United States Prevention, Pesticides EPA738-R-04-001
Environmental Protection And Toxic Substances September 2003
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Sodium Acifluorfen
738R04001
CM-YL
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8C)
EPA-738-F-O4-OO1
September 2OO3
&EPA R.E.D. FACTS
Sodium Acifluorfen
(Blazer®)
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first registered
before November 1,1984, be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act (FQPA) of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public to
pesticide residues from all sources, and the cumulative effects of pesticides and
other compounds with common mechanisms of toxicity. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet current human health
and safety standards and can be used without posing unreasonable risks to human
health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 2605,
sodium acifluorfen.
Sodium acifluorfen is an herbicide for post-emergent weed control on
agricultural crops and for residential spot treatment. Formulations include liquid,
ready-to-use and soluble concentrate. Sodium acifluorfen is sometimes
formulated or packaged with other herbicides, such as bentazon, imazaquin,
sethoxydim, or glyphosate. Sodium acifluorfen is applied by aircraft, boom
sprayer, and other ground equipment, and by hand held sprayer and trigger bottle.
Sodium acifluorfen was first registered as a pesticide in the U.S. in 1980.
There is no Registration Standard for sodium acifluorfen, but EPA issued three
Data Call-Ins (DCIs) in June 1991, March 1995, and October 1995. Currently,
12 sodium acifluorfen products are registered, only one of which is registered for
use in residential settings. The residential use product is labeled for application
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by spot treatment only. Because this product is packaged in a ready-to-use spray
trigger bottle, broadcast treatment is not expected to occur.
Human Health Toxicity
Assessment Sodium acifluorfen generally has been shown to have low acute oral and
dermal toxicity and practically no inhalation toxicity. It is a severe eye irritant
and moderate skin irritant but is not a skin sensitizer. Toxicity Categories, which
range from I (most toxic) to IV (least toxic), were Category I for acute eye
irritation, Category II for skin irritation, Category III for acute oral and dermal
toxicity, and Category IV for acute inhalation toxicity for sodium acifluorfen.
Toxicology studies in animals showed kidney effects following exposure to
sodium acifluorfen. Because a rat developmental toxicity study showed fetal
effects, the 10X FQPA Safety Factor was retained to account for special
sensitivity to developing organisms. A confirmatory developmental neurotoxicity
study is being required to provide additional information about susceptibility of
developing organisms.
Sodium acifluorfen is associated with tumors in rodent studies, but is not
genotoxic. In light of new information on the mechanism of tumor formation,
EPA recently classified sodium acifluorfen as "likely to be carcinogenic to
humans at high enough doses to cause the biochemical and histopathological
changes in livers of rodents but unlikely to be carcinogenic at doses below those
causing these changes." In other words, sodium acifluorfen is carcinogenic, but
only above a certain threshold, at high doses.
Dietary Exposure and Risk
People may be exposed to residues of sodium acifluorfen through food or
drinking water. EPA has assessed the dietary risk posed by sodium acifluorfen
and found that dietary risk from food and drinking water is below the Agency's
level of concern.
Acute and chronic dietary (food) risks are substantially less than 100% of
the acute and chronic Population Adjusted Dose (aPAD and cPAD, respectively)
for the general U.S. population and all population subgroups. This assessment
incorporates the 10X FQPA Safety Factor to account for special sensitivity to
infants and children. Because the chronic dietary risk assessment for non-cancer
effects is also protective in terms of cancer effects, the chronic dietary risk from
cancer is also below the Agency's level of concern.
People may also be exposed to acifluorfen, a degradate of sodium
acifluorfen, in drinking water. Because acifluorfen can also be derived from the
herbicide lactofen, the Agency conducted an aggregate drinking water assessment
that includes acifluorfen from both sodium acifluorfen and lactofen.
EPA estimated drinking water concentrations of total acifluorfen in surface
water and ground water using models. Estimated drinking water concentrations
for acifluorfen in both surface and groundwater were all below the corresponding
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drinking water level of concern (DWLOC), the maximum concentration of
acifluorfen in water that does not exceed EPA's risk concern.
Residential Exposure and Risk
Homeowners or residential handlers can be exposed to sodium acifluorfen
by applying it as a spot treatment, or by entering or performing other activities in
treated areas. Residential handlers include homeowner applicators performing
spot treatment of weeds along driveways, sidewalks, patios, and trees.
For the homeowner use of sodium acifluorfen, EPA is concerned about any
Margin of Exposure (MOE) less than 1000, which incorporates the FQPA safety
factor to protect females age 13-50 years (childbearing age) and any unborn
children. For the only potential exposure scenario, spot treatment with a ready-
to-use trigger sprayer, EPA estimated an MOE of 18000, a safety margin large
enough so that residential applicator risk is not of concern to the Agency.
Furthermore, EPA has no concerns for post-application residential exposure
because residential uses are limited to spot treatments, which do not include
broadcast application to lawns; therefore, post-application exposure is expected to
be negligible.
Occupational Exposure and Risk
Based on current use patterns, agricultural handlers (mixers, loaders, and
applicators) may be exposed to sodium acifluorfen during and after normal use of
liquid formulations in agricultural settings. EPA assessed occupational exposure
to sodium acifluorfen using data from the Pesticide Handler Exposure Database
(PHED) and proprietary data, including chemical-specific data submitted by the
technical registrant for sodium acifluorfen. Occupational exposure to sodium
acifluorfen is not of concern to the Agency for handlers using personal protective
equipment (PPE) specified on the current labels. Post application exposures to
agricultural workers re-entering treated areas for activities such as scouting, hand
weeding, and irrigating is not of concern with the current restricted entry interval
(REI) of 48 hours.
FQPA Considerations
FQPA requires that the Agency consider the available information on the
special sensitivity of infants and children, as well as the aggregate exposure from
food, drinking water, and residential use. The 10X FQPA Safety Factor was
retained for sodium acifluorfen to account for potential sensitivity of females age
13-50 years (childbearing age) and any unborn children. For sodium acifluorfen,
EPA has determined that the FQPA Safety Factor only applies to this population.
An aggregate assessment was conducted to assess combined exposures from
food, residential uses, and drinking water. Results of this aggregate assessment
indicate that the human health risks from these combined exposures are not of
concern; that is, combined risks from all exposures to sodium acifluorfen,
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including acifluorfen derived from lactofen, fit within the individual pesticide's
risk cup.
FQPA also requires the Agency to consider the "available information"
concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency does not
have sufficient information at this time concerning common mechanism issues to
determine whether or not sodium acifluorfen shares a common mechanism of
toxicity with other substances, including other diphenyl ethers. Therefore, for the
purposes of this risk assessment, the Agency has assumed that sodium acifluorfen
does not share a common mechanism of toxicity with any other chemicals.
Sodium acifluorfen's primary environmental degradate is the acifluorfen
anion, which is also a degradate of another herbicide, lactofen. Because lactofen
will degrade to acifluorfen in the environment, the reregistration eligibility
decision (RED) for sodium acifluorfen and the tolerance reassessment decision
(TRED) for lactofen include assessments aggregating the potential exposure to
acifluorfen from the use of both pesticides. This was done in addition to EPA's
evaluation of the combined risk from dietary exposure to residues of sodium
acifluorfen in food and water and residues resulting from residential use. EPA
does not have a risk concern for total aggregate exposure to sodium acifluorfen
residues from non-occupational exposure pathways. Therefore, EPA has
determined that risk from exposure to sodium acifluorfen is within its own "risk
cup." More detailed information can be found in the technical supporting
documents for sodium acifluorfen referenced in the RED document.
Tolerance Reassessment
The tolerances for sodium acifluorfen meet the FQPA safety standards for
the US population and sensitive populations, including infants and children.
Therefore, EPA has reassessed the sodium acifluorfen tolerances and found that 1
tolerance should be increased and 3 tolerances remain the same. The Agency is
not able to reassess the tolerance for strawberries until additional confirmatory
data are submitted and reviewed. EPA has previously revoked 15 tolerances for
livestock commodities because sodium acifluorfen does not concentrate in
livestock tissues under the current conditions of use. Also, the current tolerance
expression is appropriate and will not change. Because there are no maximum
residue limits (MRLs) for sodium acifluorfen, there are no issues of compatibility
of US tolerances with Codex MRLs.
Environmental Environmental Fate
Assessment Sodium acifluorfen is persistent on soils and in aquatic environments and is
relatively mobile. It is stable to hydrolysis and does not break down in sunlight.
Off-target transport is expected to occur initially through drift and leaching, and
later through erosion and runoff. Sodium acifluorfen exists in the anion
(negatively charged) form in most agricultural soils. Several factors, including
soil pH, soil organic carbon content, and soil iron content determine the extent to
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which acifluorfen adsorbs to soil particles. Therefore, the persistence and
mobility of acifluorfen vary with different soil conditions. Because acifluorfen's
fate properties showed that it might leach to groundwater, EPA required a small
scale prospective ground water monitoring study, which was conducted on
soybeans in the central sands of Wisconsin. Acifluorfen and two degradates were
monitored; the parent only was detected at concentrations ranging from 1 to 46
ppb (average 7.33 ppb) in 56 out of 283 samples. However, a prospective
groundwater study for the related herbicide lactofen showed no detections of
acifluorfen.
Ecological Toxicity
Sodium acifluorfen is slightly toxic to fish and aquatic invertebrates and
slightly toxic to aquatic plants. It is moderately to practically nontoxic to birds on
an acute oral basis. Sodium acifluorfen is associated with reproductive effects in
bobwhite quail but not in mallard ducks. Although no data are available on the
toxicity of sodium acifluorfen to wild mammals, it is slightly toxic to rats in
laboratory studies. No effects were seen in a rat reproductive toxicity study, but
effects were seen in a rat developmental toxicity study.
There are no available data on the toxicity of sodium acifluorfen to
honeybees; therefore, a honeybee acute toxicity study is required. Limited
information is available about the toxicity of sodium acifluorfen to non-target
terrestrial plants. However, because of the potential for adverse effects from
spray drift, EPA is requiring several label amendments to limit the potential for
drift. In addition, the EPA is requiring confirmatory plant toxicity data.
Sodium acifluorfen belongs to a class of compounds known to have a
phototropic mode of action in plants and animals. To address the potential for
increased toxicity in the presence of light, a confirmatory phototoxicity study is
required for sodium acifluorfen.
Risks to Terrestrial and Aquatic Organisms
The Agency conducted a screening level ecological risk assessment to
determine the potential impact of sodium acifluorfen use on non-target terrestrial
and aquatic organisms. The Agency used modeling to evaluate ecological risks
for sodium acifluorfen.
The Agency has minor concerns for chronic risk to birds that feed on short
grasses with RQs slightly exceeding the Agency's level of concern. In a refined
assessment, which uses mean residues, RQs range from 0.15 to 1.8, which
slightly exceed the level of concern of 1.0.
The Agency has no concerns for the impacts of sodium acifluorfen on
mammalian species. In a worst case acute scenario, the acute RQ is less than
0.01 and not of concern. The chronic RQ for mammals is less than 0.05, which
does not exceed the Agency's level of concern for any registered use.
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Risk Mitigation
The Agency has no concerns for the impacts of sodium acifluorfen on
aquatic organisms. The risk assessment shows that the RQs for all aquatic
species are less than 0.01, which is well below any of EPA's levels of concern.
The Agency's review of sodium acifluorfen resulted in a determination that
sodium acifluorfen will have "no effect" on threatened and endangered aquatic
organisms, mammals, and birds. Although chronic RQs for birds which eat short
grass exceed the level of concern, the only listed endangered species that
consumes short grass is the Hawaiian goose, which resides on golf courses in
Hawaii. Because sodium acifluorfen is not used in or around this bird's habitat,
the Agency concludes that there is "no effect" to endangered birds.
To lessen the risks posed by sodium acifluorfen, EPA is requiring the
following risk mitigation measures:
Dietary Risk
An approved labeled use for strawberries and use directions are
required, to maintain the tolerance on strawberries (OPPTS
860.1200).
• A 100-day plant-back interval is necessary for all rotated crops
except small grains, which require a 40-day plant-back interval.
• Groundwater label advisory must be maintained on all labels.
• Confirmatory data are required, including a developmental
neurotoxicity study and determination of a lower level of
quantification (LOQ) for the analytical method.
Residential Risk
No label changes are necessary.
Occupational Risk
• No label changes are necessary.
• PPE can be reduced to baseline with chemical-resistant gloves for
technical sodium acifluorfen. Additional PPE may be required on a
product-specific basis.
Additional Data
Ecological Risk
• Label amendments to minimize the potential for spray drift are
required.
• Confirmatory data are required, including Aquatic Phototoxicity
(modified fish early life stage), Honey Bee Acute Contact,
Vegetative Vigor, and Seedling Emergence studies.
EPA is requiring the following additional generic studies for sodium
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Required acifluorfen to confirm its regulatory assessments and conclusions:
UV/visible Absorption (OPPTS 830.7050)
Fish Early Life Stage Toxicity Study (OPPTS 850.1400), modified
for Aquatic Phototoxicity
Honey Bee Acute Contact Study (OPPTS 850.3020)
Directions for Use (on strawberries) (OPPTS 860.1200)
Developmental Neurotoxicity Study in Rats (OPPTS 870.6300)
The Agency is also requiring data gaps from previous data call ins be
fulfilled. These studies must be submitted to EPA in a timely manner. These
include the following data gaps:
Analytical Methods - Plants (OPPTS Guideline 885.2300) for rice
straw, to include a lower LOQ.
Seed Germination/Seedling Emergence (OPPTS 850.4100)
Vegetative Vigor (OPPTS 850.4150)
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
Product Labeling All sodium acifluorfen end-use products must comply with EPA's current
Chanqes Required pesticide product labeling requirements and with the following:
• An approved labeled use for strawberries and use directions are
required, to maintain the tolerance on strawberries (OPPTS
860.1200).
• A 100-day plant-back interval is necessary for all rotated crops
except small grains, which require a 40-day plant-back interval.
• Groundwater label advisory must be maintained on all labels.
Label amendments to minimize the potential for spray drift are
required.
• PPE can be reduced to baseline with chemical-resistant gloves for
technical sodium acifluorfen.
For a comprehensive list of labeling requirements, please see Chapter V of the
Sodium Acifluorfen RED document.
Regulatory
Conclusion
The use of currently registered products containing sodium acifluorfen in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products are
eligible for reregistration. These products will be reregistered once the required
confirmatory generic data, product specific data, CSFs, and revised labeling are
received and accepted by EPA. Products which contain active ingredients in
addition to sodium acifluorfen will be reregistered when all of their other active
ingredients also are eligible for reregistration.
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For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for sodium acifluorfen during a 30-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone, (703)305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs or http://www.epa.gov/edockets.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-
8695.
Following the comment period, the Sodium Acifluorfen RED document
also will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or
703-605-6000.
For more information about EPA's pesticide reregistration program, the
Sodium Acifluorfen RED, or reregistration of individual products containing
sodium acifluorfen, contact the Special Review and Reregistration Division
(7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard
Time, seven days a week. Their internet address is http://npic.orst.edu.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
*"t PBQ1*- AND TOXIC SUBSTANCES
CERTIFIED MAIL
JAN 15 2005
Dear Registrant:
This is to inform you that the U.S. 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 assessments for the herbicide sodium acifluorfen. Based on its
review, EPA has identified label changes that the Agency believes are necessary to address the
human health and ecological risks associated with the current use of sodium acifluorfen. EPA is
now publishing its reregistration eligibility, risk management, and tolerance reassessment
decisions for the current uses of sodium acifluorfen and its associated human health and
environmental risks. The enclosed "Reregistration Eligibility Decision for Sodium
Acifluorfen"contains the Agency's decision on the individual chemical sodium acifluorfen,
which was approved on September 26, 2003.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for Sodium
Acifluorfen is being published in the Federal Register. To obtain a copy of the RED document,
please contact the OPP Public Regulatory Docket at (703)-305-5805. Electronic copies of the
RED and all supporting documents are available on the Internet at the following address:
http//:www.epa.gov/edockets.
This document and the process used to develop it are the result of a process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for pesticides. As part of the Agency's effort to involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking
a special effort to maintain open public dockets and to engage the public in the reregistration and
tolerance reassessment processes. Subsequently, the preliminary and revised risk assessments
for sodium acifluorfen were made available to the public for comment on July 26, 2001 and
April 12,2002, respectively. This open process follows the guidance developed by the
Tolerance Reassessment Advisory Committee (TRAC), a large multi-stakeholder advisory body
that advised the Agency on implementing the new provisions of the FQPA. The Agency also
conducted a close-out conference call on September 24, 2003 to discuss the risk management
decisions and resultant changes to the sodium acifluorfen labels.
This document contains both generic or product-specific Data Call-Ins (DCIs) that
outlines further data requirements for this chemical. Note that a complete DCI, with all
pertinent instructions, is being sent to registrants under separate cover. Additionally, for
product-specific DCIs, the first set of required responses is due 90 days from receipt of the DCI
letter. The second set of required responses is due eight months from the date of the DCI.
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As part of the RED, the Agency has determined that sodium acifuorfen is eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the RED document.
Sections IV and V of the RED document describe labeling amendments for end-use products
and data requirements necessary to implement these mitigation measures.
Should a registrant fail to implement any of the label changes outlined in this document,
the Agency will continue to have concerns about the risks posed by sodium acifluorfen. Where
the Agency has identified any unreasonable adverse effect to human health and the environment,
the Agency may at any time initiate appropriate regulatory action to address this concern. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the proposed label changes, please contact the
Chemical Review Manager for Sodium Acifluorfen, Christina Scheltema, at (703) 308-2201. For
questions about product reregistration and/or the product-specific DCI that accompanies this
document, please contact Veronica Dutch at (703) 308-8585.
Sincerely,
Betty ^hackleford, A/ting Director
Special Review and Reregistration Division
Attachment
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Reregistration Eligibility Decision
for
Sodium Acifluorfen
Case No. 2605
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TABLE OF CONTENTS
EXECUTIVE SUMMARY v
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 3
C. Use Profile 3
D. Estimated Usage of Pesticide 5
in. Summary of Sodium Acifluorfen Risk Assessment 6
A. Human Health Risk Assessment 6
1. Dietary Risk from Food 7
a. Toxicity 7
b. FQPA Safety Factor 7
c. Population Adjusted Dose (PAD) 8
d. Carcinogenicity 8
e. Dietary Exposure from Food 10
f. Summary of Dietary Risk from Food 11
2. Dietary Risk from Drinking Water 12
a. Environmental Parameters Impacting Water Assessment
; 12
b. Water Monitoring 13
c. Groundwater Modeling 15
d. Estimated Drinking Water Concentrations (EDWCs) for
Groundwater 15
3. Residential Exposure and Risk 16
a. Toxicity '. 17
b. Residential Exposure 17
c. Residential Risk Summary 18
4. Aggregate Risk .' 18
a. Acute Aggregate Risk 19
b. Short-Term Aggregate Risk 19
c. Chronic Aggregate Risk 20
d. Aggregate Cancer Risk 20
5. Occupational Exposure and Risk 21
a. Toxicity 21
b. Occupational Exposure 22
c. Occupational Handler Risk Summary 23
d. Post-Application Exposure and Risk 25
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6. Incident Reports 26
B. Environmental Risk Assessment 26
1. Environmental Fate and Transport 26
2. Ecological Risk Assessment 27
a. Ecological Hazard Profile 28
b. Environmental Exposure to Non-Target Organisms
29
c. Environmental Risk to Non-Target Organisms 31
d. Ecological Incident Reports 33
IV. Risk Management and Registration Decision 33
A. Determination of Registration Eligibility 33
B. Summary of Phase 5 Comments 34
C. Regulatory Position 34
1. FQPA Assessment 34
a. "Risk Cup" Determination 34
b. Endocrine Disrupter Effects 35
c. Tolerance Summary 35
D. Regulatory Rationale 37
1. Human Health Risk Mitigation 37
a. Dietary Mitigation 37
b. Homeowner Risk Mitigation 38
c. Aggregate Risk Mitigation 38
d. Occupational Risk Mitigation 39
2. Environmental Risk Mitigation 40
3. Other Labeling 40
a. Endangered Species Statement 41
b. Spray Drift Management 41
V. What Registrants Need to Do 41
A. Technical Registrants 41
B. Registrants of End-Use Products 42
C. Additional Generic Data Requirements 43
1. Outstanding Data Requirements 43
2. Confirmatory Data Requirements 43
D. Labeling for Manufacturing-Use Products 44
E. End-Use Products 44
1. Additional Product-Specific Data Requirements 44
2. Labeling for End-Use Products 44
F. Existing Stocks 44
G. Labeling Changes Summary Table 45
VI. Related Documents and How to Access Them 52
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VII. APPENDICES 53
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SODIUM ACIFLUORFEN REREGISTRATION TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Kit Farwell
Paul Chin
Tim Dole
Bill Hazel
Felicia Fort
Environmental Fate and Effects Risk Assessment
Kevin Costello
Stephanie Syslo
James Goodyear
James Wolf
Use and Usage Analysis
Frank Hernandez
Jim Saulmon
Registration Support
Jim Stone
Joanne Miller
Risk Management
Christina Scheltema
Susan Jennings
Endangered Species
Ron Kendall
Ann Stavola
Larry Turner
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GLOSSARY OF TERMS AND ABBREVIATIONS
AGDCI
AR
BCF
CAS
CNS
CSF
CFR
CSFII
DCI
DEEM
DFR
ORES
DWLOC
EC
EEC
EP
EPA
FAO
FDA
FIFRA
FFDCA
FQPA
GENEEC
GLC
GLN
HDT
IR
LC50
LD
'50
LEL
LOG
Active Ingredient
Agricultural Data Call-In
Anticipated Residue
Bioconcentration Factor
Chemical Abstracts Service
Central Nervous System
Confidential Statement of Formula
Code of Federal Regulations
USDA Continuing Surveys for Food Intake by Individuals
Data Call-in
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Tier I Surface Water Computer Model
Gas Liquid Chromatography
Guideline Number
Highest Dose Tested
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or
ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
Lowest Effect Level
Level of Concern
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LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/ Tier II Runoff/Surface Water Computer Models
EXAMS
Q,* Unit Risk of Carcinogenic Potential of a Compound, Quantified by the EPA's Linear
Low Dose Cancer Risk Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
m
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RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Groundwater Computer Model
SF Safety Factor
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr Unit of measure for atmospheric pressure
TRR Total Radioactive Residue
UF Uncertainty Factor
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency (EPA or the Agency) has completed its review of public
comments on the revised human health and environmental risk assessments for sodium acifluorfen and is
issuing its risk management decision. The decisions outlined in this document include the final tolerance
reassessment decision for sodium acifluorfen and the reregistration eligibility decision. Fifteen meat,
milk, poultry and egg tolerances were proposed for revocation on July 16,20031. Three of the
remaining tolerances are unchanged and one tolerance will be increased based on residue data
submitted to the Agency. The tolerance for strawberries will be reassessed once use directions have
been submitted to the Agency.
