SEPA
United States Prevention, Pesticides EPA 738-R-04-012
Environmental Protection and Toxic Substances July 2004
Agency (7508C)
Reregistration
Eligibility Decision for
Benfluralin
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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 risk assessment for the dinitroaniline pesticide, benfluralin (Balan®). Based on its review, 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 benfluralin. The EPA is now
publishing its reregistration eligibility and risk management decisions for the current uses of
benfluralin, and its associated human health and environmental risks. The enclosed "Reregistration
Eligibility Decision for Benfluralin," which was approved on July 30, 2004, contains the Agency's
decision on the individual chemical benfluralin.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for benfluralin is
published in the Federal Register. To obtain a copy of the RED document, please contact the OPP
Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania Avenue NW,
Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED and all supporting
documents are available on the Internet. See http://www.epa.gov/pesticides/reregistration/status.htm.
This document and the process used to develop it are the result of EPA's program to facilitate
greater public involvement and participation in the Agency's pesticide reregistration and tolerance
reassessment decision making. Since the enactment of the Food Quality Protection Act of 1996
(FQPA), EPA has undertaken special efforts to increase transparency, consult with stakeholders, and
engage the public in developing pesticide reregistration and tolerance reassessment decisions. The
human health and environmental risk assessments for benfluralin were placed in the public docket
and issued for public comment through a Federal Register notice on February 25, 2004.
At this time, the Agency does not have sufficient data concerning common mechanism issues
to determine whether or not benfluralin shares a common mechanism of toxicity with other
substances, including other dinitroaniline or other pesticides. Therefore, for the purposes of this
action, the Agency has assumed that benfluralin does not share a common mechanism of toxicity with
any other chemicals.
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End-use product labels should be revised by the manufacturer to adopt the changes set forth in
Section V 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.
If you have questions on this document or the proposed label changes, please contact the
Special Review and Reregistration Division representative, Katie Hall, at (703) 308-0166. For
questions about product reregistration and/or the Product data call-in (DCI) that accompanies this
document, please contact Moana Appleyard at (703) 308-8175.
Debra Edwards, Ph.D.
Director, Special Review and Reregistration Division
Attachment
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Reregistration Eligibility Decision
for
Benfluralin
ListB
Case 2030
Approved By:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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Table of Contents
Glossary of Terms and Abbreviations i
Benfluralin Reregistration Eligibility Decision Team iii
Executive Summary 1
I. Introduction 6
n. Chemical Overview 8
A. Regulatory History 8
B. Chemical Identification 8
C. Use Profile 9
D. Estimated Usage of Pesticide 10
HI. Summary of Benfluralin Risk Assessments 11
A. Human Health Risk Assessment 11
1. Dietary Risk from Food 11
a. Toxicity of Benfluralin 11
b. FQPA Safety Factor 15
c. Population Adjusted Dose 15
1) Acute PAD 16
2) ChromcPAD 16
d. Exposure Assumptions 16
e. Dietary (Food) Risk Assessment 16
1) Acute Dietary Risk 16
2) Chronic (Noncancer) Dietary Risk 16
2. Dietary Risk from Drinking Water 17
a. Surface Water 17
b. Ground Water 18
3. Residential and Other Nonoccupational Exposure 18
a. Residential Applicator (Handler) 19
1) Exposure, Scenarios, Data, and Assumptions 19
2) Benfluralin Residential Handler Risk Estimates 19
b. Residential Postapplication Risk 21
1) Exposure, Scenarios, Data, and Assumptions 21
2) Benfluralin Postapplication Risk Estimates 22
4. Aggregate Risk 23
a. Short-term Aggregate Risk 23
b. Chronic Aggregate Risk 24
5. Cumulative Assessment 24
6. Occupational Risk 25
a. Occupational Toxicity 25
b. Occupational Handler Exposure 26
c. Occupational Handler Risk Summary 26
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d. Occupational Postapplication Risk Summary for Benfluralin 31
e. Human Incident Data 31
B. Environmental Risk Assessment 32
1. Environmental Fate and Transport 32
2. Ecological Risk 33
a. Risk to Birds 34
1) Toxicity (Hazard) Assessment 34
2) Exposure and Risk 35
b. Risk to Mammals 37
1) Toxicity (Hazard) Assessment 37
2) Exposure and Risk 37
c. Risk to Fish and Aquatic Invertebrates 38
1) Toxicity (Hazard) Assessment for Freshwater Species .... 38
2) Toxicity (Hazard) Assessment for Estuarine/Marine Species
40
3) Exposure and Risk 40
d. Risk to Nontarget Insects 45
e. Risk to Nontarget Terrestrial Plants 45
f. Risk to Nontarget Aquatic Plants 48
g. Food-Chain Effects 48
h. Risk to Endangered Species 49
i. Ecological Incident Reports 50
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 51
A. Determination of Reregistration Eligibility 51
B. Public Comments and Responses 51
C. Regulatory Position 51
1. Food Quality Protection Act Findings 52
a. "Risk Cup" Determination 52
b. Determination of Safety to U.S. Population 52
c. Determination of Safety to Infants and Children 52
d. Endocrine Disrupter Effects 53
e. Cumulative Risks 53
2. Tolerance Summary 54
a. Tolerances Currently Listed Under 40 CFR §180.208 54
b. Codex Harmonization 55
c. Residue Analytical Methods - Plants and Livestock 55
D. Regulatory Rationale 55
1. Human Health Risk Management 56
a. Dietary (Food) Risk Mitigation 56
b. Drinking Water Risk Mitigation 56
c. Residential Risk Mitigation 56
d. Aggregate Risk Mitigation 57
1) Acute Aggregate Risk 57
2) Short-term Aggregate Risk 57
3) Chronic (Non-Cancer) Aggregate Risk 57
e. Occupational Risk Mitigation 57
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1) Handler Exposure 57
2) Post-application Risk Mitigation 57
2. Environmental Risk Mitigation 57
3. Other Labeling Requirements 64
4. Endangered Species Considerations 65
5. Spray Drift Management 65
A. Manufacturing Use Products 67
1. Additional Generic Data Requirements 67
2. Labeling for Manufacturing-Use Products 68
B. End-Use Products 69
1. Additional Product-Specific Data Requirements 69
2. Labeling for End-Use Products 69
C. Labeling Changes Summary Table 69
VI. Appendicies 79
Appendix A. Use Patterns Subject to Reregistration for Benfluralin (Case 2030) 80
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Benfluralin
86
Appendix C. Technical Support Documents 93
Appendix D. Citations Considered to Be Part of the Data Base Supporting the Reregistration
Decision (Bibliography) 96
Appendix E. Generic Data Call-In 112
Appendix F. Product Specific Data Call-In 114
Appendix G EPA's Batching of Benfluralin Products for Meeting Acute Toxicity Data
Requirements for Reregistration 116
Appendix H. List of Registrants Sent this Data Call-In 126
Appendix I. List of Available Related Documents and Electronically Available Forms . 128
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Glossary of Terms and Abbreviations
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration.
EP End-Use Product
EPA Environmental Protection Agency
ESA Endangered Species Act
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
GLN Guideline Number
HAFT Highest Average Field Tnal
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MUP Manufacturing-Use Product
MRTD Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
NAWQA USGS National Water Quality Assessment
NPDES National Pollutant Discharge Elimination System
NR Not Required
NOAEL No Observed Adverse Effect Level
OP Organophosphate
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OPP
OPPTS
PCA
PAD
PDP
PHED
PHI
ppb
PPE
ppm
PRZM/
EXAMS
Q,*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
WPS
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Percent Crop Area
Population Adjusted Dose
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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Benfluralin Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Division
Nicole Zinn Herbicide and Insecticide Branch
Jihad Alsadek Economic Analysis Branch
Environmental Fate and Effects Division
Michael Davy Environmental Risk Branch 2
William Eckel Environmental Risk Branch 2
Dana Spate Environmental Risk Branch 2
Health Effects Division
David Anderson Reregistration Branch 2
Ken Dockter Reregistration Branch 2
Richard Griffin Reregistration Branch 2
Registration Division
Joanne Miller Herbicide Branch
Gene Wilson Herbicide Branch
Marcel Howard Herbicide Branch
Special Review and Reregistration Division
Katie Hall Reregistration Branch 2
Diane Isbell Reregistration Branch 2
Tom Myers Reregistration Branch 2
in
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Executive Summary
This document presents the Environmental Protection Agency's (the Agency or EPA)
decision regarding the reregistration eligibility of the registered uses of benfluralin. The Agency
made its reregistration eligibility determination based on the required data, the current guidelines for
conducting acceptable studies to generate such data, and published scientific literature. The Agency
has found that currently registered uses of benfluralin are eligible for reregistration, provided the
changes specified in this document are made to the label.
Benfluralin is a pre-emergent herbicide registered for use on residential and commercial turf,
alfalfa, clover, birdsfoot trefoil, lettuce, non-bearing fruit and nut trees, non-bearing berries, non-
bearing vineyards, ornamentals, non-cropland areas, fence rows/hedgerows, and Christmas tree
plantations. There are tolerances for benfluralin on alfalfa, birdsfoot trefoil, clover, and lettuce. A
use site for peanuts has been voluntarily cancelled from the technical label by the registrant, and the
peanut tolerance will be proposed for revocation by EPA. The Agency estimates that approximately
700,000 pounds of active ingredient are used annually, with approximately 80% used on turf.
Risks summarized in this document are those that result only from the use of benfluralin. The
Food Quality Protection Act (FQPA) requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that have
a common mechanism of toxicity." The reason for consideration of other substances is due to the
possibility that low-level exposures to multiple chemical substances that cause a common toxic effect
by a common toxic mechanism could lead to the same adverse health effect at would a higher level of
exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for benfluralin. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances found to
have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.
Dietary Risk from Food
Benfluralin's dietary risk assessment considered both acute and chronic risks from residues in
food based on field trials. The acute and chronic dietary (food) risks are less than 100% of the Acute
Population Adjusted Dose (aPAD) and Chronic Population Adjusted Dose (cPAD) for all population
subgroups and are not of concern.
Dietary Risk from Drinking Water
Benfluralin has at least 26 identified degradates, but none were of significant toxicity. One
degradate, 2,6-dinitro-4-trifluoromethyl-phenol, was found at a level of 0.133 ppm in an aerobic soil
study, and environmental fate data indicate that this degradate is more mobile than parent benfluralin,
and has a higher potential to leach to ground water than parent. On this basis, it is considered in the
drinking water assessment.
1
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The Agency estimates potential surface water and ground water pesticide contamination using
models. All modeled surface water EECs (< 3.5) and ground water EECs (< 0.07) are less than the
DWLOCs (50 or greater) and therefore are not of concern. The available monitoring data indicates
that benfluralin is found at a lower level in surface water than the modeling estimates indicate. All
detections are well below the DWLOCs and are not of concern.
Residential Risk
Residential handlers may be exposed to benfluralin during and after application on home
lawns and ornamental plants; or after applications at golf courses, parks, and schools. Benfluralin
products are marketed for homeowner use on residential lawns and landscape ornamental plants.
Benfluralin containing products are also marketed for use by professional applicators (Lawn Control
Operators, or LCOs) on residential turf, on golf courses, other turf such as recreational or commercial
areas, and on ornamental plantings. Based on these uses, benfluralin has been assessed for the
residential applicator (or "handler") and for children's post-application exposure that may occur from
turf contact and hand to mouth transfer.
Benfluralin is not assessed for systemic dermal toxicity (because no systemic toxicity was
observed from a dermal toxicity study in rats), but is assessed for systemic inhalation toxicity. All
residential handler MOEs are greater than 100 and therefore risks to residential handlers are not of
concern.
Benfluralin uses in the residential setting include applications to ornamentals and to lawns.
Although the type of use site for benfluralin varies from golf courses to ornamental gardens, the
scenario chosen for risk assessment (residential turf use) represents what the Agency considers the
likely upper-end estimate of possible exposure. For this assessment, children are the population
group most likely to be significantly exposed. Since systemic toxicity was not observed in a dermal
toxicity study, up to a dose level of 1,000 mg/kg/day, the only risk addressed in the assessment is the
possible oral exposure of small children from treated turf, or from treated soil (i.e., soil ingestion,
granule ingestion, and hand-/object-to-mouth transfer). A Margin of Exposure of 100 (or more) is
considered protective for this assessment. The oral MOE from all ingestion exposures to children is
above 100, and therefore these risks are not of concern. Postapplication inhalation exposure is
expected to be minimal.
Benfluralin 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).
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. In assessing drinking water risks, EPA considers acute (one day), chronic (long-term)
and cancer (overall mean) exposure, and uses either modeling or monitoring data if available, to
estimate those risks. To determine the maximum contribution from water allowed in the diet, EPA
first looks at how much of the overall allowable risk is contributed by food and then calculates a
"drinking water level of comparison" (DWLOC) to determine whether modeled or monitoring
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exposure estimates exceed the allowable risk level. Estimated environmental concentrations (EECs)
that are above the corresponding DWLOC exceed the Agency's level of concern.
Acute Aggregate Risk. There are no adverse effects expected from a single exposure to
benfluralin; therefore, an acute aggregate risk assessment was not conducted.
Short-term Aggregate Risk. Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water. Short-term aggregate risk from residential
inhalation, incidental oral exposure to children, and chronic exposure to food and drinking water are
not of concern.
Chronic Aggregate Risk. The chronic aggregate risk assessment addresses only exposure to
benfluralin residues in food and water, since there are no benfluralin uses that would result in chronic
residential exposure. Chronic aggregate risk is not of concern.
Occupational Risk
The Agency has identified 13 handler scenarios resulting from mixing/loading and applying
benfluralin for crop and non-crop uses. Of the 13 scenarios, all short- and intermediate-term
exposures resulted in an MOE above 100 and are therefore not of concern.
Ecological Risk
Available data indicates that benfluralin is of variable soil persistence with different
mechanisms of degradation. Benfluralin has low mobility in soils, according to available mobility
studies (Koc values range from 9840 to 11,660 L/kg). Acceptable field dissipation studies observed in
three different locations indicate moderate half-lives of 22 to 79 days. Benfluralin volatilizes rapidly,
as indicated in laboratory volatility studies.
Parent benfluralin is not expected to leach into ground water, based on its low mobility in soil.
However, degradate 2,6 dinitro-4-trifluoromethyl-phenol was formed at 6% of parent in the soil
metabolism study. Based on limited environmental fate information, it has the potential to
contaminate groundwater. Trifluoroacetic acid (TFA) was not found in environmental fate studies,
but was noted as a plant metabolite.
Based on its measured bioaccumulation factor in whole fish (1580), parent benfluralin is
considered to be bioaccumulative. The depuration rate was 0.54 per day for whole fish.
Most ecological risk quotient (RQ) values are 9 and below, including RQ values for acute risk
to freshwater fish, freshwater invertebrates, and estuarine invertebrates, and for chronic risk to birds,
mammals, and freshwater fish. The highest RQ value for non-cropland areas at the maximum
application rate of 12 Ib ai/A per year is 24 for chronic risk to mammals. The RQs for non-target
terrestrial and aquatic plants have not been calculated due to lack of toxicity data.
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Endangered Species
EPA has reviewed ecotoxicity and fate data for benfluralin to assess potential effects on
endangered species. This limited analysis indicates that some of the previously allowed uses are
likely to have no effects on certain taxa of listed species, but other uses might potentially be affecting
listed species. On the basis of that analysis, we have decided that some generally applicable risk
mitigation measures (e.g., reduced application rates) would be appropriate. We expect such measures
will reduce risks for non-target wildlife in general, and threatened and endangered species, in
particular. EPA anticipates refining its assessment of the potential risks to listed species and critical
habitat in the future, after additional data are submitted as required under the RED. EPA will follow
the approach for ecological risk assessment described in the Overview of the Benfluralin Risk
Assessments, dated December 15, 2003, available on the e-docket website at www.epa.gov/edocket.
To the extent the refined assessments indicate that benfluralin is harming listed species or critical
habitat, we will take appropriate steps to ensure compliance with FIFRA and the Endangered Species
Act (ESA). Such actions may include initiating consultation with the Services and/or site-specific
risk mitigation measures, consistent with the Endangered Species Protection Program.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of the
interim program, the Agency has developed County Specific Pamphlets that articulate many of the
specific measures outlined in the Biological Opinions issued to date. The Pamphlets are available for
voluntary use by pesticide applicators on EPA's website at www. epa. gov/espp. A final Endangered
Species Protection Program, which may be altered from the interim program, was proposed for public
comment in the Federal Register December 2, 2002.
Risk Mitigation Summary
To mitigate the risks of concern posed by the use of benfluralin, EPA considered the
mitigation proposed by the technical registrant, as well as risk mitigation ideas from other interested
parties, and has decided on a number of label amendments to address ecological concerns. A
summary of the risk mitigation is listed below. A complete discussion of the risks, and the label
amendments necessary to mitigate them are presented in Chapter IV of this RED.
• Reduction in application rate and limitation in the number of applications for non-
cropland areas, landscape ornamentals, field-grown ornamentals, container-grown
ornamentals, non-bearing vineyards, non-bearing fruit and nut trees, non-bearing
berries, and Christmas tree farm use sites.
• For granule applications to turf, watering in will be required.
• Peanut use site has been voluntarily cancelled from the technical labels and the peanut
tolerance will be proposed for revocation by the Agency.
Conclusions
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The Agency is issuing this Reregistration Eligibility Decision (RED) for benfluralin, 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 benfluralin. With the addition of the label restrictions and amendments detailed in this
document, the Agency has determined that all currently registered uses of benfluralin are eligible for
reregistration.
The risk assessments for benfluralin are based on the best scientific data currently available to
the Agency and are adequate for regulatory decision making.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984
and amended again by the Pesticide Registration Improvement Act of 2003 to set timeframes for the
issuance of Reregistration Eligibility Decisions. The amended Act calls for the development and
submission of data to support the reregistration of an active ingredient, as well as a review of all
submitted data by the U.S. Environmental Protection Agency (referred to as EPA or the Agency).
Reregistration involves a thorough review of the scientific database underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether or not the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act (FQPA) was signed into law. This Act
amends FIFRA to require that by 2006, EPA must reassess all tolerances in effect at the time of the
enactment. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity.
Benfluralin is a pre-emergent dinitroaniline herbicide used to control grasses on commercial
and residential turf. Benfluralin also has four food/feed use sites that include lettuce, alfalfa, clover,
and birdsfoot trefoil. Other nonfood/nonfeed sites include non-bearing fruit and nut trees, non-
bearing berries, non-bearing vineyards, turf, ornamentals, rights of way, fence rows/hedgerows, and
Christmas tree plantations.
The Agency has concluded that the FQPA Safety Factor for benfluralin should be removed
(equivalent to IX) based on a complete database for FQPA consideration and a conclusion that there
is no increased susceptibility following pre- and/or postnatal exposure. The FQPA Safety Factor
recommendation assumes that the exposure databases (food, drinking water, and residential) are
complete, the risk assessment for each potential exposure scenario includes all metabolites and/or
degradates of concern, and does not underestimate the potential risk for infants and children. These
criteria have been met in the benfluralin risk assessment.
Risks summarized in this document are those that result only from the use of benfluralin. The
Food Quality Protection Act (FQPA) requires that the Agency consider available information
concerning the cumulative effects of a particular pesticide's residues and other substances that have a
common mechanism of toxicity. The reason for consideration of other substances is due to the
possibility that low-level exposures to multiple chemical substances that cause a common toxic effect
by a common toxic mechanism could lead to the same adverse health effect that would occur at a
higher level of exposure to any of the substances individually. Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not
made a common mechanism of toxicity finding for benfluralin and any other substances and
benfluralin does not appear to produce a toxic metabolite produced by other substances. For the
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purposes of this action, therefore, EPA has assumed that benfluralin does not have a common
mechanism of toxicity with other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances found to
have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of benfluralin, including the consideration of risk to infants, children and adults for
any potential food, drinking water, dermal, inhalation or oral exposures from residential uses. In an
effort to simplify the RED, the information presented herein is summarized from more detailed
information which can be found in the technical supporting documents for benfluralin referenced in
this RED. The revised risk assessments and related addenda are not included in this document, but
are available on the Agency's web page at www.epa.gov/pesticides, and in the Public Docket at
http ://www. epa. gov/edocket.
This document consists of six sections. Section I is the introduction. Section IE provides a
chemical overview, a profile of the use and usage of benfluralin, and its regulatory history. Section
HI, Summary of Benfluralin Risk Assessment, gives an overview of the human health and
environmental assessments, based on the data available to the Agency. Section IV, Risk
Management, Reregistration, and Tolerance Reassessment Decision, presents the reregistration
eligibility and risk management decisions. Section V, What Registrants Need to Do, summarizes the
necessary label changes based on the risk mitigation measures outlined in Section IV. Finally, the
Appendices list all use patterns for reregistration, bibliographic information, related documents and
how to access them, and Data Call-In (DCI) information.
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n.
Chemical Overview
A. Regulatory History
Benfluralin has been registered in the United States since 1970 for use as a pre-emergent
dinitroaniline herbicide. During the second phase of reregistration, the Agency conducted a review of
the scientific data base underlying pesticide registrations and identified missing or inadequate studies.
Subsequent Data Call-Ins (DCIs) were issued in 1991, and 1995 for benfluralin. This Reregistration
Eligibility Decision (RED) reflects a reassessment of all data submitted to date.
There are approximately 120 products containing benfluralin, registered under Section 3 of
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Currently, there are no Section 18
(Emergency Exemption) uses, or Section 24(c) (Special Local Needs) uses registered for benfluralin.
This Reregistration Eligibility Decision document evaluates risks from all currently registered uses,
including agricultural food and non-food crops; non-bearing fruit and nut trees; non-bearing berries;
non-bearing vineyards; Christmas tree plantations; non-agricultural use areas such as rights-of-way,
and turf.
A close-out conference call was conducted on July 28, 2004, with EPA, USDA, and the
registrants to discuss the risk management decisions and resultant changes to the benfluralin labels.
B.
Chemical Identification
H3cr
N'
Common name:
Chemical name:
Chemical Family:
Empirical formula:
CAS Registry No.:
Case number:
OPP Chemical Code:
Molecular weight:
Trade name:
Basic manufacturer:
Benfluralin, Benefm
[N-butyl-n-ethyl-alpha-alpha-alpha-tri-fiuoro-2,6-
dinitro-p-toluidine]
Dinitroaniline
C13H16F3N304
1861-40-1
2030
084301
335.3
Balan
Dow AgroSciences LLC, Loveland Products LLC
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Technical benfluralin is a yellowish-orange, crystalline solid with a melting point of 65-68
°C. The water solubility of benfluralin is 0.1 ppm at pH 7.00 and 25 °C. Benfluralin has a vapor
pressure of 6.57 x 10"5 mm Hg at 25 °C.
C.
Use Profile
The following is information on the currently registered uses of benfluralin products and an
overview of use sites and application methods. A detailed table of the uses of benfluralin eligible for
reregistration is contained in Appendix A.
Type of Pesticide:
Summary of Use:
Food:
Non-Food:
Residential:
Target Pests:
Formulation Types:
Herbicide
Benfluralin is a pre-emergent dinitroaniline herbicide used to control
grasses and other weed species. Benfluralin is used alone and is also
commonly formulated with trifluralin and oryzalin.
Benfluralin is used on a single food crop (pre-plant on lettuce), and on
several feed crops (pre-plant on alfalfa, clover, trefoil). There are
tolerances for benfluralin on alfalfa, birdsfoot trefoil, clover, and
lettuce. The use for peanuts has been voluntarily canceled by the
registrant and the tolerance for peanuts will be proposed for
revocation by the Agency.
Benfluralin is registered for use on non-bearing fruit and nut trees,
non-bearing berries, non-bearing vineyards, turf, ornamentals, rights
of way (including industrial sites, utility substations, highway
guardrails, sign posts, and delineators), fence rows/hedgerows, and
Christmas tree plantations.
Benfluralin is used on residential turf and ornamental plants.
Target pests include Johnsongrass seedlings, chickweed,
lambsquarters, purslane, knotweed, clover, pigweed, plantain,
crabgrass, foxtail, goosegrass, and Poa annua, barnyardgrass and
fescue. Benfluralin works by inhibiting growth (mitotic disrupter).
Formulated as emulsifiable concentrate, granules, soluble
concentrate/liquid, water dispersible granules (dry flowable).
Method and Rates of Application:
Equipment:
Benfluralin is applied as band treatment, broadcast, golf course
treatment, soil incorporated treatment, and spray with ground or
sprinkler irrigation systems. Equipment used to apply benfluralin
include groundboom, push spreader, bellygrinder, shaker can, low
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pressure hand wand, tractor/ATV drawn spreader, pump-feed and
gravity-feed backpack sprayer, handgun sprayer, and bucket and spoon.
Application Rates: Current maximum labeled agricultural rates per application are 1.2 - 3.0
Ibs ai/A. Current maximum labeled non-agricultural rate per application
is 1.5 - 6.0 Ibs ai/A. The current maximum agricultural rate per year is 6
Ibs ai/acre. The current maximum non-agricultural rate per year is 12
Ibs ai/A.
Timing: Applied pre-emergent for all use sites.
Use Classification: General Use
Registrants: Dow AgroSciences LLC (formerly DowElanco), United Phosphorus,
Inc., and Loveland Products, (formerly Platte Chemical Company).
D. Estimated Usage of Pesticide
Table 1 summarizes the best estimates available for the uses of benfluralin. The estimate for
total domestic use (annual average) is approximately 700,000 pounds of active ingredient, with the
majority of use in the following sectors: lawn care operator, landscape, other turf, alfalfa, and lettuce.
Table 1. Benfluralin Usage Summary
Site
Lawn Care Operator
Landscape
Other Turf
Alfalfa
Lettuce
Lbs. Active Ingredient
Applied
(Weighted Average)1
430,000
85,000
100,000
50,000
35,000
Percent Crop Treated
(Likely Maximum)
—
—
—
<2%
12%
Percent Crop Treated
(Weighted Average)1
—
—
—
<1%
9%
'Weighted Average: the most recent years and more reliable data are weighted more heavily.
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ILL Summary of Benfluralin Risk Assessments
The following is a summary of EPA's human health and ecological effects risk findings and
conclusions for the pre-emergent dinitroaniline pesticide benfluralin, as presented fully in the
documents: "Benfluralin: Human Health Risk Assessment (Revised)," dated October 30, 2003
(including addendum, dated June 8, 2004); "Response to Dow AgroSciences' Comments on EFED
RED Chapter for Benfluralin," (including as an attachment, the Environmental Fate and Effects Risk
Assessment), dated June 4, 2004; here after referred to as the Environmental Fate and Effects Risk
Assessment.
The purpose of this section is to summarize the key features and findings of the risk
assessments in order to help the reader better understand the conclusions reached in the assessments.
