US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision
for Mefluidide
September 25, 2007
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United States Prevention, Pesticides EPA 738-R-07-011
Environmental Protection and Toxic Substances 2007
Agency (7508P) OPP-2007-0431
Reregistration
Eligibility Decision for
Mefluidide
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Reregistration Eligibility Decision (RED) Document for
Mefluidide
ListB
Case Number 2370
Approved by: Date:
Steve Bradbury, Ph. D.
Director
Special Review and Reregistration Division
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TABLE OF CONTENTS
Mefluidide Team v
Glossary of Terms and Abbreviations vi
Abstract 1
I. Introduction 3
II. Chemical Overview 3
A. Regulatory History 4
B. Chemical Identification of Mefluidide 4
C. Use Sites 7
D. Formulations 7
E. Methods of Application 8
F. Use Rates 8
G. Annual Usage 8
H. Technical Registrant 8
III. Links to the Mefluidide Risk Assessments 8
IV. Risk Management and Reregistration Decision 8
A. Determination of Reregistration Eligibility 8
B. Public Comments and Responses 9
C. Regulatory Position 9
1. Regulatory Rationale 9
a. Human Health Risk Management 10
1) Drinking Water Risk Mitigation 10
2) Residential Handler Risk Mitigation 10
3) Residential Postapplication Risk Mitigation. 10
4) Occupational Handler Risk Mitigation 10
5) Occupational Postapplication Risk
Mitigation 10
b. Environmental Risk Management 11
2. Endocrine Disrupter Effects 13
3. Endangered Species Considerations 13
a. The Endangered Species Program 14
4. Other Labeling Requirements 15
V. What Registrants Need to Do 15
A. Manufacturing Use Products 15
1. Additional Generic Data Requirements 15
2. Labeling for Technical and Manufacturing Use Products.... 16
B. End-Use Products 16
1. Additional Product-Specific Data Requirements 16
2. Labeling for End-Use Products 16
a. Label Changes Summary Table 17
VI. Appendices 24
iii
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Appendix A. Mefluidide Uses and Use-Patterns Eligible for
Reregistration 24
Appendix B. Table of Generic Data Requirements and Studies Used
to Make the Reregistration Decision for Mefluidide 63
Appendix C. Technical Support Documents 67
Appendix D. Citations Considered Part of the Database Supporting
the Reregistration Decision (Bibliography) 69
Appendix E. Generic Data Call-In (GDCI) 104
Appendix F. Product-Specific Data Call-In (PDCI) 105
Appendix G. EPA'S Batching of Mefluidide Products for Meeting
Acute Toxicity Data Requirements for Reregistration 106
Appendix H. List of Registrants to be Sent this Data Call-in 110
Appendix I. List of Available Related Documents and Electronically
Available Forms Ill
Appendix J: Mefluidide Human Health Risk Assessment 116
Appendix K: Mefluidide Ecological and Fate and Effects Assessment 165
IV
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Mefluidide Reregistration Eligibility Decision Team
Risk Management
Wilhelmena Livingston
Eric Olson
Health Effects Risk Assessment
Yan Donovan
Abdallah Khasawinah
Environmental Fate and Effects Risk Assessment
Marie Janson
James Hetrick
Biological and Economic Analysis Assessment
Alan Halvorson
LaVerne Dobbins
Sunil Ratnayake
Andrew Lee
Derek Berwald
Registration Support
Tony Kish
John Baziun
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Glossary of Terms and Abbreviations
Ai Active Ingredient
Ae Acid Equivalent
aPAD Acute Population Adjusted Dose
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formulation
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DNT Developmental Neurotoxicity
EC Emulsifiable Concentrate Formulation
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FQPA Food Quality Protection Act
GLN Guideline Number
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of a substance per weight or volume of water, air, or feed, e.g., mg/1, mg/kg, or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LOC Level of Concern
LOAEL Lowest Observed Adverse Effect Level
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligram Per Liter
MOE Margin of Exposure
MRID Master Record Identification Number. EPA's system for recording and tracking studies
submitted.
MUP Manufacturing-Use Product
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides, and Toxic Substances
PAD Population Adjusted Dose
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
Ppb Parts Per Billion
PPE Personal Protective Equipment
Ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
ROW Rights-of-way
RQ Risk Quotient
TGAI Technical Grade Active Ingredient
UV Ultraviolet
WPS Worker Protection Standard
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Abstract
This document presents the Environmental Protection Agency's (hereafter
referred to as EPA or the Agency) decision regarding the reregi strati on eligibility of the
registered uses of mefluidide, mefluidide diethanolamine salt, and mefluidide potassium
salt (the three active ingredients are collectly referred to as mefluidide). The Agency has
determined that mefluidide-containing products are eligible for reregi strati on provided
that: (1) the risk mitigation measures identified in this document are adopted; and (2)
labels are amended to implement these measures. Additionally, EPA will issue a data
call-in so that current data gaps are addressed.
Mefluidide is a plant growth regulator that is applied postemergence when
needed. It is used to suppress seed heads and fruiting, as well as retarding growth to
reduce mowing and trimming. It is also registered for growth control of low maintenance
turf on rights-of ways, airports, public and industrial sites. Mefluidide products can also
be used on residential lawns. As mefluidide has no food/feed uses and no U.S. tolerances
associated with its use, it is not subject to the Food Quality Protection Act of 1996. The
Agency has conducted human health and environmental fate and ecological effect risk
assessments for mefluidide. The risk conclusions of these assessments are summarized
below.
The Human Health risk assessment relies in part on studies in which adult human
subjects were intentionally exposed to a pesticide or other chemical. These studies have
been determined to require a review of their ethical conduct. These studies were
reviewed by the independent Human Studies Review Board which concurred with the
Agency's conclusions regarding both the ethical and scientific conduct of these studies,
and that the studies are appropriate for use in the risk assessment.
Overall Risk Summary
There are no food-related pesticide uses of mefluidide. Therefore, no dietary
exposure from food is expected. However, there is potential for drinking water exposure
due to the outdoor uses of mefluidide. A drinking water assessment was conducted using
Tier II (PRZM-EXAMS) modeling for surface water and Tier I (SCI-GROW) modeling
for groundwater. The mefluidide concentrations in surface water are not expected to
exceed 31 ug/L for the 1 in 10 year daily peak concentration, 9.5 ug/L for the 1 in 10 year
annual concentration, and 5.3 ug/L for the 30 year annual average concentration.
Mefluidide concentrations in ground water source drinking water are not expected to
exceed 0.665ug/L.
The acute and chronic dietary (water only) assessments were conducted using the
Dietary Exposure Evaluation Model (DEEM), and considered exposures from surface
water only. The dietary risk is below the Agency's level of concern (LOG). The
exposure for all infants, which is the most highly exposed reference subgroup, is 1% of
the acute reference dose (aRfD), and 5 % of the chronic reference dose (cRfD).
Therefore, no mitigation is needed for dietary exposure to mefluidide.
The residential handler and post-application risks for all use scenarios are below
1
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the Agency's LOG.
Occupational handlers may be exposed to mefluidide while mixing, loading,
and/or applying mefluidide products. The margins of exposure (MOEs) for occupational
handler exposures were calculated for short/intermediate term scenarios. All of the MOEs
are below the Agency's LOG with baseline personal protective equipment (PPE). Long
term exposure was not assessed because there are no long term exposure scenarios for
handlers based on the use patterns. Occupational post application risks were not assessed
because there is not likely to be any occupational post-application exposure scenarios.
The Agency's ecological fate and effects assessment shows that risks from the use
of mefluidide are below the Agency's level of concern for direct acute (listed and non-
listed) and chronic exposure to aquatic freshwater and estuarine marine organisms and
acute exposure to aquatic plants. However, the ecological fate and effects assessment
identifies potential risks of concern for direct acute (listed and nonlisted) and chronic
exposure to mammals and birds and acute (listed and nonlisted) exposure to terrestrial
and semi-aquatic plants.
Risk Mitigation
To mitigate identified risk concerns from the use of mefluidide to mammals, birds
and terrestrial and semi aquatic plants, the Agency is requiring and the registrant has
agreed to amend labels to reflect the following spray drift and run-off language:
Wind Direction
Only apply this product if the wind direction favors on target deposition.
Wind Speed
Do not apply when the wind velocity exceeds 15 mph.
Temperature Inversions
Do not make ground spray applications into temperature inversions.
Inversions are characterized by stable air and increasing temperatures with height above
the ground. Mist or fog may indicate the presence of an inversion in humid areas. The
applicator may detect the presence of an inversion by producing a smoke layer near the
ground surface.
Droplet Size
Use only Medium or coarser spray nozzle (ASABE S572).
Additional Requirements for Ground Applications
All ground boom application equipment must be properly maintained and calibrated
using appropriate carriers or surrogates. Do not apply with a nozzle height greater than 4
feet above the ground or foliage canopy.
To Prevent Run-off
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"To prevent product run-off, do not apply when raining or when rain is expected within 8
hours."
"Do not irrigate for 8 hours after application."
Next Steps
The Agency is issuing this Reregi strati on Eligibility Decision (RED) document
for mefluidide as announced in a Notice of Availability published in the Federal
Register. In the future, EPA will issue a generic Data Call-In (DCI) for additional data
necessary to confirm the conclusions of this RED for the active ingredient mefluidide.
EPA will also issue a product specific DCI for data necessary to complete product
reregi strati on for products containing mefluidide.
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregi strati on of products with active ingredients registered prior
to November 1, 1984. The amended Act calls for the development and submission of
data to support the reregi strati on of an active ingredient, as well as a review of all
submitted data by the EPA. Reregi strati on involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to
reassess the potential risks arising from the currently registered uses of the pesticide; to
determine the need for additional data on health and environmental effects; and to
determine whether or not the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA.
This document summarizes the Agency's revised human health and ecological
risk assessments and the reregi strati on eligibility decision for mefluidide. The document
consists of six sections. Section I contains the regulatory framework for reregi strati on.
Section II provides a profile of the use and usage of the chemical. Section III provides
links to the mefluidide human health and ecological risk assessments. Section IV
presents the Agency's reregi strati on eligibility and risk management decisions. Section
V summarizes label changes necessary to implement the risk mitigation measures
outlined in Section IV. Section VI provides information on how to access related
documents and contains the appendices that list related information and supporting
documents. The mefluidide risk assessments are available in the Public Docket, under
docket number EPA-HQ-OPP-2007-0431 on the web page, http://www.regulations.gov.
II. Chemical Overview
Mefluidide is a plant growth regulator that is applied postemergence when
needed, and is a member of the anilide class of compounds. It is used to suppress seed
heads and fruiting, as well as retarding growth to reduce mowing and trimming. It is also
registered for growth control of low maintenance turf on rights-of-ways, airports, public
and industrial sites. Mefluidide products can also be used on residential lawns. There are
no registered food/feed uses, and no food tolerances exist for mefluidide.
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The acute toxicology profile of mefluidide and its salts is listed in Table 1.
Table 1. Acute Toxicity of Mefluidide and its salts (114001, 114002, 114003)
Guideline
No.
870.1100
(81-1)
870.1100
(81-1)
870.1100
(81-1)
870.1100
(81-1)
870.1200
(81-2)
870.1300
(81-3)
870.1300
(81-3)
870.2400
(81-4)
870.2400
(81-4)
870.2500
(81-5 )
87.2600
(81-6)
87.2600
(81-6)
Study Type
Acute Oral (female rat)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Acute Oral (dog)
Mefluidide tech
Acute Dermal (female
rabbit)
Mefluidide tech
Acute inhalation - rat
DBA salt of Mefluidide
Acute inhalation - rat
Mefluidide tech.
Primary Eye Irritation
(rabbit) Mefluidide tech
Primary Eye Irritation
(rabbit) DBA Mefluidide
Primary Skin Irritation
(rabbit), Mefluidide tech
Dermal Sensitization
(guinea pig), Mefluidide
Dermal Sensitization
(guinea pig), Mefluidide
Results (LDso/LCso)
MRID
>4000 mg/kg
MRID 000471 18
1920.2 mg/kg
MRID 00047 117
829.8 mg/kg
MRID 00047 116
Not established
MRID 00049627; emesis precluded evaluation at
100, 500, 2000 mg/kg doses
>4000 mg/kg
MRID 00047122 & 00049628 & 00083817
>5.2 mg/L
MRID 4 1888801
>5.4 mg/L
MRID 4 1964601
minimal irritation
MRID 00047126, 00049630
minimal irritation
MRID43481203
Not a dermal irritant
MRID 00047124, 00049629, 00083819
Not a dermal sensitizer
MRID 4 1887701
Not a dermal sensitizer
MRID 00082076
Toxicity Category
III
III
III
III
IV
IV
IV
III
III
IV
N/A
N/A
A. Regulatory History
Mefluidide, mefluidide diethanolamine salt, and mefluidide potassium salt are
collectively referred to as mefluidide. Mefluidide was first registered in October 1984,
mefluidide diethanolamine salt was first registered in March 1973, and mefluidide
potassium salt was first registered in December 1988.
B. Chemical Identification of Mefluidide
Based on the structural similarities of mefluidide (114001) and its diethanolamine
(DBA) (114002) and potassium salts (114003), and the physical and chemical properties
of the DEA and potassium salts, EPA has concluded that mefluidide DEA and potassium
salts are biologically equivalent to mefluidide and thus they share the same toxicity as
free mefluidide.
Tables 2-4 provide an overview of mefluidide's structure.
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TABLE 2. Test Compound Nomenclature - Mefluidide (114001)
Chemical Structure
Empirical Formula
Common name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3SCL\ /H
2^N
H3C\xWi o
N^N^CH3
1 1 3
CH3 H
CnHjsFs^OsS
Mefluidide
5 '-( 1, 1 , 1 -trifluoromethanesulfbnamido)acet-2',4'-xylidide
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
53780-34-0
St. Aug.GR w/Fertilizer (Reg. #538-181), Scotts Turf Manager (Reg.#538-
200)
Plant growth regulators
None
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TABLE 3. Test Compound Nomenclature - Diethanolamine Mefluidide (114002)
Chemical Structure
Empirical Formula
Common name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3S09\ + XCH9CH9OH
2 N H2 N 2 2
u r 1 NCH7CI-LOH
H3C-y/^ Q
W^N^CH3
1 3
CH3 H
C15H24F3N3O5S
Diethanolamine Mefluidide
5'-(l,l,l-trifluoromethanesulfonamido)acet-2',4'-xylidide - 2,2'-
iminodiethanol (1:1)
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
compound with 2,2'-iminobis[ethanol] (1:1)
53780-36-2 (This substance is a derivative of mefluidide [53780-34-0]).
EMBARK 2-S (Reg.# 2217-759), EMBARK 1-S (RegJ 2217-763),
EMBARK E-Z-TU-USE (RegJ 2217-768), EH1 135 PGR (RegJ 2217-802),
EMBARK R-T-U Northern (RegJ 2217-787), EMBARK R-T-U Southern
(RegJ 2217-788), ER 721 (RegJ 2217-809)
Plant growth regulators
None
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TABLE 4. Test Compound Nomenclature - Potassium Mefluidide (114003)
Chemical Structure
Empirical Formula
Common name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3SCL\ +
2 N K
H3C\/^ 0
N^N^CH3
1 3
CH3 H
CnH12F3KN2O3S
Mefluidide
Potassium (EZ)-N-[5 -(1,1,1 -trifluoromethanesulfbnamido)-2,4-
xylyl]acetamide
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
monopotassium salt
83601-83-6
EMBARK 1-L (RegJ 2217-765), EMBARK 2-L (RegJ 2217-766)
Plant growth regulators
None
C. Use Sites:
The uses that are included in the reregi strati on assessment are; agricultural/farm
structures/buildings and equipment, agricultural/nonagricultural uncultivated areas/soils,
airports/landing fields, commercial industrial lawns, commercial institutional/industrial
premises/equipment, golf course turf, hospitals/medical institutions premises, household
domestic dwellings outdoor premises, industrial areas (outdoor), nonagricultural outdoor
buildings/structures, nonagri cultural rights-of-way/fencerows/hedgerows, ornamental and
or shade trees, ornamental ground cover, ornamental herbaceous plants, ornamental
lawns and turf, ornamental nonflowering plants, ornamental woody shrubs and vines,
paths/patios, paved area (private roads/sidewalks), recreational areas, and residential
lawns.
D. Formulations:
Mefluidide formulations include granular, liquid ready-to-use, and soluble
concentrate liquid.
Multiple products that contain mefluidide also contain an additional plant
growth regulator or herbicides such as paclobutrazol, imazapyr and
imazethapyr.
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E. Methods of Application:
Mefluidide can be applied as a band treatment, broadcast, spot treatment,
and spray. Mefluidide can be applied with several types of application
equipment, including backpack sprayer, groundboom, hand held pump
sprayer, handgun sprayer, hose-end sprayer, power sprayer, high pressure
handwand, and spreader (push-type and belly grinder).
F. Use rates:
The maximum application rate for mefluidide applied as ground sprays is
1.0 Ib acid equivalents (ae)/acre (A). The maximum application rate for
mefluidide, as a granular formulation, is 0.5 Ib ae/A.
G. Annual usage:
• Annual use of mefluidide in the United States is generally less than 10,000
Ib ae. The highest use areas for mefluidide include South Carolina, North
Carolina, Virginia, West Virginia, California, Nevada, Arizona, and
New Mexico.
H. Technical Registrant:
FBI/Gordon Corporation is the technical registrant.
III. Links to the Mefluidide Risk Assessments
For details on the risks associated with the use of mefluidide, please refer to the
Human Health and Ecological Risk Assessments for mefluidide located respectively in
Appendices J and K. These documents are also available in the public docket EPA-HQ-
OPP-2007-0431, located on-line in the Federal Docket Management System (FDMS) at
http://www.regulations.gov.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) calls for the Agency to determine, after submission of relevant data concerning
an active ingredient, whether pesticides containing the active ingredient are eligible for
reregi strati on. The Agency has previously identified and required the submission of the
generic (i.e., active-ingredient specific) data required to support reregi strati on of products
containing mefluidide.
The Agency has completed its assessment of the dietary (water only), residential,
occupational, and ecological risks associated with the use of pesticides containing the
active ingredient mefluidide. Food risks are not assessed because there are no food/feed
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uses of mefluidide. Based on a review of the mefluidide database and public comments
on the Agency's assessments for the active ingredient mefluidide, the Agency has
sufficient information on the human health and ecological effects of mefluidide to make
decisions as part of the reregistration process under FIFRA. The Agency has determined
that currently registered uses of mefluidide will not pose unreasonable adverse effects to
humans or the environment provided that the risk mitigation measures and label changes
outlined in this RED are implemented; therefore, products containing mefluidide are
eligible for reregistration if the risk mitigation measures outlined in the document are
adopted and label amendments are made to implement these measures. Label changes
are described in Section V of this document. Appendix B identifies the generic data that
the Agency reviewed as part of its determination of reregistration eligibility of mefluidide
and lists the submitted studies that the Agency found acceptable. EPA will issue a data
call-in to address data gaps identified in the risk assessments.
Based on its evaluation of mefluidide, the Agency has determined that mefluidide
products, unless labeled and used as specified in this document, could result in
unreasonable adverse effects on the environment. Accordingly, should a registrant fail to
implement any of the risk mitigation measures identified in this document, the Agency
may take regulatory action to address the risk concerns from the use of mefluidide. If all
changes outlined in this document are incorporated into the product labels, then current
risks for mefluidide will be adequately mitigated for the purposes of this determination
under FIFRA. Once a comprehensive endangered species assessment is completed,
further changes to these registrations may be necessary.
B. Public Comments and Responses
The Agency solicited comments from the public regarding the reregistration of
mefluidide through a 60-day comment period, which opened on June 20, 2007, and
closed on August 21, 2007. During the public comment period, the Agency received
only one set of comments which were from the technical registrant, FBI/Gordon
Corporation, on the Environmental Fate and Effects Chapter and the Drinking Water
Assessment.
To view the complete set of public comments and the Agency's responses to these
comments, please refer to the public docket at http://www.regulations.gov, EPA-HQ-
OPP-2007-0431.
C. Regulatory Position
1. Regulatory Rationale
The Agency has determined that mefluidide is eligible for reregistration provided
the risk mitigation measures outlined in this document are adopted and label amendments
are made to reflect these measures. This decision considers the risk assessments
conducted by the Agency and the significance of the use of mefluidide.
The following is a summary of the rationale for managing risks associated with
the use of mefluidide. Where labeling revisions are warranted, specific language is set
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forth in the summary table in Section V of this document.
a. Human Health Risk Management
For additional details on the mefluidide human health risk assessment, please
refer to the Human Health Risk Assessments for mefluidide located in Appendix J. This
document is also available in the public docket EPA-HQ-OPP-2007-0431, located on-line
in the Federal Docket Management System (FDMS) at http://www.regulations.gov.
1) Drinking Water Risk Mitigation
The Agency's human health assessment identifies a potential for drinking water
exposure due to the outdoor uses of mefluidide. The drinking water assessment included
surface water exposures only because estimated concentrations of mefluidide in
groundwater were minimal. Drinking water risks are below the Agency's level of
concern; therefore, no mitigation is needed.
2) Residential Handler Risk Mitigation
The Agency assessment considered several residential handler scenarios which
include loading/applying granules with a belly grinder and with a broadcast spreader. It
also assessed mixing/loading/applying with a hose-end sprayer and with a hand-held
pump sprayer. The target Margin of Exposure (MOE) is 100 for residential assessments.
This is based on 10X for intraspecies variation, and 10X interspecies extrapolation. The
MOEs exceed 100 and the risks are below the Agency's level of concern. Therefore, no
mitigation is needed.
3) Residential Post Application Risk Mitigation
The assessment considered residential post application scenarios for short term
incidental oral exposure of toddlers playing on treated turf. All of the MOEs exceed 100,
and the risks are therefore below the Agency's level of concern. Therefore, no mitigation
is needed.
4) Occupational Handler Risk Mitigation
The risk assessment considered several scenarios for short/intermediate-term
occupational handler risk which include mixing/loading liquid formulations. Long term
exposure was not assessed because there are no long term exposure scenarios for handlers
based on the use patterns. The target MOE is 100 for occupational assessments. This is
based on 10X for intraspecies variation, and 10X interspecies extrapolation. All of the
MOEs exceed 100 with baseline PPE, and the risks are below the Agency's level of
concern. Therefore no, mitigation is needed.
5) Occupational Postapplication Risk Mitigation
Occupational postapplication risk was not assessed because there is not likely to be
occupational post-application exposure. Therefore, no mitigation is needed.
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b. Environmental Risk Management
For additional details on the mefluidide ecological fate and effects risk
assessment, please refer to the Ecological Risk Assessment for mefluidide located in
Appendix K. This document is also available in the public docket EPA-HQ-OPP-2007-
0431, located on-line in the Federal Docket Management System (FDMS) at
http://www.regulations.gov.
The results of the risk assessment suggest that typical use of mefluidide may
result in exposures to nontarget plants and animals. The Agency's levels of concern
(LOCs) are not exceeded for acute and chronic effects on freshwater and estuarine marine
fish, aquatic invertebrates, and non-vascular and vascular aquatic plants in water bodies
adjacent to areas treated with mefluidide. However, the Agency's assessment identifies
potential for direct effects for acute and chronic exposure to mammals and birds, and for
acute exposure to terrestrial and semi-aquatic plants.
For mammals, the acute LOG is not exceeded. However, acute listed species
(hereafter referred to as "listed") and restricted use LOCs are exceeded for mammals
(RQs ranging from 0.0 to 0.26) using upper bound Kenega residues resulting from
maximum application rates of the liquid and granular formulations. The chronic LOG is
only exceeded for 15g mammals (RQ of 1.02) that consume short grass using upper
bound Kenega residues resulting from the maximum application rate for the liquid
formulation. However, using mean Kenega residues resulting from the maximum
application rates, no acute or chronic LOCs are exceeded for mammals, including the
acute listed and restricted use LOCs. Given the conservative assumptions in the exposure
scenarios, the Agency finds that the acute and chronic risks to mammals from exposure to
mefluidide are not of concern.
For birds, the acute LOG is not exceeded. However, acute listed and restricted
use LOCs are exceeded for small and medium sized birds (RQs ranging from <0.01 to
<0.25) using upper bound Kenega residues resulting from maximum application rates for
liquid and granular formulations. However, using mean Kenega residues resulting from
the maximum application rate of the liquid, no acute LOCs are exceeded for birds,
including the acute listed LOG. The chronic LOG for birds is also exceeded (RQs
ranging from <0.4 to <6.32) using upper bound Kenega residues resulting from the
maximum application rate for the liquid formulation. The chronic LOG using mean
Kenega residues is also exceeded for birds (RQs ranging from <0.18 to <2.24).
The RQs for birds are reported as "less than" a certain value due to the fact that
no mortality occurred at the highest level tested in the acute study used in the risk
assessment. Therefore, for acute risks, RQs are calculated for birds based on the non-
definitive LD50 value of >1500 mg ae/kg-bw, the highest value tested in the study. In
fact, all available dietary toxicity studies on avian species failed to establish definitive
acute LD50 values (i.e., the lethality values exceed the highest dose tested) including a
bobwhite quail study in which birds were dosed at 5000 mg ae/kg-bw. If the LD50 value
of 5000 mg ae/bw is used to assess acute risk to birds, no acute LOG exceedences would
occur. Therefore, use of the 1500 mg ae/kg-bw value in the ecological risk assessment
11
-------
adds uncertainty and may overestimate the acute risk to avian species.