Sodium acifluorfen is a member of the diphenyl ether group of herbicides, which includes
lactofen, oxyfluorfen, nitrofen, and fomesafen. The Agency has evidence that compounds in the
diphenyl ether group induce similar toxic effects but has not yet determined whether these compounds
exhibit a common mechanism of toxicity. For the purposes of tolerance reassessment and a
reregistration eligibility decision for sodium acifluorfen, EPA is assuming that sodium acifluorfen does
not share a common mechanism of toxicity with other compounds. However, because lactofen will
degrade to acifluorfen in the environment, the reregistration eligibility decision (RED) for sodium
acifluorfen and the tolerance reassessment decision (TRED) for lactofen include assessments
aggregating the potential exposure to acifluorfen from both pesticides.
Sodium acifluorfen was first registered in the United States in 1980 for post-emergent weed
control on agricultural crops and was subsequently registered for residential spot treatment. The
Agency did not issue a Registration Standard for sodium acifluorfen, but did issue three Data Call-ins
(DCIs) in June 1991, March 1995, and October 1995. Approximately 1.5 million pounds active
ingredient (a.i.) of sodium acifluorfen are used annually in the United States, according to Agency and
registrant estimates. The largest market for sodium acifluorfen, in terms of total pounds of al, is
allocated to soybeans (94% of a.i. produced). Use of sodium acifluorfen has been declining in recent
years with the availability of Roundup Ready® soybeans. Although sodium acifluorfen is registered for
residential use, this use is very minor compared to the agricultural uses. Only one product, which is
packaged as a spot treatment in a ready-to-use trigger sprayer, is registered for residential use.
Broadcast use on lawns is not expected because the product packaging is not designed for broadcast
application and sodium acifluorfen is a non-selective herbicide that will kill both weeds and grass.
EPA has conducted an aggregate drinking water assessment for lactofen and sodium acifluorfen
because they share an environmental degradate, acifluorfen. Because lactofen was first registered after
1984, it is not subject to reregistration under FIFRA; however, the lactofen tolerances must be
reassessed under The Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Federal Register, Vol. 68, No. 136
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Quality Protection Act (FQPA). Therefore, this RED and the tolerance reassessment for sodium
acifluorfen considers the aggregate exposures from both pesticides.
Overall Risk Summary
The Agency's human health risk assessment for sodium acifluorfen indicates minimal risks.
Both acute and chronic risks from food are well below the Agency's level of concern. Dietary
exposure from ground water or surface water sources of drinking water are also low and not of
concern. There are no concerns about the risk to homeowners or occupational workers who handle
sodium acifluorfen or are exposed to residues after sodium acifluorfen is applied to agricultural crops.
The screening-level ecological risk assessment for sodium acifluorfen shows risk quotients
(RQs) ranging from less than 0.01 to 6.0 for terrestrial organisms. For aquatic organisms, all RQs are
less than 0.01 and not of concern.
Dietary Risk
Acute and chronic dietary (food) risks are substantially less than 100% of the acute and chronic
Population Adjusted Dose (aPAD and cPAD, respectively) for the general U.S. population and all
population subgroups. Because the chronic dietary risk assessment for non-cancer effects is also
protective of cancer effects, the chronic dietary risk assessment from cancer is not of concern.
Because risk from dietary sources does not exceed the Agency's level of concern, no mitigation
measures are necessary to reduce dietary risks from food.
For sodium acifluorfen, acute dietary exposure comprises less than 1% of the acute PAD for
females age 13-50 years, the only population at potential risk from acute effects. The acute PAD for
this population group includes a 10X FQPA safety factor. Acute'dietary risk for the general population
is not of concern because no endpoint has been established.
The chronic dietary risk from food alone is also well below the Agency's level of concern.
Chronic dietary exposure comprises less than 1% of the chronic PAD for the U.S. population and all
subpopulations.
The Agency determined that an MOE approach was appropriate for assessing the chronic
dietary cancer risk from the use of sodium acifluorfen. Because this assessment would have used the
same dose and uncertainty factors that were used to calculate the chronic risk, EPA believes that the
chronic non-cancer dietary risk assessment is adequately protective of cancer effects.
VI
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Drinking Water Risk
Both sodium acifluorfen and a related pesticide, lactofen, will degrade to the degradate
acifluorfen in the environment. Therefore, EPA has conducted an aggregate drinking water assessment
that includes the degradate acifluorfen from both lactofen and sodium acifluorfen sources.
Estimated Drinking Water Concentrations (EDWCs) of total acifluorfen in surface water were
modeled using PRZM-EXAMS with the Index Reservoir and Crop Area Factors. Based on currently
registered uses, the maximum surface water EDWCs for total acifluorfen residues were 10.12 ppb for
acute exposure, 2.43 ppb for chronic exposure, and 1.34 ppb for cancer exposure.
Monitoring studies show that acifluorfen may leach to groundwater under certain conditions.
The prospective groundwater study for sodium acifluorfen showed leaching of the acifluorfen degradate
in the central sands of Wisconsin, an extremely vulnerable soil. Therefore, the current groundwater
label advisory is still necessary.
Ground water EECs for acifluorfen were derived from a Tier I screening-level model (SCI-
GROW), which estimates the maximum ground water concentrations from the application of a pesticide
to crops. The groundwater EEC for acifluorfen derived from lactofen was derived from a prospective
groundwater monitoring study for lactofen, which monitored for both compounds. The maximum
estimated ground water EDWC for total acifluorfen derived from both sodium acifluorfen and lactofen
is 3.71 ppb.
Residential Risk
Homeowners or residential handlers can be exposed to sodium acifluorfen by applying it as a
spot treatment, or by entering or performing other activities in treated areas. Residential handlers
include homeowner applicators performing spot treatment of weeds along driveways, sidewalks, patios,
and trees.
For the homeowner use of sodium acifluorfen, EPA is concerned about any MOE less than
1000, which incorporates the FQPA safety factor and is intended to be protective of females age 13-
50 years. For the only potential exposure scenario, spot treatment with a ready-to-use trigger sprayer,
EPA estimated an MOE of 18000, which is not of concern to the Agency. Furthermore, EPA has no
concerns for post-application residential exposure because residential uses are limited to spot
treatments, which do not include broadcast application to lawns, therefore, post-application exposure is
expected to be negligible.
vn
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Aggregate Risk
An aggregate assessment was conducted for exposures through food, residential uses, and
drinking water. Based on the results of this aggregate assessment, the Agency made a determination
that the human health risks from these combined exposures to sodium acifluorfen, or the acifluorfen
degradate, are not of concern.
The acute aggregate risk from food and drinking water are not of concern. The acute Drinking
Water Level of Comparison (DWLOC) is for females 13-50 years old, the only population at
potential risk from acute effects. The modeled acute surface water EDWC for the acifluorfen
degradate is 10.12 ppb and the modeled acute groundwater EDWC is 3.71 ppb.
Short-term aggregate risk from food, drinking water, and residential exposure, are not of
concern. The short-term DWLOC is 462 ppb for females 13-50 years old, the only population at
potential risk from acute effects. The DWLOC is greater than the highest modeled EDWCs for total
acifluorfen exposure of 2.43 ppb for surface water and 3.71 ppb for ground water.
The chronic aggregate risks from food and drinking water are also not of concern. The chronic
drinking water EDWCs (for both surface and ground water sources) are less than the chronic
DWLOCs, regardless of the source of drinking water. The chronic DWLOC for the general
population is 120 ppb. The highest modeled chronic (average) drinking water EDWC is 2.43 ppb for
surface water and 3.71 ppb for ground water. The cancer aggregate risk is also not of concern. The
chronic drinking water EDWCs (for both surface and ground water sources) are less than the cancer
DWLOCs.
Occupational Risk
EPA assessed occupational exposure to sodium acifluorfen using data from the Pesticide
Handler Exposure Database (PHED) and proprietary data, including chemical-specific data submitted
by the technical registrant for sodium acifluorfea Occupational exposure to sodium acifluorfen is not of
concern to the Agency for handlers using the PPE specified on the current labels or in this RED
document.
Anticipated use patterns and current labeling for sodium acifluorfen indicate six major
occupational exposure scenarios which can result in handlers receiving dermal and inhalation exposures
to sodium acifluorfen. These exposure scenarios are based on the chemical formulations, equipment
and techniques that handlers use to make sodium acifluorfen applications. At baseline PPE, handler
risks for three of the six scenarios are not of concern. For the remaining three scenarios, the use of
chemical-resistent gloves is sufficient to mitigate the risk.
vin
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The post-application occupational risk assessment considers exposures to agricultural workers
re-entering treated areas for activities such as scouting, hand weeding, and irrigating. All post-
application exposure is considered to be short- or intermediate-term based on the frequency and
duration of activities and the dissipation of acifluorfen.
The post-application worker risk calculations indicated that the MOEs were greater than 100
on Day 0, and therefore not of concern. Because sodium acifluorfen is in acute Toxicity Category I for
eye irritation and Category II for skin irritation, the current restricted entry intervals of 48 hours are
appropriate and will remain unchanged.
Ecological Risk
The Agency conducted a screening level ecological risk assessment to determine the potential
impact of sodium acifluorfen use on non-target terrestrial and aquatic organisms. The Agency used
modeling to evaluate ecological risks for sodium acifluorfen.
The Agency has minor concerns for chronic risk to birds that feed on short grasses with RQs
slightly exceeding the Agency's level of concern. In a refined assessment, which uses mean residues,
the only scenario that showed a potential risk concern was for birds that eat short grasses with RQs
ranging from 0.15 to 1.6, which slightly exceed the level of concern of 1.0.
The Agency has no concerns for the impacts of sodium acifluorfen on mammalian species. In a
worst case acute scenario, the acute RQ is less than 0.01 and not of concern. Chronic RQs for
mammals range from less than 0.05 to less than 0.01. No chronic mammalian RQs exceed the
Agency's level of concern for any registered use.
The Agency has no concerns for the impacts of sodium acifluorfen on aquatic organisms. The
risk assessment shows that the RQs for all aquatic species are less than 0.1, which is well below any of
EPA's levels of concern.
The Agency's review of sodium acifluorfen resulted in a determination lhat sodium acifluorfen
will have "no effect" on threatened and endangered aquatic organisms, mammals, and birds. Although
chronic RQs for birds which eat short grass exceed the level of concern, the only listed endangered
species that consumes short grass is the Hawaiian goose, which resides on golf courses in Hawaii.
Because sodium acifluorfen is not used in or around this bird's habitat, the Agency concludes that there
is "no effect" to endangered birds.
Limited information is available about the toxicity of sodium acifluorfen to non-target plants.
Because of the limited data, EPA is unable to conduct a risk assessment for non-target plants at this
time. Because sodium acifluorfen is an herbicide, there may be some risk to non-target plants exposed
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via drift. Therefore, the Agency is requiring several label amendments to limit the potential for drift. In
addition, the Agency is requiring confirmatory plant toxicity data.
Sodium acifluorfen belongs to a class of compounds known to have a phototropic mode of
action in plants and animals. Since there is evidence that such chemicals have increased toxicity in the
presence of light, a confirmatory phototoxicity study is required.
Regulatory Decision
The Agency has determined that sodium acifluorfen is eligible for reregistration provided that:
(1) current data gaps and additional data needs are addressed and (2) the risk mitigation measures
outlined in this document are adopted, and label amendments are made to reflect these measures. The
Agency is issuing this RED document for sodium acifluorfen, as announced in a Notice of Availability
published in the Federal Register. This RED includes guidance and requested time frames for making
any necessary label changes for products containing sodium acifluorfen. The Agency is providing a final
30-day opportunity for stakeholders to respond to the sodium acifluorfen risk management decision. If
substantive information is received during the comment period, which indicates that any of the Agency's
assumptions need to be refined and that additional risk mitigation is warranted, appropriate
modifications will be made at that time.
Summary of Mitigation Measures
EPA believes that sodium acifluorfen is eligible for reregistration provided the following actions
are implemented, combined with the general mitigation measures previously described:
Dietary Risk
• An approved labeled use for strawberries and use directions are required to maintain the
tolerance on strawberries (OPPTS 860.1200).
• A 100-day plant-back interval is necessary for all rotated crops except small grains, which
require a 40-day plant-back interval.
Groundwater label advisory must be maintained on all labels.
Confirmatory data are required, including a developmental neurotoxicity study and
determination of a lower LOQ for the analytical method.
Residential Risk
• No label changes are necessary.
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Occupational Risk
No label changes are needed.
PPE can be reduced to baseline with chemical-resistant gloves for technical sodium acifluorfen.
Additional PPE may be required on a product-specific basis.
Ecoloeical Risk
Label amendments to minimize the potential for spray drift.
Confirmatory data are required, including Aquatic Phototoxicity (modified fish early life stage),
Honey Bee Acute Contact, Vegetative Vigor, and Seedling Emergence studies.
XI
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection
Agency, henceforth 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 the pesticide
meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 19%, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require reassessment of all existing tolerances for pesticides in food and
also requires that EPA review all tolerances in effect on August 3,2006, the day before the enactment
of the FQPA, by August 3,2006. The Agency has decided that, for those chemicals that have
tolerances and are undergoing reregistration, the tolerance reassessment will be initiated through this
reregistration process. FQPA also requires that, when considering whether to establish, modify, or
revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity."
Sodium acifluorfen is a member of the diphenyl ether group of herbicides, which includes lactofen,
oxyfluorfen, nitrofen, and fomesafen. The Agency has evidence that these compounds induce similar
toxic effects but has not yet determined whether these compounds exhibit a common mechanism of
toxicity. For the purposes of tolerance reassessment, and a determination of the reregistration eligibility
for sodium acifluorfen, EPA is assuming that sodium acifluorfen does not share a common mechanism
of toxicity with other compounds. However, sodium acifluorfen's primary degradate is the acifluorfen
anion, which is also a degradate of another herbicide, lactofen. Because lactofen will degrade to
acifluorfen in the environment, the reregistration eligibility decision (RED) for sodium acifluorfen and the
tolerance reassessment decision (TRED) for lactofen include assessments aggregating the potential
exposure to acifluorfen from the use of both pesticides.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues
for which policies need to be created. These issues were refined and developed through collaboration
between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was later
superceded by the Committee to Assist with Reassessment and Transition (CARAT). Both federal
advisory committees were composed of representatives from industry, environmental groups, and other
interested parties. Although FQPA significantly affects the Agency's reregistration process, it does not
amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its reregistration
program while it resolves the remaining issues associated with the implementation of FQPA.
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On September 29,2000, the Agency issued a Pesticide Registration Notice (PR 2000-9) that
presents EPA's approach for managing risks from organophosphate pesticides to occupational users.
This Worker PR Notice describes the Agency's baseline approach to managing risks to handlers and
workers who may be exposed to organophosphate pesticides. The Agency expects that other types of
chemicals, such as sodium acifluorfen, will be handled similarly. Generally, basic protective measures
such as closed mixing and loading systems, enclosed cab equipment, or protective clothing, as well as
increased restricted entry intervals will be necessary for most uses where current risk assessments
indicate a risk and such protective measures are feasible. The policy also states that the Agency will
assess each pesticide individually, and based upon the risk assessment, determine the need for specific
measures tailored to the potential risks of the chemical. The measures included in this RED are
consistent with the Worker PR Notice.
This document presents the Agency's revised human health and ecological risk assessments; its
progress toward tolerance reassessment; and the reregistration eligibility decision for sodium
acifluorfen. This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment Section II provides a profile of the use and usage of the
chemical. Section ffl gives an overview of the revised human health and environmental effects risk
assessments resulting from public comments and other information. Section IV presents the Agency's
decision on reregistiation eligibility and risk management for sodium acifluorfen. Section V summarizes
the label changes necessary to implement the risk mitigation measures outlined in Section IV. Section
VI provides information on how to access related documents. Finally, the Appendices list references
and contain other information, such as the Data Call-ins (DCIs) to be issued with this RED. The
preliminary and revised risk assessments for sodium acifluorfen dated through April 30, 2002 are
available in the Public Docket, under docket numbers OPP-3424A and B, and on the Agency's web
page, www.epa.gov/pesticides/reregistration/status.h1in. Because the Agency implemented a new
docketing system in July 2002, documents dated from May 1,2002 to the present are in the docket
OPP-2003-0293 and on the internet at a different site, http://www.epa.gov/edockets.
II. Chemical Overview
A. Regulatory History
Sodium acifluorfen was first registered in the United States in 1980 by the Rohm and Haas
Company as the herbicide Blazer® for post-emergent weed control on agricultural crops. Sodium
acifluorfen is also registered for residential spot treatment. There is no Registration Standard for
sodium acifluorfen, but EPA issued three Data Call-Ins (DCIs) in June 1991, March 1995, and
October 1995. BASF Corporation purchased the registration and supporting data in 1987. In 1984,
another company, Rhone-Poulenc also registered a sodium acifluorfen product, Tackle®, but this
product was sold to BASF, with supporting data, in 1992. BASF is currently the only technical
registrant.
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B. Chemical Identification
Sodium Acifluorfen:
Common Name:
Chemical Name:
Chemical family:
Case number: 2605
CAS registry numbers:
OPP chemical code:
Empirical formula:
Molecular weight: 361.66
Trade and other names: Blazer®, Status®
Sodium salt of acifluorfen
Sodium 5[2-chloro-4-(trifluoromethyl)phenoxy]-2-
nitrobenzoate
Diphenyl Ether
62476-59-9 (sodium acifluorfen)
50594-66-6 (acifluorfen)
114402
Basic manufacturer:
BASF Corporation
Technical grade sodium acifluorfen (78% pure) is a light yellow powder with a melting point of
274-279° C (with decomposition), octanol/water partition coefficient of 1.55 at pH 7, and vapor
pressure of less than 1.33 x 10'5 Pascal at 25° C. Sodium acifluorfen is soluble in water (62.07 g/100
mL), and most organic solvents (64.15 g/100 mL in methanol, 5.37 g/100 mL in octanol), and is
practically insoluble (less than 5.0 x Itf5 g/100 mL) in hexane at 25° C.
C. Use Profile
The following information is based on the currently registered uses of sodium acifluorfen:
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Type of Pesticide: Herbicide
Mode of Herbicidal Action: Primary target site appears to be protoporphyrinogen oxidase
(protox), an enzyme involved with the biosynthesis of chlorophyll that is necessary for plants to
carry out photosynthesis.
Summary of Use Sites:
Terrestrial or aquatic food and/or feed crop
• Soybeans
Rice
• Peanuts
Terrestrial non-food and outdoor residential
• Mulch
• Ornamental and/or shade trees
• Ornamental herbaceous plants
• Ornamental lawns and turf
• Ornamental woody shrubs and vines
Paths/patios
Paved areas (private roads/sidewalks)
Public Health Uses: None
Target Pests: amaranth (Palmer and spiny); balloon vine; beggarweed (Florida); bindweed
(field and hedge); buckwheat (wild); buffalo bur, bur gherkin; Canada thistle; carpetweed;
cocklebur (common and heartleaf); copperleaf (hophombeam and Virginia); crabgrass (large
and smooth); crotalaria (showy); croton (tropic and woolly); cucumber (wild spring); Devil's
claw; Eclipta; foxtail (giant, green, and yellow); galinsoga (hairy and small flower); gourd
(Texas); ground cherry (cutleaf and lance leaf); jimsonweed; Johnson grass; indigo (hairy);
lady's thumb; lambs quarters (common); mallow (Venice); melon (citron and smell); milkweed
(climbing and common); morning glory (common, pitted, cypress vine, entire leaf, ivy leaf, palm
leaf, purple moonflower, scarlet, small white, small flower, tall, and willow leaf); mustard (black
and wild); nightshade (black); Panicum (fall); pigweed (prostrate, redroot, smooth, and spiny);
poinsettia (wild); poorjoe; purslane (common), pusley (Florida); ragweed (common and giant);
redvine; sandbur (field); senna (coffee); hemp sesbania; shatter cane; smartweed
(Pennsylvania); spurge (prostrate, spotted); starbur (bristley); trumpet creeper, Velvetleaf;
waterhemp (tall).
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Formulation Types Registered: Liquid, ready-to-use (RTU) and soluble concentrate
Method and Rates of Application:
Equipment - Aircraft; Boom sprayer, Ground equipment; Hand held sprayer; Trigger
spray bottle
Method - Band treatment; Broadcast; Low volume spray (concentrate); Spot
treatment; Spray
Timing - At cracking; Early boot; Late tillering; Post-emergent; Post-plant; Pre-
emergent; Tiller through boot
Use Classification: General use
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of sodium
acifluorfen, based on available pesticide usage information for the years 1987 to 1997. This
information was used in risk assessment for sodium acifluorfen. Additional details are available in the
"Quantitative Use Assessment" document, which is available in the public docket and on the Internet.
The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as
well as the variability in using data from various information sources. Approximately 1.5 million pounds
active ingredient (a.i.) of sodium acifluorfen are used annually, according to Agency and registrant
estimates. The largest markets for sodium acifluorfen, in terms of total pounds of active ingredient, is
allocated to soybeans (94% of a.i. produced). However, use of sodium acifluorfen has been declining
in recent years with the availability of Roundup Ready® soybeans. The USDA's National Agricultural
Statistics Service (NASS) reports that a total of only 325,000 Ibs of sodium acifluorfen was applied to
soybeans in 2002.
Although sodium acifluorfen is registered for residential use, this is very minor compared to the
agricultural uses. Only one product is registered for residential use, however, the use of this product is
limited to a spot treatment with a ready-to-use formulation packaged in a bottle with a trigger sprayer.
Broadcast use on lawns is not expected because the product packaging is not designed for broadcast
application, and sodium acifluorfen is a non-selective herbicide that will kill both weeds and grass.
Table 1. Sodium Acifluorfen Estimated Usage
Crop
Peanuts
Pounds Active Ingredient Applied
Weighted Average1
56,000
Estimated Maximum
113,000
Percent Crop Treated
Weighted Average
11
Likely Maximum
19
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Crop
Rice
Soybeans
Total
Pounds Active Ingredient Applied
Weighted Average1
28,000
1,360,000
1,444,000
Estimated Maximum
48,000
1,710,000
1,871,000
Percent Crop Treated
Weighted Average
4
9
N/A
Likely Maximum
6
12
N/A
1 Weighted Average is based on data for!987-1997; the most recent years and more reliable data are weighted more
heavily.
N/A, Not applicable.
III. Summary of Sodium Acifluorfen Risk Assessment
The purpose of this summary is to assist the reader by identifying the key features and findings
of these risk assessments, and to help the reader better understand the conclusions reached in the
assessments. The following list of human health and ecological risk assessment documents and
supporting information were used to formulate the safety finding and regulatory decision for the
herbicide sodium acifluorfen. These documents may be found on the Agency's web page at
www.epa.gov/pesticides/reregistration/status.htm (documents through April 2002) or at
www.epa.gov.edockets under docket OPP-2003-0293 (documents from May 2002 to the present).
Hard copies of these documents may be found in the OPP public docket numbers OPP-34241A and
B, for documents dated through April 2002, and number OPP-2003-0293, for documents dated from
May 2002 to the present. The OPP public docket is located in Room 119, Crystal Mall H, 1921
Jefferson Davis Highway, Arlington, VA. The public docket is open Monday through Friday, excluding
Federal holidays, from 8:30 a.m. to 4:00 p.m.
The term "sodium acifluorfen" refers to the technical active ingredient. Sodium acifluorfen is a
salt which dissociates to sodium (Na+) and acifluorfen (acifluorfen-) ions in the environment.