Risks summarized in this RED document are those that result only from the use of benfluralin. While
the risk assessments and related addenda are not included in this RED, they are available from the
OPP Public Docket and may also be accessed on the Agency's website at
http ://www. epa. gov/pesticides/reregistration/status. htm.
A. Human Health Risk Assessment
1. Dietary Risk from Food
A brief overview of the toxicity studies used for endpoints in the dietary risk assessments is
outlined below in Table 2. Further details on the toxicity of benfluralin can be found in the "Human
Health Risk Assessment (Revised)," dated October 30, 2003 (including addendum, dated June 8,
2004).
a. Toxicity of Benfluralin
The Agency has reviewed all toxicity studies submitted for benfluralin and has determined
that the toxicological database is sufficient for reregistration. The studies have been submitted to
support guideline requirements.
Major features of the toxicology profile are presented below. In acute studies, benfluralin has
low acute toxicity (Toxicity Category IV) by the oral and dermal routes. For primary skin and eye
irritation, benfluralin was placed in Toxicity Category El. In guinea pig studies, technical benfluralin
was found to be a dermal sensitizer. The acute toxicity data table is listed below.
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Table 2. Acute Toxicity Data on Benfluralin
Guideline No./ Study Type
870. 1 100 Acute Oral Toxicity
870.1200 Acute Dermal Toxicity
870. 1 300 Acute Inhalation Toxicity
870.2400 Acute Eye Irritation
870.2500 Acute Dermal Irritation
870.2600 Skin Sensitization
MRID
Number
00024255 (rat,
1965)
41751701
(rabbit, 1990)
4 16 13807 (rat,
1989)
00024265
(rabbit, 1976)
41751702
(rabbit, 1990)
00144283
(guinea pig,
1990)
Results
LD50 > 10 g/kg (adults) 0 out of 10
died at 5 and 10 g/kg
LD50 > 5 g/kg
LC50>2.3mg/L
Slightly irritating, reversible within 7
days
Moderate erythema and edema at day 7,
which cleared by day 1 1 .
7 out of 12 guinea pigs tested positive
in the Beuhler test
Toxicity
Category
IV
IV
IV
III
III
Skin
Sensitizer
In longer-term studies, benfluralin is toxic to the kidneys and liver (20 mg/kg/day, female rats,
MRID 44050001), and is toxic to the thyroid at high dose levels (136.3 mg/kg/day, male rats). Rats
show a lowest observed adverse effect level (LOAEL) based on kidney toxicity. Dogs show a
LOAEL based on liver toxicity and mice show a LOAEL based on liver and kidney toxicity. Other
dinitroaniline pesticides show a mixture of kidney, liver, hematological, and thyroid toxicity at their
respective LOAELs.
No appropriate endpoints (effects) attributable to a single exposure (dose) were identified in
any study including developmental studies in rabbits or rats. Therefore, an acute RfD was not
established and EPA has not assessed acute dietary risk for benfluralin.
Risk assessment for chronic dietary exposure is based on a no observed adverse effect level
(NOAEL) of the combined chronic toxicity/oncogenicity study in rats. The NOAEL for chronic
toxicity was 0.5 mg/kg/day for males and 0.7 mg/kg/day for females, based on an increased incidence
of histologic lesions of the kidney in males and females at the LOAEL of 5.4 mg/kg/day for males
and 6.8 mg/kg/day for females.
The short-term incidental oral exposure endpoint is used to assess oral exposure for a duration
up to 30 days. In a rabbit developmental study, the maternal NOAEL was determined to be 100
mg/kg/day and the LOAEL 225 mg/kg/day, based on dose related nominal body weight gain
decrement, few feces, and reduced food consumption. Intermediate-term incidental oral exposure is
not expected based on current use patterns and labeling.
In a 21-day dermal toxicity (rabbit) study conducted with benfluralin, the LOAEL was found
to be 100 mg/kg/day, the lowest dose tested. In this study, a NOAEL was not established. Dose-
related dermal effects included epidermal hyperplasia, hyperkeratosis, parakeratosis, chronic-active
12
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inflammation, edema, and hyperplasia of the sebaceous glands. No systemic effects were seen with
technical benfluralin (95.8%) at the highest dose tested (1000 mg/kg/day), but severe dermal effects
were seen in the study 3 days after starting treatment with benfluralin.
In a modified Beuhler topical patch test for skin sensitization (guinea pig), several test
animals responded with a typical delayed hypersensitivity reaction to a challenge with technical
benfluralin at 5% in 95% ethanol. Formulated products showed no evidence of sensitization in
Beuhler's assays when tested concentrations ranged from 19% to 60% benfluralin. Further testing of
benfluralin products will be conducted during product reregistration.
There are no dermal adsorption studies for benfluralin. However, the Agency estimated a 3%
dermal absorption factor for benfluralin based on the results of the dermal adsorption study for
ethalfluralin, a structurally related compound.
Risk assessment for short-term inhalation exposure is based on an oral study. The Agency
selected the developmental study in rabbits to be the basis for short-term inhalation risk assessment.
Also, an assumption is made that 100% of the estimated inhalation dose will be absorbed. Risk
estimates are based on the NOAEL dose of 100 mg/kg/day. The maternal LOAEL in the study is 225
mg/kg/day based on decreases in food consumption.
Intermediate-term inhalation risk assessment is based on the two-generation rat reproduction
study, where liver and kidney toxicity were observed at the LOAEL of 68 mg/kg/day. The NOAEL
is 7.2 mg/kg/day. As in the short-term inhalation risk assessment, an assumption is made that 100%
of the estimated inhalation dose will be absorbed. All toxicological endpoints used for risk
assessment are presented in Table 3 below.
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Table 3; Endpoints for Benfluralin Risk Assessment
Exposure
Scenario
Acute
Dietary
Chronic Dietary
(All populations)
Dermal,
Short, Intermediate
and Long-Term
Inhalation,
Short-Term
(1-30 days)
Dose used in Risk
Assessment
(mg/kg/day)
FQPA Safety Factor*,
Level of Concern for Risk
Assessment,
Uncertainty Factor, Absorption Rate
Study and Toxicological
Effects
An appropriate endpoint attributable to single dose was not identified; therefore, an acute RfD /
aPAD was not established.
NOAEL = 0.5
None
NOAEL= 100
FQPA SF = 1XUF= 100
Chronic RfD = 0.005 mg/kg/day
cPAD = 0.005/1 = 0.005 mg/kg/day
Chronic /carcinogenicity-Rat
LOAEL = 5.4 mg/kg/day
based on increased
histopathologic lesions of the
kidneys seen in males (5.4
mg/kg/day for males and 6.8
mg/kg/day for females).
There was no systemic toxicity in the 21 -day dermal study and dermal
toxicity showed no NOAEL.
Residential Level of Concern (LOG)
forMOE=100
Occupational Level of Concern (LOG)
forMOE=100
absorption rate = 100%
Oral Developmental toxicity -
Rabbits
LOAEL = 225 mg/kg/day
based on decreases in
maternal body weight gain
over a 13 day dosing period.
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE =
margin of exposure, LOG = level of concern, NA = Not Applicable
In accord with the Agency's Draft Guidelines for Cancer Risk Assessment (July, 1999), the
Agency Cancer Assessment Review Committee (CARC) classified benfluralin into the category
"suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential" by
the oral route based on the following weight of evidence considerations: 1) The two highest doses
resulted in an increase in tumors of the liver and thyroid. However, these doses were considered
excessive by the Agency review committee and no tumors were seen at lower doses, which were
considered adequate for cancer testing. This study contributes little to the overall weight of evidence
for a positive finding of carcinogenicity for benfluralin. 2) Female mice had a borderline statistically
significant increase in liver tumors by both trend and pairwise tests at doses that were adequate. No
tumors were seen in the male mice, but after considering additional new data, the Agency determined
that the doses tested in the males were not high enough and this part of the mouse cancer testing
should be repeated. 3) There was a lack of carcinogenic potential in rats, a lack of mutagenic
potential in a battery of tests, and structurally related pesticides were classified as "C" carcinogens
with their respective mutagenicity studies showing no uniform pattern of mutagenicity.
Suggestive evidence of neuropathy occurring only in rats and only at study termination was
evaluated by the Agency. This neuropathy was considered to be due to normal age related
neuropathy in aging rats at excessive dose levels. The Agency concluded that acute and subchronic
14
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neurotoxicity studies are not required because the neuropathy effects would not likely occur at the
doses that would be tested in these studies.
Benfluralin shows no developmental toxicity in two studies (in the rat and rabbit) at
maternally toxic doses. The 2-generation rat reproduction study showed pup weight decrement at
parentally toxic dose levels and decreased live pups at the highest dose level tested. Thus, there was
no evidence for quantitative or qualitative increased susceptibility of fetuses or offspring.
No obvious endocrine related effects were noted on the organs of reproduction. Thyroid
toxicity in rats was seen at the highest dose, but whether or not these thyroid effects were directly
related to endocrine modulation by benfluralin can not be determined based on the data submitted.
b. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is intended
to provide up to an additional 10-fold safety factor (lOx), to protect for special sensitivity in infants
and children to specific pesticide residues in food, drinking water, or residential exposures, or to
compensate for an incomplete database. The Agency has concluded that the FQPA Safety factor
should be removed (equivalent to IX) based on a conclusion of no increased susceptibility and no
residual uncertainty. The FQPA Safety Factor assumes that the exposure databases (food, drinking
water, and residential) are complete, the risk assessment for each potential exposure scenario includes
all metabolites and/or degradates of concern, and does not underestimate the potential risk for infants
and children. These criteria have been met in the benfluralin risk assessment. The food (dietary)
assessment for benfluralin is a Tier 1, or screening type assessment, because it is based on tolerance
level residues and assumes 100% of considered crops are treated with benfluralin. The drinking
water (dietary) assessment is based on an adequate environmental fate database for parent benfluralin
and, in the absence of complete fate data for all degradates of concern, upper-bound estimates were
made using data on the parent compound such that the estimated environmental concentrations
(EECs) are not underestimated. The benfluralin residential risk assessment is also considered an
upper-bound assessment since it is based on maximum use rates, the Agency's Residential SOPs
(which tend to be conservative) and more recent data from the Outdoor Residential Exposure Task
Force (ORETF).
c. Population Adjusted Dose
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which reflects
the reference dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA
Safety Factor (SF). This calculation is performed for each population subgroup. A risk estimate that
is less than 100% of the acute or chronic PAD is not of concern.
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1) Acute PAD
As discussed in Section IE.A.I.a, EPA has not assessed acute dietary risk for benfluralin
because no appropriate endpoint attributable to a single exposure (dose) could be identified. As a
result, an acute dietary RiD was not established.
2) Chronic PAD
Dietary risk for benfluralin is assessed by comparing chronic dietary exposure estimates (in
mg/kg/day) to the benfluralin cPAD. Dietary risk is expressed as a percent of the cPAD. The cPAD
is the chronic Population Adjusted Dose, which is the chronic Reference Dose (0.005 mg/kg/day)
modified by the FQPA safety factor. The benfluralin cPAD is 0.005 mg/kg/day based on a RiD of
0.005 mg/kg/day, and incorporating the FQPA safety factor of Ix (no special factor) for the overall
U.S. population or any populations subgroups. The cPAD was derived from a combined rat
chronic/carcinogenicity study, in which benfluralin was administered to Fischer 344 rats
(60/sex/dose) in the diet at dose levels at 0.5, 5.0, 125, and 250 mg/kg/day for up to two years, with a
NOAEL of 0.5 mg/kg/day as noted in Table 3 above.
d. Exposure Assumptions
The benfluralin chronic dietary exposure assessment was conducted using the Dietary
Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCTD™),
Version 1.3, which incorporates consumption data from the USDA's Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998. The CSFH data are based on the reported food
consumption by more than 20,000 individuals over two nonconsecutive survey days. For the chronic
exposure assessment, consumption data are averaged for the entire U.S. population and within
population subgroups. Exposure estimates are reported in mg per kg of body weight per day, and risk
is expressed as a percent of the cPAD.
e. Dietary (Food) Risk Assessment
1) Acute Dietary Risk
Acute risk is not a concern for benfluralin since no appropriate endpoint attributable to a
single dose has been identified.
2) Chronic (Noncancer) Dietary Risk
Benfluralin food and feed use sites currently include alfalfa, birdsfoot trefoil, clover, lettuce,
and peanuts at 0.05 ppm. The use on peanuts was not included in the dietary risk assessment since
the peanut use site is not being supported by the registrants. The voluntary cancellation notice was
published in the Federal Register Notice on June 25, 2003 and became effective on December 22,
2003. The established tolerance for peanuts will be proposed for revocation. Feeding studies in
ruminants and poultry demonstrated that, based on the expected residue levels in treated feed items
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(alfalfa, birdsfoot trefoil, clover), there would in turn be no expectation of finite residue in the
livestock commodities of milk, meat, poultry, and eggs.
The remaining food use for benfluralin is on lettuce. An upper-bound (tier 1) chronic dietary
risk assessment was conducted for benfluralin. The residue estimate for lettuce, the only direct food
use for benfluralin, is based on the level set for tolerance (0.05 ppm). Also, an assumption is made
that 100% of the U.S. lettuce crop is treated with benfluralin. Estimated chronic dietary risk estimates
for all population subgroups are less than 1% of the benfluralin cPAD (0.005 mg/kg/day) and do not
indicate a concern for this route of exposure.
For more information on chronic dietary risk assessment, please refer to the Dietary Exposure
and Risk Analysis sections of the "Human Health Risk Assessment (Revised)," dated October 30,
2003 (including addendum, dated June 8, 2004).
2. Dietary Risk from Drinking Water
Benfluralin has at least 26 identified degradates, but none were of significant toxicity. One
degradate 2,6-dinitro-4-trifluoromethyl-phenol was found at a level of 0.133 ppm in an aerobic soil
study, and environmental fate data indicate that this degradate is more mobile than parent benfluralin,
and has a higher potential to leach to ground water than parent. On this basis, it is considered in
drinking water assessment. For a listing of all identified degradates, see the Environmental Fate and
Effects Risk Assessment.
Drinking water exposure to pesticides can occur through ground and surface water
contamination. In assessing drinking water risks, EPA considers acute (one day), chronic (long-term)
and, if applicable, cancer (overall mean) exposure, and uses either modeling or monitoring data if
available, to estimate those risks. To determine the maximum contribution from water allowed in the
diet, EPA first looks at how much of the overall allowable risk is contributed by food and then
calculates a "drinking water level of comparison" (DWLOC) to determine whether modeled or
monitoring exposure estimates exceed the allowable risk level. Estimated environmental
concentrations (EECs) that are above the corresponding DWLOC exceed the Agency's level of
concern.
a. Surface Water
Modeling: Estimated surface water (drinking water) concentrations are based on two models
coupled together, PRZM and EXAMS. The PRZM/EXAMS combined model is a Tier II assessment
that includes refined assumptions. The Estimated Environmental Concentrations (EECs) have been
calculated for two types of dietary risk assessment: 1) acute or peak concentration; 2) non-cancer
chronic concentration. Since acute dietary risk is not a concern, the only EECs of interest for
benfluralin are the chronic (non-cancer) concentrations, which are defined as the highest (90th
percentile) in a ten-year span. All modeled surface water EECs are less than the DWLOCs and
therefore are not of concern.
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Monitoring: At the present time, the Agency has limited monitoring data on the
concentrations of benfluralin and/or degradates in surface water. The available monitoring data
indicates that benfluralin is found at a lower level in surface water than the modeling estimates
indicate. The U.S. Geological Survey (USGS) has performed monitoring for parent benfluralin under
the NAWQA program. Of over 5000 samples, benfluralin was detected in 92 samples at a maximum
concentration of 0.097 ppb. All detections are well below the DWLOCs and are not of concern.
b. Ground Water
Modeling: The SCI-GROW model was used to estimate potential ground water
concentrations. SCI-GROW is a screening tool, or tier 1 model for ground water. It is based on a
regression approach which relates the concentrations found in ground water in Prospective Ground
Water studies to aerobic soil metabolism rate and soil-water partitioning properties of the chemical.
The SCI-GROW EECs for benfluralin were 0.009 ppb for alfalfa, 0.020 ppb for turf, and 0.07 ppb for
rights of way use sites. These estimates are below the DWLOCs for all populations.
Monitoring: The Pesticides in Ground Water Database ((EPA 734-12-92-001, Sept. 1992)
shows that benfluralin was looked for in 83 wells in Arkansas in 1986-1987, 1 well in California in
1984-1989, and 22 wells in Oregon in 1985-1987. There were no detections of benfluralin.
For more information on drinking water risks and the calculations of the DWLOCs, see the
Water Exposure section of the "Human Health Risk Assessment (Revised)," dated October 30, 2003
(including addendum, dated June 8, 2004).
3. Residential and Other Nonoccupational Exposure
Residential risk assessment considers all potential pesticide exposure, other than exposure due
to residues in foods or in drinking water. Exposure may occur during and after application on home
lawns and ornamental plants; or after applications at golf courses, parks, schools, etc. Each route of
exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a Margin
of Exposure (MOE), which is the ratio of estimated exposure to an appropriate No Observed Adverse
Effect Level (NOAEL) dose. Benfluralin products are marketed for homeowner use on residential
lawns and landscape ornamental plants. Benfluralin containing products are also marketed for use by
professional applicators (Lawn Control Operators, or LCOs) on residential turf, on golf courses, other
turf such as recreational/commercial areas, and on ornamental plantings. Based on these uses,
benfluralin has been assessed for the residential applicator (or "handler") and for children's post-
application exposure that may occur from turf contact and hand to mouth transfer.
18
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a. Residential Applicator (Handler)
1) Exposure, Scenarios, Data, and Assumptions
Homeowners (or others) may be exposed to benfluralin while treating their lawns. All
homeowner-use products are in granular form with the active ingredient (ai) comprising up to 1.25%
of total formulation. Benfluralin is applied by typical push-type spreaders or belly grinders before
seasonal weed emergence, at a rate up to 3 Ibs. ai/acre. A number of assumptions, or estimates, such
as adult body weight and area treated per application, are made by the Agency for residential risk
assessment. Also, note that residential handlers are addressed somewhat differently than occupational
handlers in that homeowners are assumed to complete all elements of an application (mix/load/apply)
without use of protective equipment (assessments are based on an assumption that individuals will be
wearing short pants and short-sleeved shirts).
The quantitative exposure/risk assessment developed for residential handlers is based on these
scenarios:
Granular formulation: loading/applying with bellygrinder spreader
Granular formulation: loading/applying with push-type spreader
Granular formulation: loading/applying with shaker can.
Benfiuralin-specific data to assess the above exposure scenarios were not submitted to the
Agency in support of reregistration. Instead, exposure estimates for these scenarios are taken from
the Pesticide Handlers Exposure Database (PHED, Version 1.1 August 1998) which is used to assess
handler exposures when chemical-specific monitoring data are not available. In addition to PHED
data, this risk assessment relies on data from the Outdoor Residential Exposure Task Force (ORETF)
and proprietary studies. For more information, see the "Human Health Risk Assessment (Revised),"
dated October 30, 2003 (including addendum, dated June 8, 2004).
The following assumptions were used in the exposure calculations:
• Average body weight of an adult handler is 70 kg;
• Area treated estimate of 0.5 acres for lawn and ornamental treatments using granular
formulations with a bellygrinder spreader or push-type spreader;
• Area treated estimate of 1000 square feet for ornamental treatments using a shaker can;
and
• Exposure frequency - The residential handler exposure is expected to be of a short-term
duration (less than 30 days).
2) Benfluralin Residential Handler Risk Estimates
Benfluralin is not assessed for systemic dermal toxicity (because no systemic toxicity was
observed from a dermal toxicity study in rats), but is assessed for systemic inhalation toxicity. Risk
assessment for inhalation exposure is based on a rabbit developmental toxicity oral study NOAEL of
100 mg/kg/day. An assumption is made that 100% of the estimated inhalation dose will be absorbed.
A Margin of Exposure (MOE) greater than or equal to 100 (1 Ox for interspecies extrapolation and
lOx for intraspecies variation) is considered adequately protective for this assessment. Since all
19
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residential handler MOEs are greater than 100, risk to residential handlers is not of concern. The
benfluralin risk estimates are presented in Table 4 below.
20
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Table 4. Benfluralin Risk Estimates for Residential Handlers
Exposure Scenario
(Data Source)
Crop or Target
Application Ratea
Area Treated
Daily"
Baseline Inhalation MOEC
Mixer/Loader/ Applicato r
Loading/Applying Granulars with a
Belly Grinder
Loading/Applying Granulars with a
Push Type Spreader (ORETF)
Loading/Applying Granulars with a
Bucket and Spoon
(MRID 452507-01)
Loading/Applying Granulars with a
Shaker Can (PHED)
residential turf
ornamentals: outdoor
ornamental bulbs
residential turf
ornamentals: outdoor
ornamental bulbs
ornamentals: outdoor
ornamental bulbs
ornamentals: outdoor
ornamental bulbs
3 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
0.689 Ib ai/1000 sq
ft
0.0344 Ib ai/1000
sqft
0.689 Ib ai/1000 sq
ft
0.0344 Ib ai/1000
sqft
0.5 acres
0.5 acres
0.5 acres
0.5 acres
0.5 acres
0.5 acres
1000 sqft
1000 sqft
1000 sqft
1000 sqft
75,000
75,000
150,000
5,300,000
5,300,000
11,000,000
230,000
4,500,000
22,000
440,000
a Application rates are the maximum application rates determined from EPA registered labels for benfluralin.
b Amount handled per day values are EPA estimates of acreage treated or gallons applied based on Exposure SAC Policy
#9 "Standard Values for Daily Acres Treated in Agriculture".
c Baseline inhalation MOE = short-term NOAEL (100 mg/kg/day) / baseline inhalation dose (mg/kg/day), where baseline
inhalation dose = baseline inhalation unit exposure (|ig/lb ai) x application rate x amount handled per day x Img / lOOO^g)
/ body weight (70 kg).
b. Residential Pos tap plication Risk
1) Exposure, Scenarios, Data, and Assumptions
Benfluralin uses in the residential setting include applications to ornamentals and to lawns.
Although the type of site that benfluralin may be used on varies from golf courses to ornamental
gardens, the scenario chosen for risk assessment (residential turf use) represents what the Agency
considers the likely upper-end estimate of possible exposure. For this assessment, children are the
population group most likely to be significantly exposed. Since systemic toxicity was not observed in
a dermal toxicity study, up to a dose level of 1,000 mg/kg/day, the only scenario addressed in the
assessment is the possible oral exposure of small children from treated turf, or from treated soil (i.e.,
soil ingestion, granule ingestion, and hand-/object-to-mouth transfer). A Margin of Exposure of 100
(or more) is considered protective for this assessment.
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The quantitative exposure/risk assessment for benfluralin postapplication risk to children is
based on these scenarios:
• Hand-to-mouth activity from treated turf: Postapplication exposure to children from the
"incidental" ingestion of pesticide residues on treated turf from hand-to-mouth transfer
(i.e., those residues that end up in the mouth from children touching turf and then putting
their hands in their mouth).
• Object-to-mouth activity from treated turf: Postapplication exposure to children from
incidental ingestion of pesticide residues on treated turf from object-to-mouth transfer
(i.e., those residues that end up in the mouth from a child mouthing a handful of treated
turf).
• Soil ingestion activity: Postapplication exposure to children from incidental ingestion of
soil in a treated area.
• Ingestion of benfluralin granules from treated turf: Postapplication exposure to children
from the "episodic" (infrequent to very infrequent) ingestion of pesticide granules picked
up from treated turf. This assessment is not needed for benfluralin since an endpoint and
dose for acute oral risk assessment was not identified.
2) Benfluralin Postapplication Risk Estimates
Risk assessment for oral exposure is based on a NOAEL of 100 mg/kg/day from a rabbit
developmental toxicity study. A Margin of Exposure (MOE) of 100 (lOx for interspecies
extrapolation and lOx for intraspecies variation) is considered adequately protective for this
assessment. Table 5 below presents the MOEs for Post-Application Oral Exposure in Children.
Table 5. Post-Application Oral Exposure to Benfluralin in Children
Exposure Scenario Applied at
3.0 Ib ai/acre
Margin of Exposure
Outdoor Exposure
Hand to Mouth Activity on Turf
Object to Mouth Activity on Turf
Soil Ingestion
Ingestion of Pellets
2,200
8,900
670,000
N/A
The combined postapplication risk from all oral ingestion exposures to children is presented
below in Table 6. The total oral MOE is above 100, and thus not of concern.
22
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Table 6. Oral Ingestion and Combined Exposure to Benfluralin in Children
Exposure Scenario
Child
Turf(3.01bai/acre)
Postapplication
Hand to Mouth
Object to Mouth
Soil Ingestion
Margins of Exposure (MOEs)
(UF=10Q)
Dermal
N/A
N/A
N/A
Inhalation
N/A
N/A
N/A
Oral
MOE
2,200
8,900
670,000
Total
Oral
MOE
1,800
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 there is a reasonable certainty that no harm will
result from aggregate exposure to pesticide chemical residue, including all anticipated dietary
exposures and other exposures for which there are reliable information." Aggregate exposure will
typically include exposures from food, drinking water, residential uses of a pesticide, and other non-
occupational sources of exposure.
For benfluralin, aggregate risk assessments were conducted for short-term (up to 30 days) and
chronic (one year or more) exposures. The routes of exposure assessed are oral (food, water, and
incidental) and inhalation (residential handlers). Intermediate term and chronic residential exposures
are not expected and therefore, are not included in this aggregate assessment. Generally, combined
risks from chronic exposures that are less than 100% of the cPAD are not a risk concern.
a. Short-term Aggregate Risk
Short-term aggregate risk was considered by aggregating exposure to adult male or female
handlers, or children who may be orally exposed following application to residential turf, chronic
food exposure, and drinking water exposure.
The calculated short-term DWLOCs for benfluralin and degradates are all greater than the
EECs. Therefore, EPA expects that no adverse lexicological effect will occur due to aggregate short-
term exposure. See Table 7 below for a comparison of EECs to DWLOCs.
The surface water EECs (ranging from 0.17 - 3.5 ug/L), and groundwater EECs (ranging
from 0.009 - 0.07 ug/L) are less than the estimated DWLOC of more than 100 ppb; therefore no
adverse toxicological effect will occur due to aggregate short-term exposure. Table 7 below presents
a comparison of EECs to DWLOCs.
23
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b. Chronic Aggregate Risk
Chronic aggregate risk was considered by aggregating chronic food and drinking water
exposure. The calculated chronic DWLOCs for benfluralin and degradates are 50 parts per billion
(ppb) for children, and greater than 100 for adult females and males. Therefore no adverse
toxicological effect will occur due to aggregate chronic exposure.