No studies have been submitted to the Agency evaluating the chronic toxicity of
mefluidide to birds. For the purposes of this risk assessment, it is assumed that birds are
similar in toxicity responses to mammals in terms of the relative toxicity between acute
and chronic toxicity endpoints. Acute to chronic ratios (ACRs) are derived from
mefluidide laboratory rat and laboratory mouse data to determine the estimated chronic
NOAEC of 38 mg ae/kg value for birds. The use of this value also adds uncertainty and
may overestimate the chronic risk to avian species. Given the conservative assumptions
in the hazard determinations as well as the exposure scenarios, the Agency finds that the
acute and chronic risks to birds from exposure to mefluidide are not of concern.
For non-target terrestrial and semi-aquatic plants adjacent to treated sites, acute
LOCs are exceeded at the maximum application rate for liquid and granular formulations.
The RQs for non-endangered monocots due to exposure from spray drift and run-off
following ground spray application range from 0.57 to 4.86. For granular applications,
RQs for non-endangered monocots due to exposure from run-off alone range from 0.24 to
2.38. Dicots demonstrate more sensitivity than monocots with RQs ranging from 11.1 to
94.4 for ground spray application and 4.6 to 46.3 for granular application.
In assessing exposure to non-target terrestrial and semi-aquatic plants from spray
drift, the Agency used very fine to fine droplet size as an input to the model because the
mefluidide labels do not specify a droplet size. To reduce exposure due to spray drift, the
Agency is requiring the spray drift language listed below which includes Medium or
coarser droplet size for spray applications. The registrant will amend labels to reflect the
following spray drift language:
Wind Direction
Only apply this product if the wind direction favors on target deposition.
Wind Speed
Do not apply when the wind velocity exceeds 15 mph.
Temperature Inversions
Do not make ground spray applications into temperature inversions.
Inversions are characterized by stable air and increasing temperatures with height above
the ground. Mist or fog may indicate the presence of an inversion in humid areas. The
applicator may detect the presence of an inversion by producing a smoke layer near the
ground surface.
Droplet Size
Use only Medium or coarser spray nozzle (ASABE S572).
Additional Requirements for Groundboom Applications
All ground boom application equipment must be properly maintained and calibrated
using appropriate carriers or surrogates. Do not apply with a nozzle height greater than 4
12
-------
feet above the ground or foliage canopy.
Non-target terrestrial and semi-aquatic plants may also be exposed to mefluidide
from runoff. The Agency's runoff exposure estimate assumes a l-in-10 year rain event
and is based on a pesticide's water solubility and the amount of pesticide present on the
soil surface and its top one inch, characterized as "sheet runoff (one treated acre to an
adjacent acre) for dry areas and as "channelized runoff (10 treated acres to a distant low-
lying acre) for semiaquatic areas, and is based on percent runoff values of 0.01, 0.02, and
0.05 for water solubility of <10 ppm, 10-100 ppm, and >100 ppm, respectively. The
modeled runoff exposure estimates likely overestimate actual exposures from runoff,
given the conservative l-in-10 year rain event assumption, and also given that practices,
intended to minimize soil loss from runoff, are not taken into account. However, to
reduce potential exposure to mefluidide from runoff, the Agency is requiring the
following the label statement: "To prevent product runoff, do not apply when raining or
when rain is expected within 8 hours. Do not irrigate for 8 hours after application."
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate. " Following the recommendations of its Endocrine Disrupter Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there were scientific
bases for including, as part of the program, 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. When the appropriate
screening and/or testing protocols being considered under the Agency's Endocrine
Disrupter Screening Program (EDSP) have been developed and vetted, mefluidide may
be subjected to additional screening and/or testing to better characterize effects related to
endocrine disruption.
3. Endangered Species Considerations
Based on the available screening level information, the patterns of mefluidide use
are such that they coincide in time and space with areas frequented by avian and
mammalian wildlife. These areas have been demonstrated to be used by wildlife as
sources of food and cover. The potentially problematic wildlife food items identified by
this risk assessment are likely to be present in and around the treated areas. In addition,
there is potential for indirect effects to all taxonomic groups due to changes in habitat
caused by vegetation changes. Some uses of mefluidide may not pose a threat for avian
and mammalian wildlife, such as industrial sites that are not frequented by wildlife.
These findings are based soley on EPA's screening level assessment and do not constitute
"may effect" findings under the Endangered Species Act (ESA).
Table 5 summarizes the potential risk to listed species associated with the application of
mefluidide for turf use.
13
-------
Table 5. Potential Listed Species Risks Associated With Direct or Indirect Effects Due to
Applications of Mefluidide Based on Screening-Level Assessment
Listed Taxonomy
Terrestrial and semi-aquatic plants
- monocots
Terrestrial and semi-aquatic plants
- dicots
Terrestrial invertebrates
Birds
Terrestrial phase amphibians
Reptiles
Mammals
Aquatic vascular plants
Aquatic non-vascular plants3
Freshwater fish
Aquatic phase amphibians
Freshwater crustaceans
Mollusks
Marine/estuarine fish
Direct Effects
Yes
Yes
None
Yes
Yesb
Yes
Yes
None
None
None
Noneb
None
None
None
Indirect Effects
Yesc
Yesc
Yesc
Yes^6
Yesc'e
Yes c'd'e
YescAe
Yesc
Yesc
Yesc
Yesc
Yesc
Yesc
Yesc
a At the present time no aquatic non-vascular plants are included in Federal listings of threatened and listed
species. The taxonomic group is included here for the purposes of evaluating potential contributions to indirect
effects to other taxonomy and as a record of exceedances should future listings of non-vascular aquatic plants
warrant additional evaluation of Federal actions
b Terrestrial phase amphibians and reptiles estimated using birds as surrogates. Aquatic amphibians estimated
using freshwater fish as surrogates.
c Listed and Non-listed LOG exceeded for terrestrial and semi-aquatic plants.
d Listed, Restricted Use, and Acute LOC exceeded for some feeding guilds and size classes of birds.
e Listed, Restricted Use, and Chronic LOC exceeded for some feeding guilds and size classes of mammals.
a. The Endangered Species Program
The Endangered Species Act requires federal agencies to ensure that their actions
are not likely to jeopardize listed species or adversely modify designated critical habitat.
14
-------
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on threatened and endangered species,
and to implement mitigation measures that address these impacts. To analyze the
potential of registered pesticide uses that may affect any particular species, the Agency
uses basic toxicity and exposure data developed for the REDs and then considers
ecological parameters, pesticide use information, geographic relationship between
specific pesticide uses and species locations, and biological requirements and behavioral
aspects of the particular species. When conducted, this species-specific analysis will also
consider the risk mitigation measures that are being implemented as a result of this RED.
Following this future species-specific analysis, a determination that there is a
likelihood of potential effects to a listed species may result in limitations on use of the
pesticide, other measures to mitigate any potential effects, or consultations with the Fish
and Wildlife Service and/or the National Marine Fisheries as appropriate. If the Agency
determines use of mefluidide "may affect" listed species or their designated critical
habitat, the Agency will employ the provisions in the Services' regulations (50 CFR Part
402). Until the species-specific analysis is completed, the risk mitigation measures being
implemented through this RED will reduce the likelihood that endangered and threatened
species may be exposed to mefluidide at levels of concern. The Agency is not requiring
specific mefluidide label language at the present time relative to threatened and
endangered species. If, in the future, specific measures are necessary for the protection
of listed species, the Agency will implement them through the Endangered Species
Program.
4. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing mefluidide. For the specific
labeling statements and a list of outstanding data, refer to Section V of this document.
V. What Registrants Need to Do
The Agency has determined that mefluidide is eligible for reregistration provided
that the risk mitigation measures identified in this document are adopted and label
amendments are made to reflect these measures. Additional data are required to fill data
gaps identified and to confirm this decision. In the near future, the Agency intends to
issue Data Call-In Notices (DCIs) requiring product specific data and generic (technical
grade) data. Generally, registrants will have 90 days from receipt of a DCI to complete
and submit response forms or request time extension and/or waiver requests with a full
written justification. For product specific data, the registrant will have 8 months to
submit data and amend labels. For generic data, due dates can vary depending on the
specific studies being required. Below are tables of additional generic data that the
Agency intends to require for mefluidide.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
15
-------
The generic database supporting the reregi strati on of mefluidide has been
reviewed and determined to be adequate for this reregi strati on decision. However, the
following study in Table 6 would reduce the uncertainty in the ecological risk assessment
and will be required by the generic DCI for mefluidide.
Table 6. Confirmatory Data Requirements for Reregistration
New
Guideline
Number
850.2300
Old Guideline
Number
71-4
Study/Requirements
Avian Reproduction
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing use product
(MP) labeling should be revised to comply with all current EPA regulations, PR Notices
and applicable policies. In order to be eligible for reregi strati on, the technical registrants
also must amend all product labels to incorporate the risk mitigation measures outlined in
Section IV. The technical and MP labeling should also bear the labeling statements
contained in Table 7, the Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g) (2) (B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding a pesticide after a determination of eligibility has been made. The
registrant must review previous data submissions to ensure 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 Registrations
Response Form provided for each product.
A product-specific data call-in, outlining specific data requirements will be issued
in the near future.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Label Changes
Summary Table below.
16
-------
a. Label Changes Summary Table
In order to be eligible for reregi strati on, registrants must amend all product labels to incorporate the risk mitigation measures
outlined in Section IV. The following table describes how language on the labels should be amended.
Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 7' Summary of Labeling Changes for Meflnirlirle
For Manufacturing Products Only
Description
Amended Labeling Language
Placement on Label
For all Manufacturing
Use Products
"Only for formulation into a plant growth regulator for the following
use(s) [fill blank only with those uses that are being supported by MP
registrant]."
Formulation into end-use products that list a range of percent active
ingredient is prohibited.
Not for formulation into an end use product that allows aerial application.
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
"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
Directions for Use
17
-------
formulator or user
Environmental Hazards
Statements Required
by the RED and
Agency Label Policies
of such use (s)."
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
Precautionary Statements
End Use Products Intended for Occupational Use
Note to Product
Registrants
PPE Requirements
Established by the
RED1
For Soluble
Concentrate Liquid
Formulations
PPE Requirements
Established by the
RED1 For Liquid
End-use products that list a range of percent active ingredient are
prohibited.
"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."
"All mixers, loaders, applications and other handlers must wear:
> Long-sleeved shirt,
> Long pants and,
> Shoes plus socks."
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are"
Ingredient Statement
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
18
-------
ready-to-use and
Granular
Formulations
(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."
"All loaders, applicators and other handlers must wear:"
> Long-sleeved shirt,
> Long pants and,
> Shoes plus socks."
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no
such instructions for washables exist, use detergent and hot water. Keep
and wash PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched
or heavily contaminated with this product's concentrate. Do not reuse
them."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately following the PPE
requirements
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"Do not apply directly to water, or to areas where surface water is present
Precautionary Statements immediately
19
-------
or to intertidal areas below the mean high water mark. DO no^
contaminate water when disposing of equipment washwaters or rinsate."
"This chemical has properties and characteristics associated with
chemicals detected in ground water. The use of this chemical in areas
where soils are permeable, particularly where the water table is shallow,
may result in ground water contamination".
following the User Safety
Recommendations
Restricted-Entry
Interval for products
with directions for use
within scope of the
Worker Protection
Standard for
Agricultural Pesticides
(WPS)
Basic REI Statement
"Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 12 hours."
Directions for Use, Under Agricultural
Use Requirements Box
Entry Restrictions for
products having
occupational uses on
the label not subject to
the WPS
Entry Restriction for non-WPS uses applied as a spray:
"Do not enter or allow others to enter until sprays have dried."
Entry Restriction for non-WPS uses applied dry:
"Do not enter or allow others to enter until dusts have settled."
If no WPS uses on the product label,
place the appropriate statement in the
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural Use
Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
Early Entry Personal
Protective Equipment
for products with
directions for use
within the scope of the
WPS
"PPE required for early entry to treated areas that is permitted under the
Worker Protection Standard and that involves contact with anything that
has been treated, such as plants, soil, or water, is:
* coveralls,
* shoes plus socks,
* chemical-resistant gloves made of any waterproof material."
Direction for Use
Agricultural Use Requirements box
20
-------
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be
in the area during application."
Place in the Direction for Use directly
above the Agricultural Use Box.
Other Application
Restrictions
Note to End-Use Product Registrant: Maximum application rate and
maximum seasonal rates specified on the label must be listed as pounds
or gallons of formulated product per unit area (i.e., acre, 1,000 square
feet), not just as pounds active ingredient per unit area.
Directions for Use
Other Application
Restrictions (Risk
Mitigation)
Do not contaminate food or feed.
Do not contaminate water intended for irrigation or domestic purposes.
Do not feed clippings to livestock.
Do not graze livestock in treated areas.
Keep out of lakes, streams, and ponds.
Do not apply through any type of irrigation system.
"To prevent product run-off, do not apply when raining or when rain is
expected within 8 hours."
"Do not irrigate for 8 hours after application."
Directions for Use
Spray Drift for
products applied as a
spray
"Spray Drift Requirements:
Wind Direction
Only apply this product if the wind direction favors on target
deposition.
Wind Speed
Do not apply when the wind velocity exceeds 15 mph.
Directions for Use
21
-------
Temperature Inversions
Do not make ground spray applications into temperature
inversions.
Inversions are characterized by stable air and increasing
temperatures with height above the ground. Mist or fog may
indicate the presence of an inversion in humid areas. The
applicator may detect the presence of an inversion by producing a
smoke layer near the ground surface.
Droplet Size
Use only Medium or coarser spray nozzle (ASABE S572)
Additional Requirements for Groundboom Applications
"All ground boom application equipment must be properly
maintained and calibrated using appropriate carriers or surrogates.
Do not apply with a nozzle height greater than 4 feet above the
ground or foliage canopy."
End Use Products Intended for Residential Use
Application
Restrictions
"Do not apply this product in a way that will contact any person, pet,
either directly or through drift. Keep people and pets out of the area
during application."
Directions for Use under General
Precautions and Restrictions
Entry Restrictions
Liquid:
"Do not allow people or pets to enter the treated area until sprays have
dried."
Directions for use under General
Precautions and Restrictions
22
-------
Dry:
"Do not allow people or pets to enter the treated area until dusts have
settled."
Other application
restrictions
Note to End-Use Product Registrant: Maximum application rate and
maximum seasonal rates specified on the label must be listed as pounds
or gallons of formulated product per unit area (i.e., acre, 1,000 square
feet), not just as pounds active ingredient per unit area. Do not
contaminate food or feed.
Do not contaminate water intended for irrigation or domestic purposes.
Do not feed clippings to livestock.
Do not graze livestock in treated areas.
Keep out of lakes, streams, and ponds.
Do not apply through any type of irrigation system.
"To prevent product run-off, do not apply when raining or when rain is
expected within 8 hours."
"Do not irrigate for 8 hours after application."
Directions for Use
Environmental Hazards
"Do not apply directly to water, or to areas where surface water is present
or to intertidal areas below the mean high water mark. TJO no^
contaminate water when disposing of equipment washwaters or rinsate."
"This chemical has property and characteristics associated with chemical
detected in ground water. The use of this chemical in areas where soils
are permeable, particularly where the water table is shallow, may result in
ground water contamination".
Precautionary Statements immediately
following the User Safety
Recommendations
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be
placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
23
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VI. Appendices
Appendix A. Mefluidide Uses and Use-Patterns Eligible for Reregistration
NON-FOOD/NON-FEED USE PATTERNS SUMMARY FOR Mefluidide (CASE 2370)
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
ORNAMENTAL LAWNS AND
TURF
Early fall
Broadcast.
Spreader.
Late summer
Broadcast.
Spreader.
Spring
Broadcast.
Spreader.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply when drift is likely to occur.
Do not apply where runoff is likely to occur.
Do not contaminate food or feed.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water intended for irrigation or domestic purposes.
Do not feed clippings to livestock.
Do not graze treated areas.Keep children and domestic animals off treated areas until material is washed into soil.
Keep out of lakes, streams, and ponds.
.001248 Ib IK sq.ft
.001248 Ib IK sq.ft
.001248 Ib IK sq.ft
G
G
G
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
24
-------
NON-FOOD/NON-FEED USE PATTERNS SUMMARY FOR Mefluidide, diethanolamine salt (CASE 2370)
Application rates calculated in terms of Active Ingredient.
SITE NAME
LIMITATIONS
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
AGRICULTURAL
UNCULTIVATED AREAS
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.Do not graze treated areas.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun.
.03084 Ib IK sq.ft
1.316 Ib A
SC/L
NS
NS
NS
NS
NS
AGRICULTURAL/FARM
STRUCTURES/BUILDINGS
AND EQUIPMENT
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not graze livestock in treated areas.
Do not graze treated areas.
Foliar
Spray.
Ground /Pressure sprayer.
.01365 lb/1 gal
1.3441b/100gal
SC/L
NS
NS
NS
NS
NS
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
.0112 Ib IK sq.ft
1.3441bA
SC/L
NS
NS
NS
NS
NS
25
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
end sprayer /Power sprayer.
AIRPORTS/LANDING
FIELDS
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INDUSTRIAL
LAWNS
Foliar
Spot treatment /Spray.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.Do not feed or graze animals on treated areas.
Do not graze treated areas.
.03084 Ib IK sq.ft
2.025 Ib A
.033 Ib IK sq.ft
1.321bA
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze treated areas.
.0336 Ib IK sq.ft
1.3441bA
SC/L
NS
NS
NS
42
NS
26
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INSTITUTIO
NAL/INDUSTRIAL
PREMISES/EQUIP. (INDOOR)
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.033 Ib IK sq.ft
1.32 Ib A
Form
Code(s)
SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc & yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.03084 Ib IK sq.ft
2.025 Ib A
.01365 lb/1 gal
1.3441b/100gal
.033 Ib IK sq.ft
1.32 Ib A
.01 12 Ib IK sq.ft
1.3441bA
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
27
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
FENCEROWS/HEDGEROWS
Foliar
Spray.
Power sprayer.
GOLF COURSE TURF
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
Postemergence
Broadcast.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
.57881bA
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water
mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
Do not graze treated areas.
.0336 Ib IK sq.ft
1.344 Ib A
.033 Ib IK sq.ft
1.321bA
SC/L
SC/L
NS
NS
NS
NS
NS
NS
42
NS
NS
NS
28
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Backpack sprayer /Sprayer.
HOSPITALS/MEDICAL
INSTITUTIONS PREMISES
(HUMAN/VETERINARY)
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
HOUSEHOLD/DOMESTIC
DWELLINGS OUTDOOR
PREMISES
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
PFfl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.03084 Ib IK sq.ft
2.025 Ib A
.01365 lb/1 gal
1.3441b/100gal
.033 Ib IK sq.ft
1.321bA
.01 12 Ib IK sq.ft
1.3441bA
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
29
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
When neededBand treatment
/Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
INDUSTRIAL AREAS
(OUTDOOR)
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
1.003E-051b linear
ft
.03084 Ib IK sq.ft
2.025 Ib A
.01365 lb/1 gal
1.3441b/100gal
.01281 Ib IK linear
ft
.01 12 Ib IK sq.ft
1.3441bA
1.037E-061b linear
ft
RTU
SC/L
RTU, SC/L
NS
NS
NS
NS
NS
NS
NS
NSNS
NS
NS
NS
NS
NS
NS
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
30
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
When needed
Band treatment.
Sprayer.
NONAGRICULTURAL
OUTDOOR
BUILDINGS/STRUCTURES
After mowing
Band treatment.
Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not feed or graze animals on treated areas.
Do not graze treated areas.
1.003E-051b linear
ft
.03084 Ib IK sq.ft
2.025 Ib A
.01281 Ib IK linear
ft
1.037E-061b linear
ft
RTU
SC/L
RTU
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
1.003E-051b linear
ft
RTU
NS
NS
NS
NS
NS
31
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Band treatment /Spot treatment
/Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
NONAGRICULTURAL
RIGHTS-OF-
WAY/FENCEROWS/HEDGER
OWS
After mowing
Band treatment.
Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.03084 Ib IK sq.ft
2.025 Ib A
.033 Ib IK sq.ft
1.321bA
.01281 Ib IK linear
ft
.01 12 Ib IK sq.ft
1.344 Ib A
1.037E-061b linear
ft
Form
Code(s)
SC/L
SC/L
RTU, SC/L
Max.
Seasonal
Rate
NS
NS
NS
Max. #
Apps/
cc & yr
NS
NS
NS
NS
NS
NS
MRI
NS
NS
NS
REI
NS
NS
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not feed or graze animals on treated areas.
Do not graze livestock in treated areas.
Do not graze treated areas.
1.003E-051b linear
ft
RTU
NS
NS
NS
NS
NS
32
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When neededBand treatment
/Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
NONAGRICULTURAL
UNCULTIVATED
AREAS/SOILS
Foliar
Spray.
Power sprayer.
ORNAMENTAL AND/OR
SHADE TREES
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.03084 Ib IK sq.ft
2.025 Ib A
.01365 lb/1 gal
1.3441b/100gal
.033 Ib IK sq.ft
1.321bA
.01281 Ib IK linear
ft
.01 12 Ib IK sq.ft
1.3441bA
1.037E-061b linear
ft
Form
Code(s)
SC/L
SC/L
RTU, SC/L
Max.
Seasonal
Rate
NS
NS
NS
Max. #
Apps/
cc & yr
NS
NS
NS
NS
NSNS
MRI
NS
NS
NS
REI
NS
NS
NS
PLfl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
.57881bA
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
33
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL GROUND
COVER
Foliar
Broadcast /Spray .Ground /Hand
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.033 Ib IK sq.ft
2.025 Ib A
.033 Ib IK sq.ft
1.321bA
.01 12 Ib IK sq.ft
1.344 Ib A
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze treated areas.
.033 Ib IK sq.ft
2.025 lbA.01365
SC/L
NS
NS
NS
NS
NS Geographic
allowable: CA
34
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
held sprayer /Power sprayer
/Pressure sprayer /Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
ORNAMENTAL
HERBACEOUS PLANTS
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
PostemergenceBroadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL LAWNS AND
TURF
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
lb/1 gal
1.3441b/100gal
.033 Ib IK sq.ft
1.321bA
Form
Code(s)
SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc & yr
NS
NS
MRI
NS
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.033 Ib IK sq.ft
2.025 Ib A
.0331blKsq.ftl.32
IbA
.01 12 Ib IK sq.ft
1.344 IbA
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NSNS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
35
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
After mowing
Band treatment.
Sprayer.
Foliar
Broadcast /Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer
/Spreader.
When needed
Band treatment.
Sprayer.
ORNAMENTAL
NONFLOWERING PLANTS
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not feed clippings to livestock.
Do not graze treated areas.
1.003E-051b linear
ft
.0336 Ib IK sq.ft
1.344 Ib A
.033 Ib IK sq.ft
1.32 Ib A
.01281 Ib IK linear
ft
1.037E-061b linear
ft
RTU
SC/L
G, SC/L
RTU
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
42
NS
NS
NS
NS
NS
NS
Geographic allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
36
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL WOODY
SHRUBS AND VINES
Foliar
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.Do not graze treated areas.
.033 Ib IK sq.ft
2.025 Ib A
.033 Ib IK sq.ft
1.32 Ib A
.01 12 Ib IK sq.ft
1.3441bA
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.Do not graze treated areas.
.033 Ib IK sq.ft
SC/L
NS
NS
NS
NS
Geographic allowable: CA
37
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
PATHS/PATIOS
After mowing
Band treatment.
Sprayer.
Foliar
Spray.
Ground /Pressure sprayer.
Postemergence
Broadcast.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
2.025 Ib A
.033 Ib IK sq.ft
1.32 Ib A
.01 12 Ib IK sq.ft
1.3441bA
Form
Code(s)
SC/L
SC/L
Max.
Seasonal
Rate
NS
NS
Max. #
Apps/
cc & yr
NS
NS
NS
NS
NS
MRI
NS
NS
REI
NS
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.Do not graze treated areas.
1.003E-051b linear
ft
.01365 lb/1 gal
1.3441b/100gal
.033 Ib IK sq.ft
1.321bA
RTU
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
38
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Backpack sprayer /Sprayer.
When needed
Band treatment /Spot treatment
/Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
PAVED AREAS (PRIVATE
ROADS/SIDEWALKS)
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.01281 Ib IK linear
ft
.01 12 Ib IK sq.ft
1.344 Ib A
1.037E-061b linear
ft
Form
Code(s)
RTU, SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc & yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water
mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
1.003E-051b linear
ft
.03084 Ib IK sq.ft
2.025 Ib A
.033 Ib IK sq.ft
1.32 Ib A
RTU
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
39
-------
SITE NAME
LIMITATIONS
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
When needed
Band treatment /Spot treatment
/Spray .Boom sprayer /Handgun
/Hose-end sprayer /Power sprayer
/Sprayer.
.01281 Ib IK linear
ft
.0112 Ib IK
sq.ftl.3441bA
1.037E-061b linear
ft
RTU, SC/L
NS
NS
NS
NS
NS
RECREATION AREA LAWNS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
Do not graze treated areas.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
.0336 Ib IK sq.ft
1.3441bA
SC/L
NS
NS
NS
42
NS
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
.033 Ib IK sq.ft
1.32 Ib A
SC/L
NS
NS
NS
NS
NS
RESIDENTIAL LAWNS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
40
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.Do not graze treated areas.