Therefore, the term "acifluorfen ion" or "acifluorfen degradate" is used to describe the chemical species
that is seen in the environment under most conditions.
Lactofen, a pesticide related to sodium acifluorfen, can also degrade to the acifluorfen
ion/degradate in the environment. Lactofen is an herbicide used on soybeans, snap beans, and cotton
and in forestry. Plant and animal metabolism studies show that acifluorfen is not found in treated food,
making drinking water the only potential source of exposure to the acifluorfen degradate derived from
lactofen. Because approximately 58% of applied lactofen can degrade to acifluorfen in the
environment, EPA estimated total acifluorfen residues from use of both sodium acifluorfen and lactofen
to estimate the risk of exposure to the acifluorfen ion/degradate from drinking water.
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A. Human Health Risk Assessment
EPA released its preliminaiy risk assessments for sodium acifluorfen for public comment on July
26,2001 (Phase 3 of the public participation process). In response to comments received and new
studies submitted during Phase 3, the risk assessments were updated and refined. EPA issued the
revised risk assessments for sodium acifluorfen for a second public comment period on April 12,2002
(Phase 5). The risk assessment was revised again on July 14,2003 to incorporate comments and
additional studies submitted by the registrant during and after Phase 5. Major revisions to the human
health risk assessment include the following:
• Revising the cancer classification of sodium acifluorfen to include the mode of action of tumor
formation from new studies and the Agency's revised cancer risk assessment guidelines;
• Using a margin of exposure (MOE) approach to evaluate cancer risks;
• Revising the drinking water assessment to include results from a new prospective groundwater
monitoring study for lactofen;
Considering personal protective equipment on current acifluorfen labels in the occupational
exposure assessment; and
• Incorporating chemical-specific foliar dislodgeable residue data into the occupational exposure
assessment.
1. Dietary Risk from Food
a. Toxicity
EPA has reviewed all toxicity studies submitted to the Agency and has determined that the
toxicity database is substantially complete for all currently registered uses. Further details on the
toxicity of sodium acifluorfen can be found in the technical support documents cited in Appendix C.
The toxicology studies used for the dietary risk assessment are outlined in Table 2 in this document.
For the purposes of this RED, sodium acifluorfen and the acifluorfen ion/degradate are assumed to be
of equal toxicity.
b. FQPA Safety Factor
For acute dietary exposure, the 10X FQPA safety factor was retained based on (1) qualitative
evidence of increased susceptibility to offspring following in utero exposure to sodium acifluorfen in a
rat developmental toxicity study and (2) the lack of a developmental neurotoxicity study (OPPTS
870.6300) to further define neurotoxic potential. The rat developmental toxicity study showed
treatment related anomalies in the development of the fetal nervous system in the presence of minimal
maternal toxicity at the same dose. The developmental neurotoxicity study is designed to evaluate
neurotoxic effects on the mother and fetus from fertilization of the egg through birth. This study is
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expected to provide additional information which could be used to further characterize the effects of
sodium acifluorfen on the developing fetus, and will be included in the DCI for this RED as confirmatory
data. The acute FQPA safety factor of 10X applies only to women of childbearing age (females age
13-50 years). Because the existing toxicology database for sodium acifluorfen shows no other acute
effects relevant to the general population, the FQPA safety factor is not relevant to any other population
subgroup. For the same reasons the 10X FQPA safety factor is applied to acute dietary exposure, a
10X FQPA safety factor is also applied to short-term residential exposure (to be discussed later in this
document).
For chronic dietary exposure, the FQPA safety factor was reduced to 3X for women of
childbearing age, infants, and children based on the data gap for the developmental neurotoxicity study.
As previously mentioned, this study provides important information about the susceptibility of infants,
children, and women of childbearing age to potential neurotoxic effects following single or repeated
exposure to a chemical in utero. For sodium acifluorfen, EPA has determined that the increased
susceptibility seen in the rat developmental toxicity study, which supported use of a 10X FQPA safety
factor for acute exposure, has no bearing on chronic exposure scenarios because the developmental
effects could occur after a single dose.
c. Population Adjusted Dose (PAD)
The Population Adjusted Dose (PAD) is the dose at which an individual could be exposed
where no adverse health effects would be expected. The PAD is derived from the acute or chronic
Reference Dose (RfD), adjusted to account for the FQPA safety factor (i.e., the PAD is the acute or
chronic RfD divided by the FQPA safety factor). In the case of sodium acifluorfen, the Agency has
determined that different FQPA safety factors should be used to assess acute and chronic exposure.
Specifically, the Agency has determined that a 1 OX FQPA safety factor should be used to assess risk
from acute exposure and a 3X FQPA safety factor should be used to assess risk from chronic
exposure. The acute PAD for females 13-50 years old is 0.02 mg/kg/day. No acute PAD has been
established for the general population because the toxicity database did not indicate any potential acute
effects other than developmental toxicity, which is relevant only to females of childbearing age. The
chronic PAD for infants, children, and females 13-50 years old is 0.004 mg/kg/day and 0.013
mg/kg/day for all other population subgroups. Table 2 summarizes the data and the uncertainty factors
used to derive each PAD used in the dietary risk assessment.
d. Carcinogenicity
Sodium acifluorfen was previously classified as a B2 chemical carcinogen (probable human
carcinogen). Cancer risk from sodium acifluorfen was quantified using the Agency's default approach
described in the Agency's 1986 Cancer Risk Assessment Guidelines. When much uncertainty exists
regarding the mode of carcinogenic action, EPA assumes the tumor dose response from a cancer study
is linear. In the absence of adequate information to the contrary, the linearized multistage procedure is
8
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applied to the tumor response data to calculate the cancer unit risk (Qi *), which is the upper
confidence limit (95th percentile) of the dose response curve. This linear low dose approach used to
estimate cancer risk is believed to be conservative.
In accordance with the Agency's draft 1999 Cancer Risk Assessment Guidelines, a Margin of
Exposure (MOE) approach may be used for non-mutagenic carcinogens when a mode of action has
been clearly demonstrated and the tumor dose-response data are not linear. This approach assumes
that tumors occur only at doses above a certain threshold (at which effects are seen in rodent studies).
Cancer risk is calculated as an MOE by dividing a NOAEL for cancer (or a precursor effect) by the
exposure value. The uncertainty factors) that determine whether a cancer MOE is of concern will vary
according to the specific chemical and the nature of the tumor and its precursor effects.
In February 2001, the registrant petitioned the Agency to reevaluate the cancer risk assessment
for sodium acifluorfen using an MOE approach rather than the traditional linear low dose (Qi *)
approach. As part of the petition to reevaluate the cancer risk assessment, the registrant developed
additional data on a possible cancer mode of action involving peroxisome proliferation in the mouse
liver, and submitted these data to the Agency. EPA evaluated these data using criteria developed at a
1995 International Life Sciences Institute (ILSI) workshop on peroxisome proliferation.2 Based on this
review, the Agency determined that these data are sufficient to support peroxisome proliferation as the
mode of action of acifluorfen liver tumors in mice.
Based on the results of the mode of action studies with sodium acifluorfen and reviews of the
carcinogen bioassays conducted with the pesticide, the Agency classified sodium acifluorfen as "likely
to be carcinogenic to humans at high enough doses to cause the biochemical and histopathological
changes in livers of rodents but unlikely to be carcinogenic at doses below those causing these
changes." The Agency also determined that the forestomach papillomas seen in male and female mice
are of questionable relevance to human health risk assessment because humans do not have a
forestomach and because the rodent forestomach has a structure and function not found in the human
stomach. For sodium acifluorfen, EPA determined that an MOE approach is appropriate to estimate
human cancer risk and that the NOAEL of 1.25 mg/kg/day from a rat 2-generation reproductive
toxicity study is adequately protective. This NOAEL was used to derive the chronic RfD for sodium
acifluorfen and is considered to be protective of all chronic effects, including the physiological changes
that lead to cancer. Because of the threshold nature of the cancer effect, the cancer endpoint for
sodium acifluorfen is relevant only to chronic or long-term exposure scenarios.
2 The ILSI Criteria were published in Regulatory Toxicology and Pharmacology 27:47-60, 1998.
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Table 2. Summary of lexicological Endpoints and Other Factors Used in the Human Dietary Risk
Assessment of Sodium Acifluorfen
Population
Group(s)
NOAEL
(mg/kg/day)
Endpoint
Study
Uncertainty
Factors
FQPA
Safety
Factor
PAD
(mg/kg/day)
Acute Dietary
Females 13-
50 years
All Other
Groups
20
(LOAEL = 90)
None
decreased fetal weight &
increased incidence of
anatomical variations of
brain
No relevant acute endpoint
Rat
Developmental
Toxicity
(MRID 00122743)
None
100
N/A
10
N/A
0.02
None
Chronic Dietary (Noncancer)
Infants,
Children,
Females 13-
50yrs
All
Populations
1.25
(LOAEL = 25)
1.25
(LOAEL = 25)
Kidney lesions (dilated
renal tubules of outer
medulla) in females of both
generations
Kidney lesions (dilated
renal tubules of outer
medulla) in females of both
generations
Rat 2-Gen. Repro.
Toxicity Study
(MRID 00155548)
Rat 2-Gen. Repro.
Toxicity Study
(MRID 00 155548)
100
100
3
1
0.004
0.013
Chronic Dietary (Cancer)
All
Populations
1.25
(LOAEL = 25)
Kidney lesions (dilated
renal tubules of outer
medulla) in females of both
generations
Rat 2-Gen. Repro.
Toxicity Study
(MRID 001 55548)
100
1
0.013
NOAEL, no observed adverse effect level.
LOAEL, lowest observed adverse effect level.
UF, uncertainty factor used to derive RfD from the NOAEL. Typically, a UF of 10X is used to account for
intraspecies variability and another 10X UF is used to account for interspecies extrapolation.
PAD, population adjusted dose, derived from the acute or chronic RfD adjusted for the FQPA safety factor.
e. Dietary Exposure from Food
Specific assumptions used in the acute, chronic, and cancer dietary assessments are
summarized below. Dietary exposure to residues in food is from use of sodium acifluorfen herbicide
only, and not from the use of lactofen because plant and animal metabolism studies show that lactofen
does not metabolize to acifluorfen in food.
The dietary exposure analysis is based on the Dietary Exposure Evaluation Model (DEEM™).
The DEEM™ analysis evaluated individual food consumption as reported by respondents in the USDA
1989-92 Continuing Surveys for Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. Because no Food and Drug Administration (FDA) or US Department
10
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of Agriculture (USDA) residue monitoring data were available for sodium acifluorfen, the residue values
used in the dietary risk assessment were based on field trial data. The acute, chronic, and cancer
dietary risk assessments were highly refined, Tier III probabilistic assessments, which incorporate
percent crop treated information.
For the acute dietary exposure, high-end field trial residues incorporating the likely maximum
percent crop treated information (from Table 1) were used as a point estimate for the blended
commodities, rice, peanuts, and soybeans. Because no relevant effects following a single exposure of
sodium acifluorfen were identified for the U.S. general population, an acute dietary risk assessment for
the entire U.S. population was not conducted. The only acute effect identified was developmental
toxicity, which is relevant only to women of childbearing age. Therefore, an acute dietary risk
assessment was conducted for females 13-50 years of age only, because developmental effects could
occur after a single dietary exposure.
For the chronic (non-cancer) dietary risk assessment, EPA used anticipated residue values
based on field trial studies and concentration factors from processing studies. The Agency also used an
average of consumption values for each sub-population combined with average residue values in/on
commodities over a 70-year lifetime to determine average exposure.
Chronic (cancer) dietary risk is typically calculated by using the average consumption values for
food and average residue values for those foods. For sodium acifluorfen, the chronic dietary cancer
risk is based on the same NOAEL and uncertainty factors that were used to calculate the chronic PAD.
Therefore, the chronic dietary risk assessment is considered to be protective of cancer effects.
f. Summary of Dietary Risk from Food
In general, a dietary risk estimate that is less than 100% of the acute or chronic PAD does not
exceed the Agency's level of concern. The sodium acifluorfen acute and chronic dietary risk from food
is well below the Agency's level of concern. The Tier HI assessment showed that acute dietary
exposure from food comprises less than 1% of the acute PAD for females age 13-50 years, the only
population at potential risk from acute effects. Acute dietary risk for the general population is not of
concern because no acute PAD has been established for this population group.
The chronic dietary risk from food alone is also well below the Agency's level of concern.
Chronic dietary exposure from food comprises less than 1% of the chronic PAD for the U.S.
population and all subpopulations. As mentioned previously, the chronic dietary (food) risk assessment
for non-cancer effects is identical to protective of cancer effects. Therefore, the chronic dietary risk
from cancer is also not of concern.
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2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through groundwater and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either screening-level modeling or actual monitoring data, if available, to estimate those risks.
Modeling is a screening tool that provides a high-end estimate of risk. The PRZM-EXAMS models
with the Index Reservoir and Crop Area Factor were used to estimate surface water concentrations.
The SCI-GROW model was used in conjunction with the results of a sodium acifluorfen prospective
groundwater monitoring study to estimate groundwater concentrations of the degradate acifluorfen.
Although some surface water monitoring data were available for acifluorfen, these data were not
considered appropriate to use as a basis for a national drinking water assessment.
In the environment, when Hie pH is greater than 3.5, sodium acifluorfen dissociates to sodium
(Na+) and the acifluorfen (acifluorfen') ion/degradate. Lactofen, a related pesticide, can also degrade
to the acifluorfen ion in the environment by a different pathway. Because approximately 58% of
applied lactofen can degrade to acifluorfen, EPA estimated total acifluorfen residues, from both sodium
acifluorfen and lactofen uses, to estimate the risk of exposure to the acifluorfen degradate. In other
words, the Agency considered all sources of potential drinking water exposure to the acifluorfen
degradate.
a. Environmental Parameters Impacting Water Assessment
The persistence and mobility of acifluorfen vary with soil conditions. Sodium acifluorfen exists
as the negatively charged acifluorfen anion in most agricultural soils because it has an acid dissociation
constant (pKJ of 3.5. Soil pH usually exceeds the pKa for sodium acifluorfen; therefore, under typical
environmental conditions, the sodium acifluorfen salt dissociates to the sodium cation (Na+) and the
acifluorfen anion (acifluorfen). When acifluorfen exists as the anion, it is not expected to sorb to
negatively charged soil particles, such as clay, but it may be sorbed by other types of chemical
reactions. The adsorption and desorption of acifluorfen to soil is dependent on soil pH, organic carbon
content, and amount and type of clay, and content of other minerals. Sorption of the acifluorfen anion
appears to be a non-equilibrium, time dependent process.
Sodium acifluorfen is extremely soluble in water and stable to hydrolysis in soil. An aerobic soil
metabolism study for sodium acifluorfen shows that the acifluorfen degradate is relatively persistent in
soil, with a half-life ranging from 108 to 200 days. The aerobic aquatic metabolism study also showed
that the acifluorfen degradate is relatively stable in aquatic environments, with an approximate half-life of
117 days. However, sodium acifluorfen degrades more rapidly under anaerobic conditions, where the
soil half-life is 30 days and the aquatic half-life is estimated to be 2.75 days.
The acifluorfen degradate may reach surface water via runoff events or from discharge of
contaminated groundwater into surface water. In some vulnerable areas, acifluorfen may also migrate
12
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to groundwater, where it is expected to persist due to its stability to abiotic hydrolysis. Additional
information about the environmental fate of sodium acifluorfen may be found in the environmental fate
and ecological effects risk assessment and other technical support documents listed in Appendix C.
b. Water Monitoring
Because the environmental fate properties of the acifluorfen degradate and retrospective
groundwater monitoring studies for sodium acifluorfen showed that acifluorfen has the potential to leach,
EPA required a small-scale prospective groundwater (PGW) monitoring study for sodium acifluorfen.
This study was conducted in the Central Sands of Wisconsin, on a soil type that is highly vulnerable to
leaching. This study analyzed for acifluorfen and two other degradates, but only acifluorfen was
detected, in concentrations ranging from 1 to 46 ppb in 56 of 283 groundwater samples. The mean
concentration of all samples from this study was 8.36 ppb. The average concentration for the detects
from the last day of sampling was 15.2 ppb. By comparison, modeled estimates of acifluorfen
concentrations in groundwater range from 0.19 to 10.33 ppb. hi the PGW study, acifluorfen was
generally found in the shallowest monitoring wells, suggesting that it was moving with groundwater flow.
Based on the multiple detections of acifluorfen residues and known use of sodium acifluorfen at the
study site, EPA believes that acifludrfen may contaminate shallow groundwater in areas with highly
vulnerable soils, such as the Central Sands of Wisconsin.
The acifluorfen degradate has also been detected in surface and groundwater monitoring
conducted by the US Geological Survey (USGS) in the National Water Quality Assessment Program
(NAWQA). For surface water, NAWQA reports a maximum detection of 2.2 ppb for acifluorfen.
For groundwater, NAWQA reports acifluorfen detects ranging from 0.035 to 0.19 ppb. Other
groundwater monitoring studies cited in the EPA's Pesticides in Groundwater Database showed
detections ranging from 0.003 to 0.025 ppb in 4 of 1,185 wells sampled. However, none of this
monitoring was specifically targeted to sodium acifluorfen use sites.
Lactofen, another herbicide which also degrades to acifluorfen, is not routinely included in
water monitoring studies due to its short half-life and low mobility. The Agency is not aware of any
reported detections of lactofen in surface water or groundwater. The lactofen registrant sponsored a
small-scale, PGW study for lactofen, which was inconclusive because it did not confirm whether or not
leaching actually occurred at the site. A second small-scale, lactofen PGW study conducted in
Michigan was recently completed and submitted to the Agency (MRID 45691701). This study was
also used to inform the decision for sodium acifluorfen. hi this most recent study, neither lactofen nor
acifluorfen were found in groundwater, although acifluorfen residues were detected in lysimeters at
shallow and medium depths (3 and 6 feet). The limit of detection in the study was 0.05 ppb for lactofen
and 0.035 ppb for acifluorfen. From this study, EPA concludes that lactofen is not expected to leach to
groundwater, but that the acifluorfen degradate is likely to leach.
13
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Much lower levels of the acifluorfen degradate were detected in the PGW study for lactofen
than in the study for sodium acifluorfen. EPA believes that this is due to differences in the material
tested (sodium acifluorfen vs. lactofen), different degradation pathways, and the sorption of the
acifluorfen degradate. Specifically, in the lactofen study, less acifluorfen degradate was available
because only a percentage of lactofen (58%) applied degrades to acifluorfen and because a lower
application rate was used. Also, lactofen does not degrade instantaneously to acifluorfen in the soil.
Lactofen may degrade via two pathways, either lactofen degrades directly to acifluorfen or lactofen
degrades to desethyl lactofen and then to acifluorfen. The acifluorfen degradate derived from lactofen,
therefore, will not move through the soil matrix as a single pulse. Literature suggests that sorption of
acifluorfen to soil particles is time dependent; greater sorption occurs with longer contact time.
In conclusion, acifluorfen derived from sodium acifluorfen may have greater potential to leach to
groundwater than acifluorfen derived from lactofen. The existing water monitoring data for acifluorfen
and lactofen show that acifluorfen may leach to groundwater under certain conditions, but that these
compounds do not leach to groundwater in all vulnerable soils. The PGW study for sodium acifluorfen
showed leaching of the acifluorfen degradate in the Central Sands of Wisconsin, an extremely
vulnerable soil. The acifluorfen degradate also leached to soil pore water in the PGW study for
lactofen, but because of the factors discussed in the previous paragraph, the levels seen were much
lower, and it was not found in groundwater.
A Tier IIPRZM-EXAMS screening-level model was used to estimate the upper-bound
concentrations of acifluorfen in drinking water derived from surface water sources. This model includes
the Index Reservoir (IR) and Percent Crop Area (PCA) refinements. Two model scenarios were
selected to represent sodium acifluorfen uses: peanuts in North Carolina and soybeans in Mississippi.
Two modeling scenarios were also considered for lactofen: cotton and soybeans in Mississippi. The
scenarios with lactofen reflect acifluorfen derived from lactofen. Soybeans and cotton uses were
modeled because they are the crops with the highest application rates. EPA incorporated the PCA
factor refinement into the model results, which are summarized in Table 3 below. The model results
provided are Estimated Drinking Water Concentrations (EDWCs) of the degradate acifluorfen.
14
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TableS. Estimated Drinking Water Concentrations (EDWCs)1 of Acifluorfen in Surface Water
Crop/Source of Acifluorfen
PCA
Surface Water EDWC (ppb)
1 in 10 Year
Maximum
(Acute)
1 in 10 Year
Average
(Chronic)
1 in 30 Year
Average
(Cancer)
Acifluorfen Derived from Sodium Acifluorfen
Soybeans
Peanuts2
0.41
0.87
0.38
7.47
11.40
4.98
1.91
4.22
1.84
1.10
2.51
1.10
Acifluorfen Derived From Lactofen
Cotton
Soybeans
0.20
0.41
2.99
2.65
0.53
0.52
0.21
0.24
Total Acifluorfen from all Sources
Total from Soybeans
N/A
10.12
2.43
1.34
1 Estimated values were calculated using the Tier II PRZM/EXAMS model, which was adjusted for the
Percent Crop Area (PCA) factor.
2 For peanuts, two PCA factors were modeled, a default PCA of 0.87 developed in 2000 and a regional PCA of
0.38 developed in 2003.
c. Groundwater Modeling
A Tier I screening-level model, SCI-GROW, was used to estimate the potential concentration
of acifluorfen from sodium acifluorfen uses in groundwater sources for drinking water, such as wells or
aquifers. The SCI-GROW screening model is used to estimate pesticide concentrations under
vulnerable hydrological conditions. For the acifluorfen degradate, there is considerable uncertainty in
several fate parameters used as model inputs, including the soil partition coefficient (K,,,.), the aerobic
soil metabolism half-life, and the sorption, which is influenced by site specific soil parameters such as
pH and mineral content. Another major area of uncertainty is the sorption/desorption of acifluorfen to
various soils. Therefore, EPA has considerable uncertainty in the estimated concentrations of
acifluorfen in groundwater from sodium acifluorfen uses. To compensate for these uncertainties, EPA
used conservative assumptions for the groundwater modeling, as discussed below.
d. Estimated Drinking Water Concentrations (EDWCs) for
Groundwater
SCI-GROW estimates of acifluorfen concentrations in groundwater range from 0.61 to 3.67
ppb. These values may be uncertain in some vulnerable soils, because when the parameters from the
Wisconsin PGW study were used as inputs to the SCI-GROW model, the model predicted the
acifluorfen concentration to be 5.5 ppb, which is slightly less than the average monitoring value of 8.36
ppb. However, the 3.67 ppb value was used to assess risks of acifluorfen concentrations derived from
sodium acifluorfen because it was modeled using the K^. for sandy soil.
15
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To assess the potential exposure to acifluorfen derived from lactofen, results of the lactofen
PGW study were used, rather than model estimates. Because the study demonstrated that the
acifluorfen degradate (from use of lactofen) did not meet or exceed the limit of detection (LOD, 0.035
ppb in groundwater), the LOD value was used to estimate the concentration of acifluorfen in
groundwater, consistent with the available evidence. EDWCs for acifluorfen in groundwater are
summarized in Table 4. For groundwater, only a single value is given to represent acute and chronic
exposures because the concentration of a pesticide in groundwater is expected to be relatively constant
over time, compared with concentrations in surface water, which are likely to peak at certain times of
the year when pesticide use or runoff is high.