The surface water EECs (ranging from 0.17 - 3.5 ug/L), and groundwater EECs (ranging
from 0.009 - 0.07 ug/L) are less than the estimated DWLOCs of 50 ppb for exposure to children, and
over 100 ppb for adult males and females; therefore no adverse toxicological effect will occur due to
aggregate chronic exposure. Table 7 below presents a comparison of EECs to DWLOCs.
Table 7. Short-Term and Chronic DWLOC Calculations
Short-Term DWLOC Calculation
Population
Subgroup
Children
Females
Males
Groundwater EEC (ng/L)
<0.07
<0.07
<0.07
Surface Water EEC (ug/L)
<3.5
< 3.5
<3.5
DWLOC (jig/L)
>100
>100
>100
Chronic DWLOC Calculations
Children
Females
Males
<0.07
<0.07
<0.07
<3.5
< 3.5
<3.5
50
>100
>100
5.
Cumulative Assessment
Risks summarized in this document are those that result only from the use of benfluralin. The
Food Quality Protection Act (FQPA) requires that the Agency consider available information
concerning the cumulative effects of a particular pesticide's residues and other substances that have a
common mechanism of toxicity. The reason for consideration of other substances is due to the
possibility that low-level exposures to multiple chemical substances that cause a common toxic effect
by a common toxic mechanism could lead to the same adverse health effect as would a higher level of
exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for benfluralin and any other substances . For information regarding
EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate
the cumulative effects of such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for cumulating
24
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effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
6. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide,
or re-entering treated sites. Occupational handlers of benfluralin include: workers in agricultural
areas, workers in rights-of-way areas, and workers applying benfluralin on commercial or residential
lawns or ornamental plants. Occupational 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 benfluralin MOEs greater
than 100 do not exceed the Agency's level of concern. For workers entering a treated site, MOEs are
calculated for each day after application to determine the minimum length of time required before
workers can safely reenter.
Occupational risk estimates are expressed as MOEs, which are the ratio of estimated exposure
to an established dose level (NOAEL). Benfluralin MOEs are determined by a comparison of
specific exposure scenario estimates to the inhalation NOAEL of 100 mg/kg/day (from the oral rabbit
developmental toxicity study) for short-term assessment, or 7.2 mg/kg/day (from the oral rat
reproduction toxicity study) for intermediate-term assessment. Since no dermal endpoint was
identified, only inhalation risk was assessed. For benfluralin users an MOE of 100 has been
determined to be adequately protective (for both short- and intermediate-term exposure) based on the
standard uncertainty factors of lOx for interspecies extrapolation and lOx for intraspecies variability.
Long-term worker exposure is not expected for benfluralin.
Occupational risk is assessed for exposure at the time of application (termed "handler"
exposure) and assessed for exposure following application, or post-application exposure. Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site, and by the application
rate required to achieve an efficacious dose. Post-application risk is assessed for activities such as
scouting, irrigating, pruning, and harvesting and is based primarily on dermal exposure estimates.
Note that occupational risk estimates are intended to represent pesticide workers, and on this basis
assumptions are made concerning acres treated per day and the seasonal duration of exposure.
For more information on the assumptions and calculations of potential risk of benfluralin to
workers, see the Occupational Exposure Assessment (Section 7.0) in the "Human Health Risk
Assessment (Revised)," dated October 30, 2003 (including addendum, dated June 8, 2004).
a. Occupational Toxicity
Table 8 below provides a listing of the toxicological endpoints used in the benfluralin
occupational risk assessment.
Table 8: Toxicological Endpoints for the Benfluralin Occupational Risk Assessment
25
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Exposure
Scenario
Short-Term
(1-30 days)
Inhalation
Intermediate -
Term
(1-6 months)
Inhalation
Dose used in
Risk
Assessment
(mg/kg/day)
NOAEL= 100
NOAEL= 7.2
Margin of
Exposure (MOE)
for Risk
Assessment
MOE = 100
MOE = 100
Study and Toxicological Effects
Developmental Toxicity -Rabbits
LOAEL = 225 mg/kg/day based on decreases in maternal body
weight gain over a 13 day dosing period.
Reproduction and Fertility Effects-Rats
LOAEL = 68. 1 mg/kg/day based on progressive chronic
nephropathy in adult males and females and pup weight
decrement.
For more occupational toxicity information, see the benfluralin "Human Health Risk
Assessment (Revised)," dated October 30, 2003 (including addendum, dated June 8, 2004).
b. Occupational Handler Exposure
Occupational handler risk estimates have been assessed for both short- and intermediate-term
exposure durations. For most benfluralin handlers, exposure for more than 30 days are unlikely since
it is used pre-plant, or timed specifically for the seasonal emergence of weeds. However, since the
duration of exposure is uncertain, intermediate-term risk estimates are provided as an upper-bound
assessment.
Occupational handler assessments are conducted using increasing levels of protection. The
Agency typically evaluates all exposures with minimal protection and then considers additional
protective measures using a tiered approach (going from minimal to maximum levels of protection) in
an attempt to obtain an adequate MOE. The lowest tier is represented by the baseline clothing
scenario (i.e., single layer clothing, socks, and shoes), followed by, if MOEs are of concern,
increasing levels of risk mitigation such as personal protective equipment (PPE) and engineering
controls (EC). In the case of benfluralin, MOEs for every occupational exposure scenario are above
100 at baseline PPE (long-sleeved shirt, long pants, socks, and shoes). While the generic assessment
for benfluralin does not indicate a need for additional PPE, evaluation of end-use product toxicity
data may. End-use product PPE will be assessed on a product-by-product basis.
c. Occupational Handler Risk Summary
The Agency has determined that there are potential exposures to individuals who mix, load,
apply, and otherwise handle benfluralin during the usual use patterns associated with the pesticide's
use. Based on the use patterns, 13 major occupational handler exposure scenarios were identified as
follows:
(1) mixing/loading dry flowables to support ground applications;
(2) mixing/loading granulars to support ground applications;
(3) applying sprays with groundboom equipment;
26
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(4) applying granules with a tractor/ATV-drawn spreader;
(5) mixing/loading/applying dry flowables with a low pressure handwand;
(6) mixing/loading/applying dry flowables with a backpack sprayer;
(7) mixing/loading/applying dry flowables with a low pressure, high volume
turf/handgun sprayer;
(8) mixing/loading/applying granules with a pump-feed backpack spreader;
(9) mixing/loading/applying granules with a gravity-feed backpack spreader;
(10) mixing/loading/applying granules with a belly grinder spreader;
(11) mixing/loading/applying granules with a push-type spreader;
(12) mixing/loading/applying granules with a bucket and spoon; and
(13) mixing/loading/applying granules with a shaker can.
Occupational Handler Exposure Assumptions
When possible, the assumptions for daily areas treated are taken from the Health Effects
Division Science Advisory Committee on Exposure Policy 9: Standard Values for Daily Acres
Treated in Agriculture (July 5, 2000). In other instances, the daily areas to be treated were defined
for each handler scenario by best scientific judgement.
Chemical-specific data to assess the above exposure scenarios were not available for
benfluralin. Analyses were completed using acceptable surrogate exposure data for the scenario
assessed. Several handler assessments were completed using data from the Pesticide Handler
Exposure Database (version 1.1). No data were available to assess mixing/loading/applying dry
flowable formulations with a low-pressure handwand sprayer, therefore PHED data for
mixing/loading/applying liquid formulations with a low-pressure handwand sprayer were used as a
reasonable surrogate. Some handler assessments (i.e., handheld handgun equipment, push-type
spreader) were completed using data from the Outdoor Residential Exposure Task Force (ORETF).
The following assumptions and factors were used in order to complete the exposure and risk
assessments for occupational handlers and applicators:
• Average body weight of an adult handler is 70kg;
• Average occupational workday is 8 hours;
• Non-crop land and rights-of-way treatments are assessed at the maximum labeled single
application rate of 6.0 pounds active ingredient per acre;
• Christmas trees are assessed at the maximum labeled application single rate of 4.0 pounds
active ingredient per acre;
• Landscape ornamentals, field/container grown ornamentals, residential and golf course
turfgrass (dry flowable formulations) are assessed at the maximum labeled single application
rate of 3.0 pounds active ingredient per acre;
• Residential and golf course turfgrass (granular formulations) are assessed at the application
rate of 2.0 pounds active ingredient per acre;
• Alfalfa, birdsfoot trefoil, clover, lettuce, and ornamental bulbs are assessed at the maximum
labeled single application rate of 1.5 pounds active ingredient per acre;
• For alfalfa, birdsfoot trefoil, and clover, the area treated daily is 200 acres for ground
applications;
-------
• For lettuce, non-crop lands, and rights-of-way, the area treated daily is 80 acres for ground
applications;
• For Christmas tree and ornamental (other than bulb) applications, the area treated daily is 40
acres for tractor- or ATV-drawn spreaders; 10 acres for backpack spreaders; 5 acres for push-
type spreaders, 1 acre for bellygrinder spreaders, and 5,000 square feet for shaker cans;
• For turf applications, the area treated daily is 40 acres for ground applications (golf courses);
5 acres for ground applications (commercial areas), 5 acres for low-pressure handwand
sprayers, handgun sprayers, and push-type spreaders; and 1 acre for bellygrinders; and
• For ornamental bulb applications, the area treated daily is 5 acres for tractor- or ATV-drawn
spreaders; 10 acres for backpack spreaders; 5 acres for push-type spreaders, 1 acre for
bellygrinder spreaders, and 5,000 square feet for shaker cans.
Summary of Risk Concerns and Data Gaps for Handlers
Short- and intermediate-term inhalation Margin of Exposure estimates for occupational
handler scenarios are greater than 100 at the baseline level of protection (i.e., long-sleeved shirt, long
pants, shoes plus socks, no respirator). Short-term MOEs range from 4,000 to 900,000, and
intermediate-term MOEs range from 290 to 65,000. Therefore, short- and intermediate-term
occupational risk is not of concern.
There is a data gap identified for evaluating exposure when mixing/loading/applying
benfluralin using backpack equipment. However, estimates based on low pressure handwand is
considered a reasonable surrogate to evaluate this risk. Table 9 provides a listing of the short- and
intermediate-term risk estimates for handlers.
Table 9. Occupational Handler Short and Intermediate-Term Risk Summary
Exposure Scenario
Crop or Use Site
Application
Rate8
Area
Treated
Daily"
Baseline Short-
term Inhalation
MOEC
Baseline
Intermediate-term
Inhalation MOEC
Mixer/Loader
Mixing/Loading Dry
Flowables for
Groundboom
Application
Loading Granulars for
Drop Type Tractor (or
ATV) Drawn Spreader
Application
alfalfa, birdsfoot
trefoil, clover
lettuce
turf: golf courses
turf: residential and
commercial areas
turf: commercial
areas and golf
courses; and
ornamentals:
container grown,
field grown and
landscape
Christmas trees
non-crop land, rights-
of-way
1.5 Ib ai/acre
1.5 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
4 Ib ai/acre
6 Ib ai/acre
200 acres
80 acres
40 acres
5 acres
40 acres
40 acres
80 acres
30,000
76,000
76,000
610,000
34,000
26,000
8,600
2,200
5,500
5,500
44,000
2,500
1,900
620
28
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Exposure Scenario
Crop or Use Site
ornamental bulbs
Application
Ratea
1.5 Ib ai/acre
Area
Treated
Daily"
5 acres
Baseline Short-
term Inhalation
MOEC
550,000
Baseline
Intermediate-term
Inhalation MOEC
40,000
Applicator
Applying Sprays with
Groundboom
Application
\pplying Granulars with
Drop Type Tractor (or
ATV) Drawn Spreader
alfalfa, birdsfoot
trefoil, clover
lettuce
turf: golf courses
turf: residential and
commercial areas
turf: commercial
areas and golf
courses; and
ornamentals:
container grown,
field grown and
landscape
Christmas trees
non-crop land, rights-
of-way
ornamental bulbs
1.5 Ib ai/acre
1.5 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
4 Ib ai/acre
6 Ib ai/acre
1.5 Ib ai/acre
200 acres
80 acres
40 acres
5 acres
40 acres
40 acres
80 acres
5 acres
32,000
79,000
79,000
630,000
49,000
36,000
12,000
780,000
2,300
5,700
5,700
45,000
3,500
2,600
880
56,000
Mixer/Loader/Applicator
vtixing/Loading/Applyin
g Dry Flowables with a
^ow Pressure Handwand
vtixing/Loading/Applyin
g Dry Flowables with a
Backpack Sprayer
vlixing/Loading/Applyin
g Dry Flowables with a
Handheld Handgun
(ORETF)
turf
turf
turf
3 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
5 acres
5 acres
5 acres
16,000
16,000
210,000
1,100
1,100
15,000
29
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Exposure Scenario
Loading/Applying
Granulars with a Pump
7eed Backpack Granular
Spreader (MRID
451672-01)
Loading/Applying
jranulars with a Gravity
7eed Backpack Granular
Spreader (MRID
452507-01)
Loading/Applying
Granulars with a Belly
Grinder
Loading/Applying
Granulars with a Push
Type Spreader (ORETF)
Loading/Applying
Granulars with a Bucket
and Spoon (MRID
452507-01)
Crop or Use Site
Christmas trees
container grown,
field grown and
landscape
ornamentals
ornamental bulbs
Christmas trees
container grown,
field grown and
landscape
ornamentals
ornamental bulbs
Christmas trees
turf
container grown,
field grown and
landscape
ornamentals
ornamental bulbs
Christmas trees
turf: residential areas,
commercial areas,
and golf courses; and
ornamentals:
container grown,
field grown, and
landscape
ornamental bulbs
Christmas trees
ornamentals:
container grown,
field grown and
landscape
Application
Ratea
4 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
4 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
4 Ib ai/acre
3 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
4 Ib ai/acre
3 Ib ai/acre
1.5 Ib ai/acre
0,0918 Ibai/ 1000
sqft
0.0689 Ib ai/ 1000
sqft
Area
Treated
Daily"
10 acres
10 acres
10 acres
10 acres
10 acres
10 acres
1 acres
1 acres
1 acres
1 acres
5 acres
5 acres
5 acres
5000 sq ft
5000 sq ft
Baseline Short-
term Inhalation
MOEC
42,000
56,000
110,000
4,000
5,300
11,000
28,000
38,000
38,000
75,000
48,000
64,000
130,000
340,000
450,000
Baseline
Intermediate-term
Inhalation MOEC
3,000
4,000
8,000
290
380
760
2,000
2,700
2,700
5,400
3,500
4,600
9,200
24,000
33,000
30
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Exposure Scenario
Loading/Applying
Granulars with a Shaker
Can (PHED)
Crop or Use Site
ornamental bulbs
Christmas trees
ornamentals:
container grown,
field grown and
landscape
ornamental bulbs
Application
Ratea
0.0344 Ib ai/ 1000
sqft
0.0918 lbai/1000
sqft
0.0689 Ib ai/ 1000
sqft
0.0344 Ib ai/ 1000
sqft
Area
Treated
Daily"
5000 sq ft
5000 sq ft
5000 sq ft
5000 sq ft
Baseline Short-
term Inhalation
MOEC
900,000
32,000
43,000
87,000
Baseline
Intermediate-term
Inhalation MOEC
65,000
2,300
3,100
6,200
Footnotes
a Application rates are the maximum application rates determined from EPA registered labels for benfluralin.
b Amount handled per day values are EPA estimates of acreage treated or gallons applied based on Exposure SAC
Policy #9 "Standard Values for Daily Acres Treated in Agriculture".
c Baseline inhalation MOE = short-term NOAEL (100 mg/kg/day) / baseline inhalation dose (mg/kg/day), where
baseline inhalation dose = baseline inhalation unit exposure (|ig/lb ai) x application rate x amount handled per day x
Img / lOOOug) / body weight (70 kg).
For more information, see the Occupational Exposure Assessment (Section 7.0) in the "Human
Health Risk Assessment (Revised)," dated October 30, 2003 (including addendum, dated June 8,
2004).
d. Occupational Postapplication Risk Summary for Benfluralin
Benfluralin uses are varied, since it is used in agriculture, rights-of-way, on ornamentals, and
on turf (lawns, golf courses). As a result, a wide array of individuals can potentially be exposed by
working in areas that have been previously treated. However, since no dermal endpoint has been
identified for systemic toxicity, and post-application inhalation exposure is expected to be negligible,
no occupational post-application exposure and risk assessment is warranted. As a result, the general
12 hour REI, as established by the Worker Protection Standard, applies to all benfluralin agricultural
use products.
e.
Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from the National Poison
Control Centers (PCC), the Agency's Office of Pesticide Program's Incident Data System (IDS), and
the California Pesticide Illness Surveillance Program.
Relatively few incidents of illness have been reported due to benfluralin. There was some
evidence of dermal effects, but these cases may be due to not wearing required personal protective
equipment (PPE) (long-sleeved shirt, long pants, shoes plus socks, gloves, and other PPE dependent
on end-use product formulation). The following data bases have been consulted for the poisoning
incident data on the active ingredient benfluralin.
31
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The PCC database contained 47 occupational and non-occupational cases of benfluralin
exposure. Three of the cases required medical attention due to flushing, skin irritation or pain, and
itching sufficient to require medical attention. The other exposures resulted in minor irritation or no
irritation, and did not require attention in a health care facility. None of the exposures required
hospitalization.
In the IDS and California Pesticide Illness Surveillance Program databases, there were a total
of 7 cases of benfluralin exposure reported to Poison Control Centers for the years 1982-2001. Of
these, 6 cases occurred in a single residential incident, and 1 case occurred in a occupational incident.
None of these cases reported hospitalization as an outcome.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. Benfluralin
has several registered use sites: turf, non-bearing fruit and nut trees, non-bearing vineyards, citrus,
non-bearing berries, Christmas tree plantations, non-cropland sites, alfalfa, clover, birdsfoot trefoil,
and lettuce. The following risk characterization is intended to describe the magnitude of the
estimated environmental risks for benfluralin use sites and any associated uncertainties.
For detailed discussions of all aspects of the environmental risk assessment, see the "Revised
Environmental Risk Assessment for Benfluralin", dated June 4, 2004, the "Drinking Water Estimates
for Benfluralin," dated January 31, 2003, the "Addendum to Drinking Water Estimates for
Benfluralin, Multiple Applications to Turf, Christmas Tree Farms, Rights-of-Way," dated March 5,
2003, the "Second Addendum to Drinking Water Estimates for Benfluralin, Non-Bearing Vineyards,
Fruit Trees, Nut Trees, and Berries" dated April 25, 2003, and the Environmental Fate and Effects
Risk Assessment. These documents are also available in the OPP public docket and on the Agency's
website at: http://www. epa. sov/pesticides/reregistration/status. htm.
1. Environmental Fate and Transport
The environmental fate database for benfluralin is sufficient to conduct a preliminary
assessment for benfluralin use.
Available data indicates that benfluralin is of variable soil persistence with different
mechanisms of degradation. Based on acceptable studies, benfluralin is metabolized with a half-life
of 20 to 86 days under aerobic soil conditions. This represents a variable soil metabolism pattern. In
anaerobic soils, benfluralin laboratory studies indicate a half-life of 12 days. A soil photolysis study
showed that benfluralin has a half-life of 12.5 days. Benfluralin is stable to hydrolysis and has a half-
life of 5.5 to 9.9 hours in aqueous photolysis studies. In an anaerobic aquatic metabolism study
benfluralin was determined to have a half-life of 38 hours. No major degradates were formed in soil
metabolism studies.
Benfluralin has low mobility in soils, according to available mobility studies (Koc values range
from 9840 to 11,660 L/kg). Acceptable field dissipation studies observed in three different locations
32
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indicate moderate half-lives. At one turf site in CA where benfluralin was applied as a granular
broadcast the half-life was determined to be 22 days. At two sites where benfluralin was applied as
an incorporated spray the half-lives were determined to be 62 days in a field dissipation trial in GA on
peanuts, and 79 days in a lettuce field dissipation trial in CA.
Benfluralin volatilizes rapidly, as indicated in laboratory volatility studies. Oxidation by
hydroxyl radicals in the atmosphere has the potential to be a dissipation pathway for benfluralin.
However, benfluralin is formulated and applied to minimize volatilization. For example, spray
formulations are incorporated into the soil before planting or at the time of planting because of the
volatile nature of benfluralin, and granular formulations are manufactured to slow volatilization.
Benfluralin has a short estimated half-life in air (less than half a day) which indicates that it may not
be persistent in air.
Parent benfluralin is not expected to leach into ground water, based on its low mobility in soil.
However, degradate 2,6 dinitro-4-trifluoromethyl-phenol was formed at 6% of parent in the soil
metabolism study. Based on limited environmental fate information, it has the potential to
contaminate groundwater. Trifluoroacetic acid (TFA) was not found in environmental fate studies,
but was noted as a plant metabolite.
Based on its measured bioaccumulation factor in whole fish (1580), parent benfluralin is
considered to be bioaccumulative. The depuration rate was 0.54 per day for whole fish.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
studies to estimated environmental concentrations (EECs) based on environmental fate characteristics
and pesticide use data. To evaluate the potential risk to nontarget organisms from the use of
benfluralin products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to the
most sensitive toxicity endpoint values, such as the median lethal dose (LD50) or the median lethal
concentration (LC50). These RQ values are then compared to the Agency's levels of concern (LOCs)
which indicate whether a chemical, when used as directed, has the potential to cause adverse effects
on nontarget organisms. When the RQ exceeds the LOG for a particular category, the Agency
presumes a risk of concern to that category of organisms. The LOCs and the corresponding risk
presumptions are presented in Table 10.
33
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Table 10. LOCs and Associated Risk Presumptions
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOG of 0.5
The acute RQ >LOC of 0.2
The acute RQ > LOG of 0. 1
The chronic RQ > LOC of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered Species
Chronic risk and Chronic effects may occur in Endangered Species
Fish and Aquatic Invertebrates
The acute RQ > LOC of 0.5
The acute RQ > LOC of 0. 1
The acute RQ >LOC of 0.05
The chronic RQ > LOC of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered Species
Chronic risk and Chronic effects may occur in Endangered Species
Terrestrial and Aquatic Plants
The acute RQ > LOC of 1
Acute risk and Acute effects may occur in Endangered Species
For a more detailed explanation of the ecological risks posed by the use of benfluralin, please
refer to the Revised Environmental Fate and Effects Risk Assessment for Benfluralin.
a. Risk to Birds
1) Toxicity (Hazard) Assessment
Because there are no mortalities at the highest concentration tested (LD50 greater than 2000
mg/kg, LC50 greater than 4360 ppm), benfluralin is considered to be practically non-toxic to birds on
an acute and subacute basis. The likelihood of acute or subacute risk to non-endangered and
endangered species of birds is low.
Benfluralin caused reproductive effects in chronic avian studies. Avian reproductive toxicity
was assessed in two studies that are presented in Table 11 below. The bobwhite quail endpoint
cannot be assumed conservative, as effects were observed at the lowest dose tested of 96 ppm.
Another quail study is needed to establish a No Observed Adverse Effect Concentration (NOAEC)
for reproductive effects since a NOAEC was not established in this test.
At the Lowest Observed Adverse Effect Concentration (LOAEC) the reproductive toxicity
study with the Northern Bobwhite Quail, showed developmental effects that included a decrease in
the number of surviving hatchlings, decreased egg set, and decrease in 14-day hatchling survivor
weight. At the LOAEC, of the reproductive toxicity study with the Mallard Duck showed an increase
in the percentage of eggs that cracked.
34
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Table 11. Reproductive Toxicity to Birds
Test Species
Northern Bobwhite Quail
(Colinus virginianus)
Mallard Duck
(Anas plafyrhynchos)
%a.L
95.6
95.6
NOAEC
(ppm ai)
<96
288
LOAEC
(ppm ai)
96
975
LOAEC
Endpoints
fewer survivors,
egg set and 14
day survivors
weight
percentage eggs
cracked
MRID
42145502
42145501
Study Classification
Supplemental
Core
2) Exposure and Risk
Acute
As no acute endpoint was determined, risk quotients (RQs) were not calculated for benfluralin.
The likelihood of acute or subacute risk to non-endangered and endangered species of birds is low.
Chronic
Chronic risks to birds are expected from both spray and granular formulations of benfluralin.
Benfluralin is typically incorporated into the soil for application to alfalfa, birdsfoot trefoil, clover,
and lettuce. Exposure at these use sites could occur at the end of field rows where bordering plants
could potentially be food for birds. A foliar half-life of 12.5 days was assumed for chronic
assessments of spray applications. Table 12 below summarizes the Level of Concern (LOG)
exceedances for birds associated with benfluralin residues in plants at the edge of the field that may
be incidentally sprayed during application to the crop. The avian chronic LOG is exceeded on all
food items except seeds at lettuce and alfalfa use sites.
Table 12. Avian Chronic Risk Quotients for Use on Lettuce and Alfalfa Based on a Bobwhite
NOAEC of < 96 ppm.
Use Sites
Alfalfa (3 Ibs ai/A)
Lettuce (1.5 Ibs ai/A)
Maximum Residue
on Short Grass
7.5
3.75
Maximum Residue
on Tall Grass
3.44
1.72
Maximum Residue
on Broadleaf
Plants/Insects
4.22
2.11
Maximum Residue
on Seeds
<1
<1
Risk quotients (RQs) in bold print signify an exceedance of the level of concern (LOG) for risk to birds including
endangered species.
The Agency believes that chronic risk to birds from granular formulations is likely for the
following reasons. First, a NOAEC was not found in the bobwhite quail avian reproduction study.
For the risk assessment, the current endpoint for reproductive effects is the LOAEC of less than 96
ppm. Also, calculations based on average granule size and weight plus the results from the avian
reproduction study on bobwhite quail indicate that for the benfluralin fertilizer blend, 5 to 6 granules
contain the equivalent amount of benfluralin to represent 96 ppm in the bobwhite quail reproduction
study. It is also reasonable to assume that a bobwhite quail consumes at least 6 granules per day as a
daily intake of grit since several bird species are known to consume up to 18 granules per day.
35
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Smaller avian species such as passerines and songbirds may be affected by smaller amounts of
pesticide than the bobwhite quail due to lower body weight.
Currently the Agency does not have a standard procedure for assessing chronic risk to avian
species from granular products. Estimating long term exposure from granular applications is difficult,
since the granules are not expected to remain intact over extended periods. Over a period of time, the
granular formulation will break down in the soil. The chemical is expected to become distributed in
the soil as the granules dissipate. The Hoerger-Kenaga nomogram could not be used for estimating
environmental concentrations of residues since it was used only with spray applications. Therefore, a
fugacity model was used to estimate exposure in the soil to birds.