Foliar
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-end
sprayer /Power sprayer /Pressure
sprayer.
.0336 Ib IK sq.ft
1.3441bA
SC/L
NS
NS
NS
42
NS
NON-FOOD/NON-FEED USE PATTERNS SUMMARY FOR Mefluidide, diethanolamine salt (CASE 2370)
Application rates calculated in terms of Acid Equivalent.
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
AGRICULTURAL
UNCULTIVATED AREAS
Foliar
Spot treatment /Spray.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
PFfl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.Do not graze treated areas.
.02344 Ib (AE) IK
sq.ft
SC/L
NS
NS
NS
NS
NS
41
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Boom sprayer /Hand held sprayer
/Handgun.
AGRICULTURAL/FARM
STRUCTURES/BUILDINGS
AND EQUIPMENT
Foliar
Spray.
Ground /Pressure sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
AIRPORTS/LANDING
FIELDS
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
1 Ib (AE) A
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not graze livestock in treated areas.
Do not graze treated areas.
8.531E-041b(AE)/l
gal
.084 Ib (AEyiOO gal
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.Do not feed or graze animals on treated areas.
Do not graze treated areas.
(L)
.02344 Ib (AE) IK
sq.ft
SC/L
NS
NS
NS
NS
NS
42
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INDUSTRIAL
LAWNS
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INSTITUTIO
NAL/INDUSTRIAL
PREMISES/EQUIP. (INDOOR)
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
1.5391b(AE)A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
Form
Code(s)
SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc &yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze treated areas.
.02344 Ib (AE) IK
sq.ft
1 Ib (AE) A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
SC/L
SC/L
NS
NS
NS
NS
NS
NS
42
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
43
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
FENCEROWS/HEDGEROWS
Foliar
Spray.
Power sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.02344 Ib (AE) IK
sq.ft
1.5391b(AE)A
8.531E-041b(AE)/l
gal
.084 Ib (AE)/100 gal
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
(L)
SC/L
NS
NS
NS
NS
NS
44
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
GOLF COURSE TURF
Do not apply directly to water or wetlands.Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water
mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
Do not graze treated areas.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
(L)
.02344 Ib (AE) IK
sq.ft
1 Ib (AE) A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
SC/L
SC/L
NS
NS
NS
NS
NS
NS
42
NS
NS
NS
HOSPITALS/MEDICAL
INSTITUTIONS PREMISES
(HUMAN/VETERINARY)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
45
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
HOUSEHOLD/DOMESTIC
DWELLINGS OUTDOOR
PREMISES
After mowing
Band treatment.
Sprayer.
Foliar
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.02344 Ib (AE) IK
sq.ft
1.5391b(AE)A
8.531E-041b(AE)/l
gal
.084 Ib (AE)/100 gal
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
Form
Code(s)
SC/L
SC/L
SC/L
Max.
Seasonal
Rate
NS
NS
NS
Max. #
Apps/
cc &yr
NS
NS
NS
NS
NS
NS
MRI
NS
NS
NS
REI
NS
NS
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
.02344 Ib (AE) IK
RTU
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
46
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
When neededBand treatment
/Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
INDUSTRIAL AREAS
(OUTDOOR)
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
sq.ft
1.5391b(AE)A
8.531E-041b(AE)/l
gal
.084 Ib (AE)/100 gal
.009338 Ib (AE) IK
linear ft
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
8.062E-07 Ib (AE)
linear ft
Form
Code(s)
RTU, SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc &yr
NS
NSNS
MRI
NS
REI
NS
PFfl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not feed or graze animals on treated areas.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
(L)
.02344 Ib (AE) IK
sq.ftl.5391b(AE)A
RTU
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
47
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
/Handgun /Power sprayer.
When needed
Band treatment.
Sprayer.
NONAGRICULTURAL
OUTDOOR
BUILDINGS/STRUCTURES
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.009338 Ib (AE) IK
linear ft
8.062E-07 Ib (AE)
linear ft
Form
Code(s)
RTU
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc &yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
.02344 Ib (AE) IK
sq.ft
1.5391b(AE)A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
.009338 Ib (AE) IK
RTU
SC/L
SC/L
RTU, SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
48
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Band treatment /Spot treatment
/Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
NONAGRICULTURAL
RIGHTS-OF-
WAY/FENCEROWS/HEDGER
OWS
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Ground /Hand held
sprayer /Handgun /Power sprayer
/Pressure sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
linear ft
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
8.062E-07 Ib (AE)
linear ft
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
NS
MRI
REI
PFfl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not feed or graze animals on treated areas.
Do not graze livestock in treated areas.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
(L)
.02344 Ib (AE) IK
sq.ft
1.5391b(AE)A
8.531E-041b(AE)/l
gal
.084 Ib (AE)/100 gal
RTU
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
49
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When neededBand treatment
/Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
NONAGRICULTURAL
UNCULTIVATED
AREAS/SOILS
Foliar
Spray.
Power sprayer.
ORNAMENTAL AND/OR
SHADE TREES
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
.009338 Ib (AE) IK
linear ft
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
8.062E-07 Ib (AE)
linear ft
Form
Code(s)
SC/L
RTU, SC/L
Max.
Seasonal
Rate
NS
NS
Max. #
Apps/
cc &yr
NS
NS
NSNS
MRI
NS
NS
REI
NS
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
(L)
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
50
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL GROUND
COVER
Foliar
Broadcast /Spray .Ground /Hand
held sprayer /Power sprayer
/Pressure sprayer /Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not graze treated areas.
.025 Ib (AE) IK
sq.ft
1.5391b(AE)A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic
allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze treated areas.
.025 Ib (AE) IK
sq.ft
1.539 lb(AE)
A8.531E-04 Ib
(AE)/1 gal
.084 Ib (AE)/100 gal
SC/L
NS
NS
NS
NS
NS
Geographic
allowable: CA
51
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
ORNAMENTAL HERBACEO
US PLANTS
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
PostemergenceBroadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL LAWNS AND
TURF
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
Form
Code(s)
SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc &yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
Do not graze treated areas.
.025 Ib (AE) IK
sq.ft
1.5391b(AE)A
.025 Ib (AE) IK
sq.ftl lb(AE)A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NSNS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
52
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
After mowing
Band treatment.
Sprayer.
Foliar
Broadcast /Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer
/Spreader.
When needed
Band treatment.
Sprayer.
ORNAMENTAL
NONFLOWERING PLANTS
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not feed clippings to livestock.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
(L)
.009338 Ib (AE) IK
linear ft
8.062E-07 Ib (AE)
linear ft
RTU
SC/L
G, SC/L
RTU
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
42
NS
NS
NS
NS
NS
NS
Geographic
allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
53
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
ORNAMENTAL WOODY
SHRUBS AND VINES
Foliar
Broadcast /Spray.
Hand held sprayer /Power sprayer
/Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.Do not graze treated areas.
.025 Ib (AE) IK
sq.ft
1.5391b(AE)A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
SC/L
SC/L
SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic
allowable: CA
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.Do not graze treated areas.
.025 Ib (AE) IK
sq.ft
1.5391b(AE)A
SC/L
NS
NS
NS
NS
NS
Geographic
allowable: CA
54
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer.
PATHS/PATIOS
After mowing
Band treatment.
Sprayer.
Foliar
Spray.
Ground /Pressure sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Band treatment /Spot treatment
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
Form
Code(s)
SC/L
SC/L
Max.
Seasonal
Rate
NS
NS
Max. #
Apps/
cc &yr
NS
NS
NS
NS
MRI
NS
NS
REI
NS
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
8.531E-041b(AE)/l
gal
.084 Ib (AE)/100 gal
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
.009338 Ib (AE) IK
linear ft
RTU
SC/L
SC/L
RTU, SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
55
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
/Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Sprayer.
PAVED AREAS (PRIVATE
ROADS/SIDEWALKS)
After mowing
Band treatment.
Sprayer.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Power sprayer.
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
When needed
Band treatment /Spot treatment
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
8.062E-07 Ib (AE)
linear ft
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water or wetlands.Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water
mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not contaminate water.
Do not graze livestock in treated areas.
Do not graze treated areas.
7.480E-06 Ib (AE)
linear ft
.02344 Ib (AE) IK
sq.ft
1.5391b(AE)A
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
.009338 Ib (AE) IK
linear ft
RTU
SC/L
SC/L
RTU, SC/L
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
56
-------
SITE NAME
LIMITATIONS
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
/Spray .Boom sprayer /Handgun
/Hose-end sprayer /Power sprayer
/Sprayer.
7.000E-04 Ib (AE)
IK sq.ft
.084 Ib (AE) A
8.062E-07 Ib (AE)
linear ft
RECREATION AREA LAWNS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to any body of water.
Do not apply when drift is likely to occur.
Do not apply when wind velocity is 10 mph or greater.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.
Do not contaminate water, food, or feed by storage or disposal.
Do not feed or graze animals on treated areas.
Do not graze treated areas.
Foliar
Spot treatment /Spray.
Boom sprayer /Hand held sprayer
/Handgun /Hose-end sprayer
/Power sprayer /Pressure sprayer.
(L)
.02344 Ib (AE) IK
sq.ft
1 Ib (AE) A
SC/L
NS
NS
NS
42
NS
Postemergence
Broadcast.
Backpack sprayer /Sprayer.
.025 Ib (AE) IK
sq.ft
1 Ib (AE) A
SC/L
NS
NS
NS
NS
NS
RESIDENTIAL LAWNS
Do not apply directly to water or wetlands.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
Do not apply through any type of irrigation system.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of equipment wash waters.Do not graze treated areas.
57
-------
Foliar
Spot treatment /Spray.
Boom sprayer /Handgun /Hose-
end sprayer /Power sprayer
/Pressure sprayer.
.0021 Ib (AE) IK
sq.ft
.084 Ib (AE) A
SC/L
NS
NS
NS
42
NS
58
-------
NON-FOOD/NON-FEED USE PATTERNS SUMMARY FOR Potassium mefluidide (CASE 2370)
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
AIRPORTS/LANDING
FIELDS
When needed
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INDUSTRIAL
LAWNS
When needed
Broadcast.
Backpack sprayer /Sprayer.
COMMERCIAL/INSTITUTIO
NAL/INDUSTRIAL
PREMISES/EQUIPMENT
(OUTDOOR)
When needed
Broadcast.
Backpack sprayer /Sprayer.
GOLF COURSE TURF
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc &yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
59
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
When needed
Broadcast.
Backpack sprayer /Sprayer.
HOSPITALS/MEDICAL
INSTITUTIONS PREMISES
(HUMAN/VETERINARY)
When needed
Broadcast.
Backpack sprayer /Sprayer.
INDUSTRIAL AREAS
(OUTDOOR)
When neededBroadcast.
Backpack sprayer /Sprayer.
NONAGRICULTURAL
OUTDOOR
BUILDINGS/STRUCTURES
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ftl Ib
A
SC/L
NS
NSNS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
60
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
When needed
Broadcast.
Backpack sprayer /Sprayer.
NONAGRICULTURAL
RIGHTS-OF-
WAY/FENCEROWS/HEDGER
OWS
When needed
Broadcast.
Backpack sprayer /Sprayer.
PATHS/PATIOS
When needed
Broadcast.
Backpack sprayer /Sprayer.
PAVED AREAS (PRIVATE
ROADS/SIDEWALKS)
When needed
Broadcast.
Backpack sprayer /Ground
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
.025 Ib IK sq.ft
lib A
Form
Code(s)
SC/L
Max.
Seasonal
Rate
NS
Max. #
Apps/
cc & yr
NS
NS
MRI
NS
REI
NS
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
61
-------
SITE NAME
Application Timing (for any
Reg.# at any rate)
Application Type (for any RegJ
at any rate).
Application Equipment (for any
Reg.# at any rate).
/Sprayer.
RECREATIONAL AREAS
When needed
Broadcast.
Backpack sprayer /Sprayer.
LIMITATIONS
Max. Single Appl.
Rate to a Single
Site
Form
Code(s)
Max.
Seasonal
Rate
Max. #
Apps/
cc & yr
MRI
REI
Pffl/PGI/PSI
Use Limitations
(May not
apply to all Reg. #s)
Do not apply directly to water.
Do not apply when drift is likely to occur.
Do not contaminate water by cleaning of equipment or disposal of waste.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze livestock in treated areas.
.025 Ib IK sq.ft
lib A
SC/L
NS
NS
NS
NS
NS
62
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Mefluidide
Guide to Appendix B
Appendix B contains the list of data requirements which support the reregi strati on for active
ingredients within case #2073 (mefluidide) covered by this RED. It contains generic data
requirements that apply to mefluidide in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. The reference numbers accompanying each test refer to
the test protocols set in the Pesticide Assessment Guidance, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161
(703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify 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 (Appendix D) for a complete citation of
the study.
63
-------
New Guideline
Number
Old Guideline
Number
Requirement
Use Pattern
Bibliographic Citation(s)
Product Chemistry
830.7000
830.7050
830.7200
830.7300
830.7370
830.7840
830.7950
63-12
N/A
63-5
63-7
63-10
63-8
63-9
pH
UV/Visible absorption
Melting point/melting range
Density
Dissociation Constants in Water
Water Solubility
Vapor Pressure
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
259274. 41913301 and 02, 422513 01 through 04, 42309901,
42283301 through 03, 42331401 and 02, 42251401 through 05,
42282001, 42282002, 42302301, and 42323501.
41913301 and 02, 422513 01 through 04, 42309901, 42283301
through 03, 42331401 and 02. 42251401 through 05,
42282001, 42282002, 42302301, and 42323501.
259274. 41913301 and 02, 422513 01 through 04, 42309901,
42283301 through 03, 42331401, and 02, 42251401 through
05, 42282001, 42282002, 42302301, and 42323501.
259274. 41913301 and 02, 422513 01 through 04, 42309901,
42283301 through 03, 42331401 and 02, 42251401 through 05,
42282001, 42282002, 42302301, and 42323501.
41913301 and 02, 422513 01 through 04, 42309901, 42283301
through 03, 42331401 and 02, 42251401 through 05,
42282001, 42282002, 42302301, and 42323501.
259274. 41913301 and 02, 422513 01 through 04, 42309901,
42283301 through 03, 42331401 and 02, 42251401 through 05,
42282001, 42282002, 42302301, and 42323501.
42355501. 42251401 through 05, 42282001, 42282002,
42302301, and 42323501.
Environmental Fate
35.2120
835.2240
835.2410
835.4100
835.4300
835.1240
835.6100
850.1730
161-1
161-2
161-3
162-1
162-3
163-1
164-1
165-4
Hydrolysis
Photodegradation Water
Photodegradation Soil and Air
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Terrestrial Field Dissipation
Fish Bioaccumulation
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
226846, 42935401
226851
43040801
43162201
43120001
43020801
43276802, 43276801
226851
Ecological Effects
850.2100
71-la
Avian Oral LD50 Quail/Duck
C,J,K
41601901
64
-------
850.2200
850.2300
850.1075
850.1010
850.1045
850.1025
850.1400
850.1400
850.1300
850.1350
850.1500
850.4225
850.4250
850.4400
850.5400
850.3020
850.3030
71-2
71-4
72-1
72-2
72-3a
72-3b
72-4a
72-4a
72-4b
72-4c
72-5
123-la
123-lb
123-2
123-2
141-1
141-2
Avian Dietary LC50 Quail
Avian Reproduction
Freshwater Fish LC50
Freshwater Invertebrate LC50
Estuarine/Marine Fish LC50
Estuarine/Marine Mollusk EC50
Fish Early Life-Stage (freshwater)
Fish Early Life-Stage
(estuarine/marine)
Aquatic Invertebrate Life-Cycle
(freshwater)
Aquatic Invertebrate Life-Cycle
(estuarine/marine)
Fish Full Life-Cycle
Seedling Emergence (Tier II)
Vegetative Vigor (Tier II)
Aquatic Plant Growth (Tier II)
Algal Toxicity (Tiers I and II)
Honey Bee Acute Contact LD50
Honey Bee Residue on Foliage
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
41601902,41601903
Data Gap
41893701,41893702
41893703
42562303
42562401
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
47190701
Data Gap
43526605
43526601
42562801
425628-01
Toxicology
870.1100
870.1100
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3100
870.3150
870.3150
870.3200
81-1
81-1
81-1
81-2
81-3
81-4
81-5
81-6
82-la
82-la
82- Ib
82- Ib
82-2
Acute Oral Toxicity Rat
Acute Oral Toxicity Mouse
Acute Oral Dog
Acute Dermal Toxicity Rabbit
Acute Inhalation Toxicity Rat
Primary Eye Irritation Rabbit
Primary Skin Irritation Rabbit
Dermal Sensitization Guinea pig
90-Day Oral Toxicity SD Rat
90-Day Oral Toxicity Wistar rat
90-Day Oral Toxicity Dog
21 -Day Dermal Toxicity Rabbit
21 -Day Dermal Toxicity
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
00047118
00047117,00047116
00049627
00047122, 00049628, 00083817
41888801
00047126, 00049630, 43481203
00047124, 00049629, 00083819
41887701, 00082076
00047136
00047136
00047141
00082073
00082073, 42029601, 41972901
65
-------
870.3700b
870.3800
870.4100b
870.4200b
870.4300a
870.5100
870-5300
870.5300
870.5550
N/A
N/A
N/A
N/A
83-1
83-2
83-3a
N/A
N/A
84-2
84-2
N/A
N/A
Developmental Toxicity NZW
Rabbit
3 -Generation Reproduction
Charles River Rat
Chronic Toxicity Dog
Carcinogenicity Mouse
Prenatal Developmental Toxicity
Study - Rat
Ames, S typhimurium
In vitro Cell (CHO) Chromosomal
Aberration
In vitro Mammalian Cell HGPRT
Test
Unscheduled DNA Synthesis
Non GDL Metabolism &
Pharmacokinetics
Unacceptable/NG
Non GDL Carcinogenicity Rats
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
C,J,K
00132992, 00047138, 00047139
00082748
00132995
00082747
00061930, 42097201, 42097701, 42026102
00132996, 41888804
00132996
41888803
41888802, 00132996
000610307, 00082737
66
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket EPA-HQ-
OPP-2006-0874. This docket may be accessed in the OPP docket room located at Room S-
4900, One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA. It is open Monday through
Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. All documents may be
viewed in the OPP docket room or downloaded or viewed via the Internet at the following
site: http://www.regulations.gov.
The docket initially contained preliminary risk assessments, supporting documents, and
technical (or manufacturing-use) registrant error comments for chlorflurenol as of June 20,
2007. After a sixty-day public comment period, EPA considered the public comments that
were submitted to the docket and revised the risk assessments as necessary. The revised risk
assessments, any supporting documents that needed to be revised, and memos describing the
Health Effects Division (HED), the Ecological Fate and Effects Division (EFED), and the
Biological and Economic Assessment Division (BEAD) response to public comments will be
added to the docket in September 2007.
The Agency documents in the docket include:
1. Federal Register Notice: Mefluidide Risk Assessment; Notice of Availability
(Phase 3 of 4-Phase Process)
2. Reader's Guide to the Mefluidide E-docket # EPA-HQ-OPP-2007-0431
3. Mefluidide Use Closure Memo
4. Table A3. Non-Food/Non-Feed Use Patterns Summary for
Mefluidide (Case 2370)
5. Table A3. Non-Food-Feed Use Patterns Summary for Mefluidide,
diethanolamine salt (CASE 2370)
6. Table A3. Non-Food/Non-Feed Use Patterns Summary for
Potassium mefluidide (CASE 2370)
7. Table A3. Non-Food/Non-Feed Use Patterns Summary for
Mefluidide, diethanolamine salt by Acid Equivalent
(CASE 2370)
8. Mefluidide; Diethanolamine Mefluidide, and Potassium
Mefluidide- Phase 2, (30-Day Error only Correction), HED
Chapter of the Re-registration Eligibility Decision Document
(RED).
67
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9. Mefluidide - Toxicology Section for the Reregi strati on Eligibility
Decision Document (RED)
10. Mefluidide - Occupational and Residential Exposure and Risk
Assessment for the Reregi strati on Eligibility Decision (RED)
11. Appendix A 1-3 Standard Formulas Used for Calculating
Occupational and Residential Exposures to Mefluidide;
Ocupational Handler Exposure Data and; Risk Calculations for
Mefluidide; Residential Handler Exposure Data and Risk
Calculations for Mefluidide
12. Appendix B - Mefluidide Occupational Handler Risks
13. Appendix C - Residential Handler Risks
14. Appendix D - Residential Turf Post Application Risk
Assessment for Mefluidide
15. Mefluidide Incident Report
16. Error Corrections First Phase for Reregi strati on of Mefluidide
acid, Mefluidide-DEA and Mefluidide-K
17. Re-registration Eligibility Document Environmental Fate and
Effects Science Chapter
18. Drinking Water Assessment for N-[2,4-dimethyl-5-
[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
(Mefluidide), N-{2,4-dimentyl-5-
]]trifluoromethyl)sulfonyl]amino]phenyracetamide
monopotassium salt (Potassium Mefluidide), and N-[2,4-
dimethyl-5[[(trifluoromethyl)salfonyl]amino]phenyl]actamide
Compound with 2,2-iminobsi[ethanol] (1:1)
19. Response to comments Phase III for Reregi strati on of Mefluidide acid, Mefluidide-
DEA and Mefluidide-K
20. Re-registration Eligibility Document Environmental Fate and
Effects Science Chapter (dated 9/13/07)
21. Alternative Assessment of Mefluidide
68
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Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography)
Guide to Appendix D
1. Contents of Bibliography. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been
considered, are included.
2. Units of Entry. The unit of entry in this bibliography is called a "study." In the case
of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. Identification of Entry. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the
six-digit "Accession Number" which has been used to identify volumes of submitted
studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries
added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. Form of Entry. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified,
the Agency has chosen to show a personal author. When no
individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When
no author or laboratory could be identified, the Agency has
shown the first submitter as the author.
b. Document date. The date of the study is taken directly from
the document. When the date is followed by a question mark,
69
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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.
70
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Bibliography
MRID
9775
12064
12098
16108
16148
17088
32574
47115
47116
47117
Citation Reference for Mefluidide (114001)
Wu, C.H.; Santelmann, P.W. (1974) Plant Growth Regulators in Pea- nuts: No. GR 74-4.
(Unpublished study received May 12, 1976 under 400-103; prepared by Oklahoma State
Univ., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:230881-V)
Monaco, T. (1974) Weed Control in Blueberries: Ideal Tract. (Un- published study
received Dec 19, 1975 under 6E1719; prepared by North Carolina State Univ., submitted
by Interregional Research Project No. 4, New Brunswick, N.J.; CDL:095364-AH)
Talbert, R.E.; Howell, S.L.; Kennedy, J.M.; et al. (1974) Field Evaluation of Herbicides
in Small Fruit and Nut Crops, 1974. (Unpublished study received Mar 14, 1977 under
7E1936; prepared by Univ. of Arkansas, Dept. of Agronomy and Dept. of Horticul- ture
and Forestry, submitted by Interregional Research Project No. 4, New Brunswick, N.J.;
CDL:097354-C)
Wilson, H.P.; Hines, I.E. (1974) Soybeans-1974: Preemergence IV: Test No. 10077.
(Unpublished study received Jan 19, 1977 under 100-583; prepared by Virginia Truck
and Ornamentals Research Station, Eastern Shore Branch, Dept. of Plant Physiology,
sub- mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095751-P)
Murray, D.S.; Soteres, J.K.; Jolley, E.R. (1976) Preemergence and Postemergence
Seedling Johnsongrass Control in Soybeans: Test No. 10864. (Unpublished study
received Jan 19, 1977 under 100- 583; prepared by Auburn Univ., Dept. of Agronomy,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095762-AD)
Harger, T. (1976) Red Rice Control in Soybeans: Test No. 11178. (Unpublished study
received Oct 20, 1978 under 100-583; submit- ted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:235357-H)
Osgood, ?; Teshime, ? (19??) Supporting Efficacy Data for Ethrel Use on Sugarcane.
(Unpublished study received May 15, 1980 un- der 264-EX-59; submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099426-B)
3M Company (1976) Synopsis. Summary of studies 226850-B through 26850-AB.
