas Co., Centre Analytical Labs., Inc. and McKenzie
Labs. 246 p.
44400203 Bruns, G.; Nelson, S. (1996) Independent Laboratory Validation of the Tolerance
Enforcement Method (TR34-95-111) for GOAL Herbicide (Oxyfluorfen) in Crop
Commodities Using Peanut Nutmeat as a Sample: Lab Project Number:
34P-96-56: 3107.14: RHC09.REP. Unpublished study prepared by Enviro-Test
Labs. 168 p.
44400204 Zhang, Q.; Martin, D. (1997) Oxyfluorfen (Goal) Meat, Milk and Egg Tolerance
Enforcement Method with GLC/MSD Confirmation: Lab Project Number:
34-95-110: TR 34-95-110: 34-93-114. Unpublished study prepared by Rohm and
Haas Co., Centre Analytical Labs., Inc. and XenoBiotic Labs., Inc. 279 p.
(OPPTS 860.1340}
44407801 Zhang, Q. (1997) Rohm and Haas Company Partial Response to EPA CBTS
Review of Livestock Feeding, Ruminant Metabolism and Analytical Method Data
Submitted for Oxyfluorfen (Case 2490) Reregi strati on (MRID #43307502,
43346401, 433075503, and 43317701 DB Barcode D207134, CBTS #14321 and
114
-------
BIBLIOGRAPHY
MRID CITATION
14323): Lab Project Number: 34-95-164: TR 34-95-164: TR 34-93-46.
Unpublished study prepared by Rohm and Haas Company. 393 p. (OPPTS
860.1300}
44506601 Szuter, S. (1995) Independent Laboratory Method Validation: Oxyfluorfen (Goal
Herbicide) and its Isomers Residue Analytical Method (TR 34-95-110) for Meat,
Milk, and Egg: Final Report: Lab Project Number: TR 34-96-151: TR-34P-95-85:
TR-34-93-17. Unpublished study prepared by McKenzie Laboratories, Inc. 194 p.
44575901 Martin, D. (1998) Magnitude of Oxyfluorfen (GOAL Herbicide) Residue in
Pears: Lab Project Number: 96317: 34P-96-96A: 34-97-18. Unpublished study
prepared by Centre Analytical Laboratories, Agri Business Group, and A.C.D.S.
Research Inc. 114 p. {OPPTS 860.1500}
44712001 Wells, D. (1997) Galigan - Characterization of the Pure Active Ingredient (AI):
Final Report: Lab Project Number: 97-1-6852: 11742.0896.6108.210.
Unpublished study prepared by Springborn Laboratories, Inc. 61 p.
44712002 Guzikevich, G. (1996) Analysis of 5 Lots of Oxyfluorfen Technical: Lab Project
Number: 96-08: 9000849B. Unpublished study prepared by Agan Chemical
Manufacturers Ltd. 120 p.
44712003 Wells, D. (1997) Galigan TGAI - Determining the Product Chemistry: Final
Report: Lab Project Number: 97.1.6831: 11742.0896.6109.885. Unpublished
study prepared by Springborn Laboratories, Inc. 66 p.
44712004 Harley, D. (1997) Galigan TGAI - Determination of Solubility in Water and Six
Organic Solvents: Final Report: Lab Project Number: 97.1.6861:
11742.0896.6110.700. Unpublished study prepared by Springborn Laboratories,
Inc. 51 p.
44712005 Wells, D. (1998) Galigan (Oxyfluorfen) TGAI - Determination of Water
Solubility: Final Report: Lab Project Number: 98.4.7297: 11742.0997.6137.702.
Unpublished study prepared by Springborn Laboratories, Inc. 33 p.
44712006 Wells, D. (1997) Galigan (Oxyfluorfen) TGAI - Determination of Vapor Pressure
Using a Gas Saturation Method: Final Report: Lab Project Number: 97.1.6853:
11742.0896.6111.740. Unpublished study prepared by Springborn Laboratories,
Inc. 57 p.
115
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BIBLIOGRAPHY
MRID CITATION
44712007 Hartley, D. (1997) Oxyfluorfen (Galigan PAI) - Determination of the
n-Octanol/Water Partition Coefficient: Final Report: Lab Project Number:
97.1.6856: 11742.0896.6112.705. Unpublished study prepared by Springborn
Laboratories, Inc. 42 p.