A fugacity model is designed to estimate exposure in the soil to organisms after the granule
has degraded and distributed through the soil column to a certain depth. Many of the inputs for the
fugacity model, such as food ingestion rates, fraction of diet, weight of animals, and amount of food
eaten per day, were derived from the Wildlife Exposure Factors Handbook, (EPA, 1993). The
Wildlife Exposure Factors Handbook was also used to scale exposure estimates from quail to robin,
and from rat to mouse. For more information on fugacity model inputs, refer to the Environmental
Fate and Effects Risk Assessment, dated June 4, 2004.
The estimated concentrations for the fugacity model used to estimate exposure in the soil to
birds are measured from the top 1.0 cm and top 7.6 cm of the soil. The top 1 cm is to represent turf
use sites which have a thatch and the top 7.6 cm will represent other bare soil use sites at time of
application. The fugacity model used for the top 7.6 cm of soil assumes that an average residue level
is distributed evenly throughout the top 7.6 cm.
Table 13 below shows the avian risk quotient results when exposures are estimated with the
fugacity model.
Table 13. Avian Fugacity Exposure (for Granular Applications) and Risk Quotient
Application Rate
3 Ib ai/A (turf, non-
bearing berries, non-
bearing fruit trees,
ornamentals,
Christmas trees, non-
bearing nut trees,
non-bearing
vineyards, non-
cropland areas)
Robin
1 cm soil depth
exposure
(mg/kg/day)
217
RQ
2.3
7.5 cm soil depth
exposure
(mg/kg/day)
26.7
RQ
-------
Application Rate
6 Ib ai/A (turf, non-
bearing berries, non-
bearing fruit trees,
ornamentals,
Christmas trees, non-
bearing nut trees,
non-bearing
vineyards, non-
cropland areas)
9 Ib ai/A (non-
bearing berries, non-
bearing fruit trees,
non-bearing nut trees,
non-bearing
vineyards, non-
cropland areas)
12 Ib ai/A (non-
cropland areas)
Robin
1 cm soil depth
exposure
(mg/kg/day)
425
642
850
RQ
4.4
6.7
8.9
7.5 cm soil depth
exposure
(mg/kg/day)
49.4
74.1
99.0
RQ
<1
1.0
Quail
1 cm soil depth
exposure
(mg/kg/day)
169
254
338
RQ
1.8
2.6
3.5
7.5 cm soil depth
exposure
(mg/kg/day)
19.3
29.0
38.7
RQ
<1
< l
< l
Risk quotients (RQs) in bold print signify an exceedance of the level of concern (LOG) for risk to birds including endangered
species.
b. Risk to Mammals
1) Toxicity (Hazard) Assessment
Benfluralin is classified as practically nontoxic to small mammals on an acute oral basis with an
LD50 value of greater than 10,000 mg/kg. Mammalian toxicity data indicate that the use of benfluralin
is of concern for chronic risk to mammals. Chronic toxicity from the 2-generation rat reproduction study
indicate decreased body weight, body weight gains and food consumption, liver and kidney
enlargement, progressive chronic nephropathy, dead pups, and decreased pup size at the LOAEL of
1000 ppm. The endpoint for chronic risk assessment to mammals is the NOAEL of 100 ppm. Table 16
discusses the data that support the chronic endpoint used in assessing the risks to mammals.
2) Exposure and Risk
Acute
Since the acute rat LD50 (10,000 mg/kg-bw) is greater than the highest dose tested and there was
no mortality observed at the highest concentration dose, it is assumed that unacceptable acute risk to
mammals is not likely. Therefore, no risk quotients (RQs) were calculated for acute risk to mammals.
Chronic
37
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There is potential for exposure to mammals from soil-incorporated spray applications and
granular applications. The mammalian chronic LOG exceedance from exposure to soil-incorporated
spray applications follow the same pattern as for birds (Table 14). A foliar half-life of 12.5 days was
assumed for chronic assessments of spray applications. LOCs are exceeded for all food items except for
seeds.
Table 14. Mammalian Chronic Risk Quotients for Spray-Incorporated Benfluralin Based on a
Rat Chronic NOAEC of 100 ppm (7.2 mg/kg/day, males).
Crop
Alfalfa (3 Ibs ai/A)
Lettuce (1. 5 Ibsai/A)
Short Grass
7.2
3.6
Tall Grass
3.30
1.65
Broadleaf
Plants/Insects
4.05
2.03
Seeds
<1
<1
RQS in bold print signify an exceedance of the LOG for risk to birds including endangered species.
For an explanation of how chronic risk was assessed for granular exposure to mammals using a
fugacity model see discussion preceding Table 13 presented previously.
Table 15. Fugacity Exposure and Risk Quotient with Mammalian Chronic Endpoint = 5
mg/kg-body weight
Application Rate
3 Ib ai/A
6 Ib ai/A
9 Ib ai/A
121bai/A
Deer Mouse (21 grams)
1 Cm Soil Depth
Exposure
31
61
91
120
RQ
6.2
12.2
18.2
24.0
7.5 cm Soil Depth
Exposure
3.7
7.0
10.5
14.0
RQ
-------
however, and there are currently no adequate daphnid acute data using technical grade benfluralin.
Table 19 displays the acute toxicity endpoints for freshwater fish and invertebrates.
Table 16. Acute Toxicity Endpoints for Freshwater Fish/Invertebrates.
Test Species
Rainbow Trout
(Oncorhynchus
mykiss)
Bluegill Sunfish
(Lepomis
macrochirus)
Water Flea
(Daphnia magna)
Test Type
Fish Toxicity
Fish Toxicity
Invertebrate
Toxicity
%a.i
19.9
(End Use Product
96.4
(Technical Grade Active
Ingredient)
20.1
(End Use Product
Toxicity Value
(ppm of a.i)
(96-hour LC50)
0.288
(96-hour LC50)
0.0317
(48-hour LC50)
2,18
Toxicity
Category
Highly Toxic
Very Highly
Toxic
Moderately
Toxic
MRIDor
Accession
Number
42419201
Ace. No. 234214
42390802
Chronic data for freshwater fish show that growth and development was the most sensitive
endpoint for benfluralin. Test results indicate that benfluralin may affect fish length and survival at
concentrations greater than 1.9 ppb. The chronic toxicity endpoint for freshwater fish is listed in Table
17.
Table 17. Early Life-Stage Toxicity to Freshwater Fish
Test Species
Rainbow Trout
(Oncorhynchus
mykiss)
Test Type
Fish - Early Life
Stage
% a.i.
95.9
NOAEL (ppm
ai)
0.0019
LOAEL (ppm
ai)
0.005 larval
length
MRID or Accession
Number.
41613805
A freshwater aquatic invertebrate life-cycle study using technical grade benfluralin was
conducted (MRID 41613806). The NOAEL for this study was 15.5 ppb a.i. It is classified as
supplemental and not upgradable because the negative control appears to have far less neonates due to
loss of neonates, which could have been the result of the unusual test design. This creates much
uncertainty with the control population. Since the controls were affected, there may be more chronic
sensitivity of Daphnids exposed to benfluralin than the faulty test study indicated. It is worthwhile to
note that the Daphnia NOAEC for trifluralin is 2.4 ppb, which may indicate that potentially, the
benfluralin chronic NOAEC may also be very low. Uncertainties in the Daphnia life cycle study appear
to underestimate the potential chronic risk to aquatic invertebrates. An updated Daphnia life-cycle study
will reduce much of this uncertainty.
39
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2) Toxicity (Hazard) Assessment for Estuarine/Marine Species
Estuarine/Marine Species
Although initially considered acceptable, the acute toxicity data for estuarine fish were found to
be invalid upon reexamination. The study exceeds the Agency's guidance of a 1.5 variability limit for
test concentrations as recommended by the Rejection Rate Analysis and ASTM E-729, p. 392,
11.9.3.4(2). The measured concentrations ranged from 6% to 8% of the nominal concentrations.
Precipitation was observed at the three highest concentration levels, resulting in an LC50 that is
uncertain since actual test concentrations and time of exposure are not well understood. The Agency is
unable to provide a risk assessment for estuarine fish because of the lack of adequate data.
Available acute toxicity data on technical benfluralin indicate that it is very highly toxic to
estuarine/marine invertebrates. The 96-hour flow-through study yielded an EC50 of 0.043 ppm a.i. And
NO ABC of 16 ppb. Table 18 below lists the acute toxicity endpoint for estuarine/marine invertebrates.
Table 18. Acute Toxicity to Estuarine/Marine Invertebrates
Test Species
Mysid
(Americamysis bahia)
Test Type
Invertebrate Toxicity
% a.i.
96.6
96-hour EC50
(ppm a.i.)
0.043
Toxicity
Category
Very Highly
Toxic
MRID or Accession
No.
41613804
No data are available to assess chronic toxicity endpoints for estuarine/marine fish and
invertebrates. An estuarine/marine invertebrate life-cycle toxicity study using the TGAI is required for
benfluralin because the end-use product is expected to be transported to the estuarine environment from
the intended use sites (turf and non-bearing fruit trees), the mysid LC50 is less than 1 mg/L, the EEC in
water is equal to or greater than 0.01 of the acute mysid LC50 of 43 ppb, and studies of birds and
mammals indicate the reproductive physiology may be affected. The preferred test species is mysid
shrimp.
3) Exposure and Risk
Because of uncertain aquatic toxicity data, alternative methods were used to ascertain the
potential for acute and chronic risk to aquatic species. One method was to analyze the data from other
very similar dinitroaniline herbicides, trifluralin and ethalfluralin. There are some similarities in aquatic
toxicity data between trifluralin, ethalfluralin, and benfluralin. However, there are uncertainties in this
approach, as the solubility for benfluralin (100 ppb) is one-third that of trifluralin and ethalfluralin (300
ppb). This may affect the amount of exposure in water bodies and perhaps the toxicity of the chemical
to the organisms. Another uncertainty is that the toxicity of the other dinitroaniline herbicides may not
accurately reflect similar trends of toxicity of benfluralin.
Chronic data for the three herbicides are similar, particularly for the trout early life stage study.
The supplemental daphnia chronic toxicity test for benfluralin (NOAEC 15.5 ppb) appears to be between
that of trifluralin (2.4 ppb) and ethalfluralin (24 ppb). This would indicate the need for chronic data to
assess chronic risk.
40
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The Estimated Environmental Concentrations (EECs) used to determine the risk quotients (RQS)
were estimated by modeling for surface water in a farm pond scenario. Benfluralin's high organic
carbon partitioning coefficient (Koc = 10,750), indicates that it has a strong tendency to bind to soil rather
than dissolve in water. Thus, any transport to water from the soil to which it is applied is probably due
to transport of suspended soil particles. Benfluralin may also be transported from soil to water by
volatilization and re-condensation, but this phenomenon cannot be quantified at this time.
Volatility from soil was not modeled in the farm pond analysis, because incorporation of spray
applications and use of granular formulations are both intended to suppress volatilization. Table 19
below lists the EECs for all modeled scenarios. The EECs are then used to determine the risk that a
benfluralin application might pose in the given scenario.
41
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Table 19. Estimated Environmental Concentrations (EECs) for Benfluralin (Farm Pond
scenario) in Parts-Per-Billion (ppb)
Scenario
Application Rate (Ibs ai/A)
Peak
96-hr
21-day
60-day
Alfalfa
Alfalfa, All Sites (Range in Ppb)1
(1.5)
0.74-0.96
0.56-0.76
0.20-0.32
0.11-0.23
Turf
Florida Turf, 1 Application
(3)
Florida Turf, 2 Applications
(3)
Pennsylvania Turf, 1 Application
(3)
Pennsylvania Turf, 2 Applications
(3)
2.4
5.6
1.7
3.7
1.8
4.0
1.2
2.6
0.73
1.8
0.47
1.0
0.41
1.1
0.29
0.57
Christmas Tree Farms
Oregon Christmas Trees
(4)
1.5
1.3
0.47
0.27
Non-bearing Fruit Trees, Nut Trees, Vineyards & Berries
North Carolina Apples
(3)
30.3
24.0
9.6
5.6
GENEEC
Non-agricultural Areas - 1
Application
(6)
Non-agricultural Areas - 2
Applications
(12)
30.4
50.2
29.0
47.9
22.5
37.2
13.9
23.0
1 The EEC values for lettuce will be approximately one-half of the alfalfa values since lettuce is applied at one-half rate of
alfalfa and California alfalfa scenarios appear to reflect lettuce scenarios.
The PRZM-EXAMS model was used to calculate acute and chronic exposure concentrations for
uses of benfluralin on turf, alfalfa, Christmas tree farms, and non-bearing agricultural areas. Acute risk
assessments are performed using peak estimated environmental concentration (EEC) values for single
and multiple applications. Chronic risk assessments are performed using the 21 -day EECs for
invertebrates and 60-day EECs for fish.
GENEEC, a Tier 1 screening exposure program, was used to calculate acute and chronic
exposure concentrations for benfluralin use on non-agricultural land such as rights-of-way, because there
is no PRZM-EXAMS scenario for these uses. These estimates are considered to be conservative. Acute
42
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risk assessments are performed using peak EEC values for single and multiple applications. Chronic
risk assessments are performed using the 21-day EECs for invertebrates and 56-day EECs for fish.
There are no acute risks expected to fish and aquatic invertebrates from soil-incorporated
applications of benfluralin. No acute LOG is exceeded at use sites where soil-incorporated applications
of benfluralin are made (lettuce and alfalfa). Also, no LOG is exceeded for granular applications to
Christmas tree use sites.
Acute risks to aquatic species are of concern for many use sites where there are granular
applications of benfluralin. For freshwater fish, the LOG for acute risk (0.5) was exceeded for non-
cropland areas (two applications). Presumption of restricted use LOG (0.1), as well as the endangered
species LOG (0.05) was exceeded in non-agricultural areas, non-bearing fruit trees, nut trees, vineyards,
berries, and turf.
For freshwater invertebrates, the LOG for acute risk (0.5) was exceeded in non-agricultural areas
(two applications). Presumption of restricted use LOG (0.1) was exceeded at non-cropland areas, non-
bearing fruit trees, nut trees, vineyards, and berries. The endangered species LOG (0.05) was exceeded
in non-agricultural areas, non-bearing fruit trees, nut trees, vineyards, berries, and turf.
For estuarine invertebrates, the LOG for acute risk (0.5) was exceeded for non-cropland areas,
non-bearing fruit trees, nut trees, vineyards, and berries. Presumption of risk LOG (0.1) and endangered
species LOG (0.05) was exceeded in non-agricultural areas, non-bearing fruit trees, nut trees, vineyards,
berries, and turf.
The risk quotients (RQs) and LOCs for acute risk from benfluralin for both freshwater and
estuarine organisms are outlined in Table 20.
Table 20. Acute Risk Quotients for Freshwater Fish (bluegill LC50 = 69.7 ppb), Freshwater
Invertebrates (Daphnia magna LC50 > 100 ppb), and Estuarine Invertebrates (mysid shrimp LC50 =
43 ppb).
Use Site
Application Rate
(Ibs ai/A)
Type of Application
Acute RQ
Freshwater
Fish
Acute RQ
Freshwater
Invertebrate2
Acute RQ
Estuarine
Invertebrate
Non-agricultural Areas (GENEEC)
Non-cropland Areas
(6)
broadcast (Ix)
broadcast (2x)
0.44
0.72
0.29
0.48
0.71
1.17
Alfalfa
Alfalfa - All Sites
(1.5)
incorporated
<0.05
<0.05
<0.05
Christmas Tree Farms
Christmas Trees - Oregon
(4)
broadcast (2x)
<0.05
<0.05
<0.05
43
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Use Site
Application Rate
(Ibs ai/A)
Type of Application
Acute RQ
Freshwater
Fish
Acute RQ
Freshwater
Invertebrate2
Acute RQ
Estuarine
Invertebrate
Turf
Turf - Florida
(3)
Turf - Pennsylvania
(3)
broadcast (Ix)
broadcast (2x)
broadcast (Ix)
broadcast (2x)
<0.05
0.08
<0.05
0.05
<0.05
<0.06
<0.05
<0.05
0.06
0.13
<0.05
0.09
Non-bearing Fruit Trees, Nut Trees, Vineyards & Berries
Peaches - Georgia
(3)
Almonds - California
(3)
Citrus - Florida
(3)
Apples - North Carolina
(3)
Apples - Oregon
(3)
Berries - Oregon
(3)
Filberts - Oregon
(3)
broadcast
broadcast
broadcast
broadcast
broadcast
broadcast
broadcast
0.26
<0.05
0.19
0.43
0.06
0.05
0.05
0.18
<0.05
0.13
0.30
<0.05
<0.05
<0.05
0.43
0.06
0.30
0.70
0.09
0.08
0.09
As stated previously, the chronic level of concern (LOG) is 1.0. Risk quotients for chronic risk to
freshwater fish are presented below in Table 21. The chronic LOG is exceeded for non-cropland areas,
non-bearing fruit trees, nut trees, vineyards, and berries when compared to the 60-day average EEC. No
chronic LOCs were exceeded for alfalfa or turf use sites.
44
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Table 21. Chronic Risk Quotients for Freshwater Fish Early Life Stage Toxicity using Rainbow
Trout (Oncorhynchus mykiss) (NOAEC 1.9 ppb) Based on 56-day EEC.
Site
Christmas Trees - Oregon - 2
Non-agricultural Areas - 1
Non-agricultural Areas - 2
Alfalfa - All Sites
Turf - Pennsylvania - All Sites
Peaches - Georgia
Almonds - California
Citrus - Florida
Apples - North Carolina
Apples - Oregon
Berries - Oregon
Filberts - Oregon
Chronic RQ Freshwater Fish *
-------
uncertain without additional data. Table 22 below outlines the terrestrial plant seedling emergence
toxicity EC25s and NOAECs determined from a study administered with technical benfluralin.
Table 22. Nontarget Terrestrial Plant Seedling Emergence Toxicity (Tier H)
Species
Monocot- Corn
Monocot- Sorghum
Monocot- Onion
Monocot- Wheat
Sunflower
Cabbage
Cotton
Cucumber
Radish
Soybean
Percent Active
Ingredient
95.6 Technical
EC25
(Ib ai/A)
>3
1.3
>3
>3
>3
>3
>3
>3
>3
>3
NOAEC
(Ib ai/A)
0.375
0.75
3
3
3
3
3
3
3
3
MRIDNo.
Author/Year
43599201
Schwab, 1995
Table 23 below outlines the results of a vegetative vigor study completed with technical
benfluralin.
Table 23. Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier If)
Species
Corn
Onion
Sorghum
Wheat
Cabbage
Cotton
Cucumber
Radish
Soybean
Sunflower
Percent
Active
Ingredient
95.6
EC2S
(Ibs ai/A)
>3
>3
>3
>3
>3
>3
>3
>3
2.3
>3
ECOS
(Ib ai/A)
3
3
0.05
3
1.5
3
0.38
3
0.38
0.05
MRIDNo.
Author/Year
43599201
Schwab, 1995
46
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f. Risk to Nontarget Aquatic Plants
The Agency is unable to assess risk to non-target aquatic plants due to a lack of toxicity data.
Only data on green algae (Selenastrum capricornutum) were submitted, which showed the EC50 to be
greater than the solubility limit. Data on four additional species are needed to complete the data set for a
screening level risk assessment.
The level of concern (LOG) for acute risk to endangered aquatic plant species is 1.0. Using the
96-hour environmental effect concentration (EEC) as the exposure concentration, and 100 ppb
(solubility limit) as the concentration causing 49% growth inhibition in a green algae, there are no LOG
exceedances. A new study of all four recommended aquatic plant species would clarify what
concentration is toxic to aquatic plants. The results of a study on the toxicity of technical benfluralin to
green algae are outlined in Table 24 below.
Table 24. Toxicity to Aquatic Plants (Tier I)
Species
Green algae (formerly
Selenastrum capricorntum)
Kirchneria subcavitata
Percent
Active
Ingredient
95.9
Concentrat
ion (ppm)
0.100
Percent
Response
49
MRID Number
Author/Year
41613809
Cocke, 1990
g-
Food-Chain Effects
Benfluralin residues may bioconcentrate (Bioconcentration Factor (BCF) = 1,580) in fish near
high benfluralin use areas such as non-cropland sites or orchards. Fish-eating birds that consume fish
containing 30 to 48 ppm (North Carolina apple scenario) benfluralin residues may suffer chronic effects
(NOAEC < 96 ppm). The risk quotient (0.3 to 0.5) for birds eating benfluralin-contaminated fish is
uncertain, due to the uncertainty in the chronic no-effect concentration for birds (NOAEC < 96 ppm),
and due to the uncertainty of the water concentrations estimated by PRZM-EXAMS. The RQ may be
lower if actual water concentrations are lower, but may be higher if the NOAEC proves to be much
lower when new data are submitted. Based on the data currently available to the Agency, it is
reasonable to conclude that benfluralin exposure in fish-eating birds (in use areas such as non-cropland
areas or orchards) may approach levels causing chronic toxicity. An avian reproduction study is needed
to reduce the uncertainty of this risk.
Fugacity calculations (see Appendix VII of the Environmental Fate and Effects Risk Assessment
dated, June 4, 2004) indicate that earthworms may accumulate concentrations of benfluralin
approximately fifteen (15) times what is found in the soil. For instance, the earthworm will accumulate
180 ppm of benfluralin from soil containing 12 ppm (Table VII-B). These concentrations are well above
the concentrations that cause chronic effects in mammals and birds that consume earthworms.
47
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h. Risk to Endangered Species
As shown in Table 25, the Agency's screening level risk assessment for benfluralin concluded
that there is a potential for risk to endangered species. Additional information, including the Preliminary
Benfluralin Endangered Species Risk Assessment, dated July 12, 2004, can be found in Agency's e-
docket website, www. epa. gov/e-docket.
Reductions in application rates and/or number of applications will reduce overall risk. As
indicated in Table 29, rates for non-cropland sites, ornamentals, and Christmas tree farms are being
reduced. The use of benfluralin on alfalfa and lettuce is limited in terms of application rate, frequency
of application and the states that use it for these crops. The endangered species assessment on all use
sites will be refined using data that will be submitted as a result of this RED. A list of required studies is
shown in Section V of this document. After the new data are reviewed, the risk assessment will be
refined, and exceedences of the levels of concern for risks for endangered species will be addressed.
Table 25. Potential Risks of Concern for Endangered Species Per Use Site
Use Site
(Maximum Use Rate on
Current Labels)
Risk of Concern
(Target RQ)
Species Group of Concern
(RQ exceedance range)
Non-cropland Areas: Industrial
Sites, Utility Substations, Highway
Guardrails, Sign Posts, and
Delineators
(12 Ib ai/A per year)
Acute Risk
(0.05)
Chronic Risk
(1.0)
Freshwater Fish
(0.72)
Freshwater Invertebrates
(0.48)
Estuarine Invertebrates
(1.17)
Freshwater Fish
(12.1)
Birds
(1.0-8.9)
Mammals
(2.8-24.0)
Turf
(6 Ibs ai/A per year)
Acute Risk
(0.05)
Chronic Risk
(1.0)
Freshwater Fish
(0.05-0.08)
Freshwater Invertebrates
(less than 0.06)
Estuarine Invertebrates
(0.06-0.13)
Birds
(1.8-4.4)
Mammals
(1.4-12.2)
48
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Use Site
(Maximum Use Rate on
Current Labels)
Risk of Concern
(Target RQ)
Species Group of Concern
(RQ exceedance range)
Landscape Ornamentals, Field-
grown and Container-grown
Ornamentals, Non-Bearing
Vineyards, Fruit Trees, Nut Trees,
and Berries
(9 Ibs ai/A per year)
Acute Risk
(0.05)
Chronic Risk
(1.0)
Freshwater Fish
(0.05-0.43)
Freshwater Invertebrates
(0.13-0.30)
Estuarine Invertebrates
(0.06-0.70)
Freshwater Fish
(1.2 - 2.9)
Birds
(2.6-6.7)
Mammals
(2.1-18.2)
Christmas Tree Farms
(8 Ibs ai/A per year)
Chronic Risk
(1.0)
Birds
(less than 2.6 - 6.7)
Mammals
(less than 2.1 - 18.2)
Alfalfa, Lettuce (spray)
(1.5 Ibs ai/A per year)
Chronic Risk
(1.0)
Birds
(1.72 - 3.75)
Mammals
(1.65-3.6)
Note: While risks to endangered estuarine invertebrates are potentially of concern, there are currently no federally listed
endangered or threatened estuarine invertebrate species.
i. Ecological Incident Reports
There are three incidents reported for benfluralin in the Ecological Incident Information System
(BITS) data base. The first was a 1997 incident associated with adverse effects (damage) to freshwater
fish. Benfluralin was applied to a lawn up to the edge of a pond. A rainfall occurred, and the resulting
wash of benfluralin to the pond resulted in a fish kill.
There were two plant incidents in 1994 that occurred with benfluralin mixed with sulfonylurea
herbicides. The compound drifted over non-target plants and caused plant damage.
49
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether or not products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient-specific) data required to support reregistration of products containing benfluralin as an
active ingredient. The Agency has completed its review of these generic data, and has determined that
the data are sufficient to support reregistration of all products containing benfluralin.
The Agency has completed its assessment of the dietary, occupational, residential, and ecological
risk associated with the use of pesticide products containing the active ingredient benfluralin. Based on
a review of these data and on public comments on the Agency's assessments for the active ingredient
benfluralin, the Agency has sufficient information on the human health and ecological effects of
benfluralin to make decisions as part of the tolerance reassessment process under FFDCA and
reregistration process under FIFRA, as amended by FQPA. The Agency has determined that benfluralin
containing products are eligible for reregistration provided that: (i) current data gaps and 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 SectionV.
Appendix A summarizes the uses of benfluralin that are eligible for reregistration. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of benfluralin, 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 benfluralin, the Agency has determined that benfluralin 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 the use of
benfluralin. If all changes outlined in this document are incorporated into the product labels, then all
current risks for benfluralin will be adequately mitigated for the purposes of this determination.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with stakeholders
and the public to reach the regulatory decisions for benfluralin. During the public comment period on
the risk assessments, which closed on April 26, 2004, the Agency received comments from two
commentors, Dow AgroSciences and the U.S. Fish and Wildlife Service. These comments in their
entirety are available in the public docket, www.epa.gov/.edocket (OPP-2003-0381). An individual
response to these comments is being prepared by EPA and will be made available in the public docket,
www. epa. gov/. edocket (OPP-2004-0210).