(Unpublished study received Nov 9, 1976 under 7182- 7; CDL:226850-A)
Sibinski, L.J.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Mice
with Technical MBR 12325 (Lot No. 2) Test No. AT2-59. (Unpublished study received
Nov 9, 1976 under 7182- 7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-B)
Sibinski, L.J.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Mice
with Technical MBR 12325 (Lot No. 6): Test No. AT 3-77. (Unpublished study received
Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-C)
71
-------
47118 Sibinski, L.J.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Rats
with Technical MBR 12325 (Lot No. 6): Test No. AT 3-65. (Unpublished study received
Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-D)
47121 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Dogs
with Technical MBR 12325 (Lot No. 8): Test No. AT4-18. (Unpublished study received
Nov 9, 1976 under 7182- 7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-G)
47122 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Toxicity Study in
Rabbits with Technical MBR 12325 (Lot No. 6): Test No. AT3-64. (Unpublished study
received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL:226850-H)
47124 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in
Rabbits with Technical MBR 12325 (Lot No. 4): Test No. IS3-29. (Unpublished study
received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:
226850-J)
47126 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Ocular Irritation Study in
Rabbits with Technical MBR 12325 (Lot No. 4): Test No. IS3-31. (Unpublished study
received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:
226850-L)
47133 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Oral Toxi- city Study with S-
15017 in Albino Rats: Test No. 475A0283. (Un- published study received Nov 9, 1976
under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-S)
47134 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Oral Toxi- city Study with S-
15753 in Albino Rats: Test No. 475A0276. (Un- published study received Nov 9, 1976
under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-T)
47135 Sibinski, LJ. (1974) S12325: 28 Day Subacute Diet Toxicity: Charles River Rats: Test
No. St 3-32. (Unpublished study re- ceived Nov 9, 1976 under 7182-7; submitted by 3M
Co., St. Paul, Minn.; CDL:226850-U)
47136 Goldenthal, E.I.; Wazeter, F.X.; Geil, R.G.; et al. (1975) Three Month Subacute Toxicity
Study in Rats: IRDC No. 102-025. (Un- published study received Nov 9, 1976 under
7182-7; prepared by International Research and Development Corp., submitted by 3M
Co., St. Paul, Minn.; CDL:226850-V)
47137 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) A 21 Day Dose Range Finding
Feeding Study in Dogs with Technical MBR 12325, Lot No. 9: Test No. 175R0002.
(Unpublished study received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul,
Minn.; CDL: 226850-W)
47138 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) A 14 Day Dose Range Finding Oral
Intubation Study in Rabbits with Technical MBR 12325, Lot No. 9: Test No. 475R0015.
(Unpublished study received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul,
72
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Minn.; CDL:226850-X)
47139 Wiseth, L.O.; Tufte, M.E.; Gortner, E.G.; et al. (1975) Rabbit Teratology Study of MBR
12325: Test No. RBT-14. (Unpublished study received Nov 9, 1976 under 7182-7;
submitted by 3M Co., St. Paul, Minn.; CDL:226850-Y)
47140 Goldenthal, E.I.; Wazeter, F.X.; Geil, R.G. (1975) Three Month Sub- acute Oral Toxicity
Study in Rats: IRDC No. 102-024. (Unpub- lished study received Nov 9, 1976 under
7182-7; prepared by International Research and Development Corp., submitted by 3M
Co., St. Paul, Minn.; CDL:226850-Z)
47141 Nelson, R.; Fischer, C.A.; Robl, M.G. (1975) Report to Riker Labo- ratories, Inc.,
Subsidiary of 3M Company: 90-Day Subacute Oral Toxicity Study with MBR 12325 in
Beagle Dogs: IBT No. 611-07135. (Unpublished study received Nov 9, 1976 under
7182-7; prepared by Industrial Bio-Test Laboratories, Inc., submitted by 3M Co., St.
Paul, Minn.; CDL:226850-AA)
47142 Rohlfmg, S.R.; Saunders, D.R.; Nelson, R.A. (1975) A Mutagenicity Study in
Salmonella typhimurium with Technical MBR 12325 (Lot 8). (Unpublished study
received Nov 9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL:226850-AB)
47533 3M Company (1975) Synopsis: ?MBR 12325|. Summary of studies 222232-B through
222232-D. (Unpublished study received Nov 4, 1975 under unknown admin, no.;
CDL:222232-A)
47534 Green, C.D.; Crowell, J.D. (1975) Manufacturing Process and Purity of Technical MBR
12325: Report No. 25. (Unpublished study re- ceivedNov 4, 1975 under unknown
admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL:222232-B)
47535 Green, C.D. (1975) Chemistry of MBR 12325: Report No. 55. (Unpub- lished study
received Nov 4, 1975 under unknown admin, no.; sub- mitted by 3M Co., St. Paul,
Minn.; CDL:222232-C)
47537 Todd, J.W. (1975) Gas Chromatographic Analysis of Technical MBR 12325: Report No.
19. Method dated Jul 16, 1975. (Unpublished study received Nov 4, 1975 under
unknown admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL:222232-E)
47539 Lillquist, G.J.; Newmark, R.A.; Sparrow, C.R. (1975) IR, NMR and Mass Spectral
Analyses of MBR 12325: Report No. 6244. (Unpub- lished study received Nov 4, 1975
under unknown admin, no.; sub- mitted by 3M Co., St. Paul, Minn.; CDL:222232-G)
47541 Clark, H.B. (1975) Photodegradation of Radiolabeled MBR 12325 in Well Water under
Simulated Sunlight Conditions: Report No. 24. (Unpublished study received Nov 4,
1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL:222232-I)
47542 Daftsios, A.C.; Dobbs, C.L. (1975) MBR 12325 Hydrolysis Studies, pH 5, 7 and 9:
Report No. 27. (Unpublished study received Nov 4, 1975 under unknown admin, no.;
submitted by 3M Co., St. Paul, Minn.; CDL:222232-J)
73
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47543 Bandal, S.K. (1974) Determination of Carbon-14 Activity in Aqueous and Non-aqueous
Solutions by Liquid Scintillation Counting: Re- port No. 100. Method dated Jul 24,
1974. (Unpublished study received Nov 4, 1975 under unknown admin, no.; submitted
by 3M Co., St. Paul, Minn.; CDL:222232-K)
47544 Bandal, S.K. (1974) Cleanup, Purification and Identification of Chemical Substances by
Thin-Layer Chromatography: Report No. 101. Method dated Jul 24, 1974. (Unpublished
study re- ceived Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul,
Minn.; CDL:222232-L)
47545 Bandal, S.K. (1974) Analysis of Radioactive Compounds by Thin-Layer
Chromatography-Radioautography: Report No. 102. Method dated Jul 24, 1974.
(Unpublished study received Nov 4, 1975 under un- known admin, no.; CDL:222232-M)
47546 3M Company (1975) MBR 12325 Plant Growth Regulator: Efficacy and Phytotoxicity
Information on Turf. (Reports by various sources; unpublished study including published
data, received Nov 4, 1975 under unknown admin, no.; CDL:222234-A)
49088 Green, C.D. (1975) Chemistry of MBR 12325. Summary of studies 223583-G, 223583-1
and 223583-J. (Unpublished study received Nov 4, 1975 under 7182-EX-16; submitted
by 3M Co., St. Paul, Minn.; CDL:223583-C)
49090 Lillquist, G.J.; Newmark, R.A.; Sparrow, C.R. (1975) IR, NMR and Mass Spectral
Analyses of MBR 12325: Report No. 6244. (Unpub- lished study received Nov 4, 1975
under 7182-EX-16; submitted by 3M Co., St. Paul, Minn.; CDL:223583-G)
49626 3M Company (1975) Synopsis: ?Toxicity Studies with Technical MBR 12325|.
Summary of studies 222233-B through 222233-U. (Unpub- lished study received Nov 4,
1975 under unknown admin, no.; CDL: 222233-A)
49627 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Dogs
with Technical MBR 12325: (Lot No. AT4-18. (Unpublished study received Nov 4,
1975 under un- known admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL: 222233-
G)
49628 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Toxicity Study in
Rabbits with Technical MBR 12325 (Lot No. 6): Test No. AT 3-64. (Unpublished study
received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL: 222233-U)
49629 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in
Rabbits with Technical MBR 12325 (Lot No. 4): Test No. IS3-29. (Unpublished study
received Nov 4, 1975 under unknown admin, no.; CDL:222233-J)
49630 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Ocular Irritation Study in
Rabbits with Technical MBR 12325 (Lot No. 4): Test No. IS3-31. (Unpublished study
received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL:222233-L)
74
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49633 Wazeter, F.X.; Goldenthal, E.I.; Geil; R.G.; et al. (1975) Three Month Subacute Toxicity
Study in Rats: IRDC No. 102-025. (Un- published study received Nov 4, 1975 under
unknown admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL:222233-P)
56005 Sibinski, L.J.; Case, M.T.; Nelson, R.A. (1974) S12325: 28 Day Sub- acute Diet
Toxicity: Charles River Rats: Experiment No. ST 3-32. (Unpublished study received
Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL:222233-O)
56006 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) A 21 Day Dose Range Finding
Feeding Study in Dogs with Technical MBR 12325, Lot No. 9: Test No. 175R0002.
(Unpublished study received Nov 4, 1975 under unknown admin, no.; submitted by 3M
Co., St. Paul, Minn.; CDL:222233-Q)
56007 Wazeter, F.X.; Goldenthal, E.I.; Geil, R.G. (1975) Three Month Subacute Oral Toxicity
Study in Rats: IRDC No. 102-024. (Unpub- lished study received Nov 4, 1975 under
unknown admin, no.; pre- pared by International Research and Development Corp.,
submitted by 3M Co., St. Paul, Minn.; CDL:222233-T)
58485 Manufacturing Chemists Association, Incorporated (1952) Properties and Essential
Information for Safe Handling and Use of Sodium chlorate. Rev. Washington, D.C.:
MCA. (Chemical safety data sheet SD-42; available from MCA, Publications Dept,
1825 Con- necticut Ave., Washington, DC 20009; also In unpublished sub- mission
received Oct 14, 1976 under 4581-328; submitted by Pennwalt Corp., Philadelphia, Pa.;
CDL:232133-F)
58946 3M Company (1974) Synopsis: ?Environmental Studies with MBR 12325|. Summary of
studies 223579-B through 223579-T. (Unpublished study received Nov 4, 1975 under
7182-EX-16; CDL:223579-A)
58948 Steifer, LJ. (1975) Translocation of MBR 12325-A14IC in Park Kentucky Bluegrass
(~Poa pratensis-): Report No. 23. (Unpub- lished study received Nov 4, 1975 under
7182-EX-16; submitted by 3M Co., St. Paul, Minn.; CDL:223579-G)
58949 Daftsios, A.C.; Dobbs, C.L. (1975) MBR 12325 Hydrolysis Studies, pH 5, 7 and 9:
Report No. 27. (Unpublished study received Nov 4, 1975 under 7182-EX-16; submitted
by 3M Co., St. Paul, Minn.; CDL:223579-1)
58951 Howell, S.M. (1975) MBR 12325 Baseline Soil Persistence Study: Report No. 60.
(Unpublished study including letters dated Sep 27, 1972 from G.R. Blake to David
Pauley and dated Jun 18, 1973 from G.R. Blake to Dr. Bandal, received Nov 4, 1975
under 7182- EX-16; submitted by 3M Co., St. Paul, Minn.; CDL:223579-L)
58953 Howell, S.M. (1975) MBR 12325 Laboratory Leaching Study: Report No. 62.
(Unpublished study including letter dated Sep 27, 1972 from G.R. Blake to David
Pauley, received Nov 4, 1975 under 7182-EX-16; submitted by 3M Co., St. Paul, Minn.;
CDL:223579-N)
75
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58955 Howell, S.M. (1975) Determination of MBR 12325 Residues in Soil: Report No. 20.
Undated method. (Unpublished study received Nov 4, 1975 under 7182-EX-16,
submitted by 3M Co., St. Paul, Minn.; CDL:223579-P)
58956 Steifer, LJ. (1974) Determination of A14IC Activity in Soil Sam- pies by Combustion-
Liquid Scintillation Using a Packard 306 Oxidizer: Report No. 103. Undated method.
(Unpublished study received Nov 4, 1975 under 7182-EX-16; submitted by 3M Co., St.
Paul, Minn.; CDL:223579-T)
58957 Green, C.D. (1975) Determination of Moisture in Soils: Report No. 113. Method dated
Jul 1974. (Unpublished study received Nov 4, 1975 under 7182-EX-16; submitted by
3M Co., St. Paul, Minn.; CDL:223579-U)
61930 Ferrell, J.F. (1979) Two-Year Feeding Study-Rats: IRDC Study 102- 028. (Unpublished
study received Oct 22, 1980 under 7182-9; prepared by Experimental Pathology
Laboratories, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:243521-A)
62862 3M Company (1980) Reasonable Grounds in Support of the Temporary Tolerance
Petition: ?MBR 12325 2S Plant Growth Regulator). Summary of studies 099799-H,
099799-J and 099799-K. (Unpub- lished study received Dec 8, 1980 under 7182-EX-22;
CDL: 099798-A)
62863 3M Company (1980) Synopsis and Data Summary Tables: ?Mefluidide|. Summary of
studies 099799-B and 099799-G through 099799-K. (Unpublished study received Dec 8,
1980 under 7182-EX-22; CDL: 099799-A)
62867 Green, C.D. (1979) Determination of Mefluidide Residues in Green Plants: Report No.
222. Method dated Jun 15, 1979. (Unpub- lished study received Dec 8, 1980 under 7182-
EX-22; submitted by 3M Co., St. Paul, Minn.; CDL:099799-G)
62869 Ivie, G.W. (1980) Fate of the Plant Growth Regulator Mefluid- ide ... in the Cow and
Sheep: 3M Agrichemicals Report No. 234. (U.S. Dept. of Agriculture, Science and
Education Administra- tion, Agricultural Research, Veterinary Toxicology and Entomol-
ogy Research Laboratory; unpublished study; CDL:099799-J)
62870 Clark, D.E. (1980) A 28-Day Residue Study with the Plant Growth Regulator,
Mefluidide ... in the Milk and Tissues of Lactating Dairy Cows: 3M Agrichemicals
Report No. 244. (Unpublished study received Dec 8, 1980 under 7182-EX-22; prepared
in cooperation with Texas A & M Univ., Dept. of Animal Sciences, Dairy Sciences
Section and U.S. Dept. of Agriculture, Science and Education
Administration/Agricultural Research, Veterinary Toxicology and Entomology Research
Laboratory, submitted by 3M Co., St. Paul, Minn.; CDL:099799-K)
67241 3M Company (1980) Supplement II to the Brochure Entitled: MBR 12325 (Mefluidide)
Herbicide/Plant Growth Regulator: Analytical, Meta- bolic and Residue Information on
Soybeans and Processed Products. (Unpublished study received Oct 22, 1980 under
7182-9; CDL:243520-A)
76
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67572 Goldenthal, E.I.; Geil, R.G. (1978) Interim Report: Liver Pathology: MBR 12325
Technical: IRDC No. 102-026; 3M Agrichemicals Report No. 202. (Unpublished study
received Jan 12, 1978 under 7182-7; prepared by International Research and
Development Corp., submitted by 3M Co., St. Paul, Minn.; CDL:232640-A)
68798 Rohlfmg, S.R. (1977) Evaluation of MBR 12325 Technical (Free Acid) in the
Salmonella/Mammalian-microsomeMutagenicity Test: Report No. 199. (Unpublished
study received Jun 30, 1977 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL:230848-A)
69065 Howell, S.M. (1975) The Effects of Microorganisms on the Breakdown of MBR 12325
in Soil: Report No. 58. (Unpublished study re- ceived Nov 4, 1975 under 7182-EX-16;
submitted by 3M Co., St. Paul, Minn.; CDL:223579-J)
73632 Fink, R. (1975) Final Report: Acute Oral LDI50A-Mallard Ducks: Project No. 136-103.
(Unpublished study received Nov 4, 1975 under 7182-EX-16; prepared by Truslow
Farms, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:223579-B)
73633 Fink, R. (1975) Final Report: Eight-Day Dietary LCI50A-Mallard Ducks: Project No.
136-102. (Unpublished study received Nov 4, 1975 under 7182-EX-16; prepared by
Truslow Farms, Inc., submit- ted by 3M Co., St. Paul, Minn.; CDL:223579-C)
73634 Fink, R. (1975) Final Report: Eight-Day Dietary LCI50A-Bobwhite Quail: Project No.
136-101. (Unpublished study received Nov 4, 1975 under 7182-EX-16; prepared by
Truslow Farms, Inc., sub- mitted by 3M Co., St. Paul, Minn.; CDL:223579-D)
73635 Rausina, G. (1975) Report to Riker Laboratories, Inc.: Four-Day Static Aquatic Toxicity
Studies with MBR 12325 Technical and MBR 12325-4S in Rainbow Trout and
Bluegills: IBT No. 621-07032. (Unpublished study received Nov 4, 1975 under 7182-
EX-16; pre- pared by Industrial Bio-Test Laboratories, Inc., submitted by 3M Co., St.
Paul, Minn.; CDL:223579-E)
80027 Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 (Technical) to the
Rainbow Trout (-Salmo gairdneri-): ?Submit- ter Report No. 172. (Unpublished study
received Aug 27, 1981 under 7182-EX-19; prepared by Biospherics, Inc., submitted by
3M Co., St. Paul, Minn.; CDL:245799-A)
80028 Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 (Technical) to the
Bluegill Sunfish (-Lempmis macrochirus-): Laboratory No. 80-PL-14-AQ; Report No.
173. (Unpublished study received Aug 27, 1981 under 7182-EX-19; prepared by
Biospherics, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:245799-B)
80031 Nye, D.E. (1979) Bioaccumulation of Mefluidide-A14IC in the Blue- gill Sunfish
-Lepomis macrochirus-: 3M Agrichemicals Report No. 238. (Unpublished study
received Aug 27, 1981 under 7182- EX-19; prepared by Stoner Laboratories, Inc.,
submitted by 3M Co., St. Paul, Minn.; CDL:245800-A)
80370 3M Company (1980) Synopsis: Supplement III. (Compilation; unpub- lished study
77
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received Aug 27, 1981 under 7182-EX-19; CDL: 245797-A; 245798)
82066 3M Company (1978) Synopsis: Supplement II. Summary of studies 097684-C through
097684-O. (Unpublished study received Dec 6, 1978 under 7182-9; CDL:097684-A)
82072 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) 35 Day Subacute Diet Toxicity
Study with MBR 12325, Technical Free Acid, in Albino Mice: Report No. 158.
(Unpublished study received Dec 6, 1978 under 7182-9; submitted by 3M Co., St. Paul,
Minn.; CDL:097684-H)
82073 Goldenthal, E.I.; Wazeter, F.X.; Geil, R.G.; et al. (1977) Three Week Dermal Toxicity
Study in Rabbits: 102-029; Report No. 170. (Unpublished study received Dec 6, 1978
under 7182-9; prepared by International Research and Development Corp., submitted by
3M Co., St. Paul, Minn.; CDL:097684-K)
82074 Rohlfmg, S.R. (1978) Mutagenicity Study with S-12207, S-15017, S-15733, S-22241, S-
22242~Concomitants in Technical Mefluidide F5401-Lot 502: 3M Agrichemical Report
No. 154. (Unpublished study received Dec 6, 1978 under 7182-9; submitted by 3M Co.,
St. Paul, Minn.; CDL:097684-J)
82075 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1978) Demyelination Study with S-12325-
2S in Chickens: Report No. 171. (Unpublished study received Dec 6, 1978 under 7182-
9; submitted by 3M Co., St. Paul, Minn.; CDL:097684-K)
82076 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1977) Sensitization Study with MBR
12325 Free Acid Technical in Albino Guinea Pigs: Report #200. (Unpublished study
received Dec 6, 1978 under 7182-9; submitted by 3M Co., St. Paul, Minn.;
CDL:097684-M)
82737 Goldenthal, E.I.; Jessup, D.C.; Geil, R.G.; et al. (1979) Two-year Feeding Study in Rats:
MBR 12325: IRDC Study 102-028. (Unpublished study received Jul 31, 1979 under
7182-9; prepared by International Research and Development Corp. in cooperation with
Experimental Pathology Laboratories, Inc., submitted by 3M Co., St. Paul, Minn.;
CDL:098868-A; 098869; 098870)
82746 3M Company (1978?) Synopsis: Supplement III: MBR 12325. Summary of studies
098866-B and 098867-A. (Unpublished study received Jul 31, 1979 under 7182-9;
CDL:098866-A)
82747 Goldenthal, E.I.; Jessup, D.C.; Geil, R.G.; et al. (1979) Lifetime Carcinogenicity Study
in Mice: MBR 12325 Technical: 102-026; 3M Agrichemicals Report No. 223. Rev.
(Unpublished study received Jul 31, 1979 under 7182-9; prepared by International
Research and Development Corp., submitted by 3M Co., St. Paul, Minn.; CDL:098866-
B)
82748 Goldenthal, E.I.; Jessup, D.C.; Geil, R.G.; et al. (1979) Multigeneration Reproduction
Study in Rats: MBR 12325: 102-027; 3M Agrichemicals Report No. 224. (Unpublished
study received Jul 31, 1979 under 7182-9; prepared by International Research and
78
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Development Corp., submitted by 3M Co., St. Paul, Minn.; CDL:098867-A)
82869 3M Company (1977) Reasonable Grounds in Support of the Temporary Tolerance
Petition: ?Vistar|. (Unpublished study received Dec 11, 1979 under 7182-EX-19;
CDL:099115-A)
83815 Sibinski, L.J.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Toxicity Study in Mice
with Technical MBR 12325 (Lot No. 2): Experiment No. AT2-59. (Unpublished study
received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL:226432-B)
83816 Sibinski, L.J.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Toxicity Study in Mice
with Technical MBR 12325 (Lot No. 6): Experiment No. AT 3-77. (Unpublished study
received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL:226432-C)
83817 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Toxicity Study in
Rabbits with Technical MBR 12325 (Lot No. 6): Experiment No. AT3-64. (Unpublished
study received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul,
Minn.; CDL:226432-H)
83819 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in
Rabbits with Technical MBR 12325 (Lot No. 4): Experiment No. IS3-29. (Unpublished
study received Nov 4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul,
Minn.; CDL:226432-J)
83823 Steffen, G.R.; Saunders, D.R.; Nelson, R.A. (1975) A 21 Day Dose Range Finding
Feeding Study in Dogs with Technical MBR 12325, Lot No. 9: Experiment No.
175R0002. (Unpublished study received Nov 4, 1975 under unknown admin, no.;
submitted by 3M Co., St. Paul, Minn.; CDL:226432-Q)
83824 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) A 14 Day Dose Range Finding Oral
Intubation Study in Rabbits with Technical MBR 12325, Lot No. 9: Experiment No.
475R0015. (Unpublished study received Nov 4, 1975 under unknown admin, no.;
submitted by 3M Co., St. Paul, Minn.; CDL:226432-R)
84674 3M Company (1977) Acute Inhalation LCI50A in Male and Female Rats: Audit of IBT
Study No. 665-07031: Report No. 64A. (Unpublished study received Nov 23, 1977
under 7182-7; CDL:096650-A)
87475 Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 (Technical) to the
Bluegill Sunfish (Lepomis macrochirus): Laboratory No. 80-PL-14-AQ; Report No. 173.
(Unpublished study received Aug 27, 1981 under 7182-EX-19; prepared by Biospherics,
Inc., submitted by 3M Co., St. Paul, Minn.; CDL:245799-B)
88359 Magill, L.J. (1977) Letter sent to Robert J. Taylor dated Dec 29, 1977: EmbarkA(R)I 2-S
Plant Growth Regulator, file #7182-T; Em- barkA(R)I 4-S Plant Growth Regulator, file
#7182-T. (Unpub- lished study received Dec 30, 1977 under 7182-7; submitted by 3M
79
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Co., St. Paul, Minn.; CDL:232562-A)
112516 Medical Products (1976) MBR 12325 Plant Growth Regulator: Efficacy and
Phytotoxicity Information on Turf. (Compilation; unpub- lished study received Nov 9,
1976 under 7182-7; CDL:226847-A; 226849)
124075 Medical Products (1977) MBR 12325 (Mefluidide) Herbicide: Efficacy, Phytotoxicity
and Yield Information on Soybeans. (Compilation; unpublished study received Jan 31,
1977under7182-EX-19; CDL: 095823-A; 095824; 095825)
125260 Medical Products (1980) Melfluidide: Formulator's Manual. (Com- pilation; unpublished
study received Jan 12, 1983 under 7182- 15; CDL:249268-A)
127712 Nomura, N. (1978) Adsorption and Mobility of VEL 5026-14C in Five Hawaiian
Sugarcane Soils. (Unpublished study received Aug 21, 1978 under 876-EX-36; prepared
by Hawaiian Sugar Planters' As- soc., submitted by Velsicol Chemical Corp., Chicago,
IL; CDL: 234819-H)
132991 Medical Products (1981) Synopsis: Supplement VI: ?Technical MBR 12325-Toxicity
Studies on Rats, Rabbits, Mice and Dogs|. (Un- published study received Dec 9, 1983
under 7182-9; CDL:251957-A)
132992 Gortner, E.; Lamprecht, E.; Case, M.; et al. (1982) Oral Teratology Study of MRB-
12325 in Rats: Experiment No. 0681TR0095; Report No. 176. (Unpublished study
received Dec 9, 1983 under 7182-9; prepared by Riker Laboratories, Inc., submitted by
Medical Products Div., 3M Co., St. Paul, MN; CDL:251957-B)
132993 Sibinski, L.; Henderson, J.; Case, M.; et al. (1981) One Year Oral (Diet) Toxicity Study
ofMBR-12325 in Rats: Experiment No. 0280CR0012; Report No. 177. (Unpublished
study received Dec 9, 1983 under 7182-9; prepared by Riker Laboratories, Inc.,
submitted by Medical Products Div., 3M Co., St. Paul MN; CDL: 251957-C)
132994 Goldenthal, E.; Geil, R. (1981) Lifetime Carcinogenicity Study in Mice: (MBR 12325):
102-026; Report No. 230. Addendum to final rept. (Unpublished study received Dec 9,
1983 under 7182-9; prepared by International Research and Development Corp.,
submitted by Medical Products Div., 3M Co., St. Paul, MN; CDL: 251957-D)
132995 Sibinski, L.; Case, M. (1982) Twelve Month Diet Feeding Study of MBR-12325 in
Dogs: Experiment No. 0280CD0021; Report No. 273. (Unpublished study received Dec
9, 1983 under 7182-9; prepared by Riker Laboratories, Inc., submitted by Medical Pro-
ducts Div., 3M Co., St. Paul, MN; CDL:251957-E)
132996 Medical Products (1983) Genetic Toxicology Studies with EL-565 (Compound 151065):
(Compilation; unpublished study received Dec 9, 1983 under 7182-9; CDL:251957-F)
135017 Clark, H. (1976) Determination of Residues of MBR 12325 in Soil: Report No. 153.
(Unpublished study received Jan 31, 1977 under 7182-EX-19; submitted by Medical
Products Div., 3M Co., St. Paul, MN; CDL:095822-M)
80
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135023 Medical Products (1977) Embark Sugarcane Ripener: Analytical, Met- abolic and
Residue Information on Sugarcane and Sugarcane Pro- cessed Products. (Compilation;
unpublished study received Apr 5, 1977 under 7G1944; CDL:096064-A)
135352 Medical Products (1978) Supplement I to the Brochure Entitled: MBR 12325 ...
Herbicide/Plant Growth Regulator: Analytical, Metabolic and Residue Information on
Soybeans and Processed Products. (Compilation; unpublished study received Dec 6,
1978 under 7182-EX-19; CDL:097664-A)
135359 Medical Products (1978) Supplement II to the Brochure Entitled: MBR 12325 and MBR
12325 4S Plant Growth Regulator: Chemistry and Manufacturing Processes.