Table 4. Estimated Drinking Water Concentrations (EDWC) for Acifluorfen in Groundwater
Crop
EDWC, ppb
(Acute and Chronic)
Acifluorfen Derived from Sodium Acifluorfen
Peanut/Soybean
Cotton/Soybean
3.67
Acifluorfen Derived from Lactofen
0.035*
Total Acifluorfen from All Sources
Soybean
3.71
* LOD for acifluorfen in groundwater in lactofen PGW study.
3. Residential Exposure and Risk
Homeowners or residential handlers can be exposed to sodium acifluorfen by applying it as a
spot treatment, or by entering or performing other activities in treated areas. Residential handlers
include homeowner applicators performing spot treatment of weeds along driveways, sidewalks, patios,
and trees.
Risk to residential handlers is estimated using an MOE, which is the ratio of the No Observed
Adverse Effect Level (NOAEL) from an animal study with exposure. For sodium acifluorfen,
residential MOEs greater than 1000 are not of concern to the Agency. As previously stated, the
Agency retained the 10X FQPA safety factor for the short-term residential risk assessment. Because
all residential handler exposure is expected to occur on an intermittent short-term basis, the Agency
assessed only short-term (1 to 30 days) risks associated with the use of residential products. Hence,
intermediate-term (1 to 6 months) and long-term (greater than 6 months) residential risks were not
assessed. Moreover, long-term (chronic) exposure would be necessary to cause the physiological
changes that can lead to tumor formation. Therefore, in the absence of long-term residential exposure,
a residential cancer risk assessment is not necessary.
16
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a. Toxicity
The toxicological endpoints, and other factors used in the occupational and residential risk
assessments for sodium acifluorfen are listed in Table 5. The assessment uses Hie NOAEL of 20
mg/kg/day from the rat developmental toxicity study as the endpoint for short-term dermal and
inhalation exposure. The rat 21-day dermal toxicity study on sodium acifluorfen was not selected for
dermal risk assessment because effects were seen at a lower dose in the rat oral developmental toxicity
study. As previously mentioned, a chronic risk assessment (for cancer and noncancer) for residential
exposure is not necessary or relevant.
To correct for differences in absorption between the oral and dermal routes of exposure, a
20% dermal absorption factor was used. This value is based on a dermal penelration study in rats, the
toxicity observed in a 21-day dermal toxicity study, and the ratio of the Lowest Observed Adverse
Effect Levels (LOAELs) from dermal and oral toxicity studies. Results of a dermal penetration study
showed very little test compound in urine or feces, with about 40% of the test material remaining on the
skin after washing and available for absorption, at the end of the study. The 21-day dermal toxicity
study showed effects, including death at 570 mg/kg/day, which indicated that acifluorfen was absorbed
through the skin. By taking all of these factors into consideration, the Agency believes that a dermal
absorption factor of 20% is adequately protective and appropriate for use in the residential and
occupational risk assessment for sodium acifluorfen. An absorption factor was not determined for
inhalation exposure, therefore, the Agency assumed 100% absorption for this exposure route.
Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human Occupational
and Residential Risk Assessments for Sodium Acifluorfen
Assessment
Short- and
intermediate-
term dermal
Short- and
intermediate-term
inhalation
Chronic
inhalation &
dermal exposure
Effect Level
NOAEL = 20
mg/kg/day
(LOAEL = 90)
N/A
Endpoint
Decreased fetal weight &
increased incidence of
dilated lateral ventricles of
the brain
Study
Rat Developmental
Toxicity Study
(MRID 00122743)
No chronic exposure expected
Absorption factor, %
of oral absorption
20
100
N/A
Endpoints for short and intermediate-term exposure are included in this table for use in both the occupational (to be
discussed later) and residential risk assessments. EPA assumes adult body weight of 60 kg for all scenarios.
b. Residential Exposure
The Agency has determined that residential handlers may be exposed to sodium acifluorfen
while spot treating weeds in driveways, sidewalks, patios, and around trees. Although residential
17
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handlers may apply sodium acifluorfen to lawns as a spot treatment for weeds, broadcast use on lawns
is not expected because the product packaging is not designed for broadcast application and sodium
acifluorfen is a non-selective herbicide that will kill both weeds and grass. EPA assumes that residential
handlers do not use any protective clothing and typically wear a short-sleeved shirt, short pants, and no
gloves. Because homeowners often lack access to personal protective equipment (PPE) or knowledge
of the proper use of PPE, the Agency does not believe that a tiered mitigation approach like that used
for assessing occupational handler risk is appropriate for residential uses. As previously stated, sodium
acifluorfen products are only used for spot treatment in residential settings and homeowners are
expected to be exposed for less than seven days, which is considered to be short-term exposure.
EPA used exposure monitoring data from a surrogate chemical to evaluate exposure to
homeowner handlers. This residential exposure monitoring study included ready-to-use trigger sprayer
applications of an insecticide to home vegetable plants and was considered to be the best available data
to assess residential exposure from use of sodium acifluorfen.
c. Residential Risk Summary
For the homeowner use of sodium acifluorfen, EPA is concerned about any MOE less than
1000, which incorporates the FQPA safety factor and is intended to be protective of females age 13-
50 years. For the only potential exposure scenario, spot treatment with a ready-to-use trigger sprayer,
EPA estimated an MOE for combined dermal and inhalation exposures of 18000, which is not of
concern to the Agency. Furthermore, EPA has no concerns for post-application residential exposure
because residential uses are limited to spot treatments, which do not include broadcast application to
lawns, therefore, post-application exposure is expected to be negligible.
4. Aggregate Risk
An aggregate risk assessment evaluates the combined risk from dietary exposure to residues in
food and drinking water and, if applicable, residential exposure to homeowners who apply pesticide
and toddlers who receive incidental oral exposure from mouthing grass or other items treated with
pesticides. For sodium acifluorfen, EPA conducted acute, short-term and chronic (cancer and non-
cancer) aggregate risk assessments. The aggregate risk assessment compares the Drinking Water
Level of Comparison (DWLOC) for each scenario with the appropriate Estimated Drinking Water
Concentrations (EDWCs) for the pesticide. The DWLOC is the maximum concentration in drinking
water which, when considered together with food, and, if appropriate, residential exposure, does not
exceed EPA's level of concern. Generally, EDWCs that are less than the corresponding DWLOC are
not of concern to the Agency.
The aggregate assessment for sodium acifluorfen compares DWLOCs with the EDWCs for
total residues of the acifluorfen degradate from the use of both sodium acifluorfen and lactofen, a
related pesticide, which can degrade to acifluorfen in the environment. Total acifluorfen residues were
18
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calculated for the soybean scenario because both herbicides are registered for use on soybeans.
Additional details of the Agency's drinking water analysis for sodium acifluorfen may be found in the
drinking water section and in technical support documents listed in Appendix C.
a. Acute Aggregate Risk
The acute aggregate risk assessment for sodium acifluorfen includes only food and drinking
water exposure. The acute DWLOC for acifluorfen is 600 ppb, and the acute EDWCs for acifluorfen
from all sources is 10.12 ppb for surface water and 3.71 ppb for groundwater. Because the acute
DWLOC is greater than the estimated acute concentrations of acifluorfen in both surface water and
groundwater, the Agency does not have a concern for acute aggregate risk for females age 13-50, the
only population at potential risk from acute affects. Although the sodium acifluorfen prospective
groundwater study showed a value as high as 46 ppb acifluorfen, this value is still substantially below
the acute DWLOC and not of concern. Moreover, as previously discussed, the Agency has some
uncertainty of the modeled EDWC of acifluorfen in groundwater from sodium acifluorfen use.
However, the value predicted by the model as well as the concentrations detected in the monitoring
studies are all also substantially less than the calculated DWLOCs, and are therefore not of concern for
acute exposure (and other exposure durations to be discussed below). The acute aggregate
assessment is summarized in Table 6.
Table 6. DWLOCs for Acute Aggregate Risk
Population Subgroup
Estimated Drinking Water Concentration (EDWC) of
Acifluorfen (ppb)
Groundwater
Surface Water
Acute DWLOC
(Ppb)
Derived from Sodium Acifluorfen
Females 13-50 years
3.67
7.47
600
Derived from Lactofen
Females 13-50 years
0.035
2.65
600
Total Acifluorfen from All Sources
Females 13-50 years
3.71
10.12
600
b. Short-Term Aggregate Risk
The short-term aggregate risk assessment for sodium acifluorfen includes chronic dietary (food
and drinking water) and short-term residential (dermal and inhalation) exposures. The short-term
aggregate risk was estimated only for females age 13-50 years because this is the only population at
potential risk from acute affects. The short-term DWLOC of 462 ppb is greater than the chronic
EDWCs of 2.43 ppb for surface water and 3.71 ppb for groundwater; therefore, EPA has no concerns
about risk from short-term aggregate exposure. The short-term aggregate assessment is summarized in
Table 7.
19
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Table 7. DWLOCS for Short-Term Aggregate Risk
Population Subgroup
Estimated Drinking Water Concentration (EDWC) of
Acifluorfen (ppb)
Groundwater
Surface Water
Short-term DWLOC7
(PPb)
Derived from Sodium Acifluorfen
Females 13-50 years
3.67
1.91
462
Derived from Lactofen
Females 13-50 years
0.035
0.52
462
Total Acifluorfen from All Sources
Females 13-50 years
3.71
2.43
462
c. Chronic Aggregate Risk
The chronic aggregate risk assessment for sodium acifluorfen includes only food and drinking
water. Residential exposure was not included in the chronic assessment because chronic exposures are
not expected from residential use. For sodium acifluorfen, the chronic DWLOC is 40 ppb for infants
and children age 1-6, the two most highly exposed subgroups of the US populatioa This DWLOC for
infants and children is greater than the chronic EDWCs of 2.43 ppb for surface water and 3.71 ppb for
groundwater; therefore, EPA has no concerns about risk from chronic aggregate exposure. The
chronic aggregate assessment is summarized in Table 8.
Table 8. DWLOCs for Chronic Aggregate Risk
Population Subgroup
Estimated Drinking Water Concentration (EDWC)
of Acifluorfen (ppb)
Groundwater
Surface Water
Chronic DWLOC (ppb)
Derived from Sodium Acifluorfen
Children l-6yrs
Infants < 1 yr
3.67
3.67
1.9
1.9
40
40
Derived from Lactofen
Children l-6yrs
Infants < 1 yr
0.035
0.035
0.53
0.53
40
40
Total Acifluorfen from all Sources
Infants and Children
3.71
2.43
40
d. Aggregate Cancer Risk
Similar to the chronic assessment for sodium acifluorfen, the aggregate cancer risk assessment
includes only food and drinking water. Residential exposures were not included because lifetime
20
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exposure from residential use was not assessed. The cancer DWLOC for sodium acifluorfen is 455
ppb, which is greater than the EDWC of 2.43 for surface water and 3.71 for groundwater. Therefore,
EPA has no concern for aggregate cancer risk from total acifluorfen residues in drinking water. The
aggregate cancer assessment is summarized in Table 9 below.
Table 9. DWLOCs for Aggregate Cancer Risk.
Population Subgroup
Estimated Drinking Water Concentration (EDWC)
of Acifluorfen (ppb)
Groundwater
Surface Water
Chronic DWLOC (ppb)
Acifluorfen Derived from Sodium Acifluorfen
General Population
3.67
1.9
455
Acifluorfen Derived from Lactofen
General Population
0.035
0.52
455
Total Acifluorfen from All Sources
General Population
3.71
2.43
455
5. Occupational Exposure and Risk
Occupational workers can be exposed to a pesticide through mixing, loading, applying a
pesticide, or re-entering treated sites. For sodium acifluorfen, occupational handlers of sodium
acifluorfen include individual farmers or growers who mix, load, and/or apply pesticides, as well as
professional or custom agricultural applicators.
Risk to occupational handlers is estimated using an MOE, which is the ratio of the NOAEL
from an animal study with exposure. For sodium acifluorfen, MOEs greater than 100 for occupational
handlers are not of concern to the Agency. Because sodium acifluorfen products are typically applied
one or two times per year, the Agency assessed only short- (1 to 30 days) and intermediate-term (1 to
6 months) risks associated with the use of agricultural products. Hence, long-term (greater than 6
months) occupational handler risks were not assessed. Moreover, long-term (chronic) exposure would
be necessary to cause the physiological changes that can lead to tumor formation. Therefore, in the
absence of long-term exposure, an occupational cancer risk assessment was not conducted.
a. Toxicity
The toxicological endpoints, and other factors used in the occupational risk assessment for
sodium acifluorfen were previously listed in Table 5. The assessment uses the NOAEL of 20
mg/kg/day from the rat developmental toxicity study as the endpoint for short- and intermediate-term
dermal and inhalation exposure and a dermal absorption factor of 20%. The acute toxicity profile for
sodium acifluorfen is summarized in Table 9. Sodium acifluorfen is a severe eye irritant and a moderate
skin irritant, but it is not a dermal sensitizer. Sodium acifluorfen is classified as Toxicity Category n for
21
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acute oral toxicity in the dog, based on an acute study performed with 50-70% active ingredient.
Acute oral, dermal, and inhalation toxicity in other species are classified as Toxicity Category HI,
and IV, respectively.
Table 9. Acute Toxicity Profile for Sodium Acifluorfen
Guideline
81-1
81-1
81-2
81-3
81-4
81-5
81-6
MRID
00071887
00071889
00122725
00122726
00126597
00126597
00122728
% a.i.
21.4
40
20.2
20.3
21.4
21.4
20.2
Study Type
Acute Oral (rats)
Acute Oral (dog)
Acute Dermal (rabbits)
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Results
LD50 = 2025 mg/kg (males)
LD50 = 1370 mg/kg (females)
LD50= 186 mg/kg
LD50 > 2000 mg/kg (males/females)
LC50 > 6.9 mg/L
Severe eye irritant
Moderate dermal irritant
Not a skin sensitizer
Toxicity
Category
III
II
III
IV
I
II
N/A
b. Occupational Exposure
Agricultural Handler Exposure. EPA assessed occupational exposure to sodium acifluorfen
using the Pesticide Handlers Exposure Database (PHED) and proprietary data, including chemical-
specific monitoring data submitted by BASF. In addition, EPA used standard assumptions about
average body weight, work day, and daily areas treated. Because the short- and intermediate-term
risk assessment endpoints for sodium acifluorfen are based on an endpoint from a developmental
toxicity study, the standard adult female body weight of 60 kg was used. EPA derived information
about use patterns, application methods, and the range of application rates used in the exposure
assessment from the current sodium acifluorfen labels. The application rates specified on the sodium
acifluorfen labels range from 0.158 to 0.375 Ibs aiVA in agricultural settings. The Agency typically uses
acres treated per day values that are thought to represent eight hours of application work for specific
types of application equipment.
Occupational handler exposure assessments are conducted by the Agency using different levels
of personal protection. The Agency typically evaluates all exposures with minimal protection and then
adds additional protective measures using a tiered approach until the MOEs are no longer of concern,
going from minimal to maximum levels of protection. The lowest suite of personal protective equipment
(PPE) is baseline (long sleeve shirt, long pants, shoes and socks). If MOEs are of concern (less than
100) at baseline, increasing levels of PPE are applied. If MOEs are still less than 100, engineering
controls are applied. For sodium acifluorfen, EPA also conducted an assessment using baseline PPE
plus chemical-resistant gloves.
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Based on currently registered uses, the Agency identified the following major occupational
exposure scenarios for sodium acifluorfen:
(1) Mixing/loading/applying liquids using groundboom equipment
(2) Mixing/loading liquids for groundboom application
(3) Applying liquids with a groundboom sprayer
(4) Mixing/loading liquids for aerial application
(5) Applying liquid spray with aircraft
(6) Flagging aerial spray applications
Sodium acifluorfen labels contain a variety of PPE, depending on the toxicity of the end-use
product and the risk to users from any additional active ingredients. All sodium acifluorfen labels
minimally require the PPE of long-sleeved shirt, long pants, shoes, socks, and gloves. Protective
eyewear is generally required on the basis of the toxicity of the end-use product. Labels for Blazer®
(EPA Reg. No. 7969-79) and Conclude Ultra® (EPA Reg. No. 7969-168) require chemical-resistant
headgear for overhead exposure. In addition, the label for Conclude Ultra® requires coveralls,
chemical-resistant gloves, and chemical-resistant footwear. This RED will address PPE needed solely
based on the risk of the active ingredient sodium acifluorfen.
Agricultural Handler Risk. To assess exposure to mixer/loader/applicators using
groundboom equipment (Scenario 1), EPA used chemical-specific monitoring data for sodium
acifluorfen. In a biomonitoring study on private grower/applicators who used sodium acifluorfen for
weed control on sites in Wisconsin, New York, and Maryland and Delaware, sodium acifluorfen was
applied to soybean fields at a rate of 0.5 Ibs a.i./A using groundboom sprayers pulled by open cab
tractors. The study monitored workers who mixed, loaded, and applied sodium acifluorfen. Because
of study limitations, the Agency only used the dermal and inhalation exposure data from this study.
EPA did not use the biomonitoring component of the study due to uncertainties in the pharmacokinetics
of sodium acifluorfen and the limited number of test subjects.
EPA used PHED to estimate worker exposure for both private growers and custom applicators
for the remaining five scenarios listed above because PHED unit exposure values are the best available
estimates of exposure. The quality of the data used for each scenario assessed is discussed in depth in
the occupational and residential exposure and risk assessment for sodium acifluorfen, listed in Appendix
C.
c. Occupational Handler Risk Summary
As previously mentioned, EPA assessed exposure and risk for six scenarios. For sodium
acifluorfen, an MOE greater than 100 does not exceed the Agency's level of concern for effects from
short- or intermediate-term exposure. EPA did not evaluate cancer risk to agricultural handlers
because no chronic or long-term exposure is expected from the use of sodium acifluorfen.
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There are some risks of concern for agricultural handlers that are summarized in Table 10.
When handlers are wearing baseline attire (long sleeve shirt, long pants, shoes, and socks), handler
MOEs are of concern for two scenarios: (2) mixing and loading liquids for groundboom application
and (4) mixing/loading liquids for aerial application. Also, scenario (1) mixing/loading/applying liquids
for groundboom application was not assessed for baseline attire. However, the remaining scenarios,
including (3) applying spray with a groundboom sprayer, (5) applying liquid spray with aircraft; and (6)
flagging resulted in MOEs greater than 100 with baseline attire and are therefore not of concern.
When chemical-resistent gloves are added to handlers for scenarios 1,2 and 4, the MOEs are
greater than 100 and not of concern. Therefore, chemical-resistent gloves are needed to mitigate risk
to agricultural handlers for these scenarios (mixers/loaders and mixer/loaders/applicators of liquid
formulations).
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Table 10. Summary of Acifluorfen Occupational Handler Risk
Exposure Scenario
(1) Mix/Load/Apply Liquids -
Groundboom
(2) Mix/Load Liquids for
Groundboom Application
(3) Apply Spray with a Groundboom
Sprayer
(4) Mix/Load Liquids for Aerial
Application
(5) Applying Spray with Fixed-Wing
Aircraft
(6) Flagging Aerial Spray
Applications
Application
Rate
(Ibs a.i./Acre)
0.158
0.375
0.158
0.375
0.158
0.375
0.158
0.375
0.158
0.375
0.158
0.375
Area
Treated"
(Acres/Day)
80
200
80
200
80
200
350
1200
350
1200
350
1200
Combined (Dermal and Inhalation)
Short-/Intermediate-Term Margin of Exposure
(MOE)b
Baseline0
Not
Applicable
Not
Applicable
160
28
27000
4500
37
4.6
20,000
2500
8500
1000
Baseline + Chemical-Resistent
Gloves
1000
420
1600
2800
27000
4500
3700
460
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Amounts of acreage treated per day are maximum values from the HED Science Advisory Council for
Exposure Policy #009 " Standard Values for Daily Acres Treated in Agriculture," dated July 5, 2000.
b MOE (unitless) = NOAEL (mg/kg/day) •*- Combined Absorbed Daily Dose (mg/kg/day), where a NOAEL of
20 mg/kg/day is used for short-term and intermediate-term dermal and inhalation exposures. The dermal
exposure component was adjusted with a 20% dermal absorption factor.
c Baseline PPE includes long pants, long sleeved shirt, shoes, socks.
d. Post-Application Exposure and Risk
The post-application occupational risk assessment considers exposures to agricultural workers
re-entering treated areas for activities such as scouting, hand weeding, and irrigating. High contact re-
entry activities performed in the past, such as hand transplanting and hand harvesting were not assessed
because these tasks are now largely automated and because the existing preharvest intervals preclude
exposure to workers performing harvesting activities. All post-application exposure is considered to be
short- or intermediate-term, based on the frequency and duration of activities and the dissipation of
acifluorfen. Only dermal exposure was assessed, because inhalation exposures are not anticipated for
re-entry workers.
Data from a foliar dislodgeable residue study for sodium acifluorfen on soybeans were used as
surrogate data to assess dermal exposure to re-entry workers for sodium acifluorfen use on peanuts
and rice. This study measured dislodgeable foliar residues (DFR) following groundboom application of
sodium acifluorfen to control weeds in soybean fields in Indiana, Mississippi and Georgia. The DFR
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data for the Indiana and Mississippi sites were used for the calculations of post- application exposures
and risks. The data from the Georgia site were not used because DFR values on the day of treatment
were substantially less than those for the Indiana and Mississippi sites. EPA used the more
conservative (and more protective) values.
The post-application worker risk calculations indicated that the MOEs were greater than 100
on Day 0, and therefore not of concern. Because sodium acifluorfen is in acute Toxicity Category I for
eye irritation, the current restricted entry intervals (REIs) of 48 hours are appropriate and will remain
unchanged. The results of EPA's re-entry assessment for sodium acifluorfen are summarized in Table
11 below.
Table 11. Estimated Post-Application Occupational Exposure and Risk for Sodium Acifluorfen
Crop
Soybeans
Transfer Coefficient
(cm2/hr)
1500
Re-Entry Activities
Irrigate and Scout -Medium
Exposure
MOE on Day 0
740 (IN data)
680 (MS data)
6. Incident Reports
No poisoning incidents related to the use of sodium acifluorfen were reported in any of the data
sources available to the Agency. Little or no usage has been reported for this pesticide, either in
surveys of home use or agricultural use in California. Sodium acifluorfen was not reported to be
involved in any human incidents in calls to the National Pesticide Telecommunications Network
(NPTN) received calls from 1984-1991.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the technical support documents
listed in Appendix C. Documents dated through April 30,2002 are available in the public docket
(OPP-34241A and B) and on the internet at http://www.epa.gov/oppsrrdl/reregistration/acifluorfen.
Because the Agency implemented a new docketing system in July 2002, documents dated from May 1,
2002 to the present are in the docket OPP-2003-0293 and on the internet at a different site,
http://www.epa.gov/edockets.