C. Regulatory Position
1. Food Quality Protection Act Findings
50
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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 benfluralin is
within its own "risk cup." An aggregate assessment was conducted for exposures through food, drinking
water, and residential uses. The Agency has determined that the human health risks from these
combined exposures are within acceptable levels. In other words, EPA has concluded that the tolerances
for benfluralin meet FQPA safety standards. In reaching this determination, EPA has considered the
available information on the special sensitivity of infants and children, as well as aggregate exposure
from food, water, and residential uses.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for benfluralin, 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, and that there is a reasonable certainty no harm will result to the general
population or any subgroup from the use of benfluralin. In reaching this conclusion, the Agency has
considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of benfluralin. As discussed in Chapter 3, the total acute dietary (food alone)
risk was not assessed as no acute oral endpoint was observed. Further, the chronic dietary (food alone)
risk from benfluralin is not of concern.
Acute and chronic risks from drinking water exposures are not of concern. Models have been
used to estimate ground and surface water concentrations. The DWLOC calculated to assess the surface
water contribution to chronic (noncancer) dietary exposure is a range of less than 0.07 to less than 3.5 for
the U.S. general population (all population subgroups). The surface water EECs are below the DWLOC
for all population subgroups (see Table 8). Drinking water monitoring data from the U.S. Geological
Survey National Water Quality Assessment (NAWQA) Program confirm that concentrations of
benfluralin are less than modeled estimates.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for benfluralin, with amendments and changes
as specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The
safety determination for infants and children considers factors on the toxicity, use practices and
environmental behavior noted above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific consumption patterns of infants and children,
as well as the possibility of increased susceptibility to the toxic effects of benfluralin residues in this
population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects
from benfluralin residues, the Agency considered the completeness of the database for developmental
and reproductive effects, the nature of the effects observed, and other information. The FQPA Safety
Factor has been removed (i.e., reduced to IX) for benfluralin because: 1) there is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits to in utero or postnatal exposure; 2) a
51
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DNT study with benfluralin is not required; and 3) the dietary (food and drinking water) and non-dietary
(residential) exposure assessments will not underestimate the potential exposures to 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 a
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
One study showed that benfluralin is toxic to the thyroid at high dose levels (136.3 mg/kg/day,
male rats). However, these doses were considered excessive by the Agency review committee and no
tumors were seen at lower doses. When the appropriate screening and/or testing protocols being
considered under the EDSP have been developed, benfluralin may be subject to additional screening
and/or testing.
e. Cumulative Risks
Risks summarized in this document are those that result only from the use of benfluralin. The
Food Quality Protection Act (FQPA) requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that have a
common mechanism of toxicity." The reason for consideration of other substances is due to the
possibility that low-level exposures to multiple chemical substances that cause a common toxic effect by
a common toxic mechanism could lead to the same adverse health effect as would a higher level of
exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for benfluralin. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances found to
have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
Tolerances are established for "negligible" residues of the herbicide benfluralin (N-butyl-N-ethyl-
a,cc,cc- trifluoro-2,6-dinitro-p-toluidine) in/on the raw agricultural commodities (RACs) of alfalfa,
birdsfoot trefoil, clover, lettuce, and peanuts at 0.05 ppm [40 CFR §180.208]. Because there is no
52
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expectation of residues of benfluralin in poultry or cattle, tolerances are not required for animal and
processed food/feed commodities.
a. Tolerances Currently Listed Under 40 CFR §180.208
Sufficient field trial data have been submitted (or were translated when appropriate) to reassess
the established tolerances for the following plant commodities, as defined: alfalfa, birdsfoot trefoil,
clover, and lettuce.
For the peanut use, the technical registrant has requested voluntary cancellation of that use. A
Federal Register Notice was published on June 25, 2003, announcing the receipt of this voluntary use
cancellation request. The cancellation was effective on December 22, 2003 (68 FR 37811). The
tolerance will be proposed for revocation. Table 26 provides a listing of the tolerances currently
registered for benfluralin.
Table 26. Tolerance Reassessment Summary for Benfluralin.
Commodity
Current
Tolerance
(ppm)
Maximum Residue Value
(ppm)
Reassessed
Tolerance (ppm)
Comment
Tolerance Listed Under 40 CFR §180.208
Alfalfa, forage
Afalfa, hay
Clover, forage
Clover, hay
Lettuce
Peanuts
Trefoil, birdsfoot,
forage
Trefoil, birdsfoot,
hay
0.05(N)'
O.OSCN)1
0.05CN)1
O.OSCN)1
0.05CN)1
0.05CN)1
0.05CN)1
0.05CN)1
alfalfa forage =<0.01
alfalfa hay = 0.0 14
alfalfa forage =<0.01
alfalfa hay = 0.0 14
head lettuce with wrapper
leaves = 0.014
leaf lettuce = 0.02
--
alfalfa forage =<0.01
alfalfa hay = 0.0 14
0.05
0,05
0.05
0.05
0.05
Revoke
0.05
0.05
The available data for alfalfa may
be translated.
The peanut use has been
voluntarily canceled in a Federal
Register Notice dated June 25,
2003.
The available data for alfalfa may
be translated.
1 EPA expects to remove the "(N)" designation from all entries to conform with current administrative practice ("(N)"
designation means negligible residues).
b.
Codex Harmonization
No Codex maximum residue levels (MRLs) have been established for benfluralin.
c. Residue Analytical Methods - Plants and Livestock (GLN 860.1340)
53
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The reregistration requirements for residue analytical methods are fulfilled. Adequate methods
are available for data collection and for the enforcement of tolerances for residues of benfluralin/>er se
in/on plant commodities. Since no tolerances exist, or are required for milk, eggs, and edible livestock
tissues, enforcement methods for the determination of benfluralin residues in livestock commodities are
not needed.
The Pesticide Analytical Manual (PAM, Vol. H, Section 180.208) lists two methods, designated
as Methods I and A, for determination of benfluralin per se in/on plant commodities. Method I lists the
PAM, Vol. I multiresidue methods for organochlorine compounds. Method A is a GC/ECD method
with detection limits of 0.005-0.01 ppm. Because ethalfluralin may interfere with determination of
benfluralin, PAM Vol. II also includes references to methods for ethalfluralin and trifluralin, which may
be used for confirmation of benfluralin residues.
Samples of alfalfa and lettuce from more recent study submissions were analyzed using the Dow
AgroSciences GC/ECD Method Am-AA-CA-R027-AA-755 in a study titled "Determination ofBenefin
in Agricultural Crops and Soil. " A brief description of the method follows: residues were extracted
with methanol, diluted with 10% sodium chloride, and the extract was partitioned into dichloromethane
(DCM). Decane was added as a keeper, and the DCM was evaporated under vacuum. The concentrated
DCM phase was subjected to Florisil column chromatography; residues were eluted with hexane.
Decane was added again, the hexane was evaporated, and residues were re-dissolved in toluene for
quantitation by GC/ECD. The reported Limit of Quantitation was 0.01 ppm. This method is similar to
MethodAmPAMVol.il.
The Agency notes that Method A in PAM Vol. n requires the use of benzene (as the solvent for
GC/ECD determination). Since benzene is known to be a hazardous substance, the registrants should
propose the data-collection Method Am-AA-CA-R027-AA-755 as a replacement for Method A.
Because the two methods are similar, no independent laboratory validation of the method would be
required.
D. Regulatory Rationale
The Agency has determined that benfluralin is eligible for reregistration provided that: additional
data that the Agency intends to require confirm this decision; and the risk mitigation measures outlined
in this document are adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the use of
benfluralin. Where labeling revisions are warranted, specific language is set forth in the summary tables
of Section V of this document. Some application rates have been reduced, and other measures are
needed to reduce risks to wildlife. The risk reduction by these actions have not been completely
quantified but will reduce exposure to benfluralin. Table 29 lists all the use sites that have revised
application rates and label requirements.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
54
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Benfluralin is not acutely toxic. No adverse effects attributed to a single exposure were identified
in any available study including developmental studies in rabbits or rats. Therefore, no acute dietary
assessment was conducted and no mitigation is needed.
The chronic non-cancer dietary analysis indicates all risk estimates are below the Agency's level
of concern for all population subgroups for benfluralin. The highest chronic dietary risk estimates are
less than 1% of the chronic population adjusted dose (PAD). Therefore, the chronic dietary (food) risk
estimate is not of concern, and no risk reduction measures are necessary.
b. Drinking Water Risk Mitigation
Estimated environmental concentrations (EECs) of benfluralin and its degradates for both
groundwater and surface water sources of drinking water are below the Agency's drinking water levels
of concern (DWLOCs). Therefore, no mitigation is needed for drinking water.
c. Residential Risk Mitigation
Residential exposure to benfluralin may occur during and after application at homes; or after
applications at golf courses, parks, schools, or other areas where benfluralin may be applied to turf or
ornamental plants. Since systemic toxicity was not observed in a dermal toxicity study up to a dose level
of 1000 mg/kg/day, the only risk addressed is the possible inhalation exposure to residential handlers.
For residential lawn uses, the short-term inhalation risk from exposure to the granular formulation of
benfluralin indicates that inhalation MOEs are not of concern. Therefore, the short-term risks to
homeowners from residential exposure are not of concern and no residential handler mitigation is
needed.
Post-application residential exposure to benfluralin is anticipated to include applications to
ornamental plants and to lawns. Although the type of site that benfluralin may be used on varies from
golf courses to ornamental gardens, the scenario chosen for risk assessment represents what the Agency
considers to be the likely upper-end of possible exposure. For this assessment, children are the
population group of concern. Since systemic toxicity was not observed in a dermal toxicity study, the
only potential risk considered is the possible oral exposure of small children from treated turf, or from
treated soil (i.e., soil ingestion, granule ingestion, and hand/object to mouth). The Total Oral MOE for
post-application exposure to a child from all three turf scenarios is 1800, well above 100, and is thereby
not of concern. Therefore, no mitigation is needed.
d. Aggregate Risk Mitigation
1) Acute Aggregate Risk
There are no adverse effects expected from a single exposure to benfluralin; therefore, an acute
aggregate risk assessment was not conducted.
2) Short-term Aggregate Risk
55
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Short-term aggregate exposure takes into account residential exposure plus chronic exposure to
food and water. Short-term aggregate risks from food, residential inhalation, and drinking water are not
of concern; therefore, no mitigation is required.
3) Chronic (Non-Cancer) Aggregate Risk
The chronic aggregate risk assessment addresses only exposure to benfluralin residues in food
and water; since there are no benfluralin uses that could result in chronic residential exposure. The
estimated environmental concentrations (EECs) do not exceed the drinking water level of comparison
(DWLOC). Chronic dietary (food + water) risk and chronic aggregate risk are below the Agency's
level of concern and therefore no mitigation is required.
e. Occupational Risk Mitigation
1) Handler Exposure
Handler exposure assessments are completed by EPA using a baseline (long-sleeved shirt and
long pants) exposure scenario and, if required, increasing levels of mitigation (Personal Protective
Equipment (PPE) and engineering controls) to achieve and adequate margin of exposure (MOE). For
benfluralin the target MOE for workers is 100. Analyses for handler/applicator exposures were
performed using PHED, ORETF, and available studies. The calculations indicate that the MOEs for all
occupational handler scenarios are above 100 at the baseline level and are not of concern. Therefore, no
mitigation is needed.
2) Post-application Risk Mitigation
Dermal exposure is the only significant exposure for benfluralin. Since no dermal endpoint was
identified, no re-entry risk assessment was undertaken for benfluralin. These risks are not of concern;
therefore, no mitigation is needed.
2. Environmental Risk Mitigation
EPA's screening level ecological risk assessment shows some exceedance of the acute and
chronic levels of concern for risk to birds, small mammals, freshwater fish, freshwater invertebrates, and
estuarine invertebrates. The levels of concern are also exceeded for risk to endangered birds, mammals,
freshwater fish, freshwater invertebrates, and estuarine invertebrates. Table 27 details the revised
application rates and application intervals that were agreed upon by the registrants.
Table 27. Revised Use Site Parameters and Requirements for Benfluralin.
Crop
Turf
Range of Single
Application Rates
(Ib ai/A)
Previous
Revised
Minimum
Retreatment
Interval
56 - 70 days/
Maximum
Number of
Applications Per
Year
Previous
Revised
Yearly
Maximum Rate
(Ib ai/A)
Previous
Revised
Current
REI
(hours)
12
days
56
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Crop
Alfalfa
Clover
Bird's Foot
Trefoil
Lettuce
Non-bearing
Berries
Non-bearing
Fruit Trees
Ornamentals
Christmas
Trees
Warm
Season Turf
Non-bearing
Nut Trees
Non-bearing
Vineyards
Non-
cropland
Areas
Range of Single
Application Rates
(Ib ai/A)
1.5-3
1.2- 1.5
1.2-1.5
1.2-1.5
1.2- 1.5
2-3
2-3
2-3
2-4
1 -1,5
2-3
2-3
2-6
1.5-3
1.2- 1.5
1.2-1.5
1.2-1.5
1.2- 1.5
3
3
2
2
1-1.5
3
3
2-4
Minimum
Retreatment
Interval
none
none
none
none
2-4 months
2-4 months
2-4 months
2 months
60 - 90 days
2-4 months
2-4 months
2-8 months
Maximum
Number of
Applications Per
Year
1 -2
1
1
1
1
3
3
2
2
2
3
3
3
1 -2
1
1
1
1
2
2
2
2
2
2
2
2
Yearly
Maximum Rate
(Ib ai/A)
6
1.5
1.5
1.5
1.5
9
9
6
8
3
9
9
12
6
1.5
1.5
1.5
1.5
6
6
4
4
3
6
6
4
Current
REI
(hours)
12
12
12
12
241
241
241
241
241
241
241
241
'The 24-hour REI is for products that also contain oryzalin; other products with only benfluralin or benfluralin combined with
trifluralin have a 12-hour REI.
The tables below outline the species group of concern and risk of concern per use site for species
of concern other than endangered species and endangered species. Tables 28 and 29 also provide a
characterization of the risk and risk mitigation strategies employed.
57
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Table 28. Risk Characterization and Mitigation Strategies for Ecological Risks of
Benfluralin.
Use Site
(Maximum Use
Rate)
Risk of
Concern
(TargetRQ)
Species Group of Concern
(Current RQ range)
(Approx. Revised RQ Range)
Characterization and Mitigation
Non-cropland
Areas: Industrial
Sites, Utility
Substations,
Highway
Guardrails, Sign
Posts, and
Delineators
(4 Ibs ai/A per
year)
Acute Risk
(0.5)
Freshwater Fish
(0.72)
(0.24)
Estuarine Invertebrates
(1.17)
(0.4)
Chronic Risk
(1.0)
Freshwater Fish
(12.1)
(4.0)
Birds
(1.0-8.9)
(0,33-3.0)
Mammals
(2.8-24.0)
(0.9 - 8)
The maximum rate for non-cropland areas has been
reduced from 12 Ibs ai/A per year to a yearly
maximum application rate of 4 Ibs ai/A. The risk
assessment was calculated with the maximum use rate,
which has been reduced. Also, the target RQ for acute
risk to freshwater fish is only slightly exceeded.
The Agency has received significant information from
non-cropland area stakeholders, including utilities
companies, and the registrant that this is a minor use
with very little acreage. Since there is very little usage
the Agency has determined that this reduction in label
rate and limited use will reduce potential ecological
impacts.
The approximate revised RQ s for acute risk indicate
that when rate reductions are implemented, acute risk
for freshwater fish and estuarine invertebrates will not
be of concern.
Turf
(6 Ibs ai/A per
year)
Chronic Risk
(1.0)
Birds
(1.8-4.4)
All labels with turf use sites will recommend watering
in of the granule as a mitigation measure. Since the
concern in this scenario is for birds and mammals
eating the granules, watering after application will
reduce the granule availability, promote degradation,
and reduce exposure.
Mammals
(1.4 -12.2)
(same)
Landscape
Ornamentals,
Field-grown and
Container-grown
Ornamentals,
Non-Bearing
Vineyards, Fruit
Trees, Nut Trees,
and Berries
(6 Ibs ai/A per
year)
Acute Risk
(0.5)
Estuarine Invertebrates
(0.06-0.7)
(0.03 - 0.35 for Landscape
Ornamentals)
(0.04 - 0.46 for Field-grown
Ornamentals, Non-bearing)
Chronic Risk
(1.0)
Freshwater Fish
(1.2-2.9)
(0.6 - 1.45 for Landscape
Ornamentals)
(0.8-1.9 for Field-grown
Ornamentals, Non-bearing)
The maximum use rate for landscape ornamentals has
been reduced from 8 Ibs ai/A per year to 4 Ibs ai/A per
year. The maximum use rate for field-grown and
container-grown ornamentals, and non-bearing fruit
trees, nut trees, vineyards, and berries has been
reduced from 9 Ibs ai/A per year to 6 Ibs ai/A per year.
These reduction in label rates will reduce potential
ecological impacts.
The approximate revised RQ s indicate that when rate
reductions are implemented, acute risk to estuarine
invertebrates will not be of concern.
Birds
(2.6-6.7)
(1.3 - 3.35 for Landscape
Ornamentals)
(1.7 - 4.5 for Field-grown
Ornamentals, Non-bearing)
58
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Use Site
(Maximum Use
Rate)
Risk of
Concern
(Target RQ)
Species Group of Concern
(Current RQ range)
(Approx. Revised RQ Range)
Characterization and Mitigation
Mammals
(2.1 - 18.2)
(1.1 -9.1 for Landscape
Ornamentals)
(1.4 - 12.1 for Field-grown
Ornamentals, Non-bearing)
Christmas Tree
Farms
(4 Ibs ai/A per
year)
Chronic Risk
(1.0)
Birds
(approx. 2.6-6.7)
(1.3-3.35)
Mammals
(approx. 2.1 -18.2)
(1.1 -9.1)
The maximum use rate for Christmas tree farms has
been reduced from 8 Ibs ai/A per year to 4 Ibs ai/A per
year. This reduction in label rates will reduce
potential ecological impacts.
Alfalfa, Lettuce
(Spray)
(1.5 Ibs ai/A per
year)
Chronic Risk
(1.0)
Birds
(1.72 - 3.75)
Mammals
(1.65-3.6)
The Agency has received significant comments from
stakeholders, including USD A, and the registrant, that
benfluralin is used on alfalfa and lettuce use sites in
CA, AZ, and TX. Also, benfluralin liquid spray is soil
incorporated at alfalfa and lettuce use sites. This
application method should minimize exposures to
birds and mammals. Additionally, benfluralin is only
applied once per year at these use sites, which will
reduce the likelihood and duration of exposure to birds
and mammals.
Note: While risks to endangered estuarine invertebrates are potentially of concern, there are currently no federally listed
endangered or threatened estuarine invertebrate species.
59
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Table 29. Potential Risks of Concern for Endangered Species and Risk Characterization and
Mitigation Strategies for Ecological Risks of Benfluralin.
Use Site
(Maximum Use
Rate)
Non-cropland
Areas:
Industrial Sites,
Utility
Substations,
Highway
Guardrails,
Sign Posts, and
Delineators
(4 Ib ai/A per
year)
Turf
(6 Ibs ai/A per
year)
Risk of
Concern
(Target RQ)
Acute Risk
(0.05)
Chronic
Risk
(1.0)
Acute Risk
(0.05)
Chronic
Risk
(1.0)
Species Group of
Concern
(RQ exceedance range)
(Approx. Revised RQ
Range)
Freshwater Fish
(0.72)
(0.24)
Freshwater Invertebrates
(0.48)
(0.16)
Estuarine Invertebrates
(1.17)
(0.4)
Freshwater Fish
(12.1)
(4.0)
Birds
(1.0 - 8.9)
(0.3 - 3.0)
Mammals
(2.8-24.0)
(0.9 - 8.0)
Freshwater Fish
(0.05-0.08)
(same)
Freshwater Invertebrates
(less than 0.06)
(same)
Estuarine Invertebrates
(0.06-0.13)
(same)
Birds
(1.8 - 4.4)
(same)
Mammals
(1.4-12.2)
(same)
Characterization and Mitigation
Further evaluation of endangered species will be
conducted by the Agency at a later date. The future
assessment will be built upon the data and use patterns
from this risk assessment.
The maximum rate for non-cropland areas has been
reduced from 12 Ibs ai/A per year to a maximum yearly
application rate of 4 Ibs ai/A. The Agency has received
significant information from non-cropland stakeholders,
including utilities companies and the registrant that this
is a minor use with very little acreage. Since there is
very little usage the Agency has determined that this
reduction in label rate and limited use will reduce
potential exposure to listed species. Data on fish and
aquatic invertebrate life cycle, avian reproduction, and
other studies are being required as a result of the
reregistration of benfluralin. These data will further
inform EPA's endangered species analysis.
Further evaluation of endangered species will be
conducted by the Agency at a later date. The future
assessment will be built upon the data and use patterns
from this risk assessment.
All labels with turf use sites will recommend watering
in of the granule as a mitigation measure. Since the
concern in this scenario is for birds and mammals eating
the granules, watering after application will begin to
degrade the granule on the ground and reduce the
exposure to birds and mammals which will reduce
potential exposure to listed species. Data on fish and
aquatic invertebrate life cycle, avian reproduction, and
other studies are being required as a result of the
reregistration of benfluralin. These data will further
inform EPA's endangered species analysis.
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Use Site
(Maximum Use
Rate)
Risk of
Concern
(Target RQ)
Species Group of
Concern
(RQ exceedance range)
(Approx. Revised RQ
Characterization and Mitigation
Acute Risk
(0.05)
Landscape
Ornamentals,
Field-grown
and Container-
grown
Ornamentals,
Non-Bearing
Vineyards,
Fruit Trees,
Nut Trees, and
Berries
(6 Ibs ai/A per
year)
Chronic
Risk
(1.0)
Freshwater Fish
(0.05-0.43)
(0.03 - 0.2 for Landscape
Ornamentals)
(0.03 - 0.3 for Field-grown
Ornamentals and Non-
Freshwater Invertebrates
(0.13-0.30)
(0.07 - 0.15 for Landscape
Ornamentals)
(0.09 - 0.2 for Field-grown
Ornamentals and Non-
Estuarine Invertebrates
(0.06-0.70)
(0.03 - 0.35 for Landscape
Ornamentals)
(0.04 - 0.5 for Field-grown
Ornamentals and Non-
Freshwater Fish
(1.2 - 2.9)
(0.6 - 1.45 for Landscape
Ornamentals)
(0.8- 1.9 for Field-grown
Ornamentals and Non-
Birds
(2.6-6.7)
(1.3 - 3.4 for Landscape
Ornamentals)
(1.73 - 4.5 for Field-grown
Ornamentals and Non-
Mammals
(2.1-18.2)
(1.1 - 9.1 for Landscape
Ornamentals)
(2.1 - 12.1 for Field-grown
Ornamentals and Non-
Further evaluation of endangered species will be
conducted by the Agency at a later date. The future
assessment will be built upon data and use patterns from
this risk assessment.
The maximum use rate for landscape ornamentals has
been reduced from 8 Ibs ai/A per year to 4 Ibs ai/A per
year. The maximum use rate for field-grown and
container-grown ornamentals has been reduced from 9
Ibs ai/A per year to 6 Ibs ai/A per year. These reduction
in label rates will reduce potential exposure to listed
species. Data on fish and aquatic invertebrate life cycle,
avian reproduction, and other studies are being required
as a result of the reregistration of benfluralin. These
data will further inform EPA's endangered species
analysis.
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Use Site
(Maximum Use
Rate)
Risk of
Concern
(Target RQ)
Species Group of
Concern
(RQ exceedance range)
(Approx. Revised RQ
Characterization and Mitigation
Christmas Tree
Farms
(4 Ibs ai/A per
year)
Chronic
Risk
(1.0)
Birds
(less than 2.6 - 6.7)
(less than 1.3 -3.4)
Mammals
(less than 2.1-18.2)
(less than 1.1 -9.1)
Further evaluation of endangered species will be
conducted by the Agency at a later date. The future
assessment will be built upon the data and use patterns
used in this risk assessment.
The maximum use rate for Christmas tree farms has
been reduced from 8 Ibs ai/A per year to 4 Ibs ai/A per
year. This reduction in label rates will reduce potential
exposure to listed species. Data on fish and aquatic
invertebrate life cycle, avian reproduction, and other
studies are being required as a result of the reregistration
of benfluralin. These data will further inform EPA's
endangered species analysis.
Alfalfa, Lettuce
(spray)
(1.5 Ibs ai/A per
year)
Birds
(1.72-3.75)
Chronic
Risk
(1.0)
Mammals
(1.65-3.6)
Further evaluation of endangered species will be
conducted by the Agency at a later date. The future
assessment will be built upon the data and use patterns
used in this risk assessment.
The Agency has received significant comments from
stakeholders, including USDA, and the registrant, that
benfluralin is used on alfalfa and lettuce use sites in CA,
AZ, and TX. Also, benfluralin liquid spray is soil
incorporated at alfalfa and lettuce use sites. This
application method should minimize exposures to birds
and mammals. Additionally, benfluralin is only applied
once per year at these use sites, which may reduce the
likelihood and duration of chronic exposure to birds and
mammals. Data on fish and aquatic invertebrate life
cycle, avian reproduction, and other studies are being
required as a result of the reregistration of benfluralin.
These data will further inform EPA's endangered
species analysis.
Note: While risks to endangered estuarine invertebrates are potentially of concern, there are currently no federally listed
endangered or threatened estuarine invertebrate species.
As an herbicide, benfluralin has the potential to affect federally listed threatened and endangered
vascular plants. Until additional data are submitted and a determination made whether a species specific
assessment needs to be conducted for listed species, the mitigation strategy articulated in this document
will serve to reduce the likelihood that listed plant species will be exposed to benfluralin.
3. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be included in the
labeling of all end-use products containing benfluralin. For the specific labeling statements and a list of
outstanding data, refer to Section V of this RED document.
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4. Endangered Species Considerations
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 that may affect any particular
species, EPA uses basic toxicity and exposure data developed for the REDs and considers ecological
parameters, pesticide use information, geographic relationship between specific pesticide uses and
species locations, and biological requirements and behavioral aspects of the particular species. This
analysis will consider the risk mitigation measures that are being implemented as a result of this RED.
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. EPA is not
requiring specific label language at the present time relative to threatened and endangered species. The
general risk mitigation required through this RED will serve to reduce exposure to listed species of
potential concern until such time as the agency refines its risk assessment for plants and for chronic
effects to fish, avian and mammalian species and acute risks to fish and invertebrates. If in the future
specific measures are necessary for the protection of listed species, the Agency will implement them
through the Endangered Species Protection Program.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of the interim
program, the Agency has developed County Specific Pamphlets that articulate many of the specific
measures outlined in the Biological Opinions issued to date. The Pamphlets are available for voluntary
use by pesticide applicators on EPA's website at www. epa. gov/espp. A final Endangered Species
Protection Program, which may be altered from the interim program, was proposed for public comment
in the Federal Register December 2, 2002.
5. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches for
mitigating risks to human health and the environment from pesticide spray and dust drift. As part of the
reregistration process, we will continue to work with all interested parties on this important issue.