(Compilation; unpublished study re- ceived Dec 6, 1978 under 7182-9; CDL:097683-A)
135360 Medical Products (1978) Supplement IV to the Brochure Entitled: MBR 12325 and
MBR 12325 4S Plant Growth Regulator: Environmental Chemistry and Fish and
Wildlife Toxicology Data: ? Summary of Re- ports). (Unpublished study received Dec 6,
1978 under 7182-9; CDL:097685-A)
135361 Holmstead, R.; Schmidt, E. (1978) Effect of MBR 12325 (Mefluidide) Herbicide/Plant
Growth Regulator on Microbial Activities in Three Minnesota Soils: Report No. 209.
(Unpublished study re- ceived Dec 6, 1978 under 7182-9; submitted by Medical
Products Div., 3M Co., St. Paul, MN; CDL:097685-B)
135362 Todd, J. (1978) Photodecomposition of Mefluidide in Distilled Water upon Irradiation
with Simulated Sunlight: Report No. 213. (Un- published study received Dec 6, 1978
under 7182-9; submitted by Medical Products Div., 3M Co., St. Paul, MN;
CDL:097685-C)
135363 Medical Products (1978) ?MBR 12325-S: Environmental Chemistry: To- matoes|.
(Compilation; unpublished study received Dec 6, 1978 under 7182-9; CDL:097685-D)
135364 Steifer, L. (1978) Sensitivity of Various Plant Species to Poste- mergence Applications
of Mefluidide: Report No. 216. (Unpub- lished study received Dec 6, 1978 under 7182-
9; submitted by Medical Products Div., 3M Co., St. Paul, MN; CDL:097685-E)
135366 Hargroder, T. (1977) MBR 12325 Carry-over Study (Wheat Rotation In- formation):
Report No. 765. (Unpublished study received Dec 6, 1978 under 7182-9; submitted by
Medical Products Div., 3M Co., St. Paul, MN; CDL:097685-G)
135367 Hargroder, T. (1977) 76-41 Wheat Rotational Information following MBR 12325
Applications on Soybean Varieties: Report No. 766. (Unpublished study received Dec 6,
1978 under 7182-9; submitted by Medical Products Div., 3M Co., St. Paul, MN;
CDL:097685-H)
135721 Medical Products (1977) Audit of IBT Study No. 611-07135: 90 Day Feeding Study in
Male and Female Dogs: Agrichemical Report No. 78A. (Unpublished study received
Nov 23, 1977 under 7182-7; CDL:096651-A)
136864 Steifer, L.; Hilton, H.; Bandal, S. (1976) Adsorption and Leaching of Mefluidide-14C in
81
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Five Hawaiian Soils: Report No. 168. (Un- published study received Apr 5, 1977 under
7182-EX-20; submitted by Medical Products Div., 3M Co., St. Paul, MN; CDL:096062-
C)
136865 Hilton, H.; Nomura, N.; Steifer, L.; et al. (1976) Volatilization of Mefluidide-14C and Its
Diethanolamine Salt Formulation under Greenhouse Conditions from Glass and
Sugarcane Leaf Surfaces: Report No. 169. (Unpublished study received Apr 5, 1977
under 7182-EX-20; submitted by Medical Products Div., 3M Co., St. Paul, MN;
CDL: 096062-D)
136866 Hilton, H.; Nomura, N.; Steifer, L.; et al. (1976) Translocation of the Radiocarbon in
Sugarcane Plants after Foliar Application of Formulated Mefluidide-14C: Report No.
159. (Unpublished study received Apr 5, 1977 under 7182-EX-20; submitted by Medical
Products Div., 3M Co., St. Paul, MN; CDL:096062-F)
148437 ICI Americas, Inc. (1985?) Applicator Exposure Assessment: [Scotts Turf Products
Containing Paclobutrazol]. Unpublished study. 6 p.
155169 Clark, H. (1975) Metabolism of Formulated MBR 12325-[carbon-14] Plant Growth
Regulator in a Sandy Loam Soil: Rep. No. 18. Un- published study prepared by 3M Co.
24 p.
155170 Clark, H.; Hewitt, J. (1976) Long-Term Metabolism Study of Formu- lated MBR 12325-
[carbon-14] Plant Growth Regulator in a Sandy Loam Soil: Rep. No. 85. Unpublished
study prepared by 3M Co. 23 p.
155171 Clark, H.; Hewitt, J. (1976) Short-term Metabolism Study of Formu- lated MBR 12325-
[carbon-14] Plant Growth Regulator in a Sandy Loam Soil: Rep. No. 90. Unpublished
study prepared by 3M Co. 16 p.
155172 Clark, H. (1976) Photodegradation of MBR 12325-[carbon-14] in Well Water Under
Simulated Sunlight Conditions: Report No. 92. Un- published study prepared by 3M Co.
14 p.
155173 Hewitt, J. (1976) The Effect of MBR 12325 on the Overall Microbial Activity in Soil:
Rep. No. 157. Unpublished study prepared by 3M Co. lip.
155174 Nomura, N.; Hilton, H.; Bandal, S. (1976) Metabolism of Formulated Mefluidide-
[carbon-14] in Two Hawaiian Sugarcane Soils: Rep. No. 165. Unpublished study
prepared by 3M Co. 24 p.
159215 Sibinski, L.; Saunders, D.; Nelson, R. (1975) Acute Oral Toxicity Study in Mice with
Technical MBR 12325 (Lot No. 2): Experiment No. AT2-59. Unpublished study. 1 p.
159216 Sibinski, L.; Saunders, D.; Nelson, R. (1975) Acute Oral Toxicity Study in Mice with
Technical MBR 12325 (Lot No. 6): Experiment No. AT 3-77. Unpublished study. 1 p.
159217 Sibinski, L.; Saunders, D.; Nelson, R. (1975) Acute Oral Toxicity Study in Rats with
Technical MBR 12325 Lot No. 6): Experiment No. AT 3-65. Unpublished study. 1 p.
82
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40618600 Life Sciences Sector (1988) Submission of Chemistry Data in Support Mefludide.
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40618601 Magill, L.; MacKay, D. (1987) Mefludide-Octanol/Water Partition Co- efficient-3M
Submission of August 26, 1987, in Response to EPA's Letter of July 27, 1987.
Unpublished compilation. 10 p.
41183300 U. S. EPA (1980) Administrative Record of Laboratory Audits of IBT Reports.
Transmittal of 5 studies.
41183301 US EPA (1980) Administrative Record of Laboratory Audit of IBT: Study No. 621-
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41183302 US EPA (1980) Administrative Record of Laboratory Audit of IBT: Study No. A-243:
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41635100 Pbi/Gordon Corp. (1990) Submission of Environmental Fate Data to Support the
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41635101 Shah, J. (1990) A Hydrolysis Study of ?carbon 14|-Mefluidide: Lab Project Number:
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41887700 FBI/Gordon Corp. (1991) Submission of Data To Support Reregistra- tion of Potassium
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41887701 Rush, R. (1991) Dermal Sensitization Study in Guinea Pigs with Mefluidide Technical -
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41964601 Jackson, G.; Hardy, C. (1990) Technical Mefluidide: Acute Inhala- tion Toxicity in Rats
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42097201 Rodwell, D. (1991) Range-Finding Teratology Study in Rats with Mefluidide Technical:
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42935400 FBI/Gordon Corp. (1993) Submission of Environmental Fate Data in Support of
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MRID
Citation Reference for Mefluidide Diethanolamine (114002)
47115
47119
47120
47123
3M Company (1976) Synopsis. Summary of studies 226850-B through 26850-AB. (Unpublished
study received Nov9, 1976 under 7182- 7; CDL226850-A)
Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Rats with the
Diethanolamine salt Formulation of MBR 12325 (Lot No. XG-2-1-16) Test No. 475A0116.
(Unpublished study received Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL226850-E)
Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Toxi- city Study in Rats with S
15733, a Manufacturing Precursor for MBR 12325: Test No. 475A0009. (Unpublished study
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Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Tox- icity Study in Rabbits with
the Diethanolamine salt Formulation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475A0115.
(Unpub- lished study received Nov9, 1976 under 7182-7; submitted by 3M Co.; St. Paul, Minn.;
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CDL226850-I)
47125 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in Rabbits with
the Diethanolamine salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475E0020.
(Unpublished study received Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL226850-K)
47127 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Ocular Irritation Study in Rabbits with
the Diethanolamine salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475E0093.
(Unpublished study received Nov9, 1976, under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL226850-M)
47128 Kinert, J.C. (1975) Report to Riker Laboratories, Inc.: Acute Aer- osol Inhalation Toxicity Study in
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47129 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Oral Toxi-city Study with Embark 2s
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received Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-O)
47130 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Dermal Tox- icity Study with Embark 2s
Dithanolamine salt Formulation in Albino Rabbits: Test No. 476A0219. (Unpublished study
received Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-P)
47131 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Primary Skin Irritation Test with Embark 2s
Diethanolamine salt Formulation in Albino Rabbits: Test No. 476E0221. (Unpublished study re-
ceived Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.; CDL:226850-Q)
47132 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Ocular Irritation Test with Embark, 2s
(LotXH-68 7/15) Diethanolamine salt Formulation in Albino Rabbits: Test No. 476E0220.
(Unpub- lished study received Nov9, 1976 under 7182-7; submitted by 3M Co., St. Paul, Minn.;
CDL226850-R)
47533 3M Company (1975) Synopsis: ?MBR 12325|. Summary of studies 222232-B through 222232-D.
(Unpublished study received Nov4, 1975 under unknown admin, no.; CDL:222232-A)
47536 Green, C.D.; McConville, J.W. (1975) Formulated MBR 12325-MBR 12325 4S Plant Growth
Regulator: Report No. 56. (Unpublished study received Nov4, 1975 under unknown admin, no.;
submitted by 3M Co., St. Paul, Minn.; CDL222232-D)
47538 Todd, J.W. (1975) Gas Chromatographic Analysis for MBR 12325 in MBR 123254S: Report No.
57. Method dated Aug 1975. (Unpublished study received Nov4, 1975 under unknown admin.
no.; submitted by 3M Co., St. Paul, Minn.; CDL222232-F)
47540 Lillquist, G.J.; Newmark, R.A.; Stebbings, W.L. (1975) IR, NMR and Mass Spectral Analyses of
MBR 12325-47: Report No. 6376. (Un- published study received Nov4, 1975 under unknown
admin, no.; submitted by 3M Co., St. Paul, Minn.; CDL:222232-H)
47546 3M Company (1975) MBR 12325 Plant Growth Regulator: Efficacy and Phytotoxicity Information
on Turf. (Reports by various sources; unpublished study including published data, received Nov
4, 1975 under unknown admin, no.; CDL:222234-A)
49089 Green, C.D.; McConville, J.W. (1975) Formulated MBR 12325-MBR 12325 4S Plant Growth
Regulator. Summary of studies 223583-F and 223583-H. (Unpublished study received Nov 4,
1975 under7182-EX-16; submitted by 3M Co., St. Paul, Minn.; CDL223583-D)
49091 Lillquist, G.J.; Newmark, R.A.; Stebbings, W.L. (1975) IR, NMR and Mass Spectral Analyses of
MBR 12325-47: Report No. 6376. (Un- published study received Nov 4, 1975 under7182-EX-16;
85
-------
submitted by 3M Co., St. Paul, Minn.; CDL223583-H)
49626 3M Company (1975) Synopsis: ?Toxicity Studies with Technical MBR 12325|. Summary of
studies 222233-B through 222233-U. (Unpub- lished study received Nov4, 1975 under unknown
admin, no.; CDL: 222233-A)
49631 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Ocular Irritation Study in Rabbits with
the Diethanolamine salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475E0093.
(Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by 3M Co., St.
Paul, Minn.; CDL222233-M)
49632 Kinert, J.C. (1975) Report to Riker Laboratories, Inc.: Acute Aer- osol Inhalation Toxicity Study in
Rats: IBT No. 663-07031. (Un- published study received Nov4, 1975 under unknown admin, no.;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by 3M Co., St. Paul, Minn.;
CDL222233-N)
49634 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) A 14 Day Dose Range Finding Oral
Intubation Study in Rabbits with Technical MBR 12325, Lot No. 9: Test No. 475R0015.
(Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by 3M Co, St.
Paul, Minn.; CDL222233-R)
50641 3M Company (19??) Confidential Statement of Formula for MBR 12325 4-S Plant Growth
Regulator. (Unpublished study received Nov4, 1975 under7182-EX-16; CDL:223581-A)
50649 3M Company (1975) MBR 12325 Plant Growth Regulation: Efficacy and Phytotoxicity
Information on Turf. (Reports by various sources; unpublished study received Nov4, 1975 under
7182-EX-16; CDL: 223582-A)
56002 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Toxi- icity Study in Rats with S
15733, a Manufacturing Precursor for MBR 12325: Test No. 475A0009. (Unpublished study
received Nov4, 1975 under unknown admin, no.; submitted by 3M Co., St. Paul, Minn.;
CDL222233-F)
56003 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Tox- icity Study in Rabbits with
the Diethanolamine salt Formulation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475A0115.
(Unpub- lished study received Nov4, 1975 under unknown admin, no.; submitted by 3M Co., St.
Paul, Minn.; CDL222233-I)
56004 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in Rabbits with
the Diethanolamine salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475E0020.
(Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by 3M Co., St.
Paul, Minn.; CDL222233-K)
58946 3M Company (1974) Synopsis: ?Environmental Studies with MBR 12325|. Summary of studies
223579-B through 223579-T. (Unpublished study received Nov4, 1975 under7182-EX-16;
CDL223579-A)
58950 Clark, H.B. (1975) Photodegradation of the Diethanolamine Salt Formulation of Radiolabeled
MBR 12325 Plant Growth Regulator on Soil Surfaces: Report No. 59. (Unpublished study
received Nov4, 1975 under7182-EX-16; submitted by 3M Co., St. Paul, Minn.; CDL223579-K)
58952 Howell, S.M. (1975) MBR 12325 Persistence in Loamy Sand Soil under Field Conditions in St.
Paul, Minnesota: Report No. 61. (Unpub- lished study received Nov4, 1975 under 7182-EX-16;
submitted by 3M Co., St. Paul, Minn.; CDL223579-M)
58954 Howell, S.M. (1975) MBR 12325 Persistence in Sandy Loam Soil under Field Conditions in
Fairhope, Alabama: Report No. 63. (Unpub- lished study including letter dated Sep 27, 1972
86
-------
from G.R. Blake to David Pauley, received Nov4, 1975 under 7182-EX-16; sub- mitted by 3M
Co., St. Paul, Minn.; CDL223579-O)
62862 3M Company (1980) Reasonable Grounds in Support of the Temporary Tolerance Petition:
?MBR 12325 2S Plant Growth Regulator]. Summary of studies 099799-H, 099799-J and
099799-K. (Unpub- lished study received Dec 8, 1980 under 7182-EX-22; CDL: 099798-A)
62863 3M Company (1980) Synopsis and Data Summary Tables: ?Mefluidide|. Summary of studies
099799-B and 099799-G through 099799-K. (Unpublished study received Dec 8, 1980 under
7182-EX-22; CDL: 099799-A)
62864 Holmstead, R.L.; Steifer, L.J. (1980) Metabolism of MBR 12325-A14IC 2S Plant Growth
Regulator in Tall Fescue Pasturegrass: Report No. 232. (Unpublished study received Dec 8,
1980 under 7182- EX-22; submitted by 3M Co., St. Paul, Minn.; CDL099799-B)
62865 Bandal, S.K. (1974) Determination of Carbon-14 Activity in Aqueous and Non-aqueous Solutions
by Liquid Scintillation Counting: Report No. 100. Method dated Jul 24, 1974. (Unpublished study
received Dec 8, 1980 under 7182-EX-22; submitted by 3M Co., St. Paul, Minn.; CDL:099799-C)
62866 Steifer, L.J. (1975) Determination of Carbon-14 Activity by Com- bustion-Liquid Scintillation
Using a Packard 306 Oxidizer: Report No. 111. Method dated Jan 10, 1975. (Unpublished study
received Dec 8, 1980 under 7182-EX-22; submitted by 3M Co., St. Paul, Minn.; CDL:099799-F)
62868 Hewitt, J.T.; Bandal, S.K. (1980) Determination of Mefluidide Resi- dues in Predominately Tall
Fescue Pasturegrass from a Single Broadcast Spray Application of MBR 12325 25 PGR: Report
No. 503. (Unpublished study received Dec 8, 1980 under7182-EX-22; sub- mitted by 3M Co.,
St. Paul, Minn.; CDL099799-H)
67242 3M Company (1979) Environmental Data Summary Table ME: Studies in Plant and Soil Systems-
-Supplement V. Summary of studies 243522-B and 243522-C. (Unpublished study received Oct
22, 1980 under 7182-9; CDL243522-A)
67243 Green, C.D. (1979) Mefluide-A14IC Rotational Crop Studies: Report No. 220. (Unpublished study
received Oct 22, 1980 under 7182-9; submitted by 3M Co., St. Paul, Minn.; CDL243522-B)
67244 Green, C.D.; Morton, W.E. (1979) Dissipation of Mefluidide/Bentazon Combination from Sandy
Loam and Loam Soils: Report No. 779. (Unpublished study received Oct 22, 1980 under 7182-9;
prepared in cooperation with BASF Wyandotte Corp., submitted by 3M Co., St. Paul, Minn.;
CDL243522-C)
67415 Green, C.D.; Fredrickson, R.L. (1978) Determination ofANA-Nitroso- diethanolamine in MBR
12325 25 Formulations: Report No. 203. Unpublished study; 14 p.
72938 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Oral Tox- icity Study in Rats with the
Diethanolamine salt Formulation of MBR 12325 (Lot No. XG-2-1-16): Test No. 475A011b.
(Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by 3M Co., St.
Paul, Minn. CDL222233-E)
73635 Rausina, G. (1975) Report to Riker Laboratories, Inc.: Four-Day Static Aquatic Toxicity Studies
with MBR 12325 Technical and MBR 12325-4S in Rainbow Trout and Bluegills: IBT No. 621-
07032. (Unpublished study received Nov4, 1975 under7182-EX-16; pre- pared by Industrial
Bio-Test Laboratories, Inc., submitted by 3M Co., St. Paul, Minn.; CDL:223579-E)
79038 3M Company (19??) Reasonable Grounds in Support of a Tolerance Petition: ?Vistar|.
(Unpublished study received Jul 22, 1981 under 7182-12; CDL070205-C)
80029 Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 2-S to the Rainbow Trout
(?~Salmo gairdneri-?): Laboratory No. 80-PL-13-AQ; Report No. 174. (Unpublished study
87
-------
received Aug 27, 1981 under7182-EX-19; prepared by Biospherics, Inc., submitted by 3M Co.,
St. Paul, Minn.; CDL245799-C)
80030 Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 2-S to the Bluegill Sunfish
(~Lempomis macrochirus~): Labora- tory No. 80-PL-13-AQ; Report No. 175. (Unpublished study
re- ceived Aug 27, 1981 under 7182-EX-19; prepared by Biospherics, Inc., submitted by 3M Co.,
St. Paul, Minn.; CDL245799-D)
82067 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Oral Toxic- ity Studies with Embark 2S,
Diethanolamine Salt Formulation, in Male Albino Rats: Report No. 156. (Unpublished study
received Dec 6, 1978 under 7182-9; submitted by 3M Co., St. Paul, Minn.; CDL097684-C)
82068 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1977) Acute Oral Toxic- ity Study with S-15733 in
Albino Rats: Agrichemical Report #195. (Unpublished study received Dec 6, 1978 under 7182-9;
submitted by 3M Co., St. Paul, Minn.; CDL097684-C)
82069 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1977) Acute Dermal Toxicity Study with S-15733 in
Albino Rabbits: Agrichemical Re- port #196. (Unpublished study received Dec 6, 1978 under
7182- 9; submitted by 3M Co., St. Paul, Minn.; CDL097684-E)
82070 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Primary Skin Ir- ritation Test with S-15733 in
Albino Rabbits: Agrichemical Re- port #197. (Unpublished study received Dec 6, 1978 under
7182- 9; submitted by 3M Co., St. Paul, Minn.; CDL097684-F)
82071 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1976) Acute Ocular Ir- ritation Test with S-15733 in
Albino Rabbits: Agrichemical Re- port #198. (Unpublished study received Dec 6, 1978 under
7182- 9; submitted by 3M Co., St. Paul, Minn.; CDL097684-G)
82077 O'Malley, K.D.; Ebbens, K.L.; Nelson, R.A. (1977) Sensitization Study with MBR 12325-2S in
Albino Guinea Pigs: Report #201. (Unpublished study received Dec 6, 1978 under 7182-9;
submitted by 3M Co., St. Paul, Minn.; CDL097684-N)
83818 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Dermal Toxicity Study in Rabbits with
the Diethanolamine Salt Formula- tion of MBR 12325 (Lot No. XG-2-1-16): Experiment No.
475A0115. (Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by
3M Co., St. Paul, Minn.; CDL226432-I)
83820 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Primary Skin Irritation Study in Rabbits with
the Diethanolamine Salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Experiment No.
475E0020. (Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by
3M Co., St. Paul, Minn.; CDL: 226432-K)
83821 Ebbens, K.L.; Saunders, D.R.; Nelson, R.A. (1975) Acute Ocular Irritation Study in Rabbits with
the Diethanolamine Salt Formu- lation of MBR 12325 (Lot No. XG-2-1-16): Experiment No.
475E0093. (Unpublished study received Nov4, 1975 under unknown admin, no.; submitted by
3M Co., St. Paul, Minn; CDL: 226432-M)
83822 Kinert, J.C. (1975) Report to Riker Laboratories, Inc.: Acute Aero- sol Inhalation Toxicity Study in
Rats: IBT No. 663-07031. (Un- published study received Nov4, 1975 under unknown admin, no.;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by 3M Co., St. Paul, Minn.;
CDL226432-N)
86787 3M Company (1981) Synopsis and Data Summary Tables: ?Mefluidide|. Summary of study
070405-B. (Unpublished study received Oct23, 1981 under 7182-EX-22; CDL070405-A)
86788 Hewitt, J.T.; Bandal, S.K. (1981) Determination of Mefluidide Residues in or on Pasturegrass
and Pasturegrass Hay from a Single, Broadcast Spray Application of MBR 12325 Plant Growth
-------
87477
100788
105857
106571
106572
134842
135005
135006
135007
135008
135009
135010
135011
Regulator: Report No. 505. (Unpublished study received Oct 23, 1981 under 7182-EX-22;
submitted by 3M Co., St. Paul, Minn.; CDL070405-B)
Rhoderick, J.C.; Mountford, K. (1981) Acute Toxicity of MBR 12325 2-S to the Bluegill Sunfish
(~Lempomis macrochirus~): Labora- tory No. 80-PL-13-AQ; Report No. 175. (Unpublished study
re- ceived Aug 27, 1981 under 7182-EX-19; prepared by Biospherics, Inc., submitted by 3M Co.,
St. Paul, Minn.; CDL245799-D)
Todd, J. (1982) Applicator/Bystander Exposure Monitoring Study with Diethanolamine Salt
Formulation (Embark 150S) of Meflu- idide (N-... Acetamide): Report No. 516. (Unpublished
study received Apr 6, 1982 under 7182-7; submitted by 3M Co., St. Paul, MN; CDL247443-A)
Medical Products (1978) ?Weed Control in Soybeans and Other Crops|. (Compilation;
unpublished study received Dec 6, 1978 under 7182-9; CDL097688-A)
Hazleton Raltech, Inc. (1982) Acute Oral Toxicity-Method, Summary, Pathology; Acute Dermal
Toxicity-Method, Summary, Pathology, Histopathology Forthcoming; Primary Dermal Irritation-
Method, Summary; Primary Eye Irritation-Method, Summary: RT Lab No. 964998. (Unpublished
study received Jul 9, 1982 under 538-181; submitted by O.M. Scott & Sons Co., Marysville, OH;
CDL: 247839-A)
O.M. Scott & Sons Co. (1982) Product Chemistry to Support St. Augustinegrass Growth
Regulator with Fertilizer. (Compila- tion; unpublished study received Jul 9, 1982 under 538-181;
CDL: 247840-A)
Nomura, N. (1978) Adsorption and Mobility of VEL 5026-14C in Five Hawaiian Sugarcane Soils.