44712008 Wells, D. (1997) Galigan TGAI - Determination of Stability: Final Report: Lab
Project Number: 97.1.6837: 11742.0896. 6113.863. Unpublished study prepared
by Springborn Laboratories, Inc. 43 p.
44712009 Wells, D. (1998) Galigan (Oxyfluorfen) TGAI - Determination of the Storage
Stability Under Controlled Conditions: Final Report: Lab Project Number:
97.1.6862: 11742.0986.6114.865. Unpublished study prepared by Springborn
Laboratories, Inc. 50 p.
44720201 Guzikevich, G. (1997) Oxyfluorfen Technical - Product Properties: Lab Project
Number: 97-05. Unpublished study prepared by Agan Chemical Manufacturers,
LTD. 156 p.
44828901 Crawford, J. (1999) Product Chemistry Series 830 Group A: Product Identity,
Composition, and Analysis for Goal High Purity Technical Active Ingredient:
Lab Project Number: APR-99-060: 13-99-013TR. Unpublished study prepared
by Lancaster Laboratories. 425 p.
44828902 Crawford, J. (1999) Product Chemistry Series 830 Group B: Physical and
Chemical Characteristics of Goal High Purity Technical Active Ingredient: Lab
Project Number: APR-99-061:RAS 133/992443: 18862P. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 447 p.
92136031 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00072716.
Magnitude of Goal Residue in Artichoke. Prepared by Rohm and Haas Co. 9 p.
92136033 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00070878.
Magnitude of Goal Residue in Banana/Plantain. Prepared by Rohm and Haas Co.
Ip.
92136037 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00070878.
Magnitude of Goal Residue in Coffee. Prepared by Rohm and Haas Co. lip.
116
-------
BIBLIOGRAPHY
MRID CITATION
92136041 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00072715
and Related MRIDs 40223205. Magnitude of Goal Residue in Dates. Prepared
by Hazleton Laboratories America, Inc. 10 p.
92136042 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00070261.
Magnitude of Goal Residue in Figs. Prepared by Rohm and Haas Co. 9 p.
92136043 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00098209
and Related MRIDs 00036701. Magnitude of Residue in Grape. Prepared by
American Cyanamid Co. 10 p.
92136044 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00002537.
IR-4 Magnitude of Goal Residue in Guava. Prepared by University of Hawaii. 10
P
92136046 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00099954.
Magnitude of Goal Residue in Mint Hay. Prepared by Rohm and Haas Co. 13 p.
92136047 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00099954.
Magnitude of Goal Residue in Mint Oil. Prepared by Rohm and Haas Co. 17 p.
92136049 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00071493.
Magnitude of Goal Residue in Onion. Prepared by Applied Biological Sciences
Lab. Inc. 10 p.
92136050 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00070261
and Related MRIDs 00072714, 40223206. Magnitude of Goal Residue in
Pomefruit. Prepared by Rohm and Haas Co. 10 p.
92136051 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00072714.
Magnitude of Goal Residue in Processed Apples. Prepared by Rohm and Haas
Co. 10 p.
92136052 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00072715.
Magnitude of Goal Residue in Pomegranate. Prepared by Hazleton Laboratories
America, Inc. 9 p.
117
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BIBLIOGRAPHY
MRID CITATION
92136053 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00096876
and Related MRIDs 00095071. Magnitude of Goal Residue in Soybean. Prepared
by Chevron Chemical Co. 13 p.
92136054 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00036705
and Related MRIDs 00098209, 00036704, 00036708, 00070261, 00146340.
Magnitude of Goal Residue in Stone Fruits. Prepared by Rohm and Haas Co. 14 p.
92136055 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00099954
and Related MRIDs 00072717, 00036707, 00098209, 40223206, 00072718.
Magnitude of Goal Residue in Treenuts. Prepared by Rohm and Haas Co. 14 p.
92136056 Fisher, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID 00099954.
Magnitude of Goal Residue in Pistachios. Prepared by Rohm and Haas Co. 9 p.
92136057 Godfrey, W.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 00099270. Goal Technical Herbicide (Oxyfluorfen) Acute Toxicity to
Fathead Minnow Eggs and Fry: Rohm and Haas Report 80RC-015; Project
BW-79-7-523. Prepared by EG&G Bionomics. 15 p.
92136060 Carpenter, C. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
40478002 and Related MRIDs 40966201. Revised Product Chemistry Series 63
Physical and Chemical Characteristics for RH-2915 (Oxyfluorfen): Laboratory
Project ID CRC-90-029. 108 p.