Revisions have been made since the preliminary risk assessment was completed, and include:
(1) a re-evaluation of the environmental fate database for acifluorfen and a change to the proposed data
requirements, and (2) an evaluation of a prospective groundwater monitoring study for the herbicide
lactofen, which degrades to acifluorfen in the environment.
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1. Environmental Fate and Transport
The environmental fate of sodium acifluorfen varies based on the site-specific properties of the
soil to which it is applied. Sodium acifluorfen is extremely soluble in water, and stable to hydrolysis and
photolysis in soil. The acifluorfen ion/degradate is relatively persistent in soil, with a half-life ranging
from 108 to 200 days and is relatively stable in aquatic environments, with a half-life of approximately
117 days. However, acifluorfen degrades under anaerobic conditions. The anaerobic soil half-life is
30 days and the anaerobic aquatic half-life is estimated to be 2.75 days. Under anaerobic conditions,
acifluorfen undergoes chemical reduction to amino acifluorfen, which can be persistent depending on
soil conditions. The acifluorfen degradate is mobile in soils and available monitoring data indicate that it
has the potential to enter surface water by runoff and enter groundwater by leaching. Additional
information on the environmental fete of sodium acifluorfen can be found in the drinking water section of
this document and in the supporting documents referenced in Appendix C.
2. Ecological Risk Assessment
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 sodium
acifluorfen products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to the
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
indicates whether a chemical, when used as directed, has the potential to cause undesirable effects on
nontarget organisms. In general, the higher the RQ the greater the concern. When the RQ exceeds the
LOG for a particular category, the Agency presumes a risk of concern to that category. The LOCs
and the corresponding risk presumptions are presented in Table 12 below.
Table 12. EPA's Levels of Concern (LQCs) and Associated Risk Presumptions
IF...
THEN the Agency presumes...
Mammals and Birds
Acute RQ > LOG of 0.5,
Acute RQ >LOC of 0.2,
Acute RQ> LOG of 0.1,
Chronic RQ > LOG of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in endangered species
Chronic risk to all species
Fish and Aquatic Invertebrates
Acute RQ> LOG of 0.5
Acute RQ> LOG of 0.1
Acute RQ >LOC of 0.05
Chronic RQ > LOG of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risks to all species
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THEN the Agency presumes...
Plants
The RQ > LOG of 1
Acute risk and endangered plants may be affected
a. Ecological Hazard Profile
Numerous ecological toxicity studies were conducted to support the reregistration of sodium
acifluorfen. The results of these studies are summarized herein; for specific details, please see the
documents referenced in Appendix C.
Toxicity to Aquatic Organisms
Fish. Sodium acifluorfen is slightly toxic to both freshwater and salt water fish with acute
exposure. For Bluegill sunfish, the acute LC50 is 31 ppm. For Rainbow trout, the acute LC50 is 17
ppm. For Sheepshead minnow, the acute LC50 is 39 ppm. Chronic toxicity data are available for
freshwater fish, but not for salt water fish. In a fish early life stage study on Fathead minnow (OPP
Guideline 850.1400), reduced larval weight was reported at 1.5 ppm, the lowest dose level.
Therefore, a No Observed Adverse Effect Concentration (NOAEC) could not be determined for this
study, and the study must be repeated. In addition, fish exposed to light-dependent peroxidizing
herbicides (LDPHs) and intense light, such as sunlight, can show increased toxicity relative to fish
exposed to the same chemical in low intensity light. Because the available Fathead minnow test was
conducted under low light levels, as well as not being conducted at low enough doses to determine a
NOAEC, EPA requires that an additional fish early life stage study be conducted on sodium acifluorfen
(OPPTS 850.1400, modified). The additional study should determine the NOAEC under both high
and low intensity light.
Invertebrates. Sodium acifluorfen is slightly toxic to freshwater invertebrates. Acute toxicity
testing on Daphnia magna showed LC50 values of 28.1 ppm for technical-grade material and 77 ppm
for 25% a.i. material. Chronic toxicity testing for freshwater invertebrates was not required because
EPA's EEC for acifluorfen in surface water is less than 1% of the lowest LC50 value. Therefore, the
Agency can conclude with reasonable certainty that under the current use pattern, chronic risk to
freshwater invertebrates is negligible.
For estuarine/marine invertebrates, sodium acifluorfen is classified as slightly toxic to practically
nontoxic, based on the data submitted to support reregistration. For technical grade sodium acifluorfen,
the acute LC50 for the Eastern oyster is 74 ppm and the LC50 for the Grass shrimp is 446 ppm. For
25% a.i. formulation, the LC50 for the Mysid is 3.8 ppm. Chronic toxicity testing for saltwater
invertebrates is not being required for the same reasons discussed above.
28
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Plants. In Tier I toxicity studies for aquatic plants, no growth reduction was seen 120 hours
after exposure to the maximum label rate (355 ppb). In the Tier II toxicity studies, Duckweed was
determined to be the most sensitive vascular plant to the effects of acifluorfen. The Duckweed EC50
was 378 ppb. The Tier II studies showed no effects on nonvascular aquatic plants at the maximum
label rate.
Toxicity to Terrestrial Organisms
Birds. Sodium acifluorfen is moderately to practically nontoxic to birds on an acute oral basis.
The LD50 for the Mallard duck was 4,187 mg/kg. The LD50 for Bobwhite quail was 325 mg/kg.
Results of four subacute dietary studies showed that acifluorfen is practically nontoxic to the Bobwhite
quail and to the Mallard duck. The LC50 values range from 5620 to greater than 10,000 ppm, with no
mortality.
In an avian reproduction study, the NOAEC for the Bobwhite quail was 20 ppm and the
LOAEC was 100 ppm based on a reduced number of viable embryos. The NOAEC for the Mallard
duck was greater than 100 ppm (the highest dose level tested); no LOAEC was determined.
Mammals. Wild mammal testing was not done for sodium acifluorfen, so the Agency relied on
existing laboratory toxicity studies on rats to determine the potential acute toxicity to wild mammals. A
rat acute oral study on sodium acifluorfen showed an LDy, of 1540 mg/kg; therefore, sodium
acifluorfen is classified as slightly toxic to rats. A rat reproductive study showed a NOAEC greater
than 2,500 ppm with no reproductive effects. In a rat developmental study, the NOAEC for sodium
acifluorfen was 20 mg/kg/day (400 ppm) based on decreased fetal body weight.
Insects. There is a data gap for the honey bee acute contact study (OPPTS Guideline
850.3020). This study is required because of the high potential of sodium acifluorfen to drift to off site
vegetation in bloom.
Plants. Data from a nontarget terrestrial toxicity study were submitted to satisfy the data
requirement for nontarget plants. This study satisfied the data requirement for seedling emergence, but
not for vegetative vigor. EPA concluded that the study for vegetative vigor must be repeated (OPPTS
Guideline 850.4150) because the submitted study used a very dilute solution of sodium acifluorfen,
resulting in uncertainty in the dose used in the study
b. Environmental Exposure to Non-Target Organisms
Exposure to Aquatic Organisms
The Agency used modeling to derive estimated environmental concentrations (EECs) for the
acifluorfen degradate in surface water. Unlike the drinking water assessment described in the human
29
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health risk assessment section of this document, the ecological water resource assessment does not
include the Index Reservoir (IR) and Percent-Crop Area (PCA) factor refinements. The IR and PCA
factor represent a drinking water reservoir, not the variety of aquatic habitats, such as ponds adjacent
to treated fields, relevant to a risk assessment for aquatic animals. Therefore, the EEC values used to
assess exposure to aquatic animals are not the same as the values used to assess human dietary
exposure from drinking water sources.
Table 13. Estimated Environmental Concentrations (EECs) of Acifluorfen in Surface Water
Crop/Chemical
Soybean and Peanuts
Rice*
Scenario
MS Farm Pond
Rice Paddy
EECs of Acifluorfen in Surface Water (ppb)
1 -in- 1 0 year maximum
(Acute Exposure)
21.11
26.6
21 -day average
(Chronic Exposure)
20.69
15.96
* EECs for rice were derived from a modified version of GENEEC, GENEECx.
Exposure to Terrestrial Organisms
The Agency assessed exposure to terrestrial organisms by first predicting the amount of sodium
acifluorfen residues found on animal food items and then by determining the amount of pesticide
consumed by using information on typical food consumption by various species of birds and mammals.
The amount of residues on animal feed items are based on the Fletcher nomogram (a model developed
by Fletcher, Hoerger, Kenaga, et al.)3 and the current maximum application rate for sodium acifluorfen.
Current labels allow a maximum single application of 0.25 to 0.375 Ibs a.i./Acre and up to two 0.25 Ib
a.i7A applications per season for a total seasonal maximum rate of 0.5 Ib a.i./A. Therefore, EPA
modeled the maximum and mean residues of sodium acifluorfen in various food items immediately after
the second of two 0.25 Ibs a.i7A applications. The Agency assumed no dilution due to the growth of
the plants or degradation of sodium acifluorfen. EPA's estimates of sodium acifluorfen residues on
various wild animal food items are summarized in Table 14. No monitoring data were used in the
development of terrestrial EECs.
This model was originally developed by Hoeger and Kenaga and later modified by Fletcher,
Nellessen, and Pfleeger.
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Table 14. EECs of Sodium Acifluorfen on Wild Animal Food Items
Food Item
Short grass
Tall grass
Broadleaf plants/Insects2
Seeds
EEC (ppm)1
Predicted Maximum Residue
120
55
68
8
Predicted Mean Residue
43
18
23
4
Residual EEC immediately after the second of two applications of 0.25 Ib a.i./A, assuming no degradation of
sodium acifluorfen.
Surface to volume ratios of broadleaf plants and insects are similar; therefore, EPA assumes that they
contain similar residue levels.
c. Environmental Risk to Non-Target Organisms
As previously mentioned, EPA compares toxicity endpoints from ecological toxicity studies to
EECs for sodium acifluorfen and calculates RQs to evaluate the potential risk to nontarget organisms.
These RQ values are then compared to the Agency's levels of concern (LOCs). The sodium
acifluorfen RQs show that acute LOCs are not exceeded for terrestrial animals, freshwater and
estuarine animals, or aquatic plants. Chronic LOCs are exceeded for insectivorous and herbivorous
birds but not for mammals. Chronic LOCs are not exceeded for freshwater invertebrates and estuarine
animals. EPA has a potential risk concern for phototoxicity to aquatic organisms (i.e., toxicity
enhanced by the presence of sunlight) which will be evaluated at a later date, when adequate data are
available. The Agency was unable to conduct a chronic risk assessment for freshwater fish due to lack
of adequate data. Likewise, EPA was unable to conduct a risk assessment for terrestrial plants or
insects because there were no adequate data. Because sodium acifluorfen is an herbicide, EPA
assumes that there will be some risk to nontarget plants and therefore, it should be applied in such a
way to minimize drift.
Risk to Aquatic Organisms
Risk to Freshwater Fish. The acute RQ for Rainbow trout is less than 0.01 for sodium
acifluorfen use on soybeans and peanuts and less than 0.01 for use on rice. No acute LOCs were
exceeded for freshwater fish.
As mentioned above, EPA was unable to conduct a chronic risk assessment on freshwater fish
because a NOAEC was not established in the Fathead minnow early life stage study. This study must
be repeated (OPP 850.1400). Because acifluorfen is a light-dependent peroxidizing herbicide, aquatic
organisms inhabiting small shallow water bodies exposed to high levels of sunlight would be expected to
be at greatest risk for potential phototoxic effects. Therefore, the Agency is requiring a phototoxicity
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study using a small fish species to assess the potential of light to increase toxicity of sodium acifluorfen.
The fish early life stage study may be modified to fulfill both data requirements.
Risk to Estuarine/Marine Fish. The acute RQ for Sheepshead minnow is less than 0.01 for
sodium acifluorfen use on soybeans and peanuts and less than 0.01 for use on rice. No acute LOCs
were exceeded for estuarine fish. Chronic toxicity testing is not required for estuarine and marine fish
because the acute RQ is less than 0.01, and therefore chronic toxicity is expected to be low. The
Agency does not have any acute or chronic concerns about risk to estuarine and marine fish.
Risk to Freshwater Invertebrates. The acute RQ for Daphnia magna is less than 0.01 for
sodium acifluorfen use on soybeans, peanuts, and rice. No acute LOCs were exceeded for freshwater
invertebrates. Chronic toxicity testing is not required for freshwater invertebrates because the acute
RQ is less than 0.01, and therefore, chronic toxicity is expected to be low. The Agency does not have
any acute or chronic risk concerns for freshwater invertebrates.
Risk to Estuarine/Marine Invertebrates. The acute RQ for Mysid shrimp is less than 0.01
for soybeans, peanuts, and rice. No acute LOCs were exceeded for saltwater invertebrates. Chronic
toxicity testing is not required for saltwater invertebrates because the acute RQ is less than 0.01, and
therefore, chronic toxicity is expected to be low. The Agency does not have an acute or chronic risk
concerns for saltwater invertebrates.
Risk to Nontarget Aquatic Plants. The RQs for both vascular and nonvascular aquatic plants
are less than 1.0, based on the results of the existing Tier II aquatic plant toxicity test data. No acute
LOCs were exceeded for aquatic plants.
Risk to Terrestrial Organisms
Risk to Birds. Acute RQs from a single application of sodium acifluorfen range from less than
0.01 to 0.02. Acute RQs from two applications of sodium acifluorfen (for a seasonal maximum of 0.5
Ib a.i./A) range from less than 0.01 to 0.04. No acute LOCs are exceeded for any registered use.
Chronic RQs for birds range from 0.3 to 6.0, based on maximum residues and a reproductive endpoint
(a reduced number of viable embryos in Bobwhite quail). In a more refined assessment, which uses
mean residues, the only birds that continued to have risks of concern were those that eat short grass,
with RQs ranging from 0.15 to 1.8. These RQs slightly exceeded EPA's level of concern (1.0) for
chronic risk.
Risk to Mammals. Risks to mammals were estimated for a variety of food types, body
weights, and percentage of body weight consumed as food. In a worst case acute scenario, when
sodium acifluorfen is applied at the maximum seasonal rate of 0.5 Ib a.i./A, the acute RQ is less than
0.01, and not of concern. No acute LOCs were exceeded for any registered use. In a worst case
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chronic scenario, the chronic RQ was less than 0.05 and not of concern. No chronic mammalian
LOCs were exceeded for any registered use.
Risk to Insects. The Agency was unable to conduct a risk assessment for insects due to a data
gap for the honey bee acute contact study (OPPTS Guideline 850.3020). This study is required.
Risk to Nontarget Plants. As previously mentioned, limited information is available about the
toxicity of sodium aeifluorfen to nontarget plants because the study submitted to fulfill the FIFRA
guideline requirement used an extremely dilute test substance. Because of the limited data, EPA is
unable to conduct a risk assessment for nontarget plants at this time. However, because sodium
aeifluorfen is an herbicide, there may be some risk to nontarget plants exposed via drift.
Risk to Endangered Species
The Agency's review of sodium aeifluorfen resulted in a determination that sodium aeifluorfen
will have "no effect" on threatened and endangered aquatic species, mammals, and "no effect" from
acute exposures to avian species. Using the data available, aeifluorfen does not exceed a level of
concern for chronic effects to avian species based upon mean residues in the field except for the birds
that eat short grass. The only listed species that consumes short grass is the Hawaiian goose which
routinely is on golf courses in Hawaii. Because sodium aeifluorfen is not used on golf courses, the
Agency does not believe that its continued use would effect the Hawaiian goose or any other listed
species.
As an herbicide, sodium aeifluorfen 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 plants, the mitigation strategy articulated in
this document will serve as interim protection to reduce the likelihood that listed species will be exppsed
to sodium aeifluorfen.
d. Ecological Incident Reports
There are no reports of ecological incidents attributed to sodium aeifluorfen.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether pesticides containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
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active ingredient specific) data required to support reregistration of products containing sodium
acifluorfen as the active ingredient.
The Agency has completed its assessment of the residential, occupational, and ecological risks
associated with the use of pesticides containing the active ingredient sodium acifluorfen, as well as an
acifluorfen-specific dietary risk assessment. Based on a review of these data and public comments on
the Agency's assessments for the active ingredient sodium acifluorfen, EPA has sufficient infonnation on
the human health and ecological effects of sodium acifluorfen to make decisions as part of the tolerance
reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The
Agency has determined that sodium acifluorfen is eligible for reregistration provided that: (1) current
data gaps and additional data needs are addressed and (2) the risk mitigation measures outlined in this
document are adopted, and label amendments are made to reflect these measures. Label changes are
described in Section V. Appendix B identifies the generic data requirements that the Agency reviewed
as part of its determination of reregistration eligibility of sodium acifluorfen and lists the submitted
studies that the Agency found acceptable.
B. Summary of Phase 5 Comments
When making its reregistration decision, the Agency took into account all comments received
during Phase 5 of the public participation process for reregistration. These comments in their entirety
are available in the public docket, under docket number OPP-3424B. BASF, the technical registrant
for sodium acifluorfen, was the only entity that submitted comments. The Agency has prepared
responses to each of these comments, which are also available in the public docket and on the internet.
BASF requested that the Agency revise the cancer classification of sodium acifluorfen,
considering both the new cancer risk assessment guidelines and the proposed peroxisome proliferation
mode of action. BASF submitted additional data to support the proposed mode of action. BASF also
commented on the 10X FQPA safety factor for sodium acifluorfen and questioned the need for a
developmental neurotoxicity study. They also submitted comments on product and residue chemistry,
occupational exposure, environmental fate, and the drinking water and ecological risk assessments.
These comments, and any new information, have been considered in this regulatory decision, where
appropriate.
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
the use of sodium acifluorfen. The assessment is for this individual pesticide only. FQPA requires the
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Agency to evaluate food tolerances on the basis of cumulative risk from substances sharing a common
mechanism of toxicity. Sodium acifluorfen is a member of the diphenyl ether group of herbicides, which
includes lactofen, oxyfluorfen, nitrofen, and fomesafen. The Agency has evidence that these
compounds induce similar toxic effects but has not yet determined whether these compounds exhibit a
common mechanism of toxicity. For purposes of tolerance reassessment and determination of
reregistration eligibility of sodium acifluorfen, EPA is assuming that sodium acifluorfen does not share a
common mechanism of toxicity with other compounds.
EPA has determined that risk from exposure to sodium acifluorfen is within its own "risk cup."
In other words, EPA is able to conclude today that the tolerances for sodium acifluorfen meet the
FQPA safety standards for the US population and sensitive subgroups, including infants and children.
In reaching this determination EPA has considered the available information on the special sensitivity of
infants and children, as well as the chronic and acute food exposure. An aggregate assessment was
conducted for exposures through food, residential uses, and drinking water. Results of this aggregate
assessment indicate that the human health risks from these combined exposures are considered to be
within acceptable levels; that is, combined risks from all exposures to sodium acifluorfen, including
acifluorfen derived from lactofen, "fit" within the individual risk cup.
b. 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 such
endocrine effects as the Administrator may designate." Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases 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 the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have
an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor
Screening Program (EDSP). When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, sodium acifluorfen may be subjected to
additional screening and/or testing to better characterize effects related to endocrine disruption.
c. Tolerance Summary
In the individual assessment, tolerances for residues of sodium acifluorfen in/on plant
commodities [40 CFR §180.383] are presently expressed in terms of combined residues of parent
sodium-5[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoic acid and its metabolites (the
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corresponding acid, methyl ester, and amino analogues). The current tolerance expression is
appropriate and will remain unchanged.
Raw Agricultural Commodities, 40 CFR §180.383(a)
The nature of the residue in plants and animals is adequately understood. The current
tolerances for most plant commodities are appropriate and will remain unchanged. However, the
tolerance value for rice straw should be increased from 0.1 ppm to 0.2 ppm, based on available residue
data. Tolerances for livestock commodities are no longer needed because the residue data show that
residues do not transfer from treated feed items to livestock tissues. These 15 livestock tolerances
were proposed for revocation in the Federal Register under 40 CFR 180.6(a)(3) on July 16, 2003
(Federal Register, Vol. 68, No 136). These tolerances will be revoked pending publication of a final
rule in the Federal Register. However, the grazing restrictions for soybeans and peanuts must be
retained. The tolerance reassessment for sodium acifluorfen is summarized in Table 15.
Table 15. Tolerance Summary for Sodium Acifluorfen
Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Tolerances for Raw Agricultural Commodities
Established Under 40 CFR § 1 80.383(a)
Cattle, kidney
Cattle, liver
Egg
Goat, kidney
Goat, liver
Hog, kidney
Hog, liver
Horse, kidney
Horse, liver
Milk
Peanut
Poultry, fat
Poultry, meat
jyproducts
Poultry, meat
Rice, grain
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.1
0.02
0.02
0.02
0.1
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
0.1
Revoke
Revoke
Revoke
0.1
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Revocation pending publication of final rule
Data show that residues do not concentrate in
processed commodities; therefore, a tolerance is
needed only for rice grain.
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Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Tolerances for Raw Agricultural Commodities
Established Under 40 CFR § 1 80.383(a)
Rice, straw
Sheep, kidney
Sheep, liver
Soybean
Strawberry
0.1
0.02
0.02
0.1
0.05
0.2
Revoke
Revoke
0.1
To Be Determined*
Available data indicate maximum combined
residues of sodium acifluorfen and metabolites
were <0.124 ppm in/on rice straw
Revocation pending publication of final rule
Revocation pending publication of final rule
[Soybean, seed]
Currently there are no registered uses of sodium •
acifluorfen on strawberries, but IR4 is committed
to supporting tolerance.
Note: Existing data show that residues of acifluorfen are not transferred from treated feed items to livestock tissues.
Therefore, tolerances were proposed for revocation on July 16, 2003 (Federal Register, Vol. 68, No J36)(FRL-7301-
5).
* Strawberry tolerance to be determined pending submission of directions for use (OPPTS 860.1200) and approval of
a label for use on strawberries.
Codex
There are no Codex Maximum Residue Limits (MRLs) for sodium acifluorfen and therefore no
issues regarding compatibility of US Tolerances with Codex MRLs.
Residue Analytical Methods
Adequate methods are available for enforcement of the tolerances for sodium acifluorfen in
plant and animal commodities as currently expressed. For determination of sodium acifluorfen residues
in/on plant commodities, the Pesticide Analytical Manual Volume II (PAM n) lists a gas
chromatography/electron capture detector (GC/ECD) method, designated as Method I, for the
enforcement of tolerances in plant commodities. Method I determines residues of sodium acifluorfen,
acifluorfen, acifluorfen amine, and any other compounds that can be converted to acifluorfen methyl
ester or the heptafluorobutyramide derivative. Identifications are confirmed by Gas Liquid
Chromatography Mass Spectrometry (GLC/MS) according to Method A in PAM II. The detection
limit for Method I is 0.01-0.02 ppm. The requirement for radiovalidation data is waived based on the
low residues found in metabolism and field trial studies.
D. Regulatory Rationale
EPA has determined that certain mitigation measures and label amendments are necessary for
the currently registered uses of sodium acifluorfen to be eligible for reregistration. The following is a
summary of the rationale for managing risks associated with the current use of sodium acifluorfen.
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Where labeling revisions are warranted, specific language is set forth in the summary tables of Section
V of this document.