(Unpublished study received Jul 12, 1978 under 876-EX-35; prepared by Hawaiian Sugar
Planters'Assoc., submitted by Vesicol Chemical, Corp., Chicago. IL; CDL: 234423-J)
Medical Products (1976) ?Residue Studies of MBR 12325 on Soybeans and Rotational Crops in
Various Soil Types|. (Compilation; Unpublished study received Jan 31, 1977 under7182-EX-19;
CDL: 095822-A)
Howell, S. (1975) MBR 12325 Persistence in Silt Loam Soil under Field Conditions in St. Paul,
Minnesota: Report No. 69. (Un- published study received Jan 31, 1977 under7182-EX-19; sub-
mitted by Medical Products Div., 3M Co., St. Paul, MN; CDL: 095822-B)
Howell, S. (1975) MBR 12325 Persistence in Sandy Loam Soil under Field Conditions in
Oakway, South Carolina: Report No. 70. (Unpublished study received Jan 31, 1977 under 7182-
EX-19; submitted by Medical Products Div., 3M Co., St. Paul, MN; CDL095822-C)
Howell, S. (1975) MBR 12325 Persistence in Sandy Loam Soil under Field Conditions in
Fairhope, Alabama: Report No. 71. (Unpub- lished study received Jan 31, 1977 under 7182-EX-
19; submitted by Medical Products Div., 3M Co., St. Paul, MN; CDL095822-D)
Howell, S. (1975) MBR 12325 Persistence in Silt Loam Soil under Field Conditions in Clear
Lake, Louisiana: Report No. 72. (Un- published study received Jan 31, 1977 under7182-EX-19;
sub- mitted by Medical Products Div., 3M Co., St. Paul, MN; CDL: 095822-E)
Clark, H. (1976) MBR 12325 Residues in a Sandy Loam Soil in Fair- hope, Alabama, Resulting
from Two Consecutive Yearly Appli- cations: Report No. 179. (Unpublished study received Jan
31, 1977 under7182-EX-19; submitted by Medical Products Div., 3M Co., St. Paul, MN;
CDL095822-F)
Clark, H. (1976) MBR 12325 Residues in a Silt Loam Soil in Clear Lake, Louisiana, Resulting
from Two Consecutive Yearly Appli- cations of Embark 4S: Report No. 180. (Unpublished study
re- ceived Jan 31, 1977 under 7182-EX-19; submitted by Medical Products Div., 3M Co., St.
89
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135012
135013
135014
135015
135016
135022
135023
135024
135355
135365
135368
135489
136867
Paul, MN; CDL095822-G)
Clark, H. (1976) MBR 12325 Residues in a Silt Loam Soil in St. Paul, Minnesota Resulting from
Two Consecutive Yearly Appli- cations of Embark 4S: Report No. 181. (Unpublished study re-
ceived Jan 31, 1977 under 7182-EX-19; submitted by Medical Products Div., 3M Co., St. Paul,
MN; CDL095822-H)
Clark, H. (1976) Metabolism of MBR 12325-14C Herbicide/Plant Growth Regulator in a Sandy
Loam Soil under Field Conditions at Fairhope, Alabama: Report No. 183. (Unpublished study
received Jan 31, 1977 under7182-EX-19; submitted by Medical Products Div., 3M Co., St. Paul,
MN; CDL095822-I)
Hargroder, T. (1976) Termination of Experiment: ?Residue and Ef- ficacy Studies of MBR 12325
(4S), Embark, on Soybeans and Ro- tational Crops|: Exp. No. 75-43; Report 185. (Unpublished
study received Jan 31, 1977 under7182-EX-19; submitted by Medical Products Div., 3M Co., St.
Paul, MN; CDL:095822-J)
Clark, H.; Adams, C. (1976) Metabolism of MBR 12325-14C Herbicide/ Plant Growth Regulator
in a Silt Loam Soil under Field Con- ditions at Woodbury, MN: Report No. 186. (Unpublished
study received Jan 31, 1977 under7182-EX-19; submitted by Medical Products Div., 3M Co., St.
Paul, MN; CDL095822-K)
Gates, D.; Lowery, O. (1976) MBR-12325, Embark 4S Rotational Crops Study: DWG-50-75;
AgChem Report 188. (Unpublished study received Jan 31, 1977 under7182-EX-19; submitted
by Medical Products Div., 3M Co., St. Paul, MN; CDL095822-L)
Medical Products (1978) ?Chemistry of MBR 12325|. (Compilation; unpublished study received
1978 under 7182-EX-20; CDL096063-A)
Medical Products (1977) Embark Sugarcane Ripener: Analytical, Met- abolic and Residue
Information on Sugarcane and Sugarcane Pro- cessed Products. (Compilation; unpublished
study received Apr 5, 1977 under 7G1944; CDL:096064-A)
Medical Products (1977) Embark (Mefluidide) Sugarcane Ripener: Ef- ficacy Information on
Ripening Activity in Sugarcane. (Compila-tion; unpublished study received Apr 5, 1977 under
7182-EX-20; CDL096066-A)
Medical Products (1978) Supplement I to Brochure Entitled: Effica- cy, Phytotoxicity and Yield
Information on Soybeans: ?Vistar|. (Compilation; unpublished study received Dec 6, 1978 under
7182-EX-19; CDL:097667-A; 097666; 097665)
Hewitt, J. (1978) Laboratory Leaching of Mefluidide-14C and Its Breakdown Products after Aging
for 35 Days in Soil: Report No. 764. (Unpublished study received Dec 6, 1978 under 7182-9;
prepared in cooperation with United States Testing Co., Inc., submitted by Medical Products
Div., 3M Co., St. Paul, MN; CDL: 097685-F)
Medical Products (1978) Supplement I to the Brochure Entitled: MBR 12325 (Mefluidide)
Herbicide-Efficacy, Phytotoxicity and Yield Information on Soybeans. (Compilation; unpublished
study received Dec 6, 1978 under 7182-9; CDL097686-A; 097687)
Green, C. (1979) Mefluidide-14C Rotational Crop Studies: Report No. 220. (Unpublished study
received May 18, 1979 under 7182-9; submitted by Medical Products Div., 3M Co., St. Paul, MN;
CDL: 098313-A)
Steifer, L.; Hilton, H.; Bandal, S. (1976) Metabolism of Formulated Mefluidide-14C by Sugarcane
Plants under Field Conditions in Ha-waii: Report No. 166. (Unpublished study received Apr 5,
1977 under 7182-EX-20; submitted by Medical Products Div., 3M Co., St. Paul, MN;
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CDL096062-G)
140464
151400
151401
151402
151404
41601900
41601901
41601902
41601903
41602100
41602101
41602102
41602103
41888800
41888801
Medical Products (1977) MBR 12325 (Mefluidide) Herbicide/Plant Growth Regulator: Analytical,
Metabolic and Residue Informa- tion on Soybeans and Processed Products. (Compilation;
unpub- lished study received Jan 31, 1977 under7182-EX-19; CDL: 095821-A)
O M Scott & Sons Co. (1985) [Product Chemistry of Scotts Turf Manager]. Unpublished study.
17 p.
Madison, W. (1984) Acute Oral Toxicity - Method, Summary, Patho- logy: Acute Dermal Toxicity
- Method, Summary, Pathology: Pri- mary Dermal Irritation - Method, Summary: Primary Eye
Irrita- tion - Method, Summary: QAU Report: Raw Data Attached: [Turf Growth
Regulator/Fertilizer: S-1388]: RT No. 40500445. Unpub- lished study prepared by Hazleton
Laboratories America, Inc. 40 p.
Madison, W. (1984) Acute Oral Toxicity - Method, Summary, Patho- logy: Acute Dermal Toxicity
- Method, Summary, Pathology: Primary Dermal Irritation - Method, Summary: Primary Eye Irri-
tation - Method, Summary: QAU Report: Raw Data Attached: [Turf Growth Regulator/Fertilizer:
S-1387]: RT No. 40500444. Unpub- lished study prepared by Hazleton Laboratories America,
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Madison, W. (1984) Dermal Sensitization Study in Guinea Pigs - Method, Summary: QAU
Report: Raw Data Appendix: [Turf Growth Regulator/Fertilizer: S-1387]: RT No. 40501959.
Unpublished study prepared by Hazleton Laboratories America, Inc. 26 p.
PBI/Gordon Corp. (1990) Submission of Toxicology Studies to Support the Reregistration of the
Diethanolamine Salt of Mefluidide. Transmittal of 3 studies.
Culotta, J.; Campbell, S.; Smith, G. (1990) Diethanolamine Salt of Mefluidide: An Acute Oral
Toxicity Study with the Northern Bob- white: Lab Project Number: 281-103. Unpublished study
prepared by Wildlife International Ltd. 17 p.
Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Diethanolamine Salt of Mefluidide: A Dietary LC
50 Study with the Northern Bob-white: Lab Project Number: 281-101. Unpublished study
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Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Diethanolamine Salt of Mefluidide: A Dietary
LC50 Study with the Mallard: Lab Project Number: 281-102. Unpublished study prepared by
Wildlife International Ltd. 19 p.
PBI/Gordon Corp. (1990) Submission of Data To Support Reregistra- tion of Potassium Salt of
Mefluidide: Toxicology Studies. Transmittal of 3 studies.
Culotta, J.; Campbell, S.; Hoxter, K.; et al. (1990) Mefluidide: An Acute Oral Toxicity Study with
the Northern Bobwhite: Wildlife Int. Project No. 281-106. Unpublished study prepared by Wild-
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Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Mefluidide: A Dietary LC50 Study with the
Northern Bobwhite: Lab Project Number: 281-104. Unpublished study prepared by Wildlife Inter-
national Ltd. 17 p.
Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Mefluidide: A Dietary LC50 Study with the
Mallard: Lab Project No: 281-105. Unpublished study prepared by Wildlife International Ltd. 19 p.
PBI Gordon Corp. (1991) Submission of mutagenicity data on meflui-dide (diethanolamine salt)
to support reregistration. Trans- mittal of 4 studies.
Rush, R. (1991) Acute Inhalation Toxicity Study in Rats with Di- ethanolamine Salt of Mefluidide:
91
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Final Report: Lab Project Num- ber 229.6. Unpublished study prepared by Springborn Labs, Inc.
40 p.
41888802 McKeon, M. (1991) Genotoxicity Test on Diethanolamine Salt of Me-fluidide in the Assay for
Unscheduled DMA Synthesis in Rat Liver Primary Cell Cultures: Lab Project Number: HLA
12322-0-447/2099-1. Unpublished study prepared by Hazleton Labs America, Inc. 49 p.
41888803 Murli, H. (1991) Mutagenicity Test on Diethanolamine Salt of Me-fluidide in an In Vitro
Cytogenetic Assay Measuring Chromosonal Aberration Frequencies in Chinese Hamster Ovary
Cells: Lab Pro-ject Number: 12322-0-437: 20990. Unpublished study prepared by Hazleton
Labs America, Inc. 49 p.
41888804 Lawlor, T. (1991) Mutagenicity Test on Diethanolamine Salt of Me-fluidide in the
Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test) with a Confirmatory
Assay: Lab Project Number: 12322-0-401R. Unpublished study prepared by Hazleton Labs
America, Inc. 50 p.
41893700 PBI/Gordon Corp. (1991) Submission of Data to Support the Reregis- tration of Diethanolamine
Salt of Mefluidide: Toxicology Data. Transmittal of 3 Studies.
41893701 Murphy, D.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 96-Hour Flow-Through Acute
Toxicity Test with the Bluegill (Lep- omis macrochirus): Final Report: Lab Project Number: 281A-
114. Unpublished study prepared by Wildlife International Ltd. 56 p.
41893702 Murphy, D.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 96-Hour Flow-Through Acute
Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report: Lab Project Number:
281 A-1113. Unpublished study prepared by Wildlife International Ltd. 56 p.
41893703 Holmes, C.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 48-Hour Flow-Through
Toxicity Test with the Cladocern (Daphnia magna): Final Report: Lab Project Number: 281A-109.
Unpublished study prepared by Wildlife International Ltd. 54 p.
41913300 PBI/Gordon Corporation (1991) Submission of existing studies on salt of mefluidide in
compliance with phase IV data call in response. Transmittal of 2 studies.
41913301 Cahoy, R. (1991) Product Identity and Composition of Diethanolamine Salt of Mefluid-ide.
Unpublished study prepared by PBI/Gordon Corporation. 83 p.
41913302 Armbruster, J. (1991) Analysis and Certification of Product Ingredients for Diethanolamine Salt of
Mefluidide: Lab Project Number: . Unpublished study prepared by PBI/Gordon Corporation. 44 p.
41972900 PBI/Gordon Corp. (1991) Submission of Data To Support Reregistration of Diethanolamine Salt
of Mefluidide: Toxicology Study. Transmittal of 1 study.
41972901 Siglin, J. (1991) 21-Day Dermal Toxicity Study in Rabbits with Diethanolamine Salt of Mefluidide:
Final Report: Lab Project No: 3229.8. Unpublished study prepared by Springborn Laboratories,
Inc. 275 p.
42026100 PBI Gordon Corp. (1991) Submission of toxicity data in support of reregistration of the
diethanolamine salt of mefluidide. Trans- mittal of 2 studies.
42026101 Rodwell, D. (1991) Range-Finding Teratology Study in Rats with Diethanolamine Salt of
Mefluidide: Final Report: Lab Project Number: 3229.4. Unpublished study prepared by
Springborn Labs, Inc. 4 p.
42026102 Rodwell, D. (1991) Teratology Study in Rats with Diethanolamine Salt of Mefluidide: Final
Report: Lab Project Number: 3229.5. Unpublished study prepared by Springborn Labs, Inc. 247
P-
92
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42251300 PBI Gordon Corp. (1992) Submission of product chemistry data to support the reregistration of
Mefluidide (Diethanolamine Salts). Transmittal of 4 studies.
42251301 Sweetapple, G. (1992) Technical Diethanolamine Salt of Mefluidide-Color,Physical State, Odor:
Lab Project Number: 4102-91-0346-AS-001. Unpublished study prepared by Ricerca, Inc. 23 p.
42251302 Sweetapple, G. (1992) Technical Diethanolamine Salt of Mefluidide-Determination of Melting
Point: Lab Project Number: 4102-91-0345-AS-001. Unpublished study prepared by Ricerca, Inc.
22 p.
42251303 Sweetapple, G. (1992) Technical Diethanolamine Salt of Mefluidide-Determination of Bulk
Density: Lab Project Number: 4102-91-0344-AS-001. Unpublished study prepared by Ricerca,
Inc. 21 p.
42251304 Hambrick, A. (1992) Technical Diethanolamine Salt of Mefluidide-Analytical Characterization:
Lab Project Number: 4102-91-0352-AS-001. Unpublished study prepared by Ricerca, Inc. 50 p.
42283300 PBI/Gordon Corp. (1992) Submission of Product Chemistry Data in Support of Reregistration for
Diethanolamine Salt of Mefluidide. Transmittal of 3 studies.
42283301 Gallacher, A. (1992) Dissociation of Mefluidide Acid and Diethanolamine Salt of Mefluidide Acid
in Water: Lab Project Number: 4102-91-0333-AS-001. Unpublished study prepared by Ricerca,
Inc. 139 p.
42283302 Gallacher, A. (1992) Diethanolamine Salt of Mefluidide Analytical Characterization: Lab Project
Number: 4102-91-0255-AS. Unpublished study prepared by Ricerca, Inc. 68 p.
42283303 Furlong, K. (1992) Technical Diethanolamine Salt of Mefluidide-Determination of PH: Lab Project
Number: 4102-91-0351-AS. Unpublished study prepared by Ricerce, Inc. 31 p.
42309900 PBI/Gordon Corp. (1992) Submission of product chemistry data in support of the reregistration of
DEA Salt of Mefluidide. Transmittal of 1 study.
42309901 Douglass, M. (1992) Diethanolamine Salt of Mefluidide: Determination of Solubility: Lab Project
Number: 4102-91-0208-AS. Unpublished study prepared by Ricerca, Inc. 89 p.
42331400 PBI/Gordon Corp. (1992) Submission of product chemistry data in support of the reregistration of
Diethanolamine Salt of Mefluidide. Transmittal of 2 studies.
42331401 Douglass, M. (1992) Diethanolamine Salt of Mefluidide: Determination of Octanol/Water Partition
Coefficient: Lab Project Number: 4102-91-0210-AS. Unpublished study prepared by Ricerca, Inc.
47 p.
42331402 Sanders, J. (1992) Diethanolamine Salt of Mefluidide: Determination of Stability: Lab Project
Number: 4102-91-0285-AS. Unpublished study prepared by Ricerca, Inc. 44 p.
42355500 PBI/Gordon Corp. (1992) Submission of Product Chemistry Data in Support of Reregistration for
Diethanolamine Salt of Mefluidide. Transmittal of 1 study.
42355501 Douglass, M. (1992) Diethanolamine Salt of Mefluidide-Determination of Vapor Pressure: Lab
Project Number: 4102-91-0209-AS: 4102-91-0209-AS-001. Unpublished study prepared by
Ricerca, Inc. 64 p.
42562300 PBI/Gordon Corp. (1992) Submission of toxicity data in support of the reregistration of
Diethanolamine Salt of Mefluidide. Transmittal of 3 studies.
42562301 Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Shell Deposition
Test with the Eastern Oyster (Crassostrea virginica): Final Report: Lab Project Number: 281A-
124A. Unpublished study prepared by Wildlife International Ltd. 46 p.
93
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42562302 Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Flow-through Acute
Toxicity Test with Saltwater Mysid (Mysidopsis bahia): Final Report: Lab Project Number: 281A-
125. Unpublished study prepared by Wildlife International Ltd. 45 p.
42562303 Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Flow-through Acute
Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Final Report: Lab Project
Number: 281A-126. Unpublished study prepared by Wildlife International Ltd. 45 p.
42562800 PBI/GORDO Corp. (1992) Submission of toxicity data to support reregistration of Diethanol
Amine and Potassium Salts of Mefluidide. Transmittal of 2 studies.
42562801 Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey Bee:
Diethanolamine Salt of Mefluidide: Final Report: Lab Project Number: 281-111 A. Unpublished
study prepared by Wildlife Int'l Ltd. 16 p.
42562802 Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey Bee:
Potassium Salt of Mefluidide: Final Report: Lab Project Number: 281-112A. Unpublished study
prepared by Wildlife Int'l Ltd. 16 p.
42700500 PBI/Gordon Corp. (1993) Submission of product chemistry data in support of the reregistration of
Diethanolamine Salt of Mefluidide. Transmittal of 1 study.
42700501 Kauppila, K. (1992) Preliminary Analysis of Five Lots of Diethanolamine Salt of Mefluidide (28%
Liquid Formulation): Lab Project Number: 4102-92-0087-AS: 4102-92-0087-AS-001.
Unpublished study prepared by Ricerca, Inc. 87 p.
42762200 PBI/Gordon Corp. (1993) Submission of product chemistry data in support of registration for
Embark R-T-U Northern. Transmittal of 1 study.
42762201 Cahoy, R. (1992) Product Identity and Composition of Embark R-T-N Northern. Unpublished
study prepared by PBI/Gordon Corp. 9 p.
42762300 PBI/Gordon Corp. (1993) Submission of product chemistry data in support of registration for
Embark R-T-U Southern. Transmittal of 1 Study.
42762301 Cahoy, R. (1992) Product Identity and Composition of Embark R-T-U Southern. Unpublished
study prepared by PBI/Gordon Corp. 9 p.
43020800 PBI/Gordon Corp. (1993) Submission of Environmental Fate Data in Support of Reregistration of
DEA and Potassium Salts of Mefluidide. Transmittal of 1 Study.
43020801 Obrist, J. (1993) Leaching Characteristics of Aged (carbon 14)-Mefluidide Residues in a Sandy
Loam Soil: Final Report: Lab Project Number: HWI 6384-108. Unpublished study prepared by
Hazleton Wisconsin, Inc. 76 p.
43120000 PBI/Gordon Corp. (1994) Submittal of Environmental Fate Data in Support of Reregistration of
DEA and Potassium Salts of Mefluidide. Transmittal of 1 study.
43120001 Bashir, M. (1994) Anaerobic Aquatic Metabolism of (carbon 14)-Mefluidide in a Representative
Lake Water/Sediment: Final Report: Lab Project Number: HWI 6384-106. Unpublished study
prepared by Hazleton Wisconsin, Inc. 69 p.
43162200 PBI/Gordon Corp. (1994) Submittal of Aerobic Soil Metabolism Data in Support of Reregistration
of Mefluidide. Transmittal of 1 study.
43162201 Bashir, M. (1994) Aerobic Soil Metabolism of (carbon 14)-Mefluidide: Final Report: Lab Project
Number: HWI 6384-104. Unpublished study prepared by Hazleton Wisconsin, Inc. 84 p.
43184700 PBI/GORDON Corp. (1994) Submittal of Product Chemistry Data in Support of Reregistration of
94
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DEA Mefluidide. Transmittal of 8 studies.
43184701 Malone, S. (1992) Characterization of DAX (S-12130): Lab Project Number: 4102-92-0008-AS:
4102-92-0008-AS-001. Unpublished study prepared by Ricerca, Inc. 62 p.
43184702 Malone, S. (1992) Characterization of S-15017: Lab Project Number: 4102-92-0007-AS: 4102-
92-0007-AS-001. Unpublished study prepared by Ricerca, Inc. 61 p.
43184703 Malone, S. (1992) Characterization of S-15733: Lab Project Number: 4102-92-0004-AS: 4102-
92-0004-AS-001. Unpublished study prepared by Ricerca, Inc. 61 p.
43184704 Malone, S. (1992) Characterization of S-15753: Lab Project Number: 4102-92-0006-AS: 4102-
92-0006-AS-001. Unpublished study prepared by Ricerca, Inc. 62 p.
43184705 Malone, S. (1992) Characterization of S-12207: Lab Project Number: 4102-92-0005-AS: 4102-
92-0005-AS-001. Unpublished study prepared by Ricerca, Inc. 60 p.
43184706 Malone, S. (1992) Characterization of Dimer I: Lab Project Number: 4102-92-0009-AS: 4102-92-
0009-AS-001. Unpublished study prepared by Ricerca, Inc. 66 p.
43184707 Armbruster, J. (1994) Preparation Procedure for the TGAI of Diethanolamine Salt of Mefluidide:
Supplemental. Unpublished study prepared by PBI/GORDON Corp. 9 p.
43276800 PBI/Gordon Corp. (1994) Submission of environmental fate data in support of reregistration of
mefluidide DEA and potassium salts. Transmittal of 2 studies.
43276801 Hughes, D.; Nelson, E. (1994) Terrestrial Field Dissipation for Non-Crop (Turf and Bareground)
Use of Embark: Final Report: Lab Project Number: 6384/124: AG/1025: SARS/93/MO/01.
Unpublished study prepared by Stewart Agricultural Research Services, Inc. and Hazleton
Wisconsin, Inc. 343 p.
43276802 Hughes, D.; Nelson, E. (1994) Terrestrial Field Dissipation for Non-Crop (Turf and Bareground)
Use of Embark: Final Report: Lab Project Number: 6384/125: AG/1026: SARS/93/GA/01.
Unpublished study prepared by Stewart Agricultural Research Services, Inc. and Hazleton
Wisconsin, Inc. 342 p.
43481200 PBI Gordan Corp. (1994) Submission of Product Chemistry and Toxicity Data in Support of the
Registration of Embark R-T-U Southern and Embark R-T-U Northern. Transmittal of 4 Studies.
43481201 Cahoy, R. (1994) Embark R-T-U Southern Product Chemistry. Unpublished study prepared by
PBI/Gordon Corp. 7 p.
43481202 Cahoy, R. (1994) Embark R-T-U Northern Product Chemistry. Unpublished study prepared by
PBI/Gordon Corp. 7 p.
43481203 Douds, D. (1994) A Primary Eye Irritation Study in Rabbits with DEA Salt of Mefluidide: Final
Report: Lab Project Number: 3229.87. Unpublished study prepared by Springborn Labs, Inc. 47
P-
43481204 Douds, D. (1994) A Primary Eye Irritation Study in Rabbits with ER 707 PGR: Final Report: Lab
Project Number: 3229.86. Unpublished study prepared by Springborn Labs, Inc. 45 p.
43526600 PBI/Gordon Corp. (1995) Submission of Hazard to Aquatic Plants Data in Support of the
Reregistration of Mefluidide and its Salts. Transmittal of 5 Studies.
43526601 Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Navicula pelliculosa: Lab Project Number: 15-01-3. Unpublished study prepared by
Carolina Ecotox, Inc. 58 p.
95
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43526602 Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Skeletonema costatum: Lab Project Number: 15-01-4. Unpublished study prepared
by Carolina Ecotox, Inc. 60 p.
43526603 Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Selenastrum capricornutum: Lab Project Number: 15-01-1. Unpublished study
prepared by Carolina Ecotox, Inc. 60 p.