From its assessment of benfluralin, as summarized in this document, the Agency concludes that
certain drift mitigation measures are needed to address the risks from off-target drift for benfluralin.
Label statements implementing these measures are listed in the "spray drift management" section of the
label table (Table 31) in Chapter V of this RED document. In the future, benfluralin product labels may
need to be revised to include additional or different drift label statements.
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V. What Registrants Need to Do
The Agency has determined that benfluralin is eligible for reregistration provided that: (i)
additional data are submitted that the Agency intends to require, confirming this decision; and (ii) the
risk mitigation measures outlined in this document are adopted; and (iii) 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 D
below. The additional data requirements that the Agency intends to obtain will include, among other
things, submission of the following:
A. For benfluralin technical grade active ingredient products, the registrant needs to submit the
following items:
Within 90 days from receipt of the generic data call in (DCI):
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
1. cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact Katie Hall at (703) 308-0166 with questions regarding generic reregistration.
By US mail:
Document Processing Desk (DCI/SRRD)
Katie Hall
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Katie Hall
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1801 S. Bell Street
Arlington, VA 22202
B. For end-use products containing the active ingredient benfluralin, the registrant needs to
submit the following items for each product.
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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 reregistration (EPA Form 8570-1). Indicate
on the form that it is an "application for reregistration";
3. five copies of the draft label incorporating all label amendments outlined in
Table 31 of this document;
4. a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34); and
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 Moana Appleyard at (703) 308-8175 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be addressed as
follows:
By US mail:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1801 South Bell Street
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of benfluralin for the above eligible uses has
been reviewed and determined to be substantially complete. However, the following data requirements
listed below are necessary to confirm the reregistration eligibility decision documented in this RED.
65
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Table 30. Data Requirements for the Reregistration Eligibility Decision on Benfluralin
Guideline Study Name
UV/Visible Absorption
90-Day Inhalation - Rat
(The Agency should be contacted prior to conducting the study)
Carcinogenicity - Mouse
Directions for Use
Residue Analytical Method - Plants (propose new method)
Confined Accumulation in Rotational Crops
Field Accumulation in Rotational Crop Study
(Reserved) (Data gap for Trifluoroacetic Acid)
Avian Reproduction - Quail
Acute Fish Toxicity Bluegill
Acute Fish Toxicity Rainbow Trout
Acute Aquatic Invertebrate Toxicity
Acute Estuarine/Marine Toxicity - Fish
Acute Estuarine/Marine Toxicity - Mollusk
Life Cycle Fish
Life Cycle Aquatic Invertebrate
Aquatic Plant Growth
Seedling Germination and Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Aerobic Aquatic Metabolism
Droplet Size Spectrum (Reserved)
Drift Field Evaluation (Reserved)
New OPPTS
Guideline No.
830.7050
870.3465
870.4200
860.1200
860.1340
860.1850
860.1900
850.2300
850.1075
850.1075
850.1010
850.1075
850.1025
850.1500
850.1350
850.5400
850.4225
850,4250
850.4400
835.4300
840.1100
840.1200
Old Guideline
No.
None
82-4
83-2B
171-3
171-4C
165-1
165-2
7 1-4 A
72-1A
72- 1C
72-2A
72-3A
72-3B
72-5
72-4B
122-2
123-1A
123-1B
123-2
162-4
201-1
202-1
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 MUP labeling
should bear the labeling contained in Table 31.
B.
End-Use Products
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1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. The Registrant must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product. A product-specific data
call-in, outlining specific data requirements, will be issued separately.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific
language to incorporate these changes is specified in Table 31.
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this Reregistration Eligibility Decision document. Persons other than
the registrant may generally distribute or sell such products for 52 months from the approval of labels
reflecting the mitigation described in 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.
C. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation
measures outlined in Section IV. The following table (Table 31) describes how language on the labels
should be amended.
67
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Table 31. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.
Table 31: Summary of Labeling Changes for Benfluralin
Desciiptidri
, - ' • " Amended'Labeling La'nguagi,'--
•;." " BlaceMent tin-Libel ,.'"••'
' .:: " " J^anufaeturing IJSe.Frbd.ucts'-
For all 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
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
For Manufacturing Use
Products with >60% active
ingredient benfluralin
"Only for formulation into an herbicide for the following use(s) [fill blank only with those
uses that are being supported by MP registrant]."
"This product may be used to formulate products for specific use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the
MP label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National Pollution
Discharge Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
"Prolonged or frequently repeated skin contact may cause allergic reactions in some
individuals."
Directions for Use
Directions for Use
Precautionary Statements
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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PPE Requirements
Established by the RED1
for granular formulations
"Personal Protective Equipment (PPE)
All loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements
Established by the RED1
for liquid and dry flowable
formulations
"Personal Protective Equipment (PPE)
All mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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."
Precautionary Statements:
Hazards to Humans and
Domestic Animals immediately
following the PPE requirements
User Safety
Recommendations for all
Occupational Use Products
"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.)
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Environmental Hazards
"This pesticide is toxic to fish and aquatic invertebrates. Do not apply directly to water, or
to areas where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water when disposing of equipment washwater or rinsate. Drift
and runoff may be hazardous to aquatic organisms in water adjacent to treated areas."
Precautionary Statements
immediately following the User
Safety Recommendations
Restricted-Entry Interval for
products with directions for
use within the scope of the
Worker Protection Standard
for Agricultural Pesticides
(WPS)
"Do not enter or allow worker entry into treated areas during the restricted entry interval
(REI) of 12 hours.
Directions for Use Inside the
Agricultural Use Requirements
Box
Early Entry Personal
Protective Equipment for
products with directions for
use within the scope of the
WPS
"PPE required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, such as plants, soil,
or water, is:
* coveralls,
* shoes plus socks
* chemical-resistant gloves made of any waterproof material."
Directions for Use Inside the
Agricultural Use Requirements
Box
Entry Restrictions for
Granular Formulations with
direction for use only on
turfgrass (no other crops or
use-patterns)
"Except for those people involved in the watering-in, do not enter or allow other people (or
pets) to enter the treated area until dusts have settled and until the watering-in is complete
and the surface is dry.
If no WPS uses on the product,
place the appropriate statement
in the Directions for Use Under
General Precautions and
Restrictions If the product also
contains WPS uses (i.e.,
sodfarm uses), then create a
NonAgricultural Use
Requirements box as directed in
PR Notice 93-7 and place the
appropriate statement inside that
box.
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Entry Restrictions for
Granular Formulations with
nonWPS uses, but no
turfgrass uses
"Do not enter or allow other people (or pets) to enter the treated area until dusts have
settled."
If no WPS uses on the product,
place the appropriate statement
in the Directions for Use Under
General Precautions and
Restrictions If the product also
contains WPS uses, then create a
NonAgricultural Use
Requirements box as directed in
PR Notice 93-7 and place the
appropriate statement inside that
box.
Entry Restrictions for
Granular Formulations with
directions for use on turfgrass
and other nonWPS sites.
"Do not enter or allow other people (or pets) to enter the treated area until dusts have
settled. If watering in is required after the application - except for those people involved
in the watering-in - do not enter or allow other people (or pets) to enter the treated areas
until the watering-in is complete and the surface is dry."
If no WPS uses on the product,
place the appropriate statement
in the Directions for Use Under
General Precautions and
Restrictions. If the product also
contains WPS uses, then create a
NonAgricultural Use
Requirements box as directed in
PR Notice 93-7 and place the
appropriate statement inside that
box.
Entry Restrictions for Liquid
and Dry Flowable
Formulations with directions
for use outside the scope of
the WPS
"Do not enter or allow other people (or pets) to enter the treated areas until sprays have
dried."
If no WPS uses on the product,
place the appropriate statement
in the Directions for Use Under
General Precautions and
Restrictions If the product also
contains WPS uses, then create a
NonAgricultural Use
Requirements box as directed in
PR Notice 93-7 and place the
appropriate statement inside that
box.
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General Application
Restrictions for liquid or dry
flowable products
"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.
General Application
Restrictions for granular
products with directions for
use within the scope of the
WPS or for granular products
primarily intended for
occupational (professional)
use
"Do not apply this product in a way that will contact workers or other persons (or pets),
either directly or through drift. Only protected handlers may be in the area during
application."
Directions for Use under
General Precautions and
Restrictions
Application Restrictions for
products with directions for
use on food or feed crops
Other than the crops listed on this labeling, do not plant or transplant crops in the treated
area for at least 12 months following an application of this product.
Directions for Use under
General Precautions and
Restrictions
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Use-Specific Application
Restrictions
(Note: the maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds active ingredient per
acre.)
Alfalfa, Clover, Bird's Foot Trefoil
"Maximum of 1.5 pounds active ingredient per acre per application."
"Maximum of 1 application per year."
Lettuce
"Maximum of 1.5 pounds active ingredient per acre per application."
"Maximum of 1 application per year."
Field-Grown Ornamentals; Container-Grown Ornamentals; Non-bearing Berries,
Non-bearing Fruit Trees, Non-bearing Nut Trees, Non-bearing Vineyards
"Maximum of 3 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 6 pounds active ingredient per acre per year."
"Applications to plants that will bear fruits, berries, or nuts within 12 months are
prohibited."
Directions for Use Associated
with the Specific Use Pattern
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Use-Specific Application
Restrictions
(Note: the maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds active ingredient per
acre.)
Landscape Ornamentals
"Maximum of 2 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 4 pounds active ingredient per acre per year."
Ornamental Bulbs
>Fall Application, Coarse Soils
"Maximum of 0.75 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 1.5 pounds active ingredient per acre per year."
>Fall Application, Medium and Fine Soils
"Maximum of 1.5 pounds active ingredient per acre per application."
"Maximum of 2.25 pounds active ingredient per acre per year."
>February Through March Application, All Soils
"Maximum of 0.75 pounds active ingredient per acre per application."
"Maximum of 3 applications per year."
"Maximum of 2.25 pounds active ingredient per acre per year."
Christmas Trees
"Maximum of 2 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 4 pounds active ingredient per acre per year."
Directions for Use Associated
with the Specific Use Pattern
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Use-Specific Application
Restrictions
(Note: the maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds active ingredient per
acre.)
Turfgrass
"This product must be watered in as soon as possible after application. Watering-in must
be performed by the commercial applicator or the commercial applicator must provide the
following instructions to the resident or owner in writing:
> "This product must be watered in as soon as possible.
> "Do not enter or allow others (including children or pets) to enter the treated
areas (except those involved in the watering) until the watering-in is complete and
the surface is dry."
>Cool Season Turf
"Maximum of 3 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 6 pounds active ingredient per acre per year."
>Warm Season Turf
"Maximum of 1.5 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 3 pounds active ingredient per acre per year."
Noncropland Areas (Industrial Sites, Utility Substations, Highway Guardrails, Sign
Posts, and Delineators)
"Maximum of 2 pounds active ingredient per acre per application."
"Maximum of 2 applications per year."
"Maximum of 4 pounds active ingredient per acre per year."
Directions for Use Associated
with the Specific Use Pattern
75
-------
Spray Drift
"Apply with nozzle height no more than 2 feet above the ground. Use hooded sprayer to
direct spray toward the soil when wind speed is 10 mph or more at the application site. Use
standard nozzles and apply as a medium or coarser spray (according to ASAE standard
572)."
Directions for Use
Application Restrictions
"Do not apply this product in a way that will contact any person or pet, either directly or
through drift. Keep people and pets out of the area during application."
Directions for Use under
General Precautions and
Restrictions
Entry Restrictions
"Do not allow people or pets to enter the treated area until dusts have settled. If watering in
is required after the application - except for those people involved in the watering-in - do
not enter or allow other people (or pets) to enter the treated areas until the watering-in is
complete and the surface is dry."
Directions for use under General
Precautions and Restrictions
Environmental Hazards
"Do not apply directly to water. Do not contaminate water when disposing of equipment
washwaters or rinsate."
Precautionary Statements
immediately following the User
Safety Recommendations
76
-------
VL Appendicies
77
-------
Appendix A. Use Patterns Subject to Reregistration for Benfluralin (Case 2030)
78
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Benfluralin (Case 2030)
Site
Application Timing
Application Type
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Year
Maximum Yearly
Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations 1>2
Food/Feed Uses
Alfalfa
Pieplant
Soil incorporated
Ground
60% DF
[34704-746]
1 .5 Ib/A for fine soils
1 .2 Ib/A for coarse or
medium soils
1
Not specified (NS)
Not
applicable
(NA)
Applications may be made in 5-40 gallons of
water or liquid fertilizer per acre.
Application may be made alone or as a tank
mix with other pesticides. Application 3
weeks prior to planting is recommended.
Birdsfoot trefoil
Preplant
Soil incorporated
Ground
60% DF
[34704-746]
1 .5 Ib/A for fine soils
1 .2 Ib/A for coarse or
medium soils
1
NS
NA
See "Alfalfa."
Clover
Preplant
Soil incorporated
Ground
60% DF
[34704-746]
1 .5 Ib/A for fine soils
1 .2 Ib/A for coarse or
medium soils
1
NS
NA
See "Alfalfa."
Lettuce
Before seeding or
transplanting
Soil incorporated
Ground
60% DF
[34704-746]
1 .5 Ib/A for fine soils
1 .2 Ib/A for coarse or
medium soils
1
NS
NA
Applications may be made in 5-40 gallons of
water or liquid fertilizer per acre.
Application may be made alone or as a tank
mix with other pesticides.
Non-food/non-feed Uses
Non-bearing fruit and nut trees and non-bearing vineyards [including almond, apple, apricot, avocado, cherry (sweet and sour), fig, filbert, grape (American and
European), grapefruit, kiwi, kumquat, lemon, macadamia nut, nectarine, olive, orange, peach, pear, pecan, pistachio, plum, pomegranate, prune, and walnut (black and
English)]
79
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Benfluralin (Case 2030)
Site
Application Timing
Application Type
Application Equipment
Broadcast application
Ground
Formulation
[EPA Reg. No.]
1%G
[70506-45]
Maximum Single
Application Rate
(ai)
3.01b/A
Maximum
Number of
Applications Per
Year
2
Maximum Yearly
Rate
(ai)
6.0 Ib/A
Preharvest
Interval
(Days)
NA
Use Directions and Limitations 1>2
Use limited to nonbearing fruit and nut trees
and nonbearing vineyards comprised of
plants that will not bear fruit for at least one
year after treatment.
Nonbearing berries [including blackberry, blueberry, boysenberry, currant, dewberry, elderberry, gooseberry, loganberry, and raspberry]
Broadcast application
Ground
1%G
[70506-45]
3.01b/A
2
6.0 Ib/A
NA
Use limited to nonbearing berries comprised
of plants that will not bear berries for at least
one year after treatment.
Turf: golf course
Broadcast or spray
application
Low-pressure handwand,
backpack, handgun,
groundboom
Broadcast or spray
application
Push-type spreader,
belly grinder, tractor-drawn
spreader
60% DF
[62719-127]
0.92% G
[62719-146]
Cool season turf: 3 .0
Ib/A
Warm season turf:
1.51b/A
Cool season turf: 3 .0
Ib/A
2 per year
2 per year
Cool season turf:
6.0 Ib/A
Warm season turf:
3.0 Ib/A
Cool season turf:
6.0 Ib/A
NA
NA
Minimum retreatment interval 56 to 70 days
for cool season established turf, 70 to 84
days for warm season established turf.
Minimum retreatment interval 56 to 70 days
for cool season established turf, 70 to 84
days for warm season established turf.
80
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Benfluralin (Case 2030)
Site
Application Timing
Application Type
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Warm season turf:
1.51b/A
Maximum
Number of
Applications Per
Year
Maximum Yearly
Rate
(ai)
Warm season turf:
3.0 Ib/A
Preharvest
Interval
(Days)
Use Directions and Limitations 1>2
Turf: residential
Broadcast application
Push-type spreader,
bellygrinder
Broadcast application
Push-type spreader,
bellygrinder,
0.92% G
[62719-146]
0.82% G
[62719-327]
3.01b/A
2.0 Ib/A
2 per year
2 per year
6.0 Ib/A
6.0 Ib/A
NA
NA
Minimum retreatment interval 56 to 70 days
for cool season established turf, 70 to 84
days for warm season established turf.
Minimum retreatment interval 56 to 70 days
for cool season established turf, 70 to 84
days for warm season established turf.
Noncropland Areas (Industrial Sites, Utility Substations, Highway Guardrails, Sign Posts, and Delineators)
Broadcast application
Push-type spreader,
bellygrinder, tactor-drawn
spreader
1.0% G
[70506-45]
2.0 Ib/A
2 per year
4.0 Ib/A
NA
Minimum retreatment interval 2 to 8
months.
Christmas trees
Broadcast application
Push-type spreader,
belly grider, shaker can,
backpack granular
spreader, tractor-drawn
spreader
1.0% G
[70506-45]
2.0 Ib/A
2 per year
4.0 Ib/A
NA
Minimum retreatment interval 2 months.
Container and Field Grown Ornamentals
81
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Benfluralin (Case 2030)
Site
Application Timing
Application Type
Application Equipment
Broadcast application
Push-type spreader,
belly griner, shaker can,
backpack granular
spreader
Formulation
[EPA Reg. No.]
1,0% G
[70506-45]
Maximum Single
Application Rate
(ai)
3.01b/A
Maximum
Number of
Applications Per
Year
2 per year
Maximum Yearly
Rate
(ai)
6.0 Ib/A
Preharvest
Interval
(Days)
NA
Use Directions and Limitations 1>2
Minimum retreatment interval 2 to 4
months.
Ornamental Bulbs
Broadcast application
Push-type spreader,
belly griner, tractor-drawn
spreader
1.0% G
[70506-45]
Fall Application,
Coarse Soil; 0.75
Ib/A
Fall Application,
Medium and Fine
Soil;1.51b/A
February through
March Application,
All Soils; 0.75 Ib/A
2 per year
NS
3 per year
1.51b/A
2.25 Ib/A
2.25 Ib/A
NA
Minimum retreatment interval 2 to 4
months.
Landscape Ornamentals
Broadcast application
Push-type spreader,
belly griner, shaker can,
backpack granular
spreader
0.575% G
[70506-45]
2.0 Ib/A
2 per year
4.0 Ib/A
NA
Minimum retreatment interval 2 to 4
months.
'The restncted entry interval (RET) for the 60% DF formulation (EPA Reg. No. 34704-746) is 12 hours; the REI for the 1% G formulation (EPA Reg. No. 62719-136) is 24 hours.
2The following rotational crop restrictions are established for the 60% DF formulation (EPA Reg. No. 34704-746): wheat, barley, oats, rye, other grasses, onions, corn, milo (grain
sorghum), spinach, red beets, sugar beets, or other root crops should not be planted for 10 months following application of the 60% DF formulation in arid, irrigated areas of the Western
U.S. (AZ, CA, ID, MT, NV, OR, UT, WA, and WY).
82
-------
83
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Benfluralin
84
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Benfluralin
REQUIREMENT
Use Patterns
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.700
830.7050
830.7200
830.7220
830.7300
830.7370
830.7550
Old
Guideline
Number
61-1
6 1-2 A
61-2B
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-12
None
63-5
63-6
63-7
63-10
63-11
Product Identity and Composition
Description of materials used to
produce the product
Description of production process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated
temperatures, metals, and metal ions
PH
UV/Visable Absorption
Melting Point
Boiling Point
Density
Dissociation constants in water
Partition coefficient, shake flask
method
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
42039401, 42340801, 44258001
42039401, 42779101, 44258001
42039401,44258001
42039401,44258001
42340801, 43548701, 43548702, 44258002
42340801,44258001,
42340801, 43548702, 44258003, 44258004
00160844
00160844
00160844
42066201
N/A
Data gap
00160844
N/A
00160844
N/A
42039402
85
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Benfluralin
REQUIREMENT
830.7840
830.7950
63-8
63-9
Solubility
Vapor Pressure
Use Patterns
All
All
CITATION(S)
00160844
42785301
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1075
850.1075
850.1010
850.1010
850.1075
850.1025
850.1035
850.1300
850.1350
850.1400
850.1500
850.4100
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-4A
72-4B
72-4C
72-5
122-1A
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout - TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Fish Early Life Stage - Daphnid
Estuarine/Marine Invertebrate Life
Cycle
Freshwater Fish- Acute Toxicity
Life Cycle Fish
Terrestrial Plant Toxicity, Seedling
Emergence
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
160875, 24273, 160000
24635,234214
26954, 234214
42145502, Data gap
42145501
Data gap, 41613801, 145756, 257844, 26955, 234214
42390801
Data gap, 145756,257844
42419201
Data gap, 42390802, 257844, 00415757
42390802
Data gap, 41613802
Data gap, 4 161 3803
41613804
41613805,41613806
Data gap, 4 161 3806
41613805
Data gap
41613808
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Benfluralin
REQUIREMENT
850.5400
850.4225
850.4250
850.4400
850.3020
122-2
123-1A
123-1B
123-2
141-1
Aquatic Plant Growth
Seedling Germination and Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
Use Patterns
A,B
A,B
A,B
A,B
A,B
CITATION(S)
41613809, Data gap for Lemna gibba, Skeletonema costatum,
Anabaenaflos-aquae, and a freshwater diatom.
Corn, sorghum, onion, wheat, sunflower, cabbage, cotton,
cucumber, radish, soybean: 43599201
Data gap (TEP)
Corn, sorghum, onion, wheat, sunflower, cabbage, cotton,
cucumber, radish, soybean: 43599201
Data gap (TEP)
Data gap
41613812,00018842
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.3465
870.4100
870.3700
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
82-4
83-1B
83-3A
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day
Study Rodent
Subchronic Oral Toxicity: 90-Day
Study Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Chronic Feeding Toxicity - Non-
Rodent
Developmental Toxicity - Rat
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00024255, 243848,. 249554,. 257099,. 249185, 251206,
24255, 243848, 257847, 2456 1 1
41751701
41613807
00024265
41751702
00144283
44050001
43072301
43020201
Data gap
43628702
00147535
87
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Benfluralin
REQUIREMENT
870.3700
870.3800
870.4300
870.4200
870.5100
870.5375
870.7485
870.7600
83-3B
83-4
83-5
83-2B
84-2
84-2B
85-1
85-3
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity: Rats
Carcinogenicity Mice
Bacterial Reverse Gene Mutation
Cytogenetics
General Metabolism
Dermal Penetration and Absorption
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
42039101
43628701
44050002,44545501
Data gap, 4 102 1501
00160863
00160866
40693201, 40693207, 00132820
92062028
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2400
875.2500
133-3
133-4
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry
Exposure
A,B
A,B
45167201,
45250701
45250701
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.4300
835.1240
835.1410
835.6100
161-1
161-2
161-3
162-1
162-2
162-3
162-4
163-1
163-2
164-1
Hydrolysis
Photo degradation - Water
Photo degradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Laboratory Volatilization
Terrestrial Field Dissipation
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
257843
257843,41613814
41613815
41751703,257843
41751704
43106001
Data gap
41613816,41866201
43915701
Turf CA- 4 1778901
Lettuce CA, peanuts GA - 41778902
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Benfluralin
REQUIREMENT
None
165-4
Bioaccumulation in Fish
Use Patterns
A,B
CITATION(S)
40278401
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
860.1340
860.1380
860.1500
860.1500
860.1500
860.1500
860.1850
860.1900
171-4A
171-4B
171-4C
171-4E
171-4K
171-4K
171-4K
171-4K
165-1
165-2
Directions for Use
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Storage Stability - Plants
Crop Field Trials (Leafy Vegetables)
Crop Field Trials (Alfalfa, forage and
hay)
Crop Field Trials (Clover, forage and
hay)
Crop Field Trials (Trefoil, forage and
hay)
Confined Accumulation in 1 Rotational
Crops
Field Accumulation in Rotational Crop
Study
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Data Gap
Lettuce - 42338501, 43039901, 43624501
Alfalfa - 42370101, 42409801
Peanut -43064801
Ruminant -42 128201
Poultry - 42204801, 42854601
Data gap, 00024254, 00024258, 00024496, 00124776
43831901,43831902
43831902
43831901
43831901
43831901
Data gap, 440 19801
Reserved., Data Gap for trifluoroacetic acid
OTHER
840.1100
840.1200
201-1
202-1
Droplet Size Spectrum
Drift Field Deposition Evaluation
A,B
A,B
Reserved
Reserved
89
-------
06
-------
Appendix C. Technical Support Documents
91
-------
Appendix C. TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119,
Crystal Mall #2, 1801 South Bell Street, Arlington, VA. It is open Monday through Friday, excluding legal
holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of August 10, 1998.
Sixty days later the first public comment period closed. The EPA then considered comments, revised the risk
assessment, and added the formal "Response to Comments" document and the revised risk assessment to the
docket on June 16, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the
Internet at the following site:
www. epa. gov/pesticides/r eregistration
These documents include:
HED Documents:
1. Benfluralin: Human Health Risk Assessment (Revised) 30-Oct-2003.
2. Benfluralin: Residue Chemistry Chapter for the Reregistration Eligibility Decision. 28-May-
2003.
3. Benfluralin. Case 2030. PC Code 084301. Product Chemistry Chapter for the Reregistration
Eligibility Decision Document. 27-Mar-2003.
4. Third Report of the Hazard Identification Assessment Review Committee 03-Apr-2003.
5. Second Report of the Hazard Identification Assessment Review Committee 27-Jan-2003.
6. Report of the Hazard Identification Assessment Review Committee 10-Apr-2001.
7. Benfluralin: Health Effects Decision (HED) Metabolism Assessment Review Committee
(MARC) Decision Document 29-Apr-2003.
8. Benflluralin: Confined Rotational Crop Data on Lettuce, Mustard, Radishes, and Wheat. 20-
Mar-2003.
9. Drinking Water Estimates for Benfluralin - PRZM/EXAMS data 12-Oct-2002.
10. Second Addendum to Drinking Water Estimates for Benfluralin: Non Bearing Vineyards, Fruit,
Trees, Nut Trees, and Berries 25-Apr-2003.
11. Drinking Water Estimates for Benfluralin 31 -Jan-2003.
12. Benfluralin: Health Effects Division Response to Corrections and Comments Submitted by Dow
AgroSciences for the Phase One Human Health Risk Assessment 30-Oct-2003.
13. Evaluation of Carcinogenic Potential of Benfluralin 27-Dec-2003.
14. Benfluralin: HED Response to Comments Submitted by the Registrant (Dow Agrosciences)
on April 26, 2004. 08-June-2004.
EFED Documents:
1. "Response to Dow AgroSciences' Comments on EFED RED Chapter for Benfluralin,"
(including as an attachment, the Environmental Fate and Effects Risk Assessment), dated June 4,
2004.