1. Human Health Risk Mitigation
a. Dietary Mitigation
Food. Risk from dietary exposure to sodium acifluorfen residues in food is not of concern.
Acute dietary exposure from food comprises less than 1% of the acute PAD for females age 13-50
years, the only population at potential risk from acute effects. Chronic dietary exposure from food
comprises less than 1% of the chronic PAD for the US general population and all subgroups, which
indicates that neither chronic nor cancer dietary risk is of concern. Because there are no dietary risks
of concern from food, no risk mitigation is necessary.
Drinking Water. Risk from dietary exposure to acifluorfen residues in drinking water is not of
concern. The Agency has estimated levels of acifluorfen residues from both sodium acifluorfen and
lactofen uses. Although acifluorfen residues may leach to groundwater in certain vulnerable soils,
screening-level model results, which are designed to provide high-end estimates, indicate that
acifluorfen levels in surface water and groundwater are not of concern for any exposure duration.
Therefore, no risk mitigation is necessary for drinking water.
However, because ground water monitoring studies show that acifluorfen residues may leach to
groundwater when sodium acifluorfen is used in regions with soils vulnerable to leaching, the current
groundwater advisory shall remain on the labels. Additional adsorption/desorption studies on sandy
soils would allow the Agency to better characterize the local soil conditions under which groundwater
leaching may occur and may allow EPA to change the groundwater label advisory. Because there is no
longer a human health risk concern, these data are not required at this time.
b. Homeowner Risk Mitigation
For the homeowner use of sodium acifluorfen as a spot treatment with a ready-to-use trigger
sprayer, the combined dermal and inhalation MOE is 18000, which is not of concern to the Agency.
EPA has no additional concerns for post-application residential exposure because residential uses are
limited to spot treatments, where any post-application exposure is expected to be negligible.
Therefore, no mitigation is necessary for this specific use pattern.
c. Aggregate Risk Mitigation
As previously mentioned, the aggregate risk assessment for sodium acifluorfen includes dietary
exposure from food, drinking water, and residential exposure where appropriate. The aggregate risk
assessment also includes total residues in drinking water of the acifluorfen degradate from the use of
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both sodium acifluorfen and lactofen, a related pesticide, which can degrade to acifluorferi. Total
acifluorfen residues in drinking water were calculated for the soybean scenario, because both herbicides
are registered for use on soybeans.
Acute Aggregate Risk
The acute aggregate risk assessment for sodium acifluorfen includes only food and drinking
water. For acute aggregate risk, the potential drinking water exposure derived from either groundwater
or surface water is not of concern for females age 13-50, the only population at potential risk from
acute affects. As indicated in Table 6, the estimated acute (peak) groundwater (3.71 ppb) and surface
water (10.12 ppb) concentrations of acifluorfen are well below the acute DWLOC of 600 ppb.
Therefore, no mitigation measures are necessary to address acute aggregate risk.
Short-Term Aggregate Risk
The short-term aggregate risk assessment for sodium acifluorfen includes chronic dietary (food
and drinking water) and short-term residential exposure (dermal and inhalation). For short-term
aggregate risk, the potential exposure to drinking water derived from surface water or groundwater is
not of concern for the relevant population, females age 13-50. As indicated in Table 7, the short-term
DWLOC is 462, which is greater than the chronic (average) groundwater (3.71 ppb) and surface
water (2.43 ppb) concentrations of acifluorfen from all sources. Therefore, no mitigation measures are
necessary to address short-term aggregate risk.
Chronic Aggregate Risk
The chronic aggregate risk assessment for sodium acifluorfen includes only food and drinking
water. Residential exposure was not included in the chronic aggregate risk assessment because long-
term (chronic) exposures are not expected from use of residential products. For chronic aggregate
risk, the potential drinking water exposure derived from either groundwater or surface water is not of
concern for infants (less than 1 year old) and children (age 1-6), the most highly exposed population
subgroups. As indicated in Table 8, the chronic DWLOC of 40 ppb is greater than the chronic
concentration of acifluorfen in surface water (2.43 ppb) or groundwater (3.71 ppb). Therefore, no
mitigation measures are necessary to address chronic aggregate risk.
Aggregate Cancer Risk
Similarly, the cancer aggregate risk assessment for sodium acifluorfen includes only food and
drinking water. Residential exposure was not included in the cancer aggregate risk assessment because
long-term (chronic) exposures are not expected from use of residential products. For cancer aggregate
risk, the potential drinking water exposure derived from either ground or surface water is not of
concern for the US general population, the only population for which cancer risk is assessed. As
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indicated in Table 9, the cancer DWLOC for sodium acifluorfen is 455, which is greater than the
concentration of acifluorfen in surface water (2.43 ppb) or groundwater (3.71 ppb). Therefore, no
mitigation measures are necessary to address cancer aggregate risk.
d Occupational Risk Mitigation
Agricultural Handler Risk
There are some risks of concern for agricultural handlers which are summarized in Table 10.
When handlers are wearing baseline attire (long sleeve shirt, long pants, shoes, and socks), handler
MOEs are of concern for two scenarios: (2) mixing and loading liquids for groundboom application
and (4) mixing/loading liquids for aerial applicatioa Also, scenario (1) mixing/loading/applying liquids
for groundboom application was not assessed for baseline attire. However, the remaining scenarios,
including (3) applying spray with a groundboom sprayer, (5) applying spray with a fixed-wing aircraft;
and (6) flagging resulted in MOEs greater than 100 with baseline attire and are therefore not of
concern.
When chemical-resistent gloves are added to handlers for scenarios 1,2 and 4, the MOEs are
greater than 100 and not of concern Therefore, chemical-resistant gloves are adequate to mitigate risk
to agricultural handlers for these scenarios (mixers/loaders and mixer/loaders/ applicators of liquid
formulations). '
Post-Application Worker Risk
Post-application risks to agricultural workers re-entering areas treated with sodium acifluorfen
are summarized in Table 11. MOEs on the day of application are above 100, the Agency's level of
concern for re-entry workers; therefore, no mitigation is necessary. Restricted Entry Intervals (REIs)
are driven both by post-application worker risk and by the acute toxiciry of a pesticide. Sodium
acifluorfen is a severe eye irritant (Toxicity Category I); therefore, the current label REI of 48 hours is
appropriate.
2. Environmental Risk Mitigation
EPA has no concerns about the risk to aquatic organisms potentially exposed to acifluorfen via
runoff, so no mitigation is necessary. The Agency has no concerns about the risks to mammals. EPA's
screening-level assessment shows a slight chronic risk concern for birds that eat short grass containing
sodium acifluorfen residues; however, these risks are expected to be mitigated through additional label
language intended to minimize drift. The Agency does not have concerns about endangered species, as
discussed in Section in.
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EPA was unable to evaluate risks to honeybees because there are no available data. The
confirmatory DCI for this RED will include the Honeybee Acute Contact Study (OPPTS Guideline
850.3020). EPA will evaluate risk to honeybees, and any additional mitigation, after these data are
submitted and reviewed.
Likewise, the Agency was unable to conduct a risk assessment for nontarget plants because of
limited data. Because sodium acifluorfen is an herbicide and may therefore harm nontarget plants
exposed via drift, the Agency requires that sodium acifluorfen be applied in a manner that minimizes
spray drift. In addition, the seedling emergence and vegetative vigor studies must be repeated to
comply with a previous DCI. The registrant has submitted a schedule for completion of this study and
submission of data by June 30,2004. EPA will evaluate risks to nontarget plants, and any additional
mitigation, after these studies are repeated and the data are submitted and reviewed.
3. Other Labeling
In order to remain eligible for reregistration, other use and safety information must be placed on
the labeling of all end-use products containing sodium acifluorfen. For specific labeling statements, refer
to Section V of this document
a. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species and to implement
mitigation measures that address these impacts. 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 protect listed species of potential concern until such time as the agency
refines its risk assessment for plants. 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.
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b. 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 sodium-acifluorfen, as summarized in this document, the Agency
concludes that certain measures are needed to address the potential for off-target drift from sodium-
acifluorfen products. Label statements implementing these measures are listed in the "spray drift
management" section of the label table (Table 16) in Chapter V of this RED document. In the future,
sodium-acifluorfen product labels may need to be revised to include additional or different drift label
statements.
V. What Registrants Need to Do
To be eligible for reregistration, registrants need to implement the risk mitigation measures
outlined in Section IV and V, which include, among other things, submission of the following:
A. Technical Registrants
For sodium acifluorfen technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
• Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
• Any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
• Citations for any existing generic data which address data requirements or
submit new generic data responding to the DCI.
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Please contact Christina Scheltema at (703)308-2201 with questions regarding generic
reregistration and/or the DCI. All materials submitted in response to the generic DCI should be sent to
the following address:
Document Processing Desk (DCI/SRRD)
Christina Scheltema
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
B. Registrants of End-Use Products
By express or courier service:
Document Processing Desk (DCI/SRRD)
Christina Scheltema
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
For end-use products containing the active ingredient sodium acifluorfen, registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
• Any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
• Two copies of the confidential statement of formula (EPA Form 8570-4);
• A completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration;"
• Five copies of the draft label incorporating all label amendments outlined in
Table 16 of this document;
• A completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
• If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
• The product-specific data responding to the PDCI.
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Please contact Veronica Dutch at (703)308-8585 with questions regarding product
reregistration and/or the PDCI. Address all materials submitted in response to the PDCI to:
By US mail: By express or courier service only:
Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)
Veronica Dutch Veronica Dutch
US EPA Office of Pesticide Programs US EPA Office of Pesticide Programs
Mail Code 7508C (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
C. Additional Generic Data Requirements
1. Outstanding Data Requirements
The generic data base supporting the reregistration of sodium acifluorfen has been reviewed and
determined to be substantially complete. However, there are a few data gaps remaining. Because all of
these data requirements were included in previous DCls, they are not included in the generic DCI for this
RED, but these data must be submitted or the Agency may take regulatory action on registrations of
products containing sodium acifluorfen.
Analytical Methods - Plants (OPPTS Guideline 885.2300) for rice straw, to include a lower
LOQ.
Seed Germination/Seedling Emergence (OPPTS 850.4100)
Vegetative Vigor (OPPTS 850.4150)
Registrant has committed to conduct and submit plant studies by June 30, 2004.
2. Confirmatory Data Requirements
The Agency has determined that additional studies are necessary to confirm the regulatory
conclusions presented in this RED. The following confirmatory data requirements are included in the
generic DCI for sodium acifluorfen:
UV/visible Absorption (OPPTS 830.7050)
Fish Early Life Stage Toxicity Study (OPPTS 850.1400), modified for Aquatic Phototoxicity
Honey Bee Acute Contact (OPPTS 850.3020)
Directions for Use (on strawberries) (OPPTS 860.1200)
Developmental Neurotoxicity Study in Rats (OPPTS 870.6300)
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D. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MUP) labeling must be revised
to comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling must
bear the labeling contained in fable 16 at the end of this section.
E. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review previous
data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct
new studies. If a registrant believes that previously submitted data meet current testing standards, then the
study MRID numbers should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
A product-specific data call-in (PDCI), outlining data requirements for all sodium acifluorfen
products, accompanies this RED. Appendix G batches or groups sodium acifluorfen products for the
purpose of conducting the acute toxicity testing required as part of the PDCI.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section IV
above. Specific language to incorporate these changes is specified in Table 16.
F. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this RED document. Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this RED. However,
existing stocks time frames will be established case-by-case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy? Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell sodium acifluorfen products
bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons other than the
registrant may distribute or sell such products for 50 months from the date of the issuance of this RED.
Registrants and persons other than the registrant remain obligated to meet pre-existing label requirements
and existing stocks requirements applicable to products they sell or distribute.
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G. Labeling Changes Summary Table
To be eligible for reregistration, all product labels are to be amended to incorporate the risk
mitigation measures outlined in Section IV. Table 16, which follows, describes how language on the labels
should be amended.
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Description
Amended Labeling Language for Sodium Acifiuorfen
Placement on Label
Manufacturing Use Products
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 including
Groundwater
Statements
"Only for formulation into an herbicide for the following use(s): peanuts, rice, and soybeans and residential
spot treatment "
"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 uses(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."
Directions for Use
Directions for Use
Directions for Use
Precautionary Statements
47
-------
Description
Amended Labeling Language for Sodium Acifluorfen
Placement on Label
End Use Products Intended for Occupational Use (WPS)
PPE Requirements
Established by the
RED1
for all products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-resistant
material). If you want more options, follow the instructions for category (registrant inserts
A,B,C,D,E,F,G,or H) on an EPA chemical-resistance category selection chart.
Mixers, loaders, and applicators must wear:
long sleeve shirt,
long pants, and
shoes and socks.
In addition to the PPE above, mixers and loaders must also wear chemical-resistant gloves."
Immediately following
the
Precautionary Statements:
Hazards to Humans and
Domestic Animals
User Safety
Requirements
"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 separate from other laundry."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following
the PPE requirements
Engineering Controls
"Engineering Controls
When handlers use closed systems, enclosed cabs, or cockpits in a manner that meets the requirements listed
in the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler
PPE requirements may be reduced or modified as specified in the WPS."
Precautionary Statements:
Immediately following
User Safety Requirements
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on
clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to
Humans and Domestic
Animals immediately
Following Engineering
Controls
'Must be placed in a box.)
48
-------
Description
Environmental Hazards
Restricted-Entry
Interval
Early Entry PPE
Double Notification
Amended Labeling Language for Sodium Acifluorfen
For products that do not contain Directions for Use on rice:
"Do not apply directly to water, 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 wash waters. Do not apply when
weather conditions favor drift from target area.
For products that contain Directions for Use on rice:
"Do not apply directly to water, to areas where surface water is present, or to intertidal areas below the mean
high water mark, except as specified on this label for application to rice. Do not contaminate water when
disposing of equipment wash waters. Do not apply when weather conditions favor drift from target area."
For all products:
Ground Water Advisory
"Sodium acifluorfen is known to leach through soil to groundwater under certain conditions as a result of
label use. Use of this chemical in areas where soils are permeable (sandy or sandy/loamy soils) and water
tables are shallow could result in contamination of groundwater. Use of irrigated water in such areas will
increase the likelihood of groundwater contamination."
"Do not enter or allow workers to enter into treated areas during the restricted entry interval (REI) of 48
hours."
"The following PPE is 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:
Coveralls over long sleeved shirt and long pants,
Chemical-resistant gloves made of any waterproof material
Chemical-resistant footwear plus socks,
Chemical resistant headgear if overhead exposure, and
Protective eye wear."
"Notify workers of pesticide application by warning them orally and by posting warning signs at entrances
to treated areas."
Placement on Label
Precautionary Statements
immediately following
the User Safety
Recommendations
Directions for Use,
Agricultural Use
Requirements Box
Direction for Use,
Agricultural Use
Requirements Box
49
-------
Description
General Application
Restrictions
Amended Labeling Language for Sodium Acifluorfen
"Do not apply this product in a way that will contact workers or other people, either directly or through
drift. Only handlers wearing PPE may be in the treatment area during application."
"This pesticide is toxic to vascular plants and should be used strictly in accordance with the drift and run-
off precautions on this label to minimize off-site exposures."
"A 40-day plant back interval is necessary for small grains and a 100-day plant back interval is necessary for
all other rotated crops."
"Do not allow livestock to graze on treated forage for soybeans or peanuts. Do not feed treated vines "
Placement on Label
Place in the Direction for
Use directly above the
Agricultural Use Box.
50
-------
Description
Spray Drift Label
Language for Products
Applied Outdoors as a
Liquid
Amended Labeling Language for Sodium Acifluorfen
"SPRAY DRIFT MANAGEMENT"
"Use best practices to avoid drift to all other crops and non-target areas. Do not apply when conditions
favor drift from target areas. The interaction of many equipment-and-weather-related factors determine the
potential for spray drift. Avoiding spray drift at the application site is the responsibility of the applicator.
The applicator must follow the most restrictive use precautions to avoid drift, including those found in this
labeling as well as applicable state and local regulations and ordinances. A drift control agent may reduce
drift, however, it may also decrease weed control."
"Requirements for ground applications:"
"For ground applications, adjust nozzle height and droplet size with wind speed according to the following
table:"
Droplet size for
standard nozzles
Wind speed Nozzle height ( ASAE standard 572)
Up to 2 feet medium or coarser
Less than 10 mph 2-4 feet coarse or coarser
4-6 feet verv coarse or coarser
0-2 feet coarse or coarser
10 to 15 mph 2-4 feet very coarse or coarser
4-6 feet extremelv coarse
Do not apply when the wind speed exceeds 15 miles per hour. Do not apply with a nozzle height of greater
than 6 feet above the ground or crop canopy. Apply as a medium or coarser spray (ASAE standard 572).
Placement on Label
Directions for Use under
General Precautions and
Restrictions
51
-------
Description
Spray Drift Label
Language for Products
Applied Outdoors as a
Liquid
Amended Labeling Language for Sodium Acifluorfen
"Requirements for aerial applications:"
"For aerial applications, apply only when the wind speed is less than or equal to 1 5 miles per hour using a
release height of no more than 10 feet above the ground or crop canopy. If the wind speed is less than 10
mph, apply as a medium or coarser spray (ASAE standard 572). If the wind speed is between 10 mph and 15
mph, apply as a coarse or coarser spray (ASAE standard 572)."
"The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter."
"Do not make aerial applications into temperature inversions."
"When aerial applications are made with a cross-wind, the swath will be displaced downwind. The
applicator must compensate for this displacement at the downwind edge of the application area by adjusting
the path of the aircraft upwind."
Placement on Label
Directions for Use under
End Use Products Intended Primarily for Use by Homeowners
Spray Drift Label
Language for Home-
Use Products Applied
as a Liquid
Application/Entry
Restriction
Eligibility Restrictions
"Do not apply this product in a way that will contact people or pets, either directly or through drift."
"Use this product for spot treatment only. This product is not intended for wide area or broadcast use."
"Keep all people, children, and pets out of the treated area until sprays have dried."
For residential use, only ready-to-use products packaged in a spray trigger bottle are eligible for
reregistration.
Directions for Use under
General Precautions and
Restrictions
Directions for Use under
General Precautions and
Restrictions
Directions for Use under
General Precautions and
Restrictions
PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
52
-------
VI. Related Documents and How to Access Them
A list of technical support documents for the sodium acifluorfen RED is provided in Appendix C.
All technical support documents for this RED may be viewed on paper in the OPP Public Docket or
electronically via the Internet. These documents may be found on the Agency's web page at
www.epa.gov/pesticides/reregistration/status.htm (documents through April 2002) or at
www.epa.gov.edockets under docket OPP-2003-0293 (Documents from May 2002 to the present).
Hard copies of these documents may be found in the OPP public docket, under docket numbers OPP-
34241A or B, for documents dated through April 2002, or under docket number OPP-2003-0293, for
documents dated from May 2002 to the present. The OPP public docket is located in Room 119, Crystal
Mall n, 1921 Jefferson Davis Highway, Arlington, VA. The docket is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
53
-------
VII. APPENDICES
A. Use Patterns Eligible for Reregistration
B. Data Supporting FIFRA Guideline Requirements for the Reregistration of Sodium
Acifluorfen
C. List of EPA's Technical Support Documents for Sodium Acifluorfen
D. Bibliography of MRID Citations Supporting the RED
E. Generic Data Call In (DCI)
F. Product-Specific DCI
G. Batching of Products for Meeting Acute Toxicity Data Requirements
H. List of Registrants sent the DCI
I. List of Electronically Available Forms
54
-------
Appendix A
Sodium Acifluorfen (Case 2605): Use Patterns Eligible for Reregistration
Site
Application Timing
Application Type
Application Equipment '
Formulation [EPA
Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval,
Days
Use Directions and Limitations 2l3'4
Peanuts
Preemergence, at cracking,
or postemergence
Broadcast
Ground/Aerial
Preemergence, at cracking,
or postemergence
Broadcast
Ground/Aerial
Preemergence, at cracking,
or postemergence
Broadcast or banded foliar
Ground/Aerial
1.331b/galSC
[7969-76]
0.67 Ib/gal SC
[7969-77]
2 Ib/gal SC
[7969-79]
[7969-80]
0.25 Ib/A
0.25 Ib/A
0.375 Ib/A
2
2
2
0.5 Ib/A
0.42 Ib/A
0.5 Ib/A
75
75
75
Minimum retreatment interval is 15 days.
Do not feed or graze livestock on treated hay,
forage, or fodder.
Do not feed or graze livestock on treated hay,
forage, or fodder.
Minimum retreatment interval is 15 days.
For banded applications, minimum band width is
15 inches and minimum application volume is
15 gal/A.
Do not feed or graze livestock on treated hay,
forage, or fodder.
55
-------
Site
Application Timing
Application Type
Application Equipment '
Formulation [EPA
Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval,
Days
Use Directions and Limitations 2'3'4
Rice
Late tillering to early boot
Broadcast
Ground/Aerial
Late tillering to early boot
Broadcast or banded foliar
Ground/Aerial
1.331b/galSC
[7969-76]
2 Ib/gal SC
[7969-79]
[7969-80]
0.25 Ib/A
0.25 Ib/A
1
2
(at0.1251bai/A)
0.25 Ib/A
0.25 Ib/A
50
50
May be used on first and second (ratoon) crops.
Rice must be past the 3-leaf stage. The following
are prohibited: use of ground equipment when
fields are flooded; application where commercial
cultivation of catfish or crayfish is practiced; use
of water containing residues from rice cultivation
to irrigate crops other than soybean or peanuts.
Rjce must be past the 3-leaf stage. For banded
applications, minimum band width is 1 5 inches
and minimum of application volume is 15 gal/A.
The following are prohibited: application after
rice reaches the boot stage, harvesting catfish or
crayfish for food from treated areas; use of water
containing residues from rice cultivation to
irrigate crops other than those labeled for use
with this product.
Soybeans
Postemergence
Broadcast foliar
Ground/Aerial
1.331b/galSC
[7969-76]
0.67 Ib/gal SC
[7969-77]
0.25 Ib/A
2
0.5 Ib/A
50
Minimum retreatment interval is 15 days [EPA
Reg. No. 7969-76 only].
Do not feed or graze livestock on treated hay,
forage, or fodder.
56
(continued; footnotes follow)
-------
Site
Application Timing
Application Type
Application Equipment '
Postemergence
Broadcast or banded foliar
Ground/Aerial
Postemergence
Broadcast foliar
Ground/Aerial
Formulation [EPA
Reg. No.]
2 Ib/gal SC
[7969-79]
[7969-80]
0.84 Ib/gal SC
[7969-168]
Maximum Single
Application Rate
(ai)
0.375 Ib/A
0.25
Maximum
Number of
Applications Per
Season
2
(at 0.25 ib ai/A)
1
Maximum
Seasonal Rate
(ai)
0.5 Ib/A
0.5 Ib/A 7
Preharvest
Interval,
Days
50
75
Use Directions and Limitations 2J|4
Minimum retreatment interval is 15 days. For
banded applications, minimum band width is 15
inches and minimum application volume is 15
gal/A.
Do not feed or graze livestock on treated hay,
forage, or fodder.
Soybeans must be at the second to third trifoliate
leaf stage. Minimum retreatment interval is 5-
days.