92136067 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00072716. Magnitude of Oxyfluorfen Residues in Artichoke: RAR Code Nos.
83-0090, 83-0185, 83-0186 and 83-0187. Prepared by Rohm and Haas Co. 57 p.
92136069 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00070878. Magnitude of Oxyfluorfen Residues in Banana/Plantain. Prepared by
Rohm and Haas Co. 116 p.
92136070 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00073644 and Related MRIDs 40007203. Magnitude of Oxyfluorfen Residues in
Broccoli. Prepared by Cannon Laboratories, Inc. 157 p.
118
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BIBLIOGRAPHY
MRID CITATION
92136072 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00073644 and Related MRIDs 40007202. Magnitude of Oxyfluorfen Residues in
Cauliflower. Prepared by Cannon Laboratories, Inc. 117 p.
92136073 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00070878. Magnitude of Oxyfluorfen Residues in Coffee. Prepared by Rohm and
Haas Co. 191 p.
92136074 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00096874. Magnitude of Oxyfluorfen Residues in Corn. Prepared by Rohm and
Haas Co. 269 p.
92136075 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00110747 and Related MRIDs 00099954. Magnitude of Oxyfluorfen Residues in
Cottonseed and Cottonseed Oil. Prepared by Rohm and Haas Co. 146 p.
92136076 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00072715 and Related MRIDs 40223205. Magnitude of Oxyfluorfen Residues in
Dates. Prepared by Hazleton Laboratories, Inc. 176 p.
92136077 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00070261. Magnitude of Oxyfluorfen Residues in Figs: RAR Code Nos.
80-0229, 80-0230 and 80-0231. Prepared by Rohm and Haas Co. 49 p.
92136078 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00098209 and Related MRIDs 00036701, 00146340. Magnitude of Oxyfluorfen
Residues in Grape. Prepared by American Cyanamid Co. 175 p.
92136079 Nishimoto, R. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00002537. Magnitude of Oxyfluorfen Residues in Guava. Prepared by
University of Hawaii. 79 p.
92136081 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00099954. Magnitude of Oxyfluorfen Residues in Mint Hay and Oil. Prepared
by Rohm and Haas Co. 100 p.
92136082 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00072715 and Related MRIDs 40223204. Magnitude of Oxyfluorfen Residues in
Olives. Prepared by Hazleton Laboratories, inc. 146 p.
92136083 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00071493. Magnitude of Oxyfluorfen Residues in Onion. Prepared by Applied
Biological Sciences Lab, Inc. 261 p.
119
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BIBLIOGRAPHY
MRID CITATION
92136084 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00070261 and Related MRIDs 00072714, 40223206. Magnitude of Oxyfluorfen
Residues in Pome Fruit and Pome Fruit Byproducts. Prepared by Rohm and Haas
Co. 310 p.
92136085 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00072715. Magnitude of Oxyfluorfen Residues in Pomegranate: RAR Code Nos.
82-0413 and 82-0433. Prepared by Hazleton Laboratories, Inc. 40 p.
92136086 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00096876 and Related MRIDs 00095071. Magnitude of Oxyfluorfen Residues in
Soybean and Soybean Oil. Prepared by Chevron Chemical Co. 769 p.
92136087 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00036705 and Related MRIDs 00036704, 00036708, 00098209, 00070261,
00146340. Magnitude od Oxyfluorfen Residues in Stone Fruit. Prepared by
Rohm and Haas Co. 559 p.
92136088 Rohm and Hass Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00099954 and Related MRIDs 00072718, 00072717, 00036707, 00098209,
40223206. Magnitude of Oxyfluorfen Residues in Treenuts. Prepared by Rohm
and Haas Co. 436 p.
92136089 Rohm and Haas Co. (1990) Rohm & Haas Company Phase 3 Reformat of MRID
00099954. Magnitude of Oxyfluorfen Residues in Pistachio: RAR Code Nos.
78-0413, 78-0414 and 78-0416. Prepared by Rohm and Haas Co. 32 p.
92136101 Reibach, P. (1990) Rohm & Haas Company Phase 3 Summary of MRID
92136114. Carbon 14-Oxyfluorfen Metabolism by Alfalfa under Field
Conditions: Rohm and Haas Technical Report No. 34-90-27. Prepared by Rohm
and Haas Co. 44 p.