2. Benfluralin: Environmental Fate and Ecological Effects Risk Assessment 22-Oct-2003.
92
-------
3. Benfluralin: EFED 's Response to 3 0-Day Error Comment 22-Oct-2003.
4. Dissipation of 14-C Benefm in Soils Maintained Under Aerobic Conditions, D.F. Berard, ABC-
0289, Lilly Research Laboratories, March 1985 Guideline Number: 162-1 28-Jul-2003.
5. Anaerobic Metabolism of 14-C Benefin on Sandy Loam Soil Guideline Number: 162-2 28-Jul-
2003.
6. Aerobic Metabolism of 14-C Benefin on Sandy Loam Soil Guideline Number: 162-1 28-Jul-
2003.
7. Field Dissipation of Benefin Following Application of Balan to Bare Soil and Seeded with
Lettuce or Peanuts, O.D. Decker, DowElanco 28-Jul-2003.
8. Field Dissipation of Benefin Following One or Two Applications to Turf 28-Jul-2003.
9. DER Addenda for the Benfluralin Reregistration Eligibility Document.28-Jul-2003.
10. Response to Dow AgroSciences' Phase 3 Comments on EFED RED Chapter for Benfluralin
04-June-2004.
11. Revised Benfluralin Environmental Fate and Ecological Effects Risk Assessment 04-June-
2004.
Other Documents:
1. Quantitative Usage Analysis for Benfluralin 14-May-2002.
93
-------
Appendk D. Citations Considered to Be Part of the Data Base Supporting the Reregistration Decision
(Bibliography)
94
-------
Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE
INTERIM REREGISTRATION DECISION (BIBLIOGRAPHY)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant
by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility
Document. Primary sources for studies in this bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory decisions. Selections from other sources including
the published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published
materials, this corresponds closely to an article. In the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a level parallel to the published article from within
the typically larger volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be described with a
conventional bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master
Record Identifier, or "MRID" number. This number is unique to the citation, and should be used whenever a
specific reference is required. It is not related to the six-digit "Accession Number" which has been used to
identify volumes of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to be used
whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of material submitted to EPA, by a description of the
earliest known submission. Bibliographic conventions used reflect the standard of the American National
Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal
author. When no individual was identified, the Agency has shown an identifiable laboratory or testing
facility as the author. When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
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."
95
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(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
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Benfluralin Bibliography
Acree, W.E., Jr. Thermochim. Acta, 1991, 37.
Balcomb, R. C.A. Bowen II, D. Wright, and M. Law. 1984 Effects on Wildlife of at-planting corn applications
of granular carbofuran.
Belfroid, A., M. Sikkenk, W. Seinen, K.V. Gestel, J. Hermens. 1994. The toxicokinetic behavior of
chlorobenzenes in earthworm (Eisenia andrei) experiments in soil. Environ. Toxicol. Chem. 13: 93-99
Beyer, W.N., E.E. Connor, S. Gerould. 1994. Estimates of soil ingestion by wildlife. J.Wildl. Manage. 58: 375-
382.
Carmo, A.M., Hundal. L.S., and Thompson, M.L., "Sorption of Hydrophobic Organic Compounds by Soil
Materials: Application of Unit Equivalent Freundlich Coefficients," Environmental Science & Technology,
2000, 34, 4363-4369.
Degradates Identified in Benfluralin Fate Studies, Memorandum to file, WP Eckel, Jan. 22, 2003.
Determination of Benefm in Agricultural Crops and Soil, OD Decker and RD Griggs, Lilly Research
Laboratories, 1980. EPA Ace. No. 255775.
Dissipation of 14C Benefin in Soils Maintained Under Aerobic Conditions, DF Berard, 1985. Lilly Research
Laboratories, Greenfield, IN. Report No. ABC-0289. EPA Ace. No. 257843.
Drinking Water Estimates for Benfluralin (PC# 084301), Jan. 31, 2003 memorandum from WP Eckel, EFED to
M. Rice, SRRD. DP Barcode 288082
Dunning, J.B. 1984. Body Weights of 686 Species of North American Birds. Monograph Number 1. Western
Bird Banding Association.
Farm Chemicals Handbook, vol. 86, 2000. Meister Publishing Company, Willoughby, OH. Page C47, Benefin.
Fisher, D.L. and L.B. Best. 1995. Avian Consumption of Blank Pesticide Granules Applied at Planting to Iowa
Cornfields. Environ. Tox. Chem. 14:1543-1549.
Hansch, C., A Leo, D Hoekman, Exploring QSAR - Hydrophobic, Electronic, and Steric Constants.
Washington, DC: American Chemical Society, 1995.
Mackay, D. And S. Paterson. 1981. Calculating fugacity. Environ. Sci. Technol. 15:1006-1014.
The Merck Index, 10th Ed., M. Windholz, ed., 1983. Merck & Co., Inc., Rahway, NJ. Monograph 1038:
Benfluralin.
Nagy, K.A. 1987. Field metabolic rate and food requirement scaling in mammals and birds. Ecol. Monogr. 57:
111-128.
Processes of Retention and Loss of Benefin in Soil, BJ Simoneaux, 1969. Ph.D. dissertation, Auburn
University, Auburn, Alabama.
97
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Benfluralin Bibliography
Schwarzenbach, RP, Gschwend, PM, and Imboden, DM, Environmental Organic Chemistry, John Wiley &
Sons, New York, 1993.
Soil Degradation of Three Dinitroanilines, RL Zimdahl and SM Gwynn, 1977. Weed Science, vol. 25, no. 3, pp.
247-251.
Tomlm, CDS (ed.) The Pesticide Manual- World Compendium 10th ed. Surrey, UK: The British Crop Protection
Council, 1994.
Trapp, S. And J.C McFarlane (eds.). 1995. Plant Contamination Modeling and Simulation of Organic Chemical
Processes. Lewis Publishers. Boca Raton, Florida.
United States Environmental Protection Agency (EPA). 1993. Wildlife Exposure Factors Handbook.
EPA/600/9-93/187a. Office of Research and Development. Washington, DC.
Upgrading Benfluralin Photolysis Studies, July 9, 2002 memorandum from I. Kennedy, EFED to R. Kendall,
SRRD
Wauchope RD et al., Rev Environ Contam Toxicol 123: 1-155 (1992)
Weed Science Society of America. Herbicide Handbook, 5th ed. Champaign, IL., 1983.
Woodrow, JE, Crosby, DGand Seiber, JN, "Vapor-Phase Photochemistry of Pesticides," Res. Rev., 85, 111
(1983).
Product Chemistry MRID References
00160844 West, S.; Casell, R. (1985) Physical and Chemical Properties of Technical Benefm:
EWD8514. Unpublished study prepared by Lilly Research Laboratories. 7 p.
42039401 Handy, P.; Reinhart, R. (1991) Product Composition of Technical Benefm: Lab Project
Number: PRH9103. Unpublished study prepared by DowElanco. 20p.
42039402 Day, E.; Saunders, D.; Loh, A. (1983) Octanol/Water Partition Coefficient of Benefm: Lab
Project Number: IOEWD-93-29. Unpublished study prepared by Lilly Research Labs. 9 p.
42066201 Handy, P. (1991) Stability of Technical Benefin to Metals and Metal Ions: Lab Project
Number: FOR91062. Unpublished study prepared by DowElanco, Formulation and Environ.
Chem. Lab. 13 p.
42340801 DowElanco (1992) Analysis and Certification of Benefin Technical Grade Active Ingredient
(T2A CHEPHY US 89-139). 20 p.
42779101 Linscott, D. (1993) Techinical Benefin-Beginning materials Specification Sheets: Lab Project
Number: DJL040793. Unpublished study prepared by Lilly Research Labs. 13 p.
43 548701 Hamilton, T. (1995) Series 62-1: Preliminary Analysis of Product Sample of Benefin
Technical for Nitrosamines: Lab Project Number: FOR93097. Unpublished study prepared by
DowElanco. 22 p.
98
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Benfluralin Bibliography
43 548702 Hamilton, T. (1995) Validation of an Analytical Method for the Determination of N-Nitroso
Compounds in Benefin Technical Grade Active Ingredient: Lab Project Number:
FOR93120.01. Unpublished study prepared by DowElanco. 35 p.
44258001 Linscott, D.; Owen, I; Cook, I (1997) Series 61: Product Identity and Compostion f Balan
Technical: Lab Project Number: GH-C 4268. Unpublished study prepared by DowElanco.
123 p. (Relates to L0000159).
44258002 Hanselman, D.; Yeh, L. (1997) Preliminary Analysis of Product Samples for Active Ingredient
and Impurities in Technical Grade Benefin: (Final Report): Lab Project Number: FOR96137.
Unpublished study prepared by DowElanco. 77 p.
44258003 Hanselman, D.; Yeh, L. (1997) Analytical Method and Validation for the Determination of
Benefin in Benefin Technical by Gas Chromatography with Flame lonization Detection: Lab
Project Number: NA-AM-96-006. Unpublished study prepared by DowElanco. 22 p.
44258004 Hanselman, D. (1997) Analytical Method and Validation for the Determination of Process
Impurities in Benefin Technical by Gas Chromatography with Flame lonization Detection:
Lab Project Number: NA-AM-96-007. Unpublished study prepared by DowElanco. 81 p.
(Relates to L0000159).
Occupational and Residential MRID References
00024255 Worth, H.M.; Anderson, R.C., eds. (1965) Toxicological Studies with N-Butyl-N-
ethyl-alpha,alpha,alpha-trifluoro-2,6-dinitro-?~p~?- toluidine, Benefin. (Unpublished
study received Jul 16, 1965 under 1471-55; submitted by Elanco Products Co., Div. of
Eh Lilly and Co., Indianapolis, Ind.; CDL:006278-A)
00024265 Arthur, B.H.; Broddle, W.D.; Gibson, W.R; et al. (1976) Acute Tox- icity Studies of
Benefin Technical: Supplement. (Unpublished study received Nov 4, 1976 under
1471-55; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:226802-A)
00024275 Worth, H.M. (1964) ?Toxicity Studies on Mice, Dogs, Rats and Rab- bits).
(Unpublished study received Oct 1, 1965 under 1471-50; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:006275-C)
00132820 Bridge, T.; van Lier, R; Adams, E.; et al. (1982) Percutaneous Absorption of 14C-
Ethalfluralin (EL-161, Compound 94961) in Monkeys: Studies M-6162 and P03282.
(Unpublished study received Dec 2, 1983 under 4F3006; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:072180-B)
00144283 Mattmgly, C. (1984) A Guinea Pig Sensitization Study of Benefin, Compound 54521:
Study G01183. Unpublished study prepared by Lilly Research Laboratories. 46 p.
00147535 MacKenzie, K. (1985) Rat Teratology Study with Benefin: Study No. 6180-101.
Unpublished study prepared by Hazleton Laboratories America, Inc. 141 p.
00160863 Rexroat, M. (1985) The Effect of Benefin (EL-110, Compound 54521) on the
Induction of Reverse Mutations in Salmonella typhimurium Using the Ames Test:
Studies 850624AMS2598 and 850708AMS2598. Unpublished study prepared by
Lilly Research Laboratories. 36 p.
99
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Benfluralin Bibliography
00160866 Bewsey, B. (1985) The Effect of Benefm (EL-110, Compound 54521) on the
Induction of Forward Mutation at the Thymidine Kinase Locus of L5178Y Mouse
Lymphoma Cells: Studies 850612MLA2598 and 850724MLA2598. Unpublished
study prepared by Lilly Research Laboratories. 42 p.
40693201 Berard, D. (1988) Characterization and Identification of Radio- activity in Urine and
Feces of Rats Dosed with ?Carbon 14| Bene- fin: Project ID. ABC-0389.
Unpublished study prepared by Lilly Research Laboratories. 48 p.
40693207 Koenig, G.; Pohland, R (1988) An Overview of Radiocarbon Disposi- tion Studies
Conducted in Male and Female Fischer 344 Rats Given ?Carbon 14|-Benefin ...:
Project ID'S. R06087, R16687, R09887, R23887, R09987, R03588. Unpublished
study prepared by Lilly Research Laboratories. 19 p.
41021501 Koenig, G; Jordan, W. (1988) A Chronic Toxicity and Oncogenicity Study in B6C3F,
Mice Given Benefm (EL-110, Compound 54521) in the Diet for Two Years:
Laboratory Project ID M02785: M02885. Unpublished study prepared by Lilly
Research Laboratories. 1178 p.
41613807 Koenig, G; Allen, D.; Wolff, R. (1989) The Acute Inhalation Toxi- city of Technical
Benefm (EL-110, Compound 05421) in Fischer 344 Rat: Lab Project Number: R-H-
048-85. Unpublished study pre- pared by Lilly Research Laboratories. 37 p.
41751701 Koenig, G; Rock, G; Laska, D.; et al. (1990) The Acute Dermal Toxicity of Benefm
(El-110, Compound 054521) in New Zealand White Rabbits: Lab Project Number:
B04990. Unpublished study prepared by Lilly Research Laboratories. 28 p.
41751702 Koenig, G; Rock, G; Laska, D.; et al. (1990) The Primary Dermal Irritation of
Benefm (El-110, Compound 054521) in New Zealand White Rabbits: Lab Project
Number: B09690. Unpublished study prepared by Lilly Research Laboratories. 25 p.
42039101 Mercieca, M. (1991) Teratology Study in Rabbits with Benefm: Final Report: Lab
Project Number. Unpublished study prepared by Springborn Labs, Inc. 265 p.
43020201 McGuirk, R; Stebbins, K. (1993) Benefin: Probe and 21-Day Repeated Dose Dermal
Toxicity Study in New Zealand White Rabbits: Lab Project Number: DR-0097-3397-
002. Unpublished study prepared by The Dow Chemical Co. 198 p.
43072301 Dalgard, D. (1993) Benefin: 13-Week Oral Toxicity Study in Beagle Dogs: Lab
Project Number: HWA 174-135: DR-0097-3397-003. Unpublished study prepared by
Hazleton Washington, Inc. 273 p.
43628701 Trutter, J. (1995) Two-Generation Reproduction Study in Rats with Benefin: Final
Report: Lab Project Number: HWA 174-136. Unpublished study prepared by
Hazleton Washington, Inc. 1788 p.
43628702 Walker, M. (1995) Benefin: One-Year Oral Chronic Toxicity Study in Beagle Dogs:
Final Report: Lab Project Number: CHV 174-143: DR-0097-3397-004. Unpublished
study prepared by Corning Hazleton Inc. 381 p.
100
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Benfluralin Bibliography
44050001 Adams, E.; Jordan, W. (1996) Subchronic Toxicity Studies of Benefm (Compound
054521) Administered Orally in the Diet to Fischer 344 Rats for 3 Months: Lab
Project Number: R33989: R44089: R29990. Unpublished study prepared by Lilly
Research Labs. 702 p.
44050002 Moore, M. (1996) Benefm: Two-Year Dietary Chronic Toxicity/Oncogenicity Study
in Fischer 344 Rats: Final Report: Lab Project Number: CHV 174-133: DR-0097-
3397-005. Unpublished study prepared by Corning Hazleton Inc. 3247 p.
44545501 Moore, M. (1998) Benefm: Two-Year Dietary Chronic Toxicity/Oncogenicity Study
in Fischer 344 Rats: Final Report: Lab Project Number: CHV 174-133: DR-0097-
3397-005. Unpublished study prepared by Covance Labs., Inc. 111 p.
45167201 Urtizberea, M. (1999) Worker Exposure Study During Application in Banana
Plantation with Temik 10G: Lab Project Number: SA 98337: RPS/ALD/98072.
Unpublished study prepared by ADME Bioanalyses. 156 p. (OPPTS 875.1000}
45250701 Leffingwell, J. (1986) An Exposure Study of Mixer/Loader-Applicators Working with
MOCAPEC. Unpublished study. 140 p. {OPPTS 875.1000}
45250702 Pontal, P. (1996) Fipronil: Worker Exposure Study During Application of Regent
20GR in Banana Plantation: Lab Project Number: 338/95/0072: 94/136: 94002 HI.
Unpublished study prepared by Rhone-Poulenc Agrochemie. 196 p. {OPPTS
875.1000}
46082401 Tiu, C.; Hanley, T. (2003) Dow AgroSciences Response to the U. S. EPA's
Benfluralin: Human Risk Assessment. Project Number: KSG092603. Unpublished
study prepared by Dow AgroSciences LLC. 15 p.
92062028 Environ Corp. (1990) Dowelanco Phase 3 Summary of MRID 00132820.
Percutaneous Absorption of (Carbon-14) - Ethalfluralin in Monkeys: M-6162 and
P03282. Prepared by LILLY RESEARCH LABS. 7 p.
Environmental Fate MRID References
00148874 Hydrolysis of the Herbicide Benefin in Aqueous Buffer Solution, DG Sanders, SK Smith, and
JW Mosier, 1985. Lilly Research Laboratories, Greenfield, IN. EPA Ace. No. 257843.
40287401 Laboratory Studies of 14C Benefin Accumulation in Fish, JD Magnussen and DP Rainey,
1987. Lilly Research Laboratories, Greenfield, IN.
40457201 Moran, J.; Saunders, D. (1986) Photolysis of Benefin in Aqueous Solution: Laboratory Project
ID.: AAC8518. Unpublished study prepared by Lilly Research Laboratories. 44 p.
41613814 Determination of photolysis rate of 14C-Benefm in aqueous solution, M Carpenter, and M
Fennesey, 1988. Analytical Bio-Chemistry Laboratories, Columbia, MO. Second amended
report No. 36866.
41613815 Determination of the Photolysis rate of Benefin on the surface of soil, J Dykes, 1989.
Analytical Bio-Chemistry laboratories, Columbia, MO. Amended final report No. 36867.
101
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Benfluralin Bibliography
41613816 Adsorption and Desorption of Benefin on Soil, DG Saunders and FL Powers, 1987. Eli Lilly,
Greenfield, IN. Project ID No. EWD8724.
41751703 Aerobic metabolism of 14C Benefin on Sandy loam Soil, LK Graper, 1991. DowElanco,
Greenfield, IN.
41751704 Anaerobic metabolism of 14C Benefin on Sandy Loam Soil, LK Graper, 1991. DowElanco,
Greenfield, IN.
41778901 Field Dissipation of Benefin Following One or Two Applications of Balan to Turf, OD
Decker, 1991. DowElanco, Greenfield, IN.
41778902 Field Dissipation of Benefin Following Application of Balan to Bare Soil and Seeded with
Lettuce or Peanuts, OD Decker, 1991. DowElanco, Greenfield, IN.
41866201 Benefin Aged Soil Leaching Study, DG Saunders and FL Powers, 1991. DowElanco,
Greenfiled, IN. Project ID No. AAC908.
43106001 Anaerobic Aquatic Metabolism of 14C Benefin, BL Lawrence, A Kesterson and RH Atkins,
1994. PTRL East, Richmond, KY. Laboratory project Nos. 651, 1540.
43374901 Supplemental Report for MRID 41778902 Titled "BenefinTerrestrial Lettuce and Peanut Field
Dissipation Studies" and MRID 41778901 Titled "Benefin Terrestrial Turf Dissipation Study,
OD Decker, 1994, DowElanco Indianapolis, IN.
43915701 Laboratory Volatility of [14C]-Trifluralin formulated as an emulsifiable concentrate and as
Granules, W Skinner, 1996. PTRL West, Richmond, CA. Laboratory project ID No. 552W.
Submitted by DowElanco, Indianapolis, IN.
470208027 Photolysis of Benefin in Aqueous Solution, JW Moran and DG Saunders, 1985. Lilly
Research Laboratories, Greenfield, IN. Laboratory report No. AAC8518. EPA Ace. No.
257843.
Ecological Effects MRID References
00018842 Study Record Deleted. Study Is a Duplicate of MRID 9181.
00024273 Broddle, W.D.; Kehr, C.C.; West, H.C.; et al. (1973) The Safety of BalanA(R)I to the Mallard
and Quail. (Unpublished study re- ceived Dec 3, 1973 under 6735-201; prepared by Elanco
Products Co., Div. of Eli Lilly and Co., submitted by Tide Products, Inc., Edinburg, Tex.;
CDL:010110-A)
00024635 West, H.C.; Hamelink, J.L.; Broddle, W.D.; et al. (1978) The Toxic- ity of Compound 54521
(Benefin) in Bobwhites (?~Colinus Vir~?- ?~ginianus~?) Eight Day Dietary Study: Study No.
7008-77. (Un- published study received Jun 29, 1978 under 1471-71; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:kd-A)
00026954 West, H.C.; Hamelink, J.L.; Broddle, W.D.; et al. (1978) The Toxic- ity of Compound 54521
(Benefin) in Mallards (?~Anas Platy-?- ?~rhynchos~?) Eight Day Dietary Study: Study No.
7011-77. (Un- published study received Jun 29, 1978 under 1471-71; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:234214-B)
102
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Benfluralin Bibliography
00026955 Kehr, C.C.; West, H.C.; Hamelink, J.L.; et al. (1978) The Toxicity of Benefm in Bluegills
(?~Lepomis Macrochirus-?): A Twenty- Eight Day Continuous Flow-Through Study: Study
No. 2057-77. (Unpublished study received Jun 29, 1978 under 1471-71; submit- ted by Blanco
Products Co., Div. of Eli Lilly and Co., Indiana- polls, Ind; CDL:234214-C)
00094769 Hamelink, J.L.; Kehr, C.C.; Adams, E.R.; et al. (1978) The Toxicity of Compound 94961
(El-161) to Bluegills in a 96 Hour Soil-water Static Test: Study No. 2111-78. Includes
procedure no. 5801633 dated Sep 24, 1976. (Unpublished study received Feb 4, 1982 under
1471-122; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:070677-N)
00094770 Karnak, R.E.; Kehr, C.C.; Hamelink, T.L.; et al. (1980) The Toxic- ity of Compound 94961
(Ethalfluralin) to~Daphnia magna~in a 48- hour Static Study: Study No. 5044-78. Includes
procedure no. 5801633 dated Sep 24, 1976. (Unpublished study received Feb 4, 1982 under
1471-122; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:070677-O)
00135183 Sleight, B. (1973) Acute Toxicity of 94961 to Bluegill..., Rainbow Trout..., and Goldfish
(Carassius auratus). (Unpublished study received Aug 24, 1978 under 1471-EX-63; prepared
by Bionomics, Inc., submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
IN; CDL:097325-F)
00145756 Hamelink, J. (1985) The Acute Toxicity of Benefm (EL-110, Compound 54521) to Rainbow
Trout (Salmo gairdneri) in a Static-renewal Test System: Study F00185. Unpublished study
prepared by Eli Lilly and Co. 38 p.
00160000 Hudson, R; Tucker, R; Haegele, M. (1984) Handbook of toxicity of pesticides to wildlife:
Second edition. US Fish and Wildlife Service: Resource Publication 153. 91 p.
00160875 Seacat, I; Cochrane, R. (1985) The Toxicity of Benefm (Compound 54521) to Bobwhite in a
Fourteen-day Acute Oral Study: Study A01085. Unpublished study prepared by Lilly Research
Laborato- ries. 27 p.
00234214 West, H.C.; Hamelink, J.L.; Broddle, W.D.; et al. (1978) The Toxic- ity of Compound 54521
(Benefin) in Bobwhites (?~Colinus Vir~?- ?~ginianus~?) Eight Day Dietary Study: Study No.
7008-77. (Un- published study received Jun 29, 1978 under 1471-71; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:234214-A)
West, H.C.; Hamelink, J.L.; Broddle, W.D.; et al. (1978) The Toxic- ity of Compound 54521
(Benefin) in Mallards (?~Anas Platy-?- ?~rhynchos~?) Eight Day Dietary Study: Study No.
7011-77. (Un- published study received Jun 29, 1978 under 1471-71; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:234214-B)
Kehr, C.C.; West, H.C.; Hamelink, J.L.; et al. (1978) The Toxicity of Benefm in Bluegills
(?~Lepomis Macrochirus-?): A Twenty- Eight Day Continuous Flow-Through Study: Study
No. 2057-77. (Unpublished study received Jun 29, 1978 under 1471-71; submit- ted by Elanco
Products Co., Div. of Eli Lilly and Co., Indiana- polls, Ind.; CDL:234214-C)
103
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Benfluralin Bibliography
00243848 Dean, W.P.; Myer, J.R.; Olafsson, A.; et al. (1980) Acute Oral Toxicity (LDI50A) Study in
Rats (FIFRA): IRDC No. 446-005. (Un- published study received Dec 4, 1980 under 9198-56;
prepared by International Research and Development Corp., submitted by Anderson Lawn
Fertilizer, Div. of Free Flow Fertilizer Co., Maumee, Ohio; CDL:243848-A)
Dean, W.P.; Rajasekaran, D.; Myer, J.R; et al. (1980) Acute Dermal Toxicity (LDI50A) Study
in Rabbits (FIFRA): IRDC No. 446-003. (Unpublished study received Dec 4, 1980 under
9198-56; prepared by International Research and Development Corp., submitted by Anderson
Lawn Fertilizer, Div. of Free Flow Fertilizer Co., Maumee, Ohio; CDL:243848-B)
104
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Benfluralin Bibliography
00243 848 Ralston Purina Company (1980) Turf Care Balan Concentrate-25: RT Lab No. 5 84711.
(Compilation; unpublished study received Oct 28, 1980 under 9198-56; submitted by
Anderson Lawn Fertil- izer, Div. of Free Flow Fertilizer Co., Maumee, Ohio; CDL: 243848-C)
00245611 Koenig, G.R.; Ansley, A.D.; Gomez, S.R.; et al. (1981) The Acute Oral, Dermal, Ocular and
Inhalation Toxicity Testing of Balan EC, an Emulsifiable Concentrate Formulation (AT-0270)
Containing Benefm, LotX-29293: Study Nos. R-O-287-79; R-O-288-79; B-D-84- 79; B-E-
85-79; R-H-46-79. (Unpublished study received Jul 22, 1981 under 1471-55; submitted by
Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:245611-A)
00249185 Ansley, A.; Koenig, G.; Arthur, B.; et al. (1982) The Acute Oral, Dermal, and Ocular Toxicity
Testing of Balan Dry Flowable, a Granular Formulation (FN-3045) Containing Benefin:
Studies R-0- 21-82; B-D-25-82; B-E-28-82. (Unpublished study received Dec 16, 1982 under
1471-138; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:249185-B)
Decker, O. (1982) Benefin Residues in Peanuts and Lettuce following Application of Balan 60
DF for Weed Control: I-ODD-82-08. (Un- published study received Dec 16, 1982 under 1471-
138; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:249185-A)
00249554 Ansley, A.; Quarles, I; Gomez, S. (1982) The Acute Oral, Dermal, Ocular and Inhalation
Toxicity Testing of Balan LC, a Liquid Concentrate Formulation (FN-5014) Containing 1.5
Lbs/Gal Com- pound 54521 (Benefm): Studies R-0-133-82, B-D-91-82, B-E-93-82, and R-H-
56-82. (Unpublished study received Feb 17, 1983 under 1471-114; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:249554-A) MRID 125865
00251206 Negilski, Q.; Quarles, !; Gomez, S.; et al. (1983) The Acute Oral, Dermal, Ocular and
Inhalation Toxicity of an Aqueous Suspension Formulation (FN-7035) Containing Benefin at a
Concentration of 1.5 Pounds per Gallon: Studies R-O-101-83, B-D-92-83, B-E-99-83 and R-
H-53-83. Final rept. (Unpublished study received Sep 9, 1983 under 10404-46; prepared by
Lilly Research Laboratories, submitted by Lakeshore Equipment & Supply Co., Elyria, OH;
CDL: CDL:251206-A)
00257099 Negilski, D.; Bridge, T.; Markey, T. (1985) The Acute Oral, Dermal, Ocular, and Inhalation
Toxicity Assessment of a Granular Formu- lation (FN-9023) Containing Benefin at a
Concentration of 2.0% on Fertilizer. Unpublished study prepared by Eli Lilly & Co. 37 p.