43526604 Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Anabaena flos-aquae: Lab Project Number: 15-01-2. Unpublished study prepared
by Carolina Ecotox, Inc. 62 p.
43526605 Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Lemna gibba: Lab Project Number: 15-01-5. Unpublished study prepared by
Carolina Ecotox, Inc. 59 p.
43549600 PBI/Gordon Corp. (1995) Submission of Fate in Plants Data in Support of DEA Mefluidide
Reregistration. Transmittal of 1 Study.
43549601 Crosby, K. (1995) Effect of DEA Mefluidide on Vegetative Vigor of Plants: Lab Project Number:
6272-92-0223-BE-001. Unpublished study prepared by Ricerca, Inc. 213 p.
43586300 PBI/Gordon Corp. (1995) Submission of Hazard to Non-target Plants Data in Support of
Reregistration of Mefluidide and Salts. Transmittal of 1 Study.
43586301 Crosby, K. (1995) Effect of DEA Mefluidide on Seed Germination/Seedling Emergence of Plants:
Lab Project Number: 94-0224: 6272-94-0224-BE-001. Unpublished study prepared by Ricerca,
Inc. 208 p.
43682700 PBI/Gordon Corp. (1995) Submission of Product Chemistry and Toxicity Data in Support of
Application for Registration of EH 1135 PGR. Transmittal of 8 Studies.
43682701 Cahoy, R. (1995) Product Identity and Composition of EH 1135 PGR. Unpublished study
prepared by PBI/Gordon Corp. 8 p.
43682702 Tshabalala, M. (1994) Product Chemistry Determinations of EH 1135 PGR: (Physical State,
Density, pH, Oxidizing/Reducing Properties, Flammability, Viscosity, Miscibility, Corrosion, and
Characterization of Active Ingredients): Final Report: Lab Project Number: HWI 6384-128.
Unpublished study prepared by Hazleton Wisconsin, Inc. 49 p.
43682703 Douds, D. (1994) An Acute Oral Toxicity Study in Rats with EH 1135 PGR: Final Report: Lab
Project Number: 3229.79. Unpublished study prepared by Springborn Labs, Inc. 42 p.
43682704 Douds, D. (1994) An Acute Dermal Toxicity Study in Rabbits with EH 1135 PGR: Final Report:
Lab Project Number: 3229.80. Unpublished study prepared by Springborn Labs, Inc. 51 p.
43682705 Douds, D. (1994) An Acute Whole-Body Inhalation Toxicity Study in Rats with EH 1135 PGR:
Final Report: Lab Project Number: 3229.81. Unpublished study prepared by Springborn Labs,
Inc. 57 p.
43682706 Douds, D. (1994) A Primary Eye Irritation Study in Rabbits with EH 1135 PGR: Final Report: Lab
Project Number: 3229.82. Unpublished study prepared by Springborn Labs, Inc. 46 p.
43682707 Douds, D. (1994) A Primary Skin Irritation Study in Rabbits with EH 1135 PGR: Final Report: Lab
Project Number: 3229.83. Unpublished study prepared by Springborn Labs, Inc. 42 p.
43682708 Douds, D. (1994) A Dermal Sensitization Study in Guinea Pigs with EH 1135 PGR: Modified
Buehler Design: Final Report: Lab Project Number: 3229.84. Unpublished study prepared by
96
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Springborn Labs, Inc. 59 p.
43879200 PBI Gordon Corp. (1995) Submission of Product Chemistry Data in Support of the Reregistration
of Diethanolamine (DEA) Salt of Mefluidide. Transmittal of 1 Study.
43879201 Harsy, S.; Fathulla, R. (1995) Determination of Nitrosamines in Mefluidide: Final Report: Lab
Project Number: HWI 6384-129: 6384-129. Unpublished study prepared by Hazleton Wisconsin,
Inc. 53 p.
43882900 PBI/Gordon Corp. (1995) Submission of Environmental Fate Data in Support of the Registration
Standard for 2,4-D. Transmittal of 1 Study
43882901 Reynold, J. (1995) Anaerobic Aquatic Metabolism of (carbon 14)-(lnert Ingredient): Lab Project
Number: XBL94083: RPT00215: SR940016-8. Unpublished study prepared by XenoBiotic Labs,
Inc. 141 p.
44088700 PBI/GORDON Corp. (1996) Submission of Product Chemistry Data in Support of the Application
for Registration of ER-721. Transmittal of 2 Studies.
44088701 Sanson, D. (1996) Product Identity and Composition of ER721. Unpublished study prepared by
PBI/GORDON Corp. 7 p.
44088702 Sanson, D. (1996) Physical and Chemical Properties of ER-721. Unpublished study prepared by
PBI/GORDON Corp. 8 p.
44540300 Ringer Corp. (1998) Submission of Toxicity Data in Support of the Application for Registration of
EH1357 Herbicide. Transmittal of 6 Studies.
44540301 Wnorowski, G. (1998) Acute Oral Toxicity Limit Test (in Rats): EH-1357 Herbicide: Lab Project
Number: 5906: P320: E80127-1R. Unpublished study prepared by Product Safety Labs. 25 p.
44540302 Wnorowski, G. (1998) Acute Dermal Toxicity Limit Test (in Rats): EH-1357: Lab Project Number:
5907: P322: E80127-1R. Unpublished study prepared by Product Safety Labs. 26 p.
44540303 Wnorowski, G. (1998) Acute Inhalation Toxicity Limit Test (in Rats): EH-1357 Herbicide: Lab
Project Number: 5908: P330: E80127-1R. Unpublished study prepared by Product Safety Labs.
34 p.
44540304 Wnorowski, G. (1998) Primary Eye Irritation (in Rabbits): EH-1357 Herbicide: Lab Project
Number: 5909: P324: E80127-1R. Unpublished study prepared by Product Safety Labs. 33 p.
44540305 Wnorowski, G. (1998) Primary Skin Irritation (in Rabbits): EH-1357 Herbicide: Lab Project
Number: 5910: P326: E80127-1R. Unpublished study prepared by Product Safety Labs. 27 p.
44540306 Wnorowski, G. (1998) Dermal Sensitization Test-Buehler Method (in Guinea Pigs): EH-1357
Herbicide: Lab Project Number: 5911: P328: E80127-1R. Unpublished study prepared by
Product Safety Labs. 36 p.
44540400 PBI/Gordon Corp. (1998) Submission of Product Chemistry Data in Support of the Application for
Registration of EH1357 Herbicide. Transmittal of 2 Studies.
44540401 Sanson, D. (1998) Product Identity and Composition of EH-1357 Herbicide. Unpublished study
prepared by PBI/Gordon Corp. 10 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1650,
830.1670}
44540402 Sanson, D. (1998) Physical and Chemical Properties of EH-1357 Herbicide: Lab Project
Number: 98-001. Unpublished study prepared by PBI/Gordon Corp. 27 p. {OPPTS 830.6303,
830.7300, 830.7000, 830.6314, 830.7100, 830.6320}
97
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46683900 PBI/Gordon Corporation (2005) Submission of Product Chemistry Data in Support of the
Amended Registration of EH 1135 PGR. Transmittal of 1 Study.
46683901 Sanson, D. (2005) Product Identity and Composition of EH 1135 PGR. Unpublished study
prepared by PBI/Gordon Corp. 10 p.
47190700 PBI/Gordon Corp. (2007) Submission of Environmental Fate Data in Support of the
Reregistration of Mefluidide. Transmittal of 1 Study.
47190701 Crosby, K. (1996) Effect of DEA Mefluidide on Seed Germination/Seedling Emergence (Tier II).
Project Number: 6818/96/0077/BE/001, 6818/96/0077/BE. Unpublished study prepared by
Ricerca, Inc. 359 p.
92089000 Pbi/gordon Corporation (1990) Reregistration Phase 3 Response: Diethanolamine mefluidide (N-
(2,4-dimethyl-5-(((trifluromet.
92089001 Armbruster, J. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047536 and
Related MRIDs 00125260, 40618601. Formulated MBR12325-MBR12325 45 Plant Growth
Regulator: Report No. 56 Mefluidide: Formulators Manual. 7 p.
92089002 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047129. Acute Oral
Toxicity Study with Embark 2S Diethanolamine Salt Formulation in Albino Rats: Test No.
476A0216. 6 p.
92089003 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047119. Acute Oral
Toxicity Study in Rats with the Diethanolamine Salt Formulation of MBR12325 (Lot No. XG-2-1-
16): Test No. 475A0116. 6 p.
92089004 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047130. Acute Dermal
Toxicity Study with Embark 2s Diethanolamine Salt Formulation in Albino Rabbits: Test No.
476A0219.:7p.
92089005 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047123 and Related
MRIDs 00056003. Acute Dermal Toxicity Study in Rabbits with the Diethanolamine Salt
Formulation of MBR12325 (Lot No. XG-2-1-16): Test No. 475A0115. 7 p.
92089006 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047127. Acute Ocular
Irritation Study in Rabbits with the Diethanolamine Salt Formulation of MBR 12325 (Lot No. XG-
2-1-16): Test No. 475E0093.: 6 p.
92089007 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047132. Acute Ocular
Irritation Test with Embark 2s (Lot XH-68 7/15) Diethanolamine Salt Formulation in Albino
Rabbits: Test No. 475E0093.: 6 p.
92089008 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047125. Primary Skin
Irritation Study in Rabbits with the Diethanolamine Salt Formulation of MBR 12325 (Lot No. XG-
2-1-16): Test No. 475E0020.: 6 p.
92089009 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00047131. Primary Skin
Irritation with Embark 2s Diethanolamine Salt Formulation in Albino Rabbits: Test No.
476E0221.:6p.
92089010 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00082077. Sensitization
Study with MBR 12325-2S in Albino Guinea Pigs: Report #201.: 7 p
92089011 Wilson, R. (1990) Pbi/gordon Corporation Phase 3 Summary of MRID 00082073. Three Week
Dermal Toxicity Study in Rabbits: 102029; Report No. 170. 7 p.
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92089999 Pbi/gordon Corporation (1990) Reregistration Phase 3 Response: Diethanolamine mefluidide (N-
(2,4-dimethyl-5-(((trifluromet. Correspondence and Supporting Material.
MRID
Citation Reference for Mefluidide Potassium Salt (114003)
74605 Green, C.D. (1981) Formulated MBR 12325-K 2S Herbicide/Plant Growth Regulator: (Product
Chemistry): Report No. 514. (Unpublished study received May 22, 1981 under 7182-12;
submitted by 3M Co., St. Paul, Minn.; CDL: 245250-A)
74606 Green, C.D. (1981) Gas Chromatographic Analysis of MBR 12325-K Salt Formulations: Report
No. 125. Method dated Apr 1981. (Unpublished study received May 22, 1981 under 7182-12;
submitted by 3M Co., St. Paul, Minn.; CDL245250-B)
74607 Burke, R.D. (1981) Letter sent to C.D. Green dated Mar 9, 1981: Corrosion test on Mefluoride
2S: Report No. 515. (Unpublished study received May 22, 1981 under 7182-12; submitted by
3M Co., St. Paul, Minn.; CDL245250-C)
74608 Hewitt, J.T.; Peterson, D.M. (1981) Analysis of Soybeans Treated with a Single or Split
Application of MBR 12325-9 (Potassium Salt of Mefluidide) 2S Herbicide: Report No. 756.
(Unpublished study received May 22, 1981 under 7182-12; submitted by 3M Co., St. Paul,
Minn.; CDL245248-A)
74609 3M Company (1981) Toxicity Data Summary Table 1C: Acute Toxicity Studies: Supplement V.
Summary of studies 245249-B through 245249-E. (Unpublished study received May 22, 1981
under 7182-12; CDL245249-A)
74610 O'Malley, K.D.; Hart, G.E.; Ebbens, K.L.; et al. (1981) Acute Oral Toxicity Screen with MBR
12325-9 2S in Albino Rats: Experiment No. 0980AR0687; Report No. 775. (Unpublished study
received May 22, 1981 under 7182-12; prepared by Riker Laboratories, Inc., submitted by 3M
Co., St. Paul, Minn.; CDL245249-B)
74611 Markoe, D.M., Jr.; O'Malley, K.D.; Ebbens, K.L.; etal. (1981) Acute Dermal Toxicity Study with
MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880AB0686; Report No. 776.
(Unpublished study received May 22, 1981 under 7182-12; prepared by Riker Laboratories,
Inc., submitted by 3M Co., St. Paul, Minn.; CDL: 245249-C)
74612 Markoe, D.M., Jr.; O'Malley, K.D.; Ebbens, K.L.; etal. (1981) Primary Skin Irritation Test with
MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880EB0684; Report No. 777.
(Unpublished study received May 22, 1981 under 7182-12; prepared by Riker Laboratories,
Inc., submitted by 3M Co., St. Paul, Minn.; CDL: 245249-D)
74613 Markoe, D.M., Jr.; O'Malley, K.D.; Ebbens, K.L.; etal. (1981) Acute Ocular Irritation Test with
MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880EB0685; Report No. 778.
(Unpublished study received May 22, 1981 under 7182-12; prepared by Riker Laboratories,
Inc., submitted by 3M Co., St. Paul, Minn.; CDL: 245249-E)
41893800 PBI/Gordon Corp. (1991) Submission of Data to Support the Reregist- ration of Potassium Salt
of Mefluidide: Toxicology Data. Trans- mittal of 3 Studies.
41893801 Murphy, D.; Peters, G. (1991) Mefluidide: A 96-Hour Flow-Through Acute Toxicity Test with
the Bluegill (Lepomis macrochirus): Lab Project Number: 281A-112. Unpublished study
prepared by Wildlife International Ltd. 56 p.
99
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41893802 Murphy, D.; Peters, G. (1991) Mefluidide: A 96-Hour Flow-Through Acute Toxicity Test with
the Rainbow Trout (Oncorhynchus mykiss) Final Report: Lab Project Number: 281A-111.
Unpublished study prepared by Wildlife International Ltd. 56 p.
41893803 Holmes, C.; Peters, G. (1991) Mefluidide: A 48-Hour Flow-Through Acute Toxicity Test with
the Cladoceran (Daphnia magna): Final Report: Lab Project Number: 281 A-110. Unpublished
study prepar- ed by WildLife International Ltd. 55 p.
41920200 PBI/Gordon Corporation (1991) Submission of product identity and ingredient data on
potassium salt of mefluidide in compliance with a phase IV data call in response. Transmittal of
2 stud- ies.
41920201 Cahoy, R. (1991) Product Identity and Composition of Potassium Salt of Mefluidide.
Unpublished study prepared by PBI/Gordon Corp. 31 p.
41920202 Armbruster, J. (1991) Analysis and Certification of Product Ingred- ients for Potassium Salt of
Mefluidide. Unpublished study pre- pared by PBI/Gordon Corporation. 36 p.
42029600 PBI Gordon Corp. (1991) Submission of toxicity data to support the reregistration of Mefluidide
(Potassium Salts). Transmittal of 1 study.
42029601 Siglin, J. (1991) 21-Day Dermal Toxicity Study in Rabbits with Mefluidide Technical: Final
Report: Lab Project Number: 3229.9. Unpublished study prepared by Springborn Labs, Inc.
259 p.
42251400 PBI Gordon Corp. (1992) Submission of product chemistry data to support the reregistration of
Mefluidide, Potassium Salts. Transmittal of 5 studies.
42251401 Sweetapple, G. (1991) Potassium Salt of Mefluidide-Determination of Melting Point: Lab
Project Number: 4102-91-0203-AS-001. Unpublished study prepared by Ricerca, Inc. 21 p.
42251402 Sweetapple, G. (1991) Potassium Salt of Mefluidide-Determination of Bulk Density: Lab
Project Number: 4102-91-0204-AS-001. Un- published study prepared by Ricerca, Inc. 20 p.
42251403 Thomas, E. (1991) Potassium Salt of Mefluidide-Determination of pH: Lab Project Number:
4102-91-0205-AS-001. Unpublished study prepared by Ricerca, Inc. 24 p.
42251404 Sanders, J. (1992) Potassium Salt of Mefluidide-Determination of Stability: Lab Project
Number: 4102-91-0260-AS-001. Unpublished study prepared by Ricerca, Inc. 43 p.
42251405 Hambrick, A. (1991) Potassium Salt of Mefluidide-Analytical Characterization: Lab Project
Number: 4102-91-0128-AS-001. Unpublished study prepared by Ricerca, Inc. 58 p.
42282000 PBI/Gordon Corp. (1992) Submission of product chemistry data in support of reregistration of
the Potassium Salt of Mefluidide. Transmittal of 2 studies.
42282001 Gallacher, A. (1992) Dissociation of Mefluidide Acid and Potassium Salt of Mefluidide Acid in
Water: Lab Project Number: 4102-91-0334-AS. Unpublished study prepared by Ricerca, Inc.
69 p.
42282002 Gallacher, A. (1992) Potassium Salt of Mefluidide: Analytical Consideration: Lab Project
Number: 4102-91-0256-AS. Unpublished study prepared by Ricerca, Inc. 67 p.
42302300 PBI/Gordon Corp. (1992) Submission of Data To Support Reregistra- tion of Potassium Salt of
Mefluidide: Solubility Study. Trans- mittal of 1 study.
42302301 Douglass, M. (1992) Potassium Salt of Mefluidide-Determination of Solubility: Lab Project
Number: 4102-91-0211-AS-001. Unpub- lished study prepared by Ricerca, Inc. 85 p.
100
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42323500 PBI Gordon Corp. (1992) Submission of product chemistry data to support the reregisdtration
of Mefulidide, Potassium salts. Transmittal of 1 study.
42323501 Douglass, M. (1992) Potassium Salt of Mefluidide-Determination of Vapor Pressure: Lab
Project Number: 4102-91-0212-AS. Unpublished study prepared by Ricerca, Inc. 61 p.
42371400 PBI Gordon Corp. (1992) Submission of product chemistry data top support the reregistration
of the chemical Potassium Salt of Mefluidide. Transmittal of 1 study.
42371401 Douglass, M. (1992) Potassium Salt of Mefluidide-Determination of Octanol/Water Partition
Coefficient: Lab Project Number: 4102-91-0213-AS. Unpublished study prepared by Ricerca,
Inc. 47 p.
42562400 PBI/Gordon Corp. (1992) Submission of toxicity data in support of the reregistration of
Technical Mefluidide. Transmittal of 4 studies.
42562401 Graves, W.; Swigert, J. (1992) Technical Mefluidide: A 96-hour Shell Deposition Test with the
Eastern Oyster (Crassostrea virginica): Final Report: Lab Project Number: 281A-121.
Unpublished study prepared by Wildlife International, Ltd. 46 p.
42562402 Graves, W.; Swigert, J. (1992) Technical Mefluidide: A 96-hour Flow-through Acute Toxicity
Test with the Saltwater Mysid (Mysidopsis bahia): Final Report: Lab Project Number: 281A-
122A. Unpublished study prepared by Wildlife International, Ltd. 44 p
42562403 Graves, W.; Swigert, J. (1992) Technical Mefluidide: A 96-hour Flow-through Acute Toxicity
Test with the Sheepshead Minnow (Cyprinodon variegatus): Final Report: Lab Project
Number: 281A-123. Unpublished study prepared by Wildlife International, Ltd. 47 p.
42562404 Murli, H. (1992) Technical Mefluidide: Measuring Chromosomal Aberrations in Chinese
Hamster Ovary (CHO) Cells: Final Report: Lab Project Number: 15167-0-437. Unpublished
study prepared by Hazleton Washington, Inc. 49 p.
42562800 PBI/GORDO Corp. (1992) Submission of toxicity data to support reregistration of Diethanol
Amine and Potassium Salts of Mefluidide. Transmittal of 2 studies.
42562801 Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey
Bee: Diethanolamine Salt of Mefluidide: Final Report: Lab Project Number: 281-111 A.
Unpublished study prepared by Wildlife Int'l Ltd. 16 p.
42562802 Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey
Bee: Potassium Salt of Mefluidide: Final Report: Lab Project Number: 281-112A. Unpublished
study prepared by Wildlife Int'l Ltd. 16 p.
43020800 PBI/Gordon Corp. (1993) Submission of Environmental Fate Data in Support of Reregistration
of DEA and Potassium Salts of Mefluidide. Transmittal of 1 Study.
43020801 Obrist, J. (1993) Leaching Characteristics of Aged (carbon 14)-Mefluidide Residues in a Sandy
Loam Soil: Final Report: Lab Project Number: HWI 6384-108. Unpublished study prepared by
Hazleton Wisconsin, Inc. 76 p.
43120000 PBI/Gordon Corp. (1994) Submittal of Environmental Fate Data in Support of Reregistration of
DEA and Potassium Salts of Mefluidide. Transmittal of 1 study.
43120001 Bashir, M. (1994) Anaerobic Aquatic Metabolism of (carbon 14)-Mefluidide in a Representative
Lake Water/Sediment: Final Report: Lab Project Number: HWI 6384-106. Unpublished study
prepared by Hazleton Wisconsin, Inc. 69 p.
43162200 PBI/Gordon Corp. (1994) Submittal of Aerobic Soil Metabolism Data in Support of
101
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Reregistration of Mefluidide. Transmittal of 1 study.
43162201 Bashir, M. (1994) Aerobic Soil Metabolism of (carbon 14)-Mefluidide: Final Report: Lab Project
Number: HWI 6384-104. Unpublished study prepared by Hazleton Wisconsin, Inc. 84 p.
43184700 PBI/GORDON Corp. (1994) Submittal of Product Chemistry Data in Support of Reregistration
of DEA Mefluidide. Transmittal of 8 studies.
43184708 Armbruster, J. (1994) Preparation Procedure for the TGAI of Potassium Salt of Mefluidide:
Supplemental. Unpublished study prepared by PBI/GORDON Corp. 10 p.
92090000 PBI/Gordon Corporation (1990) Reregistration Phase 3 Response: CAS Reg. No. 83601-83-6.
92090001 Armbruster, J. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00074605 and
Related MRIDs 00125260, 40618601. Formulated MBR 12325-K 2S Herbicide/Plant Growth
Regulator; Formulators Manual; Mefluidide - Octa no I/Water Partition Coefficient. Prepared by
3M CO. 8 p.
92090003 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00047118. Acute Oral
Toxicity Study in Rats with Technical MBR 12325 (Lot No. 6): Test No. AT 3-65. Prepared by
RIKER LABORATORIES, INC. 6 p.
92090004 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00074610. Acute
Toxicity Screen with MBR 12325-9 2S in Albino Rats: Experiment No. 0980AR0687. Prepared
by RIKER LABORATORIES, INC. 6 p.
92090005 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00074611. Acute
Toxicity with MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880AB0686. Prepared by
RIKER LABORATORIES, INC. 6 p.
92090006 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00074613. Acute
Ocular Irritation Test with MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880EB0685.
Prepared by RIKER LABORATORIES, INC. 6 p.
92090007 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00074612. Primary
Skin Irritation Test with MBR 12325-9 2S in Albino Rabbits: Experiment No. 0880EB0684.
Prepared by RIKER LABORATORIES, INC. 6 p.
92090008 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00047136. A 90-Day
Feeding Study in Rats with Technical MBR12325 (Lot No. 9): Study I; IRDC 102-025.
Prepared by INTERNATIONAL RESEARCH & DEVL. CORP. 8 p.
92090009 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00047140. A 90-Day
Feeding Study in Rats with Technical MBR 12325 (Lot No. 9) Study II: IRDC 102-024.
Prepared by INTERNATIONAL RESEARCH & DEVL. CORP. 8 p.
92090010 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00082737 and Related
MRIDs 00061930. Chronic Feeding/Oncogenicity in the Rat: MBR 12325 Technical: Project
No. IRDC 102/028. Prepared by INTERNATIONAL RESEARCH & DEVL. CORP. 9 p.
92090011 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00132995. Twelve
Month Diet Feeding Study of MBR 12325 in Dogs: Project No. 0280CD0021. Prepared by
RIKER LABORATORIES, INC. 10 p.
92090012 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00082747 and Related
MRIDs 00067572, 00132994. Lifetime Carcinogenicity Study in Mice: MBR 12325 Technical:
IRDC 102-026. Prepared by INTERNATIONAL RESEARCH & DEVL. CORP. 13 p.
102
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92090013 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00132996. Genetic
Toxicology Studies with EL-565 (Compound 151065): Study 821115GPA1969. Prepared by
LILLY RESEARCH LABORATORIES. 8 p.
92090014 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00132996. Genetic
Toxicology Studies with EL-565 (Compound 151065): Study 820908MLA1969. Prepared by
LILLY RESEARCH LABORATORIES. 8 p.
92090015 Wilson, R. (1990) PBI/Gordon Corporation Phase 3 Summary of MRID 00132996. Genetic
Toxicology Studies with EL-565 (Compound 151065): Studies 820803UDS1969 and
820824UDS1969. Prepared by LILLY RESEARCH LABORATORIES. 7 p.
92090017 Goldenthal, E.; Jessup, D.; Geil, R. (1990) PBI/Gordon Corporation Phase 3 Reformat of
MRID 00082737 and Related MRIDs 00061930. Chronic Feeding/Oncogenicity in Rats: MBR
12325 Technical: IRDC 102-028. Prepared by INTERNATIONAL RESEARCH & DEVL.
CORP. 529 p.
92090018 Goldenthal, E.; Jessup, D.; Geil, R. (1990) PBI/Gordon Corporation Phase 3 Reformat of
MRID 00082747 and Related MRIDs 00067572, 00132994. Lifetime Carcinogenicity Study in
Mice: MBR 12325 Technical: IRDC 102-026. Prepared by INTERNATIONAL RESEARCH &
DEVL. CORP. 511 p.