120
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BIBLIOGRAPHY
MRID CITATION
Occupational Exposure Chapter References
42098301 Massey, J. (1990) Rohm and Haas Response to the Oxyfluorfen Reregi strati on
Phase 4 Data Call-In: Persistence of Dislodgeable Residues Under Tree Nursery
Conditions. Unpublished study prepared by Rohm and Haas. 10 p.
44459801 Merricks, D. (1997) Carbaryl Mixer/Loader/Applicator Exposure Study During
Application of RP-2 Liquid (21%), Sevin Ready to Use Insect Spray or Sevin 10
Dust to Home Garden Vegetables: Lab Project Number: 1519: 10564:
ML97-0676-RHP. Unpublished study prepared by Agrisearch Inc.,
Rhone-Poulenc Ag Co. and Morse Labs., Inc. 358 p.
44972201 Klonne, D. (1999) Integrated Report for Evaluation of PotentialExposures to
Homeowners and Professional Lawn Care Operators Mixing, Loading, and
Applying Granular and Liquid Pesticides to Residential Lawns: Lab Project
Number: OMAOO5: OMAOO1: OMAOO2. Unpublished study prepared by
Ricerca, Inc., and Morse Laboratories. 2213 p.
Revised Oxyfluorfen (Goal) Quantitative Risk Assessment (Ql*) Based on CD-I Male Mouse
Dietary Study with 3/4's Interspecies Scaling Factor; Author Lori L. Brunsman, SAB/HED/OPP
(09/24/98)
Oxyfluorfen - Report of Food Quality Protection Act Safety Factor Committee ; Author:
Brenda Tarplee, (Hed Document #014554 of 04/30/01)
Oxyfluorfen Hazard Identification And Review Committee Report; Author: Kit Farwell, DVM,
RRB1/HED/OPP; (HED Document #0145549 of 04/23/01)
Review of Oxyfluorfen Incident Reports; Authors: Jerome Blondell, PhD, and Monica Spann,
MPH, CEB1/HED/OPP; (HED Document #276054 of 07/03/01)
Oxyfluorfen Use Closure Memo; Author: Deanna Scher, Chemical Review Manager for
Oxyfluorfen, SRRD/OPP; Memo directed to Oxyfluorfen Team (7/01/99).
Draft Standard Operating Procedures for Residential Exposure Assessments. U.S. EPA.
February 10, 1998.
121
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BIBLIOGRAPHY
MRID CITATION
HED Science Advisory Council for Exposure, Policy 003.1, "Agricultural Default Transfer
Coefficients" Health Effect Division, Office of Pesticide Programs. August, 1998.
HED Science Advisory Council for Exposure, Policy.007, "Use of Values from the PHED
Surrogate Table and Chemical-Specific Data." Health Effects Division, Office of Pesticide
Programs. January, 1999.
HED Science Advisory Council for Exposure, Policy.009, "Standard Values for Daily
Acres Treated in Agriculture" Health Effects Division, Office of Pesticide Programs. July
2000.
PHED Surrogate Exposure Guide, VI. 1. Health Effects Division, Office of Pesticide
Program. August, 1998."
Application of Pesticides to Crops. G. A. Matthews, Imperial College Press, 1999
USDA Crop Profiles
"Chemical Mowing with Post-Emergent Herbicides in Fraser Fir Christmas Trees", North
Carolina Cooperative Extension Service
"Weed Management in Conifer Seedbeds and Transplant Beds", HIL-449, Joseph C. Neal, NC
State University, 1999
Growing Christmas Trees in North Carolina. North Carolina Cooperative Extension Service,
May 1997
"Exposure of Herbicide Handlers in the CALTRANS Vegetation Control Program 1993-1994"
California Environmental Protection Agency, April 27, 1995.
A Strategy for Assessing and Managing Occupational Exposures. John Mulhausen and Joseph
Damiano, AIHA Press, 2nd Edition, 1998.
Ecotoxicity Chapter References
41644001 Hoberg, J. (1990) Goal Technical: Determination of Effects on Seed Germination,
Seedling Emergence and Vegetative Vigor of Ten Plant Species: Lab Project
122
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BIBLIOGRAPHY
MRID CITATION
Number: 34-90-58: 86-1289-6105-610: 90-7-3373. Unpublished study prepared
by Springborn Laboratories Inc. 289 p.