00257843 Saunders, D. (1985) Hydrolysis of the Herbicide Benefin in Aqueous Buffer Solution:
EWD8447. Unpublished study prepared by Lilly Research Labs. 7 p.
Berard, D. (1985) Dissipation of [Carbon-14] Benefin in Soils Maintained under Aerobic
Conditions: ABC-0289. Unpublished study prepared by Lilly Research Labs. 26 p.
Berard, D. (1985) Dissipation of [Carbon-14] Oryzalin in Soils Maintained under Aerobic
Conditions: ABC-0290. Unpublished study prepared by Lilly Research Labs. 28 p.
00257844 Hamelink, J. (1985) The Acute Toxicity of Benefm (EL-110, Compound 54521) to Rainbow
Trout (Salmo gairdneri) in a Static-renewal Test System: Study F00185. Unpublished study
prepared by Eli Lilly and Co. 38 p.
Francis, P.; Grothe, D. (1985) The Acute Toxicity of Benefin (El- 110, Compound 54521) to
Daphnia magna in a Static-renewal Test System: Study COO 185. Unpublished study prepared
by Eh Lilly and Co. 37 p.
00257847 Sabol, E. (1985) Rat Acute Inhalation Toxicity [of Benefm]: Pro- ject No. 3606-85.
Unpublished study prepared by Stillmeadow, Inc. 15 p.
105
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Benfluralin Bibliography
00249554 Ansley, A.; Quarles, I; Gomez, S. (1982) The Acute Oral, Dermal, Ocular and Inhalation
Toxicity Testing of Balan LC, a Liquid Concentrate Formulation (FN-5014) Containing 1.5
Lbs/Gal Com- pound 54521 (Benefm): Studies R-0-133-82, B-D-91-82, B-E-93-82, and R-H-
56-82. (Unpublished study received Feb 17, 1983 under 1471-114; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:249554-A) MRID 125865
00415757 Miles Inc. (1990) Submission of Data To Support Registration of Cutter Insect Repellent -
Tick Repellent - Formula MMII: Product Chemistry and Toxicology Studies. Transmittal of 3
studies. 41575701 Spagnoli, J. (1990) Product Chemistry for Cutter Insect Repellent- Tick
Repellent Foprmula MMH Unpublished study prepared by Miles Inc. 18 p.
Kowalski, R; Hartangel, R (1990) Ocular Irritation of Cutter Tick Repellent Aerosol CTR-
002 in the Rabbit: Lab Project Number: MTD0164. Unpublished study prepared by Miles Inc.
23 p.
Kowalski, R.; Hartnagel, R. (1990) Dermal Irritation of Cutter Tick Repellent Concentrate
CTR-002 in the Rabbit: Lab Project Number: MTD0146. Unpublished study prepared by
Miles Inc. 20 p.
05008271 Macek, K.J.; Lmdberg, M.A.; Sauter, S.; Buxton, K.S.; Costa, P.A (1976) Toxicity of Four
Pesticides to Water Fleas and Fathead Minnows. Duluth, Minn.: U.S. Environmental
Protection Agency, Environmental Research Laboratory. (EPA report no. EPA-600/3-76-099;
available from: NTIS, Springfield, VA; PB-262 912)
40278401 Magnussen, J.; Rainey, D. (1987) Laboratory Studies of [Carbon 14] Benefm Accumulation in
Fish: Laboratory Project Identification ABC-0362, ABC-0365. Unpublished study prepared by
Lilly Research Laboratories. 53 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to Fish and Aquatic
Invertebrates: Resource Publi- cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter- pretation and Data Base for
410 Chemicals and 66 Species of Freshwater Animals. US Fish & Wildlife Service, Resource
Pub-lication 160. 579 p.
41386202 Adams, E.; Cocke, P. and Gunnoe, M. (1990) The Toxicity of Tnflu- ralm to Rainbow Trout
(Salmo gairdneri) in a 48-Day Early Life- stage Study: Lab Project Number: FO2489.
Unpublished study pre- pared by Lilly Research Laboratories. 86 p.
41613801 Cocke, P.; Koenig, G (1990) The Acute Toxicity of Benefin to Blue- gill (Lepomis
macrochirus) in a Static-Renewal Test System: Lab Project Number: F00990. Unpublished
study prepared by Lilly Research Laboratories. 41 p.
41613802 Sousa, J. (1990) Benefin-Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus)
Under Flow-through Conditions: Lab Pro-ject Number: 90-08-3416; 1982.1289.6104.505.
Unpublished study by Springborn Laboratories, Inc. 60 p.
41613803 Dionne, E. (1990) Benefin—Acute Toxicity to Eastern Oysters (Cras- sstrea virginica) Under
Flow-through Conditions: Lab Project Nu- mber: 90-07-3355; 1982.1289.6103.504.
Unpublished study prepar- ed by Springborn Laboratories, Inc. 55 p.
41613804 Sousa, J. (1990) Benefin-Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow-
through Conditions: Lab Project Number: 90-06- -3343; 1982.1289.6102.515. Unpublished
study prepared by Spring born Laboratories, Inc. 55 p.
106
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Benfluralin Bibliography
41613805 Cocke, P.; Gunnoe, M.; Koenig, G. (1990) The Toxicity of Benefin to Rainbow Trout (Salmo
gairdneri) in a 49-Day Early Life-Stage Study: Lab Project Number: F00690. Unpublished
study prepared by Lilly Research Laboratories. 88 p.
41613806 Mohr, R.; Cocke, P.; Koenig, G. (1990) The Chronic Toxicity of Benefin to Daphnia magna in
a Flow-through Life-Cycle Test: Lab Project Number: C01090. Unpublished study prepared
by Lilly Research Laboratories. 67 p.
41613808 Waldrep, T. (1989) Influence of Benefin on the Germination of Seeds of Ten Crop Plants: Tier
I: Lab Project Number: 61989010. Unpublished study prepared by DowElanco. 13 p.
41613809 Cocke, P.; Koenig, G. (1990) Toxicity of Benefin to a Freshwater Green Alga (Selenastrum
capricornurum) in a Static Test System: Lab Project Number: J00790. Unpublished study
prepared by Lilly Research Laboratories. 43 p.
41613812 Hoxter, K; Jaber, M. (1990) The Acute Contact Toxicity of Benefin to the Honey Bee: Lab
Proj ect Number: 151-115. Unpublished study prepared by Wildlife International Ltd. 3 0 p.
41613904 Sousa, J. (1990) Ethalfluralin—Acute Toxicity to Sheepshead Min- now (Cyprinodon
variegatus) under Flow-through Conditions: Lab Proj ect Number: SLI 90-7-3404: 1982. 1289.
6108. 505. Unpub- lished study prepared by Springborn Labs, Inc. 56 p.
41613905 Dionne, E. (1990) Ethalfluralin—Acute Toxicity to Eastern Oysters under Flow-through
Conditions: Lab Proj ect Number: SLI 90-07-338 1: 1982. 1289. 6107. 504. Unpublished study
prepared by Spring born Labs, Inc. 54 p.
41613906 Sousa, J. (1990) Ethalfluralin-Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) under
Flow-through Conditions: Lab Project Number: SLI 90-7-3405: 1982. 1289. 6106. 515.
Unpublished study prepared by Springborn Labs, Inc. 56 p.
41994901 Murray, A.; Meyerhoff, R.; Adams, E. (1991) The Toxicity of Ethal- fluralin to Rainbow Trout
(Salmo gairdneri) in a 50-Day Early Life-Stage Study: Lab Project Number: F02690.
Unpublished study prepared by Lilly Research Labs. 108 p.
42145501 Murray, A.; Smith, I; Grothe, D. (1991) The Toxicity of Benefin to Mallards in a One-
Generation Reproduction Study: Lab Project Number: A01090. Unpublished study prepared
by Lilly Research Labs. 437 p.
42145502 Murray, A.; Seacat, I; Grothe, D. (1991) The Toxicity of Benefin to Bobwhite in a One-
Generation Reproduction Study: Lab Project Number: A00690. Unpublished study prepared
by Lilly Research Labs. 470 p.
42176401 Murray, A.; Grothe, D.; Adams, E. (1992) The Acute Toxicity of Sonalan (FN 0802), a
Formulation Containing Ethalfluralin (EL-161, Compound 094961), to Bluegill (Lepomis
macrochirus) in a Static Renewal Test System: Lab Project Number: FO2391. Unpublished
study prepared by Lilly Research Labs. 46 p.
42176402 Grothe, D.; Adams, E. (1992) The Acute Toxicity of Sonalan EC (FN 0802), a Formulation
Containing Ethalfluralin (EL-161, Compound 094961), to Daphnia magna in a Static-Renewal
Test System: Lab Project Number: CO1191. Unpublished study prepared by Lilly Research
Labs. 37 p.
107
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Benfluralin Bibliography
42390801 Brock, D. (1992) The Acute Toxicity of Balan EC (FN 0270) a Formulation Containing
Benefin (EL-110, Compound 054521), to Bluegill (Lepomis macrochirus) in a Static Renewal
Test System: Lab Project Number: F00692. Unpublished study prepared by Lilly Research
Labs. 35 p.
42390802 Newstead, J.; Brock, D. (1992) The Acute Toxicity of Balan EC (FN 0270) a Formulation
Containing Benefin (EL-110, Compound 054521), to Daphnia magna in a Static Renewal Test
System: Lab Project Number: C01692. Unpublished study prepared by Lilly Research Labs.
36 p.
42419201 Brock, D. (1992) The Acute Toxicity of Balan EC (FN 0270), A Formulation Containing
Benefin (EL-110, Compound 054521), to Rainbow Trout (Oncorhynchus mykiss) in a Static-
Renewal Test System: Lab Project Number: F01892. Unpublished study prepared by Lilly
Research Labs. 37 p.
42449901 Parrish, P.; Dyer, E.; Enos, J.; et al. (1978) Chronic Toxicity of Chlordane, Trifluralin, and
Pentachlorophenol to Sheepshead Minnows (Cyprinodon variegatus): Lab Project Number:
EPA-600/3-78-010. Unpublished study prepared by EG&G Bionomics 69 p.
42785301 Decker, O. (1987) Vapor Pressure of Benefin: Lab Project Number: ODD8720. Unpublished
study prepared by Lilly Research Labs. 13 p.
42449902 Liu, D.; Lee, J. (1975) Toxicity of Selected Pesticides to the Bay Mussel (Mytilus edulis): Lab
Project Number: EPA-660/3-75-016. Unpublished study prepared by Stanford Research
Institute. 114 p.
42930101 Milazzo, D.; Servinski, M; Kirk, H.; et al. (1993) Ethalfluralin: Evaluation of the Chronic
Toxicity to the Daphnid, Daphnia magna Straus: Lab Project Number: 0233-3655:
DECO-ES-2666. Unpublished study prepared by Dow Chemical Co. 49 p.
Residue Chemistry MRID Referneces
00024254 Eli Lilly and Company (1966) Determination of Benefin Residues in Agricultural Crops.
Method 5801230 dated Mar 12, 1965. (Unpublished study received Feb 16, 1966 under
1471-55; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL: 092800-1)
00024258 Eli Lilly and Company (1965) [Determination of Benefin Residues in Agricultural Crops].
Method # 5800820 dated Mar 17, 1964; method # 5801110 dated Oct 15, 1964; method #
5801230 dated Mar 12, 1965. (Unpublished study received Jul 16, 1965 under
1471-55;CDL:006278-D)
00024496 Johnson, W.S.; Macy, T.; Bewley, G. (1974) Determination of Benefin in Agricultural Crops
and Soil. Undated method no. 5801620. (Unpublished study received Feb 13, 1975 under
464-322; prepared by Eli Lilly and Co., submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL: 028471-F)
00124776 Decker, O. (1982) Benefin Residues in Peanuts and Lettuce following Application of Balan 60
DF for Weed Control: I-ODD-82-08. (Unpublished study received Dec 16, 1982 under
1471-138; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:249185-A)
108
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42128201 Berard, D. (1991) Nature of Carbon 14-Benefin Residues in Bovine Tissues and Milk: Lab
Project Number: MET91002. Unpublished study prepared by DowElanco North American
Environmental Chemistry Lab. 68 p.
42204801 Dalidowicz, J. (1991) Carbon 14-Benefin Chicken Tissue and Egg Residue Study: Lab Project
Number: ABC0448. Unpublished study prepared by Lilly Research Labs. 41 p.
42338501 Rainey, D. (1992) Benefin [carbon 14] Nature of Residue Studyin Lettuce: Lab Project
Number: MET 91004. Unpublished study prepared by DowElanco. 37 p.
42370101 Rainey, D. (1992) Carbon 14 Benefin Nature of Residue Study in Alfalfa: Lab Project
Number: MET 91005. Unpublished study prepared by DowElanco. 39 p.
42409801 Rainey, D. (1992) Nature of Residue in Peanuts Treated with [carbon 14] Benefin: Lab Project
Number: ABC 0456. Unpublished study prepared by DowElanco. 52 p.
42854601 Rainey, D. (1993) Response to EPA Review of Benefin Nature of Residue Study in Poultry:
Lab Project Number: DPR072093. Unpublished study prepared by DowElanco. 13 p.
43039901 Rainey, D. (1992) (Carbon-14) Benefin Nature of Residue Study in Lettuce: Lab Project
Number: MET91004: MET91004R Unpublished study prepared by N. American
Environmental Chemistry Laboratory, DowElanco. 33 p.
43064801 Rainey, D. (1992) (Carbon-14) Benefin Nature of Residue Study in Alfalfa: Lab Project
Number: MET91005: MET91005R Unpublished study prepared by North American
Environmental Chemistry Lab., DowElanco. 43 p.
43624501 Rainey, D. (1995) (Carbon 14) Benefin: Nature of Residue Study in Lettuce: (Supplement):
Lab Project Number: MET91004: MET91004R2. Unpublished study prepared by
DowElanco. 31 p.
43 831901 Singer, G. (1995) Magnitude of the Residue of Benefin in Alfalfa Raw Agricultural
Commodities Following Ground Application: Final Report: Lab Project Number:
AA940005:94-0047: AA940005.CA2. Unpublished study prepared by American Agricultural
Services, Inc. and EN-CAS Analytical Labs, Inc. 277 p.
43 831902 Singer, G. (1995) Magnitude of the Residue of Benefin in Lettuce Following Ground
Application: Final Report: Lab Project Number: 94-011: AA940004: AA940004.AZ.
Unpublished study prepared by American Agricultural Services, Inc. and EN-CAS Analytical
Labs, Inc. 244 p.
44019801 Singer, G. (1996) Confined Accumulation Study on Rotational Crops with (carbon
14)-Benefm: Final Report: Lab Project Number: AA930005: SC980240: XBL 94121.
Unpublished study prepared by American Agricultural Services, Inc.; Battelle Labs; and
XenoBiotic Labs, Inc. 443 p.
109
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Appendix E. Generic Data Call-In
110
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Appendix E. GENERIC DATA CALL-IN
The Generic Data Call-In will be posted at a later date. See Chapter V of the Benfluralin RED for a list of
studies required.
Ill
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Appendk F. Product Specific Data Call-In
112
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Appendk F. PRODUCT SPECIFIC DATA CALL-IN
A Product Specific Data Call-In will be posted at a later date.
113
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Appendix G. EPA's Batching of Benfluralin Products for Meeting Acute Toxicity Data Requirements for
Reregistration
114
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Appendk G. EPA'S BATCHING OF BENFLURALIN PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
2. In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregistration of products containing BENFLURALIN as the active ingredient, the
Agency has batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since
some products within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the preceding
paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute
toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery
of six acute toxicological studies to represent all the products within that batch. It is the registrants' option to
participate in the process with all other registrants, only some of the other registrants, or only their own products
within a batch, or to generate all the required acute toxicological studies for each of their own products. If a
registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the
test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been
significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data
is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant must
indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the directions given
in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two response
forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, "Data
Call-In Response," asks whether the registrant will meet the data requirements for each product. The second
form, "Requirements Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to
support a batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
(Option 6). If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers
to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a
batch, the choices are Options 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.
One hundred twenty three products were found which contain Benfluralin as the active ingredient. These
products have been placed into fifteen 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:
• Batch 11: testing should be conducted with EPA Reg. No. 52287-12.
• Batch 12: testing should be conducted with EPA Reg. No. 62719-280.
115
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• Batch 14: EPA Reg. Nos. 70506-45 & 56 may not cite data generated with EPA Reg. No. 70506-49
• Batch 15: Since these products have already undergone reregistration with the Trifluralin RED that data will
be acceptable to cite to satisfy this RED. However, any new products in this batch should conduct an eye
study using the highest levels of nitrogen in the fertilizer used by the registrant.
• 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.
62719-100
68156-1
% Active Ingredient
96.6
96.6
Batch 2
EPA Reg. No.
34704-746
62719-127
% Active Ingredient
60.0
60.0
Batch 3
EPA Reg. No.
228-158
8660-107
% Active Ingredient
10.0
10.0
Batch 4
EPA Reg. No.
961-268
8660-8
34704-101
62719-96
% Active Ingredient
2.5
2.3
2.5
2.5
Batch 5
EPA Reg. No.
228-174
9198-83
10404-36
32802-7
% Active Ingredient
2.5
2.5
2.5
2.5
116
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Batch 6
EPA Reg. No.
7401-298
8660-130
% Active Ingredient
2.5
2.5
Batch 7
EPA Reg. No.
7401-46
8378-35
8660-37
8660-96
8660-243
% Active Ingredient
2.5
2.5
2.5
2.5
2.0
Batch 8
EPA Reg. No.
228-172
961-284
961-321
8378-10
8660-6
8660-27
8660-39
8660-42
8660-74
8660-112
8660-113
9198-66
32802-10
32802-11
34704-751
62719-147
62719-148
% Active Ingredient
1.175
1.720
1.220
1.500
1.150
1.720
1.200
1.280
1.300
1.130
1.650
1.280
1.175
1.300
1.200
1.150
1.250
117
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Batch 9
EPA Reg. No.
228-159
961-228
8378-11
8660-26
8660-30
8660-38
8660-40
8660-99
8660-186
8660-192
8660-235
8660-236
8660-237
8660-238
8780-57
9198-30
32802-8
32802-9
34704-750
38167-30
62719-146
% Active Ingredient
0.92
0.86
0.92
0.55
0.78
0.86
1.02
0.78
0.96
0.43
0.70
0.87
0.62
1.15
1.15
0.92
0.92
1.02
0.29
1.00
0.92
Batch 10
EPA Reg. No.
% Active Ingredient
961-390
Benfluralin: 0.82
Clopyralid: 0.18
Triclopyr: 0.50
Trifluralin: 0.43
118
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Batch 10
EPA Reg. No.
961-391
% Active Ingredient
Benfluralin: 0.82
Clopyrahd: 0.18
Triclopyr: 0.50
Trifluralin: 0.43
Batch 1 1
EPA Reg. No.
52287-10
52287-11
52287-12
% Active Ingredient
Benfluralin: 0.375
Oxadiazon: 0.500
Trifluralin: 0.375
Benfluralin: 0.250
Oxadiazon: 0.750
Trifluralin: 0.250
Benfluralin: 0.250
Oxadiazon: 1.000
Trifluralin: 0.250
Batch 12
EPA Reg. No.
62719-192
62719-280
% Active Ingredient
Benfluralin: 0.53
Isoxaben: 0.29
Trifluralin: 0.27
Benfluralin: 0.76
Isoxaben: 0.38
Trifluralin: 0.39
Batch 13
EPA Reg. No.
7401-413
7401-415
8660-16
8660-139
8660-146
32802-30
% Active Ingredient
Benfluralin: 1.00
Oryzalin: 1.00
Benfluralin: 1.00
Oryzalin: 1.00
Benfluralin: 0.86
Oryzalin: 0.86
Benfluralin: 0.86
Oryzalin: 0.86
Benfluralin: 0.86
Oryzalin: 0.86
Benfluralin: 0.85
Oryzalin: 0.85
119
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Batch 14
EPA Reg. No.
70506-45
70506-49
70506-56
% Active Ingredient
Benfluralin: 1.000
Oryzalin: 1.000
Benfluralin: 0.575
Oryzalin: 0.575
Benfluralin: 1.000
Oryzalin: 1.000
Batch 15
EPA Reg. No.
228-207
228-208
228-209
228-254
228-255
228-256
228-257
961-346
961-348
8378-17
8378-18
8378-19
8378-20
8378-37
% Active Ingredient
Benfluralin: 0.58
Trifluralin: 0.29
Benfluralin: 0.77
Trifluralin: 0.38
Benfluralin: 1.00
Trifluralin: 0.50
Benfluralin: 0.59
Trifluralin: 0.29
Benfluralin: 0.74
Trifluralin: 0.37
Benfluralin: 0.89
Trifluralin: 0.44
Benfluralin: 0.45
Trifluralin: 0.22
Benfluralin: 0.77
Trifluralin: 0.39
Benfluralin: 1.03
Trifluralin: 0.52
Benfluralin: 0.76
Trifluralin: 0.38
Benfluralin: 0.84
Trifluralin: 0.43
Benfluralin: 1.00
Trifluralin: 0.50
Benfluralin: 0.62
Trifluralin: 0.30
Benfluralin: 0.93
Trifluralin: 0.49
120
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Batch 15
EPA Reg. No.
8660-19
8660-143
8660-149
8660-151
8660-207
9198-79
9198-91
9198-94
9198-101
9198-130
10404-53
10404-56
10404-57
32802-24
32802-33
32802-35
32802-40
62719-137
% Active Ingredient
Benfluralin: 0.85
Trifluralin: 0.43
Benfluralin: 0.90
Trifluralin: 0.45
Benfluralin: 0.90
Trifluralin: 0.45
Benfluralin: 0.76
Trifluralin: 0.38
Benfluralin: 0.77
Trifluralin: 0.38
Benfluralin: 0.77
Trifluralin: 0.38
Benfluralin: 0.38
Trifluralin: 0.19
Benfluralin: 0.62
Trifluralin: 0.30
Benfluralin: 0.59
Trifluralin: 0.28
Benfluralin: 1.00
Trifluralin: 0.50
Benfluralin: 0.67
Trifluralin: 0.33
Benfluralin: 0.77
Trifluralin: 0.38
Benfluralin: 0.84
Trifluralin: 0.41
Benfluralin: 0.77
Trifluralin: 0.38
Benfluralin: 1.00
Trifluralin: 0.50
Benfluralin: 0.58
Trifluralin: 0.29
Benfluralin: 0.39
Trifluralin: 0.19
Benfluralin: 1.33
Trifluralin: 0.67
121
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Batch 15
EPA Reg. No.
62719-150
62719-151
62719-152
62719-289
62719-290
62719-327
62719-331
62719-332
% Active Ingredient
Benfluralin: 0.76
Trifluralin: 0.39
Benfluralin: 0.61
Trifluralin: 0.31
Benfluralin: 0.82
Trifluralin: 0.43
Benfluralin: 0.50
Trifluralin: 0.50
Benfluralin: 0.83
Trifluralin: 0.42
Benfluralin: 0.82
Trifluralin: 0.43
Benfluralin: 0.76
Trifluralin: 0.39
Benfluralin: 0.61
Trifluralin: 0.31
No Batch
EPA Reg. No.
829-211
5905-496
8660-104
8660-225
48234-1
62719-117
62719-317
62719-318
% Active Ingredient
Benfluralin: 2.0
Benfluralin: 19.1
Benfluralin: 1.15
2,4-D: 1.50
Benzoic acid: 0.28
Benfluralin: 0.725
Benfluralin: 0.50
Oxadiazon: 1.00
Benfluralm: 16.30
Benfluralin: 64.30
Trifluralin: 32.20
Benfluralin: 48.20
Trifluralin: 48.20
122
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Appendix H. List of Registrants Sent this Data Call-In
123
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Appendk H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN.
A list of registrants sent this data call-in will be posted at a later date.
124
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Appendix I. List of Available Related Documents and Electronically Available Forms
125
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Appendix L 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
at williams.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
8570-28
8570-30
8570-32
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product,
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing_
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
http : //www. epa. gov/opprdOO 1 /forms/8 5 70- 1 . pdf
http://www. epa. gov/opprdOO l/forms/8570-4.pdf
http : //www. epa. gov/opprdOO 1 /forms/8 570-5. pdf
http://www. epa. gov/opprdOO l/forms/8570- 1 7. pdf
http://www. epa. gov/opprdOO l/forms/8570-25. pdf
http : //www. epa. gov/opprdOO 1 /forms/8 570-27. pdf
http://www. epa. gov/opprdOO l/forms/8570-28. pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www. epa. gov/opprdOO l/forms/8570-32. pdf
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8570-34
8570-35
8570-36
8570-37
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/opppmsd 1 /PR Notices/pr98- 5 . pdf
http : //www. epa. gov/opppmsd 1 /PR Notices/pr98- 5 . pdf
http : //www. epa. gov/opppmsd 1 /PR Notices/pr98- 1 . pdf
http : //www. epa. gov/opppmsd 1 /PR Notices/pr98- 1 . pdf
Pesticide Registration Kit
www. epa. gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following pertinent
forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's
Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and
Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF
format and requires the Acrobat reader.)
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)
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g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources of
information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United States",
PB92-221811, available through the National Technical Information Service (NTIS) at the following
address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions
and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800)
858-7378 or through their website: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
1. Date of receipt;
2. EPA identifying number; and
3. Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of receipt to
the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying
file symbol or petition number for the new submission. The identifying number should be used
whenever you contact the Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when a
sample was submitted for testing by commercial or academic facilities). Please provide a chemical
abstract system (CAS) number if one has been assigned.
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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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