Do not feed or graze livestock on treated hay,
forage, or fodder.
Residential Use as a Spot Treatment
Postemergence
Ready-to-Use
Spot Treatment
0.12%a.i.
[71995-3]
Not Specified
(Spot Treatment)
Not
Applicable
Applications may be made in 10-50 gal/A by ground equipment or 5-10 gal/A by aerial equipment.
Cultivation within 5 days before or 7 days after application for peanuts, rice, and soybeans. A restricted entry interval (REI) of 48 hours and an 18-month
plantback interval for root crops are currently in effect.
One of the following additives is needed depending on crop and tank mix used: ammonium sulfate, crop oil concentrate, nonionic surfactant, or urea
ammonium nitrate.
Except as noted, the following components are approved for tank mixing. For peanuts: 2,4-DB, alachlor, bentazon, dimethenamid, imazamethapyr,
metolachlor, paraquat, and sethoxydim. For rice: bentazon, propanil, and quinclorac. For soybeans: 2,4-D LVE (preplant burndown only), 2,4-DB, bentazon,
chloransulam-methyl, chlorimuron-ethyl, clethodim, dimethenamid, fenoxaprop-p-ethyl, fluazifop-p-butyl, flumiclorac-pentyl ester, glyphosate, imazamox,
imazaquin, imazethapyr, quizalofop-p-ethyl, sethoxydim, and thifensulfuron-methyl.
57
-------
APPENDIX B: Data Supporting FIFRA Guideline Requirements
for Sodium Acifluorfen
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients
within the case 0005 covered by this Reregistration Eligibility Decision Document. It contains generic data
requirements that apply to 0005 in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear
in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidelines, which are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161 (703) 487^650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements
apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, mis column lists the
identifying number of each study. This normally is the Master Record Identification (MRID) number, but
may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
58
-------
Data Supporting FIFRA Guideline Requirements
for Sodium Acifluorfen
Guideline Requirement
Guideline Number
New
Old
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
63-7
Study Title
Use Pattern
PRODUCT CHEMISTRY
Chemical Identity & Composition
Starting Material &
Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
Melting Point
Boiling Point
Density
All
All
All
All
All
All
All
All
All
All
All
All
All
MRID Citation
41891203
41891201
41891201
41891202
41891203
41891202
41891204
41891204
41891204
New Data Requirement
41891204
N/A
41891204
59
-------
Guideline Requirement
Guideline Number
New
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.1075
850.1075
850.1075
Old
63-8
63-9
63-10
63-11
63-12
63-13
Study Title
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
Coefficient
pH
Stability
Use Pattern
All
All
All
All
All
All
MR1D Citation
41650302
41784601
41731901, 41891205
41891206
41891204
41891209
ECOLOGICAL EFFECTS
71-1
71-2A
71-2B
71-3
71-4A
71-4B
72-1A
72-1B
72-1C
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Sheepshead Minnow
Fish Toxicity Rainbow Trout
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
00083058, 00122748
00083059, 00122750
00083060, 00122749
00071887, 00122743
00107491
00107492
00107493, 00122751, 00071901
00124223
00071901,00122752
60
-------
Guideline Requirement
Guideline Number
New
850.1010
None
None
None
850.1400
850.4100
850.4150
850.4400
850.3020
Old
72-2A
72-3A
72-3B
72-3C
72-4A
123-l(a)
123-l(b)
122-2
123-2
141-1
Study Title
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Fish Early Life Stage/
Aquatic Phototoxicity
Seedling Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth, Tier I
Aquatic Plant Growth, Tier H
Honey Bee, acute contact
Use Pattern
ABCDK
ABCDK
ABCDK
ABCDK
ABCDK
BD
BD
BD
BD
ABCDK
MRID Citation
00071901, 00122754
00122753, 00124223
00111964
00111962,00122755
Data Gap/New Data Requirement
Data Gap
Data Gap
41680702
41680702
New Data Requirement
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
81-1
81-2
81-3
81-4
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
AH
All
All
All
00122724
00061626
00061627
00061628
61
-------
Guideline Requirement
Guideline Number
New
870.2500
870.2600
870.3100
870.3150
870.3200
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.5140
870.5375
None
870.7485
Old
81-5
81-6
82-1A
82-1B
82-2
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
Study Title
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
MRID Citation
00061629
40814601
Waived
Waived
00122731
00128353
00122732, 00122734
00128353
00122732, 00122734
00122743
00122744
00155548
45393901, 41480101, 41480103
00122741
00122738, 00122739, 00122742
00122746, 00156020
62
-------
Guideline Requirement
Guideline Number
New
870.6300
Old
875.2100
875.2200
875.2400
875.2500
None
None
132-1A
132-1B
133-3
133-4
231
232
835.2120
835.2240
835.2410
835.4100
161-1
161-2
161-3
162-1
Study Title
Developmental Neurotoxicity in
Rats
Use Pattern
All
MRID Citation
New Data Requirement
OCCUPATIONAL/RESIDENTIAL EXPOSURE
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry
Exposure
Inhalation Passive Dosimetry
Exposure
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure
at Outdoor Sites
ABCD
ABCD
ABCD
ABCD
ABCD
ABCD
44091101
42019301
42361501, 44459801
42361501, 44459801
42361501
42361501
ENVIRONMENTAL FATE
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
All
ABCD
ABCD
ABCD
00107479
41891208, 42793502, 44195001, 44195002
41688501,44412901
00143572
63
-------
Guideline Requirement
Guideline Number
New
835.4200
835.4400
835.4300
835.1240
835.6100
835.1850
None
Old
162-2
162-3
162-4
163-1
164-1
164-2
165-1
165-4
166-1
Study Title
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Aquatic Field Dissipation
Confined Rotational Crop
Bioaccumulation in Fish
Groundwater monitoring, small
scale retrospective
Use Pattern
ABCD
CD
CD
All
AB
CD
AD
All
All
MRID Citation
Satisfied by Anaerobic aquatic metabolism
study
43155201
42330601
42793501, 44412902
Addressed in MRID 41833202
(Groundwater Monitoring Study)
43270801
42785601, 43372501, 43666601
Waived
41833202, 42152201, 41448501, 41651101
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
171-4A
171-4B
Directions for Use (Strawberries)
Nature of Residue - Plants
Nature of Residue - Livestock
AD
ABD
ABD
New Data Requirement
41688504, 42330604, 42368301, 42368302,
42865801, 42865802, 43182001, 43181901,
43295501, 43881001, 43584501
42815601,42828201
64
-------
Guideline Requirement
Guideline Number
New
860.1340
860.1340
860.1360
860.1380
860.1480
860.1500
860.1500
860.1500
860.1500
860.1520
860.1500
860.1500
Old
171-4C
171-4D
171-4E
171-4J
171-4K
171-4K
171-4K
171-4K
171-4L
171-4K
171-4K
Study Title
Residue Analytical Method -
Plants
Residue Analytical Method -
Animals
Analytical Method for rice straw
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials
(Soybeans)
Crop Field Trials (Rice)
Crop Field Trials (Peanut)
Crop Field Trials (Strawberry)
Processed Food/Feed
Confined Rotational Crops
Field Rotational Crops
Use Pattern
ABD
ABD
ABD
ABD
ABD
ABD
ABD
ABD
ABD
ABD
ABD
ABD
MRID Citation
00028858, 42815702, 43451001, 44137901,
44153801, 92168036, 92168048
00028858, 92168036, 92168048
Data gap for rice straw
00107488, 43290101,43601401,
43666602,44137901, 92168037, 92168049,
42815601, 42828201
00107488, 92168050,
42828201, 42815601
00107488, 42815701, 92168045, 92168053
42330604, 42825701
00028857, 00028858, 92168042, 92168052
41285901
43254901, 42330605, 43584501, 43254902
42785601, 43372501, 43666601
Conditional requirement to support shorter
plant back intervals
65
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APPENDIX C:
LIST OF EPA's TECHNICAL SUPPORT DOCUMENTS
FOR SODIUM ACIFLUORFEN
Additional documentation in support of this IRED is maintained in the OPP docket, located in Room
119, Crystal Mall #2,1921 JeflFerson Davis Highway, Arlington, VA. The docket is open Monday through
Friday, excluding Federal holidays, from 8:30 am to 4:00 pm.
The preliminary and revised risk assessments for sodium acifluorfen are available in the Public Docket,
under docket numbers OPP-3424A and B, and on the Agency's web page,
www.epa.gov/pesticides/reregistration/status.htm. Because the Agency implemented a new docketing
system in July 2002, documents dated from May 1,2002 to the present are in the docket OPP-2003-
0293 and on the internet at a different site, http://www.epa.gov/edockets.
EPA released the preliminary risk assessments for sodium acifluorfen on July 26,2001 and the revised
risk assessments on April 12,2002 under docket numbers OPP-3424A and B. During and after the
second public comment period, the registrant submitted additional voluntary data for sodium acifluorfen.
EPA reviewed there data and incorporated them into the final revised risk assessments for sodium
acifluorfen. These final revised risk assessments form the basis of the regulatory decision described in the
RED.
All final revised risk assessment and technical support documents may be viewed in the OPP docket
room, in hard copy form, or downloaded or viewed electronically via the Internet at the following site:
www.epa.gov/edockets. These documents include the following:
Human Health Risk Assessment Documents
• Michael Metzger (OPP/HED/RRB1). Sodium Acifluorfen. Revision to BED Chapter for
Reregistration Eligibility Decision Document. July 14,2003.
• Jessica Kidwell (OPP/HED/SIMB). Acifluorfen: Report of the Cancer Assessment Review
Committee. July 9,2003.
• Paul Chin (OPP/HED/RRB1). Mechanism of 'ToxicitySARC Second Report: Acifluorfen. July 9,
2003.
• Paul Chin (OPP/HED/RRB1) and Irving Mauer (OPP/HED/RRB1). Acifluorfen (Tackle/Blazer):
Review of 3 mechanism studies. May 13, 2003.
- KitFarwell (OPP/HED/RRB 1). SODIUM ACIFLUORFEN. HED Chapter for the
Reregistration Eligibility Decision Document. January 15, 2002.
• Felicia A. Fort (OPP/HED/RRB1). Sodium Acifluorfen. Revised Product and Residue Chemistry
Chapters of the Reregistration Eligibility Decision. December 18, 2001.
66
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• Timothy Dole (OPP/HED/RRB1). Sodium Acifluorfen: Second Revised Occupational and
Residential Exposure and Risk Assessment for the RED. November 13,2001.
• Paul Chin and Kit Farwell (OPP/HED/RRB 1). Acifluorfen: Reponse to BASF's Phase 5
Comments on the Risk Assessment Document for Sodium Acifluorfen. August 21,2002.
Environmental Fate and Ecological Effects
• James K. Wolf (OPP/EFED/ERBffl). Addendum to EFED RED Chapter for Sodium Acifluorfen.
Addendum to TRED for Lactofen. September 15, 2003.
• James Wolf (OPP/EFED/ERBIII). Drinking Water Exposure Assessment for Lactofen, updated
for Prospective Ground Water (PGW) Monitoring Study. January 21, 2003.
• James Goodyear (OPP/EFED/ERBffl). Addendum to EFED RED Chapter for Sodium
Acifluorfen. September 15, 2003.
• James Goodyear (OPP/EFED/ERBffl). Response to the ecological effects portion of BASF's "60-
day comments " on the draft RED on Sodium Acifluorfen posted to the public docket OPP-
34241. February 4, 2002.
• James K. Wolf (OPP/EFED/ERBffl). Response to BASF Rebuttal Comment's [sic], dated May
24, 2002, to the Phase 5 risk assessment for sodium acifluorfen. March 18, 2003.
• James Goodyear (OPP/EFED/ERBffl). EFED's Phototoxicity Data Requirement for Sodium
Acifluorfen RED. February 4, 2001.
• James Goodyear (OPP/EFED/ERBffl). Response to BASF's Comments on the Red for Sodium
Acifluorfen for use on soybeans, peanuts, and rice. March 18,2003.
• Norman Birchfield, Thomas Steeger, Brian Montague (OPP/EFED/Aquatic Biology Tech Team).
Request for Phototoxicity Study Protocol for Light-Dependent Peroxidizing Herbicides. March
7,2001.
• James J. Goodyear and James K. Wolf. (OPP/EFED/ERBffl). Registration of sodium
acifluorfen. June 8, 2000.
Use and Usage
• Christina Scheltema (OPP/SRRD/RB3). Use Closure Memo for Sodium Acifluorfen, dated
November 1,1999.
• Frank Hernandez (OPP/BEAD/EIB). Quantitative Use Assessment for Sodium Acifluorfen, dated
July 9,1999.
67
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Appendk D
BIBLIOGRAPHY OF MRID CITATIONS SUPPORTING THE RED
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.
68
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b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence contained
in the document. When the date appears as (1999), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text) the following elements describing the earliest
known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses
identifies the EPA accession number of the volume in which the original submission of the
study appears. The six-digit accession number follows the symbol "CDL," which stands
for "Company Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
69
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MRID
00028858
Citation
00061626
00061627
00061628
00061629
00071323
00071887
00071889
Zogorski, W.J.; Rogerson, T.D. (1978) A Terminal Residue Analytical Method
for RH-6201 and Its Major Metabolites: Technical Report No. 34H-78-24.
Method dated Oct 17, 1978. (Unpublished study received Mar 13,1980 under
707-EX-94; prepared by Spring House Research Laboratories, submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:099306-B)
Whittaker Corporation (19??) Acute Dermal LD 50-Rabbits: Study No.
410-0250. (Unpublished study received Jan 5,1981 under 2224-EX-18;
submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:244147-E)
Cavender, F.L.; Horath, L.L. (1980) Acute Inhalation LC 50-Rats: Study No.
420-0251. (Unpublished study received Jan 5,1981 under 2224-EX-18;
prepared by Whittaker Corp., submitted by Mobil Chemical Co., Industrial
Chemicals Div., Richmond, Va.; CDL:244147-F)
Whittaker Corporation (19??) Primary Eye Irritation-Rabbits: Study No.
410-0252. (Unpublished study received Jan 5,1981 under 2224-EX-18;
submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:244147-G)
Whittaker Corporation (19??) Primary Dermal Irritation-Rabbit Study No.
410-0286. (Unpublished study received Jan 5,1981 under 2224-EX-18;
submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:244147-H)
Freeman, C.S.; Robbins, G.R. (1980) Acute Dermal Toxicity Study: Rabbit
LDI50: C.S.E. Study #04178. (Unpublished study received Oct 28, 1980 under
4816-367; prepared by Cosmopolitan Safety Evaluation, Inc., submitted by
Fairfield American Corp., Medina, N.Y.; CDL:244135-A)
Parsons, R.D. (1976) Toxicity Data: (Experimental) Herbicide RH 6201,
Aqueous Technical, 39.6% Active Ingredient; Sodium
5-(2-Chloro-4-trifluoro-methyl-phenoxy)2-nitrobenzoate, Aqueous Technical
39.6% (PL-76/8017): Report No. 76-171. (Unpublished study received Jan 17,
1977 under 707-EX-87; submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:095736-I)
Parsons, R.D.; Morici, I.J. (1976) RH-6201 Acute Oral Toxicity in Dogs.
(Unpublished study received Jan 17, 1977 under 707-EX-87; submitted by Rohm
& Haas Co., Philadelphia, Pa.; CDL:095736-K)
70
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MRID
00071901
00082897
00083058
00083059
00083060
00087478
00107479
00107484
00107485
00107491
Citation
Buccafusco, R.J. (1976) Acute Toxicity of RH-6201LC to Bluegill (Lepomis
macrochirus), Rainbow Trout (Salmo gairdneri) and the Water Flea (Daphnia
magna). (Unpublished study received Jan 17,1977 under 707-EX-87; prepared
by EG & G, Bionomics, submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:095736-AA)
Goldenthal, E.I.; Jessup, D.C.; Geil, R.G.; et al. (1979) Lifetime Dietary Feeding
Study in Mice: 285-013a. (Unpublished study received Mar 29, 1979 under 707-
149; prepared by International Re- search and Development Corp., submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:098024-A; 098025)
Fink, R. (1976) Final Report: Acute Oral LD50-Mallard Duck: Project No.
129-111. (Unpublished study received Jan 17,1977 under 707-EX-87;
prepared by Wildlife International, Ltd., submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:095736-AB)
Fink, R. (1976) Final Report: Eight-day Dietary LC50-Bobwhite Quail: Project
No. 129-108. (Unpublished study received Jan 17,1977 under 707-EX-87;
prepared by Wildlife International, Ltd., submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:095736-AC)
Fink, R. (1976) Final Report: Eight-day Dietary LC50-Mallard Duck:Project No.
129-109. (Unpublished study received Jan 17,1977 under 707-EX-87;
prepared by Wildlife International, Ltd., submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:095736-AD)
Coleman, M.E.; Murchison, T.E.; Sahota, P.S.; et al. (1978) Three and Twenty-
four Month Oral Safety Evaluation Study of RH-6201 in Rats: DRC 5800. Final
rept. (Unpublished study, including letter dated Mar 16,1979 from M.E. Coleman
to Isadore Morici, received Nov 13, 1979 under 707-149; prepared by Dawson
Research Corp., submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
099091-A; 099092; 099093; 099094)
Rohm & Haas Co. (1976) [Analyses for Residues of RH-6201 and Other
Products in Crops, Soil, and Animals]. (Compilation; unpublished study received
Jan 17, 1977 under 707-EX-87; CDL:095734-A; 095733; 095735)
Piccirillo, V.; Marshall, P.; Kundzins, W.; et al. (1978) 104-week Toxicity Study
in Dogs: RH-6201: Project No. 417-357. Final rept. (Unpublished study received
Dec 14, 1978 under 707-149; prepared by Hazleton Laboratories America, Inc.,
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:097705-C)
Weatherholtz, W.; Piccirillo, V. (1979) Final Report: Teratology Study in Rabbits:
[RH-6201 LC]: Project No. 417-374. (Unpublished study received on unknown
date under 707-149; prepared by Hazleton Laboratories America, Inc., submitted
by Rohm & Haas Co., Philadelphia, PA; CDL:097705-D; 098026)
Piccirillo, V.; Najarian, G. (1978) One-generation Reproduction Study in
Bobwhite Quail: RH-6201. Final rept. (Unpublished study received Dec 14,
71
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MRID
00107492
Citation
0107493
0107494
00111962
00111963
00111964
00122724
00122725
00122726
1978 under 707-149; prepared by Hazleton Laboratories America, Inc.,
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:097718-B)
Piccirillo, V.; Najarian, G. (1978) Final Report: One-generation Reproduction
Study in Mallard Ducks: [RH-6201]: Project No. 417-373. (Unpublished study
received Dec 14, 1978 under 707-149; prepared by Hazleton Laboratories
America, Inc., submitted by Rohm & Haas Co., Philadelphia, PA;
CDL:097718-C)
Buccafusco, R (1977) Acute Toxicity of RH-6201 Technical to Blue-gill
(Lepomis macrochirus). (Unpublished study received Dec 14,1978 under
707-149; prepared by EG & G, Bionomics, submitted by Rohm & Haas Co.,
Philadelphia, PA; CDL:097718-D)
Kuc, W. (1977) The Acute Toxicity of RH 6201, Lot #SW 77/0101 (42.4%
Active Ingredient) to the Channel Catfish, Ictalurus punctatus (Rafinesque): UCES
Proj. # 11506-33-03. (Unpublished study received Dec 14, 1978 under 707-
149; prepared by Union Carbide Corp., submitted by Rohm & Haas Co.,
Philadelphia, PA; CDL:097718-E)
Vilkas, A. (1977) Acute Toxicity of RH 6201, Lot #SW 77/0101 (42.4%Active
Ingredient) to the Grass Shrimp, Palaemonetes pugio: UCES Proj. #
11506-33-03. (Unpublished study received Dec 14, 1978 under 707-149;
prepared by Union Carbide Corp., submitted by Rohm & Haas Co., Philadelphia,
PA; CDL:097718-G)
Vilkas, A. (1977) Acute Toxicity of RH 6201, Lot #SW 77/0101 to the
Freshwater Clam Elliptic complanata: UCES Project # 11506-33-03.
(Unpublished study received Dec 14,1978 under 707-149; prepared by Union
Carbide Corp., submitted by Rohm & Haas Co., Philadelphia, PA; CDL:097718-
H)
Vilkas, A. (1977) The Acute Toxicity of RH 6201, Lot #SW 77/0101 to the
Eastern Oyster Crassostrea virginica: UCES Proj. # 11506-33-03. (Unpublished
study received Dec 14,1978 under 707-149; prepared by Union Carbide Corp.,
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:097718-I)
Calkins, J.; Wingard, B. (1980) Acute Oral LD50 Study in Rats of 04038001:
Study No. 410-0249. (Unpublished study received Dec 20, 1982 under
359-708; prepared by Toxigenics, Inc., submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071306-B)
Calkins, J.; Wingard, B. (1980) Acute Dermal Toxicity Study in Rab- bits of
04038001 at a Dose Level of 2 Grams per Kilogram of Body Weight: Study No.
410-0250. (Unpublished study received Dec 20,1982 under 359-708; prepared
by Toxigenics, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071306-C)
Cavender, F.; Horath, L.; Harlin, K.; et al. (1980) Four-hour Acute Aerosol
Inhalation Toxicity Study in Rats of Tackle 2AS Herbicide: Study No. 420-0251.
72
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Citation
00122728
00122730
00122731
00122732
00122734
00122736
(Unpublished study received Dec 20, 1982 under 359-708; prepared by
Toxigenics, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071306-D)
Calkins, J. (1980) Primary Dermal Irritation Study in Rabbits of 04038001: Study
No. 410-0286. (Unpublished study received Dec 20, 1982 under 359-708;
prepared by Toxigenics, Inc., submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL: 071306-F)
Bamett, J. (1982) Evaluation of Ninety Day Subchronic Toxicity of Tackle in
Fischer 344 Rats: GSRI Project No. 413-971-40; Rhone-Poulenc Agrochemie
No. 372-80. (Unpublished study received Dec 20,1982 under 359-708;
prepared by Gulf South Research Institute, submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071308-A)
Voss, K.; Becci, P.; Parent, R. (1981) Subchronic 21-day Dermal Toxicity Study
in Rabbits: [Tackle 2S]: FDRL Study No. 6718. (Unpublished study received Dec
20, 1982 under 359-708; prepared by Food and Drug Research Laboratories,
Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071311-A)
Bamett, J.; Jenkins, L.; Parent, R. (1982) Evaluation of the Potential Oncogenic
and Toxicological Effects of Long Term Dietary Administration of Tackle to
B6C3F1 Mice: GSRI Project No. 413-984-41. Final rept. (Unpublished study
received Dec 20,1982 under 359-708; prepared by Gulf South Research
Institute, submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071312-A)
Sigler, F. (1982) Evaluation of Oncogenic Potential of Tackle in B6C3F1 Mice:
Project No. WIL-81159. Final rept. (Unpublished study received Dec 20,1982
under 359-708; prepared by WIL Research Laboratories, Inc., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:071313-A; 071314)
Sigler, F. (1982) A Combined Oncogenic/Chronic Feeding Study of Tackle in
Fischer 344 Rats: WIL-81160. One year interim rept. (Unpublished study
received Dec 20,1982 under 359-708; submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071317-A)
73
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MRID
00122737
Citation
00122738
00122739
00122741
00122742
00122743
00122744
Bowman, I; Mackerer, C; Bowman, S.; et al. (1981) Drosophila Mutagenicity
Assays of Mobil Chemical Company Compound MC 10109: (MRI # 533): Study
No. 009-275-533-9. (Unpublished study received Dec 20,1982 under 359-708;
prepared by EG & G Mason Research Institute and others, submitted by Rhone-
Poulenc, Inc., Monmouth Junction, NJ; CDL:071318-A)
Putnam, D.; Schechtman, L.; Moore, W. (1981) Activity of T1689 in the
Dominant Lethal Assay in Rodents: MA Project No. T1689.116. Final rept.