41698801 Graves, W. (1990) Goal Technical Herbicide: A 96-Hour Static Acute Toxicity
Test with the Sheepshead Minnow (Cyprinodon variegatus) Final Report: Lab
Project Number: 129A-101; 90RC-0009. Unpublished study prepared by Rohm
& Haas Co. 161 p.
42129801 Graves, W.; Smith, G. (1991) Goal Technical Herbicide: A 96-Hour Static Acute
Toxicity Test with the Bluegill (Lepomis macrochirus): Final Report: Lab Project
Number: 129A-103A: 90RC-0097. Unpublished study prepared by Wildlife
International Ltd. 85 p.
42129802 Graves, W.; Smith, G. (1991) Goal Technical Herbicide: A 96-Hour Static Acute
Toxicity Test with the Rainbow Trout (Oncorynchus mykiss): Final Report: Lab
Project Number: 129A-102: 90RC-0098. Unpublished study prepared by
Wildlife International Ltd. 84 p.
42378901 Graves, W. (1992) Goal Technical Herbicide: A 96-Hour Shell Deposition Test
with the Eastern Oyster (Crassostrea virginica): Final Report: Lab Project
Number: 129A-111 A: 91RC-0175. Unpublished study prepared by Wildlife Intl.
Ltd. 74 p.
45271301 Sutherland, C.; Kendall, T.; Krueger, H. (2000) Goal 2XL (P) Herbicide: A
48-Hour Flow-Through Acute Toxicity Test with the Cladoceran (Daphnia
magna): Lab Project Number: 129A-174: OORC-0020. Unpublished study
prepared by Wildlife International, Ltd. 71 p. (OPPTS 850.1010}
45271302 Sutherland, C.; Kendall, T.; Krueger, H. (2000) Goal 2XL (P) Herbicide: A
96-Hour Toxicity Test with the Freshwater Alga (Selenastrum capricornutum):
Lab Project Number: 129A-176: OORC-0021. Unpublished study prepared by
Wildlife International, Ltd. 84 p. {OPPTS 850.5400}
92136057 Godfrey, W.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 00099270. Goal Technical Herbicide (Oxyfluorfen) Acute Toxicity to
Fathead Minnow Eggs and Fry: Rohm and Haas Report 80RC-015; Project
BW-79-7-523. Prepared by EG&G Bionomics. 15 p.
123
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BIBLIOGRAPHY
MRID CITATION
92136090 Godfrey, W.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 92136102. Goal Technical Herbicide (Oxyfluorfen) 21-Day Acute Oral
Toxicity Study in Bobwhite Quail: Rohm and Haas Report 86RC-077; Project
BLAL 86 QD 76. Prepared by Bio-Life Associates, Ltd. 14 p.
92136091 Godfrey, W.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 92136103. Goal Technical Herbicide (Oxyfluorfen) 8-Day Dietary LC50
Study in Bobwhite Quail: Rohm and Haas Report 86RC-075; Project BLAL 86
QC 74. Prepared by Bio-Life Associates, Ltd. 14 p.
92136092 Godfrey, W.; Longacre, S. (1990) Rohm & Haas Company Phase 3 Summary of
MRID 92136104. Goal Technical Herbicide (Oxyfluorfen): 8-Day Dietary LC50
Study in Mallard Ducklings: Rohm and Haas Report 86RC-076; Project BLAL 86
DC 75. Prepared by Bio-Life Associates, Ltd. 15 p.
Environmental Fate Chapter References
00094336 Root, M.; Taitel, C.; Doull, J. (1964) Subacute Oral Toxicity offlayer 25141 to
Male and Female Rats: submitter 14243. (Unpublished study received June 22,
1965; Feb 7, 1966 under 3125-EX- 101; prepared by Univ. of Chicago, Dept. of
Pharmacology, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:126969-C)
41999901 Reibach, P. (1991) Carbon 14-Oxyfluorfen Photolysis On Soil Under Natural
Sunlight: Lab Project Number: 34-91-46. Unpublished study prepared by Rohm
and Haas Co., and PTRL East. 309 p.
42129101 Reibach, P. (1991) Aqueous Photolysis of Carbon 14-Oxyfluorfen: Lab Project
Number: 34-91-47. Unpublished study prepared by Rohm and Haas Co. and
Xenobiotics Labs. 268 p.
42142307 Kesterson, A.; Lawrence, B.; King, D.; et al. (1989) Aqueous Photolysis of
Carbon 14 Oxyfluorfen (Nitrophenyl Ring labelled) in Natural Sunlight: RTRL
Project No. 261; Report No. 1194. Unpublished study prepared by Pharmacology
& Toxicology Research Laboratory. 138 p.