(Unpublished study received Dec 20,1982 under 359-708; prepared by
Microbiological Assoc., submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ;CDL:071318-B)
Schreiner, C.; Thompson, M.; Danna, D.; et al. (1980) A Murine Lymphoma
(Heterozygous for Thymidine Kinase) Mutagenicity Assay for the Determination of
Potential Mutagenicity of Tackle: Study No. 512-80. (Unpublished study
received Dec 20,1982 under 359-708; prepared by Mobil Environmental Health
Sciences Laboratory, submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ;CDL:071318-C)
Schreiner, C.; Skinner, M.; Mehlman, M.; et al. (1981) Metaphase Analysis of
Rat Bone Marrow Cells Treated in vivo with Tackle 2S: Study No. 1041-80.
(Unpublished study received Dec 20,1982 under 359-708; prepared by Mobil
Environmental Health Sciences Laboratory, submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071318-E)
Myhr, B.; McKeon, M. (1981) Evaluation of 06238001 in the Primary Rat
Hepatocyte Unscheduled DNA Synthesis Assay: MEHSL Study #1022-80. Final
rept. (Unpublished study received Dec 20, 1982 under 359-708; prepared by
Litton Bionetics, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071318-F)
Florek, M.; Christian, M.; Christian, G.; et al. (1981) Teratogeniciry Study of
TACU 06238001 in Pregnant Rats: Argus Project 113-004. (Unpublished study
received Dec 20,1982 under 359-708; prepared by Argus Research
Laboratories, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071319-A)
Lightkep, G.; Christian, M.; Christian, G.; et al. (1980) Teratogenic Potential of
TACU 06238001 in New Zealand White Rabbits (Segment II Evaluation): Argus
74
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MRID
00122746
00122747
00122748
00122749
00122750
00122751
Citation
Project 113-003. (Unpublished study received Dec 20,1982 under 359-708;
prepared by Argus Research Laboratories, Inc., submitted by Rhone-Poulenc,
Inc., Monmouth Junction, NJ; CDL:071319-B)
Low, L.; Meeks, J.; Mackerer, C.; et al. (1982) Pharmacokinetics and
Metabolism of MC 10978 (Sodium 5-2-Chloro-4-(trifluoro-methyl) phenoxy|-2-
nitrobenzoate): Study No. 63281 (983-80F). Final rept. (Unpublished study
received Dec 20,1982 under 359-708; prepared by Mobil Environmental and
Health Science Laboratory, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL:071321-A)
Fink, R.; Beavers, J.; Brown, R.; et al. (1981) Acute Oral LD50- Mallard Duck:
10318001: MEHSL Study No. 2031-80. Final rept. (Unpublished study received
Dec 20,1982 under 359-708; prepared by Wildlife International, Ltd. and
Washington College, submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:071322-A)
Fink, R.; Beavers, J.; Brown, R.; et al. (1981) Acute Oral LD50-Bobwhite
Quail: 10318001: MEHSL Study No. 2021-80. Final rept.(Unpublished study
received Dec 20,1982 under 359-708; prepared by Wildlife International Ltd.
and Washington College, submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ; CDL:071322-B)
Fink, R.; Beavers, J.; Brown, R.; et al. (1981) Eight-day Dietary LC50~Mallard
Duck: 10318001: MEHSL Study No. 2011-80. Final report. (Unpublished
study received Dec 20,1982 under 359-708; prepared by Wildlife International
Ltd. and Washington College, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL:071322-C)
Fink, R.; Beavers, J.; Brown, R.; et al. (1981) Eight-day Dietary
LC50-Bobwhite Quail: 10318001: MEHSL Study No. 2001-80. Final report.
(Unpublished study received Dec 20, 1982 under 359-708; prepared by Wildlife
International Ltd. and Washington College, submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL: 071322-D)
LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of 10318001 to Bluegill. Report
#BW-81-1-811. (Unpublished study received Dec 20,1982 under 359-708;
prepared by EG & G, Bionomics, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL: 071322-E)
75
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MRID
00122752
Citation
00122753
00122754
00122755
00122760
00124222
00124223
LeBlanc, G.; Sousa, J. (1981) Acute Toxicity of 10318001 to Rainbow Trout.
Report #BW-81-2-815. (Unpublished study received Dec 20,1982 under
359-708; prepared by EG & G Bionomics, submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071322-F)
Ward, G. (1981) Acute Toxicity of 1993-80 (Sample No. 10318001) to
Sheepshead Minnows. Report No. BP-81-6-111. (Unpublished study received
Dec 20,1982 under 359-708; prepared by EG & G Bionomics, submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:071322-G)
LeBlanc, G.; Surprenant, D. (1981) Acute Toxicity of 10318001 to the Water
Flea. Report #BW-81-1-807. (Unpublished study received Dec 20, 1982 under
359-708; prepared by EG & G, Bionomics, submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:071322-H)
Hollister, T. (1981) Acute Toxicity of 1992-80 (Sample No. 10318001) to Mysid
Shrimp: Report No. BP-81-6-97. Unpublished study received Dec 20,1982
under 359-708; prepared by EG & G Bionomics, submitted by Rhone-Poulenc,
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Engelhardt, G. (1990) Report on the Study of Acifluorfen (Pure Active Ingredient)
in the Ames Test (Standard Plate Test with Salmonella typhimurium): Lab Project
Number: 90/0041. Unpublished study prepared by BASF Aktiengesellschaft. 20
P-
Engelhardt, G.; Hoffmann, H. (1990) Report on the Study of Blazer (Rohm and
Haas) in the Ames Test (Standard Plate Test and Preincubation Test with
Salmonella typhimurium TA 100): Lab Project Number 90/0040. Unpublished
study prepared by BASF Aktiengesellschaft. 25 p
Friewald, R.; Wood, B.; Rose, A. (2001) A Small-Scale Prospective Ground
Water Monitoring for Lactofen Interim Report # 5: Lab Project Number: VP-
12155. Unpublished study prepared by LFR Levine-Fricke Inc., and North Coast
Laboratories. 57 p.
Mellert, W.; Kaufman, W.; van Ravenzwaay, B. (2001) Positive Control Study
for Support of Peroxisome Proliferation: DINP-Peroxisome Proliferation Study in
B6C3F1 Mice-Administration in the Diet for 4 Weeks: Lab Project Number:
2001/5003598: 99C0226/00014. Unpublished study prepared by BASF
Aktiengesellshaft. 102 p.
Mellert, W.; Deckardt, K.; van Ravenzwaay, B.; et al. (2001) Positive Control
Study for Support of Peroxisome Proliferation: DINP-Enzyme Induction Study in
B6C3F1 Mice Administration in the Diet for 1 and 4 Weeks: Lab Project
Number: 99C0226/00018: 2001/5003599. Unpublished study prepared by
BASF Aktiengesellshaft. 228 p.
Freiwald, R.; Wood, B.; Rose, A. (2002) A Small-Scale Prospective Ground
Water Study Monitoring for Lactofen: Lab Project Number: VP-12155: V-99-
12155: VAL-MI-001. Unpublished study prepared by LFR Levine Frickelnc.
and North Coast Laboratories Ltd. 1132 p.
Mellert, W.; Kaufmann, W.; van Ravenzwaay, B. (2002) Blazer Technical (Purity
46.1 %): Peroxisome Proliferation Study in B6C3F1 Mice-Administration in the
87
-------
MRID
Citation
45693402
45722201
45793901
45803601
92168036
92168037
92168042
Diet for 4 Weeks: Lab Project Number: 99C0287/98154: 2002/1005544.
Unpublished study prepared by BASF Aktiengesellschaft. 101 p.
Mellert, W.; Kaufinann, W.; van Ravenzwaay, B. (2001) Positive Control Study
for Suppoort of Peroxisome Proliferation: DINP-Enzyme Induction Study in
B6C3F1 Mice Administration in the Diet for 1 and 4 Weeks: Amendment: Lab
Project Number: 99C0226/00018: 2001/5003600. Unpublished study prepared
by BASF Aktiengesellschaft. 90 p.
Assaf, N. (2002) Metabolism of (Nitrophenyl-(Carbon 14)Lactofen in Aerobic
Soil: Lab Project Number 22584: VP-22584: V-00-22584. Unpublished study
prepared by Valent U.S.A. Corporation. 99 p.
Mellert, W.; Deckardt, K.; Beimborn, D.; et al. (2002) Blazer Technical: Enzyme
Induction Study in the Liver of B6C3F1 Mice-Oral Administration in the Diet for
4 Weeks: Lab Project Number: 2002/1011353. Unpublished study prepared by
BASF Akteingesellschaft. 76 p.
Mellert, W.; Kaufinann, W.; van Ravenzwaay, B. (2002) Blazer Technical: S-
Phase Response Study in the Liver of B6C3F1 Mice-Administration in the Diet
for 3 Days, 1 Week, and 2 Weeks: Lab Project Number: 2002/1011947:
99C0287/98153:08B0287/986053. Unpublished study prepared by BASF
Aktiengesellschaft. 278 p.
McLeod, W. (1990) BASF Corporation Phase 3 Summary of MRID 00028858.
A Terminal Residue Analytical Method for RH-6201 and Its Major Metabolites:
Technical Report No. 34H-78-24; 90/6317. Prepared by Rohm and Haas
Company. 15 p.
Ellenson, J. (1990) BASF Corporation Phase 3 Summary of MRID 00107488.
Magnitude of Residue - Storage Stability - Report No. RH-6201; 90/6315.
Prepared by Rohm and Haas Company. 13 p.
McLeod, W. (1990) BASF Corporation Phase 3 Summary of MRID 00028857
and Related MRID 00028858. Pesticide Petition for Establishment of Permanent
Tolerance for Blazer in Peanuts Section D: Residue Chemistry: 90/6320.
Prepared by Rohm and Haas Company. 9 p.
88
-------
MRID
92168045
92168048
92168049
92168050
92168052
92168053
Citation
McLeod, W. (1990) BASF Corporation Phase 3 Summary of MRID 00107488.
Pesticide Petition for Establishment of Permanent Tolerance for Blazer in
Soybeans and Animal Products Section D: Residue Reports and Methods:
90/6321. Prepared by Rohm and Haas Company. 8 p.
Zogorski, W.; Rogerson, T. (1990) BASF Corporation Phase 3 Reformat of
MRID 00028858. A Terminal Residue Analytical Method for RH-6201 and Its
Major Metabolites: 90/5029. Prepared by Spring House Research Laboratories.
169 p.
Zogorski, W.; Rogerson, T.; Conn, R. (1990) BASF Corporation Phase 3
Reformat of MRID 00107488. Acifluorfen Frozen Storage Stability Study in
Soybean, Dry Bean and Sunflower Seed: 90/5023. Prepared by Rohm and Haas
Company. 87 p.
Severn, D.; Pascarella, J. (1990) BASF Corporation Phase 3 Reformat of MRID
00107488. A Study to Determine Magnitude of Residue Levels in Milk, Tissues,
and Excreta of Cows Dosed with Carbon 14-RH-6201: Technical Report No.
34H-76-7; A Study Determining Residue in Eggs, Tissues, and Excreta of Laying
Hens Dosed w/Carbon 14- RH-6201: Technical Report No. 415-807-41.
Prepared by Rohm and Haas Company. 78 p.
McLeod, W. (1990) BASF Corporation Phase 3 Reformat of MRID 00028857
and Related MRIDs 00028858. Pesticide Petition for Establishment of Permanent
Tolerance for Blazer in Peanuts: Section D: Residue Chemistry: 90/5025.
Prepared by Rohm and Haas Company. 434 p.
McLeod, W. (1990) BASF Corporation Phase 3 Reformat of MRID 00107488.
Pesticide Petition for Establishment of Permanent Tolerance for Blazer in
Soybeans and Animal Products Section D: Residue Reports and Methods:
90/5026. Prepared by Rohm and Haas Company. 693 p.
89
-------
-------
Appendix E. GENERIC DATA CALL-IN
This is a placeholder for the Generic Data Call-In (DCI) for the active ingredient, sodium acifluorfen.
A complete generic DCI, with all pertinent instructions, will be sent to registrants under separate cover.
The attached DRAFT DCI lists all generic data requirements for this active ingredient. The generic data
requirements are also listed in the body of the RED.
91
-------
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
Page 1 of 1
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
UNITED PHOSPHORUS INC
423 RIVERVIEW PLAZA
TRENTON, NJ 08611
2. Case # and Name
2605 Sodium acifluorfen
Chemical # and Name 114402
Benzole acid,
5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro-, sodium
3. Date and Type of DCI and Number
28-Aug-2003
GENERIC
ID# GDCI-114402-20870
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
70506-61
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowinalv false or misleariinn statement mav he nnnishahle hu fine imnrisnnment nr hnth unrlpr annlirahle law
9. Date
-------
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
UNITED PHOSPHORUS INC
423 RIVERVIEW PLAZA
TRENTON, NJ 08611
2. Case # and Name
2605 Sodium acifluorfen
Chemical # and Name 114402
Benzole acid,
5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro-, sodium
3. Date and Type of DCI and Number
28-Aug-2003
GENERIC
ID# GDCI-114402-20870
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.7050
860.1200
850.1400
850.3020
870.6300
Product Chemistry Data Requirements (Conventional
Shemical)
UVA/isible absorption
Residue Chemistry Data Requirements for Food Uses
[Conventional Chemical)
Directions for use (1)
Terrestrial and Aquatic Nontarqet Organisms Data
Requirements (Conventional Chemical)
Fish early-life stage toxicity test
(4,5)
Honey bee acute contact toxicity
Toxicology Data Requirements (Conventional Chemical)
Developmental neurotoxicity study
(2,3)
A, B, II
A, B, II
A, B, II
A, B, II
A, B, II
TGAI
TEP
TGAI
TGAI
TGAI
12
18
12
48
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2605 Sodium acifluorfen
DCI Number: GDCI-114402-20870
Key: TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
II - Residential Use Conventional C
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Required for strawberry use. May be fulfilled by amending labels to include strawberry use.
2 Protocol must be approved by the Agency before the study is initiated.
3 Interim progress reports must be submitted.
4 Study must be modified to detect phototoxicity. Study should determine the NOAEC under both high and low light levels. Protocol must be approved by the Agency before study is initiated.
5 Due date for aquatic phototoxicity study may be extended, if necessary, pending issuance of a group DCI requiring this study for other light-dependent peroxidizing herbicides.
-------
Appendix F. PRODUCT SPECIFIC DATA CALL-IN
This is a placeholder for the product specific Data Call-In (DCI) for all sodium acifluorfen products. A
complete product-specific DCI, with all pertinent instructions, will be sent to registrants under separate
cover. See attached DRAFT DCI for a list of product-specific data requirements.
95
-------
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
BONIDE PRODUCTS, INC.
6301 SUTLIFF ROAD
ORISKANY, NY 13424
2. Case # and Name
2605 Sodium acifluorfen
Chemical # and Name 114402
Benzole acid,
5-(2-chloro-4-(trifluoromethyl)phehoxy)-2-nitro-, sodium
3. Date and Type of DCI and Number
02-Oct-2003
PRODUCT SPECIFIC
ID# PDCI-114402-21164
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
4-433
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knnwinnlv false nr mislearlinn statement mav he nnnishahle hv fine imnrisnnment nr hnth unrier annlirahle law
I acknowledge that any I g Date
-------
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
BONIDE PRODUCTS, INC.
6301 SUTLIFF ROAD
ORISKANY, NY 13424
2. Case # and Name
2605 Sodium acifluorfen
EPA Reg. No. 4-433
3. Date and Type of DCI and Number
02-Oct-2003
PRODUCT SPECIFIC
ID# PDCI-114402-21164
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Product Chemistry Data Requirements (Conventional
Chemical)
Product Identity and composition
(1)
Description of materials used to produce the product (2)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(3)
(4)
(5)
(6 ,7 ,8)
0)
(10)
(11)
(12)
(13)
A, B, C, D, E, F, G, H, I.
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D. E, F, G, H. I,
J, K, L, M, N, O, P,Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
MP or EP
MP or EP
MP or EP
MP or EP
MP, EP
MP.EP
MP or EP
MP, EP
MP or EP
MP, EP
MP or EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Page 2 of 4
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
BONIDE PRODUCTS, INC.
6301 SUTLIFF ROAD
ORISKANY, NY 13424
2. Case # and Name
2605 Sodium acifluorfen
EPA Reg. No. 4-433
3. Date and Type of OCI and Number
02-Oct-2003
PRODUCT SPECIFIC
ID# PDCI-114402-21164
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
Stability to sunlight, normal and elevated
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibility
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
Melting point/melting range
(14,15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23 ,24)
(25)
(26 ,27)
A, B, C, D, E. F, G, H. I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N. O, P, Q
A, B, C, D. E. F, G, H. I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E. F, G, H, I,
J, K, L. M, N, O, P, Q
A, B. C, D, E. F, G. H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O, P, Q
TGAI
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP or EP
MP, EP
MP or EP
MP or EP
TGAI
-------
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
BONIDE PRODUCTS, INC.
6301 SUTLIFF ROAD
ORISKANY, NY 13424
4. Guideline
Requirement
Number
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
5. Study Title
2. Case # and Name
2605 Sodium acifluorfen
EPA Reg. No. 4-433
Boiling point/boiling range (28 ,29)
Density/relative density (30 ,31)
Dissociation constant in water (32 ,33)
Partition coefficient (n-octanol/water), shake flask (34)
method
Partition coefficient (n-octanol/water), estimation by (35)
liquid chromatography
Water solubility: Column elution method, shake flask (36)
method
Water solubility, generator column method (37)
Vapor pressure (38 ,39)
Toxicoloav Data Reauirements (Conventional Chemical)
Acute Oral Toxicity
Acute dermal toxicity
Acute inhalation toxicity
(40,41)
(42 ,43 ,44)
(45)
P
R
0
T
0
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, (
A, B, C, D, E, F, G,
3. Date and Type of DCI and Number
02-Oct-2003
PRODUCT SPECIFIC
ID# PDCI-1 14402-21 164
H, I,
a
H I
J, K, L, M, N, O, P, Q
A, B, C, D, E. F, G, H, I,
J, K, L, M, N, 0, P, Q
A, B, C, D, E, F, G, H, I.
J, K, L, M, N, O, P, Q
A, B, C, D, E, F, G, H. I.
J, K, L, M, N, O, P, (
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, (
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, (
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, <
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, <
A, B, C, D, E, F, G,
J, K, L, M, N, 0, P, (
A, B, C, D, E, F, G,
J, K, L, M, N, O, P, (
a
H,l,
a
H, I,
a
H, I,
a
H,l,
a
H,l,
a
H, I,
a
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI
MP, EP
TGAI or PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
MP, EP
MP, EP
MP, EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
Date
-------
-------
Appendix G
BATCHING OF PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS
To reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregistration of products containing sodium acifluorfen as the active ingredient, the
Agency has batched products which can be considered similar for purposes of acute toxicity testing.
Factors considered in the sorting process include the active and inert ingredeints for each product (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.). 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. Regardless of the
batching, 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. The
registrant may choose 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.
When deciding how to meet the product-specific data requirements, registrants must follow the
directions given in the Data Call-In (DCI) 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
101
-------
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.
EPA identified ten registered products containing the active ingredient sodium acifluorfen. Of these, the
following sodium acifluorfen products can be grouped together for purposes of acute toxicity testing.
EPA Reg. No.
4-433
71995-3
% Active Ingredient
Sodium Acifluorfen: 0. 12
Glyphosate: 0.50
Sodium Acifluorfen: 0.12
Glyphosate: 0.50
The remaining registered products containing sodium acifluorfen cannot be grouped together for acute
toxicity testing. These products are listed in the following table.
EPA Reg. No.
7969-87
241-321
7969-76
7969-77
7969-79
7969-80
7969-168
7969-179
% Active Ingredient
44.0
Sodium Acifluorfen: 20.93
Imazaquin: 5.61
Sodium Acifluorfen: 13.4
Sodium Bentazon: 29.2
Sodium Acifluorfen: 6.8
Sodium Bentazon: 33.4
20.1
21.4
Sodium Acifluorfen: 9.1
Sodium Bentazon: 20.0
Sethoxydim: 14.0
Sodium Acifluorfen: 7.47
Sodium Bentazon: 16.28
Sethoxydim: 11.15
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Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN
Sample List of Registrants Attached, Final List to be Inserted at Time of DCI Mailing
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Co. Nr.
4
241
LIST OF ALL
Case # and Name
Company Name
BONIDE PRODUCTS, INC.
BASF CORPORATION
United States Environmental Protection
Agency Washington, D.C. 20460
REGISTRANTS SENT THIS DATA CALL-IN NOTICE
: 2605,Sodium acifluorfen
Agent For Address
6301 SUTLIFF ROAD
PO Box 13528
City & State Zip
ORISKANY NY 13424
RESEARCH NC 277093528
7969
70506
71995
BASF CORPORATION
UNITED PHOSPHORUS INC
MONSANTO
MONSANTO
PO Box 13528 26 DAVIS DRIVE
423 RIVERVIEW PLAZA
1300 I STREET, NW.SUITE 450 EAST
TRIANGLE PARK
RESEARCH
TRIANGLE PARK
TRENTON
WASHINGTON
NC 277093528
NJ 08611
DC 20005
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Appendix I. LIST OF ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www .epa. go v/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
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
http://www.epa.gov/opprd001/forrns/8570-l.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.gov/opprd001/forms/8570-27.ndf
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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance Fee
Filing.
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations
of Data (PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR
Notice 98-1)
http://www.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.p
df
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.p
df
http://www.epa.gov/opppmsdl/PR Notices/pr98- 1 .p
df
http://www.epa. gov/opppmsd 1 /PR Notices/pr98- 1 .p
df
Pesticide Registration Kit
Dear Registrant:
www.eDa.gov/Desticides/registrationkit/
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 (QPP):
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/opppmsd l/PR_Notices
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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. 85704, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
B. Biopesticides and Pollution Prevention Division (BPPD) Contacts
C. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
Before submitting your application for registration, you may wish to consult some additional sources of
information. These include:
1. The Office of Pesticide Programs'website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United States",
PB92-221811, available through the National Technical Information Service (NTIS) at the
following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their website.
4. The National Pesticide Information Center (NPIC) can provide information on active ingredients,
uses, toxicology, and chemistry of pesticides. You can contact NPIC by telephone at (800)
858-7378 or through their website: http://npic.orst.edu..
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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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