42142310 Korsch, B.; Doran, T. (1988) Anaerobic Soil Metabolism of Oxyfluorfen: Project
No. 87-0093; Doc. No. 1668-87-0093-EF-001; TR-34C-88-61. Unpublished
study prepared by Ricerca, Inc. 116 p.
124
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BIBLIOGRAPHY
MRID CITATION
42142311 Reibach, P. (1988) Adsorption/Desorption of Carbon 14 Oxyfluorfen R&H Tech
Report No. 34C-88-64; Protocol No. 34P-88-75. Unpublished study prepared by
Rohm & Haas Co. 196 p.
43840101 Reibach, P. (1995) Terrestrial Field Dissipation of Goal Herbicide at Two Sites in
California: Lab Project Number: 34-95-139: 002-105: 94345. Unpublished study
prepared by ABC Labs, Inc. and Centre Analytical Lab. 1416 p.
92136023 Reibach, P. (1990) Rohm & Haas Company Phase 3 Summary of MRID
00096882. Oxyfluorfen Hydrolysis: TR No. 34H-77-30. 29 p.
92136026 Reibach, P. (1990) Rohm & Haas Company Phase 3 Summary of MRID
00096883. A Residue and Metabolism Study of Carbon-14-RH-2915 in Bluegill
Sunfish: TRNo. 34-23. Prepared by Chevron Chemical Co. 31 p.
92136058 Holmdal, J. (1990) Rohm & Haas Company Phase 3 Summary of MRID
00144894. Oxyfluorfen - Spray Drift Field Evaluation. Prepared by Rohm and
Haas Co. 16 p.
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Appendix E. Generic Data Call-In
See the following table for a list of generic data requirements. Note that a complete Data Call-In (DCI),
with all pertinent instructions, is being sent to registrants under separate cover.
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134
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Appendix F. Product Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete
Data Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate
cover.
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Appendix G: EPA'S Batching of Oxyfluorfen Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing Oxyfluorfen as the
active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Not-with-standing the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
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Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Fourteen products were found which contain Oxyfluorfen as the active ingredient.
These products have been placed into four batches and a "No Batch" category in accordance with
the active and inert ingredients and type of formulation. Furthermore, the following bridging
strategies are deemed acceptable for this chemical:
• No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch 1
EPA Reg. No.
11603-29
62719-399
% Active Ingredient
97.4
99.0
Batch 2
EPA Reg. No.
62719-395
62719-400
% Active Ingredient
23.5
19.4
Batch 3
EPA Reg. No.
62719-424
66222-28
% Active Ingredient
23.0
22.2
Batch 4
EPA Reg. No.
4-432
239-2516
% Active Ingredient
Oxyfluorfen: 0.25
Glyphosate: 0.25
Oxyfluorfen: 0.25
Glyphosate: 0.25
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No Batch
EPA Reg. No.
239-2622
524-520
538-172
48234-10
58185-27
62719-447
% Active Ingredient
Oxyfluorfen: 0.70
Imazapyr: 0.08
Oxyfluorfen: 2.50
Glyphosate: 40.00
Oxyfluorfen: 2.00
Pendimethalin: 1.00
Oxyfluorfen: 2.00
Oxadiazon: 1.00
Oxyfluorfen: 2.00
Oryzalin: 1.00
41.00
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Appendix H. List of Registrants Sent This Data Call-In
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail atwilliams.nicole@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
Application for Pesticide
Regi strati on/ 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
http://www.epa.gov/opprd001/forms/8570-l.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
httD://www.eDa.gov/ODDrd001/forms/8570-27.Ddf
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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
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.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit_
www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
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Other PR Notices can be found at http://www.epa.gov/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 Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
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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: http://npic.orst.edu..
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
a. Date of receipt;
b. EPA identifying number; and
c. Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp
the date of receipt and provide the EPA identifying file symbol or petition number
for the new submission. The identifying number should be used whenever you
contact the Agency concerning an application for registration, experimental use
permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which
identify the chemical (including "blind" codes used when a sample was submitted
for testing by commercial or academic facilities). Please provide a chemical abstract
system (CAS) number if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and
may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed on
the respective Chemical Status Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science
Chapters, which include the complete risk assessments and supporting documents.
2. Detailed Label Usage Information System (LUIS) Report.
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