92090999 PBI/Gordon Corporation (1990) Reregistration Phase 3 Response: CAS Reg. No. 83601-83-6.
Correspondence and Supporting Material.
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Appendix E. Generic Data Call-In (GDCI)
Note that a complete generic DCI, with all pertinent instructions, will be sent to registrants
under separate cover.
104
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Appendix F. Product-Specific Data Call-In (PDCI)
Note that a complete product-specific DCI, with all pertinent instructions, will be sent to
registrants under separate cover.
105
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Appendix G. EPA'S Batching of Mefluidide Products for Meeting Acute Toxicity Data
Requirements for Reregistration
\
| UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
-
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
October 22, 2007
MEMORANDUM
SUBJECT: MEFLUIDIDE [PC Codes 114001, 114002, 114003], Acute Mammalian
Toxicity Batching Appendix for MEFLUIDIDE RED Document.
FROM: Marianne Lewis, Biologist [sign. MXewis 10/22/07]
Product Reregistration Branch
Special Review and Reregistration Division (7508P)
TO: Wilhelmena Livingston, CRM
Special Review Branch
Special Review and Reregistration Division (7508P)
Attached is the batching appendix for Mefluidide. Please let me know if you have
any questions regarding this document.
106
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EPA'S BATCHING OF MEFLUIDIDE PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing MEFLUIDIDE as
the active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process
described in the preceding paragraph. Notwith-standing the batching process, the Agency
reserves the right to require, at any time, acute toxicity data for an individual product should
the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit
or cite a single battery of six acute toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the process with all other registrants,
only some of the other registrants, or only their own products within a batch, or to generate
all the required acute toxicological studies for each of their own products. If a registrant
chooses to generate the data for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon previously submitted acute toxicity
data, he/she may do so provided that the data base is complete and valid by today's standards
(see acceptance criteria attached), the formulation tested is considered by EPA to be similar
for acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
107
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In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-In Notice and its attachments appended to the
RED. The DCI Notice contains two response forms which are to be completed and submitted
to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks
whether the registrant will meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the product specific data required for
each product, including the standard six acute toxicity tests. A registrant who wishes to
participate in a batch must decide whether he/she will provide the data or depend on someone
else to do so. If a registrant supplies the data to support a batch of products, he/she must
select one of the following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
(Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If
a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not
preclude other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
Twelve products were found which contain Mefluidide as the active ingredient.
These products have been placed into 3 sections: Mefluidide (PC Code 114001 - contains
one product placed in a No Batch group); Mefluidide diethanolamine salt (PC Code
114002 - contains nine products placed in 2 batches and a No Batch group); Mefluidide
potassium salt (PC Code 114003 - contains two products placed in a batch). All were
placed in these batches in accordance with the active and inert ingredients and type of
formulation.
Batching Instructions:
Mefluidide diethanolamine salt - PC Code 114002:
Batch 2: EPA Reg. No. 2217-768 may not cite data conducted on any other products in this
batch.
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Mefluidide (PC Code 114001)
No Batch
EPA Reg. No.
538-200
Percent Active Ingredient
Mefluidide: 0.02
Paclobutrazol: 0.20
Mefluidide diethanolamine salt (PC Code 114002)
-------
Batch 1
EPA Reg. No.
2217-759
2217-767
Percent Active Ingredient
28.0
28.0
Batch 2
EPA Reg. No.
2217-768
2217-787
2217-788
2217-809
Percent Active Ingredient
3.200
0.009
0.115
0.059
No Batch
EPA Reg. No.
538-181
2217-763
2217-802
Percent Active Ingredient
0.49
15.0
Mefluidide: 21.45
Imazethapyr: 4.09
Imazapyr: 0.15
Mefluidide potassium salt (PC Code 114003)
No Batch
EPA Reg. No.
2217-765
2217-766
Percent Active Ingredient
12.0
24.0
109
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Appendix H. List of Registrants to be Sent this Data Call-in
1) FBI/Gordon Corporation
110
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/fortns/.
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 following address for the Document
Processing Desk.:
Document Processing Desk (distribution code)*
Office of Pesticide Programs (7504P)
Environmental Protection Agency
1200 Pennsylvania Ave, NW
Washington, DC 20460-0001
* Distribution Codes are as follows:
(APPL) Application for product registration
(AMEND) Amendment to existing registration
(CAN) Voluntary Cancellation
(EUP) Experimental Use Permit
(DIST) Supplemental Distributor Registration
(SLN) Special Local Need
(NEWCO) Request for new company number
(NOTIF) Notification
(PETN) Petition for Tolerance
(XFER) Product Transfer
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@epamail.epa.gov. If you want these forms mailed
or faxed to you, please contact Lois White, white.lois@epa.gov or Floyd Gayles,
gayles.floyd@epa.gov.
If you have any questions concerning how to complete these forms, please contact OPP's
ombudsperson for conventional pesticide products: Linda Arlington, (703) 305-5446
The following Agency Pesticide Registration Forms are currently available via the Internet at
the following locations:
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8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance
Fee Filing
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to Citations
of Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit http://www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an on-line registration kit which contains
the following pertinent forms and information needed to register a pesticide product with the
U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
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Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
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. Please note that EPA is currently
in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office
of Pesticide Programs. We anticipate that this publication will become available
during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides. You
can contact NPTN by telephone at (800) 858-7378 or through their website:
http://npic.orst.edu
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
• Date of receipt
• EPA identifying number
• 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.
114
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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 CAS number if one has been
assigned.
115
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Appendix J: Mefluidide Human Health Risk Assessment
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM
May 30, 2007
SUBJECT: Mefluidide, Diethanolamine Mefluidide, and Potassium Mefluidide-
Phase 2 ( 30- Day Error only Correction), HED Chapter of the Re-
registration Eligibility Decision Document (RED). PC Code: 114001,
114002,114003. Reregistration Case No. 2370. DP Barcode D334500.
FROM: Yan Donovan, Chemist and Risk Assessor
Reregistration Branch 4
Health Effects Division (7509C)
And
Abdallah Khasawinah, Toxicologist
Reregistration Branch 4
Health Effects Division (7509C))
THROUGH: Susan Hummel
Branch Senior Scientist
Reregistration Branch 4
Health Effects Division (7509C)
TO: Wilhemena Livingston, Chemical Review Manager
Reregistration Branch I
Special Review & Reregistration Division (7508W)
Attached is Health Effect Division's phase II risk assessment for mefluidide RED. This is a
revised risk assessment (from phase I) incorporating registrant's error only comments dated
May 22, 2007. The team reviewers who contributed to the disciplinary chapters and the risk
assessment are listed below:
Hazard Identification Assessment; Abdallah Khasawinah, D322246, 1/31/07.
116
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Occupational and Residential Exposure Assessment; Yan Donovan, D324823, 2/28/07.
Incident Report; M. Hawkins, D324824, 07/25/06.
Drinking Water Assessment; James Hetrick from EFED, D334508, 03/08/07.
117
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TABLE OF CONTENTS
1.0 Executive Summary 120
2.0 Ingredient Profile 124
2.1. Summary of Registered/Proposed Uses 124
2.2 Structure and Nomenclature 126
2.3 Physical and Chemical Properties 128
3.0 Metabolism Assessment 131
3.1 Rat Metabolic Profile 131
3.2 Nature of the Residue in Foods 131
3.3 Environmental Degradation 132
4.0 Hazard Characterization/Assessment 132
4.1 Hazard characterization 132
4.2 Hazard considerations For Women and Children 140
4.2.1. Adequacy of the Toxicity Database 140
4.2. 2. Evidence of Neurotoxicity 140
4.2.3. Developmental Toxicity Study Conclusions 140
4.2.4. Reproductive Toxicity Study 141
4.2.5. Additional Information from Literature sources 143
4.3. Hazard Identification and Toxicity Endpoint Selection 143
4.3.1. Acute Reference Dose (aRfD) 143
4.3.2. Chronic Reference Dose (cRfD)144
4.3.3. Incidental Oral Exposure (Short-and Intermediate-term durations: 1 day - 6
months) 144
4.3.4. Dermal Absorption Factor 144
4.3.5. Dermal Exposure (Short and Intermediate: (1-30 days and 30 d-180 days)
144
4.3.6. Inhalation (Short- and Intermediate-Term) 145
4.3.7. Margins of Exposure 145
4.3.8. Classification of Carcinogenic Potential 145
5.0 Public Health Data 148
5.1 Incident Reports 148
6.0 Exposure Characterization/Assessment 149
6.1 Dietary Exposure/Risk Pathway 149
6.1.1 Food Exposure/Risk Pathway 149
6.1.2 Water Exposure/Risk Pathwayl49
6.2 Dietary Exposure Estimates 150
6.3 Residential (Non-Occupational) Exposure/Risk Pathway 151
6.3.1. Residential Handler Exposure and Risks 151
6.3.2. Residential Post Application Exposure and Risks 153
7.0 Aggregate Risk Assessments and Risk Characterization 155
7.1 Aggregate Risk 155
7.2 Cancer Risk 156
8.0 Cumulative Risk Characterization/Assessment 156
9.0 Occupational Exposure/Risk Pathway 156
9.1 Short/Intermediate-Term Handler Risk 156
9.2 Post-application Exposure and Risk 158
118
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10.0 Data Needs and Label Requirements 159
119
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1.0 EXECUTIVE SUMMARY
A risk assessment is being conducted for mefluidide, mefluidide diethanolamine salt, and
mefluidide potassium salt to support the mefluidide RED. For the purposes of this
assessment, all of the three active ingredients are collectively referred to as mefluidide.
Mefluidide is a member of the class of anilide. Mefluidide is a plant growth regulator that is
applied postemergence when needed. It is used to control ornamental and non-ornamental
woody plants, ground cover, hedges trees, turf grasses, grass and broadleaf weeds by
inhibiting plant cell division, stem elongation and seed head development. It is also
registered for growth control of low maintenance turf on rights-of-ways, airports, public and
industrial sites. Mefluidide products can also be used on residential lawns. There are
multiple active ingredient products that contain an additional plant growth regulator and
herbicides such as paclobutrazol, imazapyr, and imazethapyr. These ingredients are not
assessed in this document. Current formulations include granular, liquid ready- to- use, and
soluble concentrate/liquid. Mefluidide can be applied as a band treatment, broadcast, spot
treatment, and spray. The equipment used to apply mefluidide includes backpack sprayer,
groundboom, hand held pump sprayer, handgun sprayer, hose-end sprayer, power sprayer,
high pressure handwand, and spreader (push-type and belly grinder).
Based on the structural similarities of mefluidide and its diethanolamine (DEA) and
potassium salts, where they all share the same anion- anilide, and the physical and chemical
properties of the DEA and potassium salts, where they dissociate 100% back to free
mefluidide in aqueous environments, the risk assessment team concluded that mefluidide
DEA and potassium salts are biologically equivalent to mefluidide and thus they share the
same toxicity as the free mefluidide. Therefore, it is reasonable to bridge mefluidide toxicity
data to mefluidide salts and vice versa.
The toxicology data base of mefluidide and its salts is considered adequate for the purposes
of hazard and dose response assessment. Mefluidide has low acute toxicity by the oral,
dermal and inhalation routes (toxicity category III and IV). It is a weak eye or dermal irritant
(toxicity category III and IV). Mefluidide did not cause dermal sensitization in the guinea
pig. In rats and rabbits, critical effects of acute toxicity were tremors, hunched posture,
salivation, reduced body weight and body weight gain.
Subchronic and chronic toxicity of mefluidide is manifested by decreased body weight and
body weight gain in several species tested (rats, rabbits and dogs). Dogs appeared to be most
sensitive species with the critical toxicological effects of cortical nephrosis and body weight
loss. In rats and rabbits, critical effects observed were tremors, hunched posture, salivation,
reduced body weight and body weight gain. Based on lack of evidence of carcinogenicity in
both rats and mice, mefluidide was considered as not likely to be carcinogenic to humans.
Mefluidide exhibited a negative response in various genotoxicity screening assays.
120
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Developmental effects of mefluidide in rats included increased number of early resorptions
and mean postimplantation loss. These effects were observed at the same dose that caused
maternal toxicity indicating there was no increased susceptibility to fetuses (LOAEL =115
mg/kg/day, NOAEL = 58 mg/kg/day). The maternal toxicity included tremors, decreased
body weight, weight gain and mortality. In rabbit, the LOAEL/NOAEL for developmental
toxicity were above the highest dose tested (60 mg/kg/day). Although this study is not
acceptable alone, taking into the consideration of the results from the 14-day rabbit oral study
where mortality was seen at 100 mg/kg/day, and tremors and 100% mortality were noted at
200 mg/kg/day, the NOAEL from the rabbit developmental study is acceptable. In the 3-
generation rat reproduction toxicity study, the offspring toxicity was characterized by
decreased body weights in both sexes and both litters in all generations. The reproductive
LOAEL was not observed (NOAEL = 346/604 mg/kg bw/day in males and females).
Endpoints and dose responses have been selected for all exposure routes and durations,
except for dermal exposure, where it was determined that no quantitative dermal risk
assessment is needed.
There are no agricultural or any food related pesticide uses of mefluidide. Therefore, no
dietary exposure from food is expected. However, there is potential for drinking water
exposure due to the outdoor uses of mefluidide. A drinking water assessment was conducted
by the Environmental Fate and Effects Division (EFED) using Tier II (PRZM-EXAMS) for
surface water modeling and Tier 1 (SCI-GROW) for groundwater modeling. The mefluidide
acid concentrations in surface water are not expected to exceed 32 ug/L (= 32 ppb) for the 1
in 10 year daily peak concentration, 10 ug/L (=10 ppb) for the 1 in 10 year annual
concentration, and 5 ug/L for the 30 year annual average concentration. Mefluidide acid
concentrations in ground water are not expected to exceed 1.0 ug/L.
Dietary (Water only) Exposure and Risk Estimates
Acute and chronic dietary (water only) risk assessments were conducted using the Dietary
Exposure Evaluation Model (DEEM). The dietary exposure assessments were performed
using exposures from surface water only, as there are no food uses for this chemical. The
estimated surface drinking water concentration (32 ppb) was used in acute dietary while the
10 ppb was used for chronic. The analysis results indicated that the dietary risks are below
the Agency's level of concern. At the 95th percentile, the acute dietary exposure to U.S.
population was 0.0017 mg/kg/day, which utilized < 1% of the acute reference dose (aRfD).
The exposure for all infants, which was the most highly exposed population subgroup, was
0.006 mg/kg/day, which utilized 1% of the aRfD. For chronic dietary exposure, the
exposure for U.S. population was 0.0002 mg/kg/day, which utilized 1% of the chronic
reference dose (cRfD). The exposure for all infants, which was the most highly exposed
population subgroup, was 0.0007mg/kg/day, which utilized 5% of the cRfD.
Residential Exposure and Risk Estimates
None of the labels prohibit use by homeowners. The residential handler risks were assessed
using standard assumptions, maximum label rates, Outdoor Residential Exposure Task Force
(ORETF) studies and Pesticide Handlers Exposure Database (PHED) unit exposure data.
The MOEs are all >100, which means the risks are not of concern.
121
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Residential Post Application Exposure and Risk Estimates
Since no dermal endpoints were selected, the residential post- application assessments were
only conducted for Children (through incidental oral). Incidental oral exposures include
exposures from hand- to- mouth, object- to- mouth and soil ingestion of treated turf (all
considered short-term). Calculations used the Residential SOPs and maximum label rates.
The combined MOE is > 100 which means that the risk is below EPA's level of concern. The
residential post- application exposures to toddlers from ingesting granules that have been
applied to residential turf were also assessed using a standard method as outlined in the
Residential SOPs. The MOE was then calculated using the acute dietary NOAEL of 58
mg/kg/day and it is > 100. This means that the risks for toddler exposures from granular
ingestion are not of concern.
Aggregate Risk Assessment (food + water + residential exposure)
Although an aggregate risk assessment is not required under current Agency policies for non-
food use chemicals, to ensure that the public health is adequately protected, a screening level
aggregate risk assessment was conducted for mefluidide. For acute and chronic aggregate
risks, the only exposure is from drinking water. As stated above, the dietary exposures
(drinking water only) do not exceed 1% of the aRfD/cRfD for adult and 5% of the
aRfD/cRfD for children. For short- term, no aggregate is needed for adults since there are no
residential post- application exposures to adults. When considering the dietary exposure
(drinking water only) as a background exposure to Children for short-term risk, the level of
dietary exposure (0.0007 mg/kg/day from chronic food) is negligible when compared to the
combined incidental oral exposure (0.019 mg/kg/day) or the granule ingesting dose (0.098
mg/kg/day). No intermediate-term residential risk was identified. Therefore, short- and
intermediate- term aggregate is not of concern.
Occupational Exposure and Risk Estimates
The MOEs for occupational handler exposures were calculated for short/intermediate term
inhalation exposures using standard assumptions and unit exposure data. The unit exposure
data were taken from the PHED and the ORETF studies for professional lawn care operators.
All of the MOEs are > 100 with baseline personal protective equipment (PPE) which means
that the risks are not of concern and respiratory protection is not needed.
Occupational post application dermal risks were not assessed because there is not likely to
have occupational post-application scenario. In addition, no dermal endpoints were selected.
Mefluidide is only applied outdoors and it is not a volatile compound, inhalation exposures
are negligible.
Risk Characterization
All MOEs for occupational and residential handlers are greatly above 100. No refinement is
needed. The risk assessments for post- application exposures for Children are conservative
because they are based upon day 0 TTRs and soil residue values and did not account for
dissipation.
Environmental Justice Considerations:
122
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Potential areas of environmental justice concerns, to the extent possible, were considered in
this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal
Actions to Address Environmental Justice in Minority Populations and Low-Income
Populations," http://www.eh.doe.gov/oepa/guidance/justice/eol2898.pdf).
As a part of every pesticide risk assessment, OPP considers a large variety of consumer
subgroups according to well-established procedures. In line with OPP policy, HED estimates
risks to population subgroups from pesticide exposures that are based on patterns of that
subgroup's food and water consumption, and activities in and around the home that involve
pesticide use in a residential setting. Extensive data on food consumption patterns are
compiled by the USDA under the Continuing Survey of Food Intake by Individuals (CSFII)
and are used in pesticide risk assessments for all registered food uses of a pesticide. These
data are analyzed and categorized by subgroups based on age, season of the year, ethnic
group, and region of the country. Additionally, OPP is able to assess dietary exposure to
smaller, specialized subgroups and exposure assessments are performed when conditions or
circumstances warrant. Whenever appropriate, non-dietary exposures based on home use of
pesticide products and associated risks for adult applicators and for toddlers, youths, and
adults entering or playing on treated areas postapplication are evaluated. Further
considerations are currently in development as OPP has committed resources and expertise to
the development of specialized software and models that consider exposure to bystanders and
farm workers as well as lifestyle and traditional dietary patterns among specific subgroups.
Review of Human Research:
This risk assessment relies in part on data from studies in which adult human subjects were
intentionally exposed to a pesticide or other chemical. These studies (listed in Appendix B)
have been determined to require a review of their ethical conduct, and have received that
review.
123
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2.0 INGREDIENT PROFILE
Mefluidide is a plant growth regulator that is applied postemergence when needed. It is used
to control the growth of ornamental and non-ornamental woody plants, ground cover, hedges,
trees, turf grasses, grass and broadleaf weeds by inhibiting plant cell division, stem
elongation and seed head development. It is registered for uses on low maintenance turf on
rights-of-ways, airports, and industrial sites. It can also be used on ornamental and or shade
trees, ornamental ground cover, ornamental herbaceous plants, golf course, hospitals/medical
institutions premises ornamental lawns and turf, and residential lawns. There are multiple
active ingredient products that contain an additional plant growth regulator and herbicides
such as paclobutrazol, imazapyr and imazethapyr. Current formulations include granular,
liquid ready- to- use, and soluble concentrate/liquid. Mefluidide can be applied as a band
treatment, broadcast, spot treatment, and spray. The equipment used to apply mefluidide
includes backpack sprayer, groundboom, hand held pump sprayer, handgun sprayer, hose-
end sprayer, power sprayer, high pressure handwand, and spreader (push-type and belly
grinder). The two registrants for mefluidide, FBI/Gordon (technical and end-use registrant)
and The Scotts Company (end-use registrant) are supporting all of the existing uses for
reregi strati on on their respective labels.
2.1. Summary of Registered/Proposed Uses
Based on the information provided by the registrant at the 11-08-06 SMART meeting, all
existing mefluidide label uses (total 11 product labels) are supported by the registrant. The
registrant also indicated that among all labels, only three have active sales: Embark 2S (EPA
Reg # 2217-759), Embark T&O (EPA Reg#2217-768), and Stronghold (EPA Reg#2217-
802).
HED has analyzed all existing mefluidide product labels. The label suggested use
patterns, formulations, application methods and maximum application rates are summarized
in Table 2.1 below.
Table 2.1 - Summary of Use Patterns, Formulations, and Application Rates for Mefluidide.
Product
Type
Liquid
Liquid
Liquid
Product
Label/names
2217-759
(EMBARK
2-S)
2217-763
(EMBARK
1-S)
2217-765
(EMBARK
Application
Equipment
High pressure
handwand
Groundboom,
Turf gun
Groundboom,
Backpack sprayer
Groundboom,
Backpack sprayer
Use Sites
Ornamental trees,
Turfgrass, golf
course, rights-of-
ways
Turf, commercial-
industrial, public
area
Turf, commercial-
industrial, public
Maximum
application rates
l.Olbsai/A
l.Olbsai/A
l.Olbsai/A
Maximum
Spray dilution
0.01 Ibs
ai/gallon
0.067 Ibs
ai/gallon
0.067 Ibs
ai/gallon
0.067 Ibs
ai/gallon
124
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Liquid
Liquid
Liquid
Granules
Granules
RTU
RTU
RTU
1-L)
2217-766
(EMBARK
2-L)
2217-768
(EMBARK
E-Z-TU-
USE)
2217-802
(EH1135
PGR)
538-181
(St. Aug.GR
w/Fertilizer)
538-200
(Scotts Turf
Manager)
2217-787
(EMBARK
R-T-U
Northern)
2217-788
(EMBARK
R-T-U
Southern)
2217-809
(ER721)
Groundboom,
Backpack sprayer
Hand pump
(pressure spray),
Hose end sprayers
Conventional
power spray
Spreader
Spreader
Sprinkler can
Sprinkler can
Sprinkler can
area
Turf, commercial-
industrial, public
area
Turf grass
Ornamentals
Turf, commercial-
industrial
Lawn
Lawn
Residential areas
Residential areas
Residential areas
l.Olbsai/A
l.Olbsai/A
0.43 Ibs ai/A
0.43 Ibs ai/A
0.50 Ibs ai/A
0.04 Ibs ai/A
0.11 Ibs ai/A
1.23 Ibs ai/A
l.Olbsai/A
0.0671bs
ai/gallon
0.008 Ibs
ai/gallon
0.01 Ibs
ai/gallon
0.029 Ibs
ai/gallon
N/A
N/A
N/A
N/A
N/A
RTU = Ready- to- Use
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2.2 Structure and Nomenclature
TABLE 2.2a. Test Compound Nomenclature (Mefluidide)
Chemical Structure
Empirical Formula
Common name
Company experimental
name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3SCL\ /H
2 N
H3C\xxL Q
N^N^CH3
1 3
CH3 H
CnH^Fs^OsS
Mefluidide
MBR 12325
5 '-( 1, 1 , 1 -trifluoromethanesulfbnamido)acet-2',4'-xylidide
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
53780-34-0
St. Aug.GR w/Fertilizer (Reg. #538-181), Scotts Turf Manager (Reg.#538-
200)
Plant growth regulators
None
126
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TABLE 2.2b. Test Compound Nomenclature (Diethanolamine Mefluidide)
Chemical Structure
Empirical Formula
Common name
Company experimental
name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3SCL\ + /ChLChLOH
2^N H2 N^ 2 2
i_i f\ 1 CH0CH0OH
H3cY^ o
N^N^CH3
1 I O
CH3 H
C15H24F3N305S
Diethanolamine Mefluidide
MBR 12325
5'-(l,l,l-trifluoromethanesulfonamido)acet-2',4'-xylidide - 2,2'-
iminodiethanol (1:1)
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
compound with 2,2'-iminobis[ethanol] (1:1)
53780-36-2 (This substance is a derivative of mefluidide [53780-34-0]).
EMBARK 2-S (Reg.# 2217-759), EMBARK 1-S (RegJ 2217-763),
EMBARK E-Z-TU-USE (RegJ 2217-768), EH1 135 PGR (RegJ 2217-802),
EMBARK R-T-U Northern (RegJ 2217-787), EMBARK R-T-U Southern
(RegJ 2217-788), ER 721 (RegJ 2217-809)
Plant growth regulators
None
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TABLE 2.2c. Test Compound Nomenclature (Potassium Mefluidide)
Chemical Structure
Empirical Formula
Common name
Company experimental
name
IUPAC name
CAS name
CAS Registry Number
End-use product/EP
Chemical Class
Known Impurities of
Concern
CF3SCL\
2 N K
H3CxA^ 0
N^N^CH3
1 1 O
CH3 H
CnH12F3KN2O3S
Mefluidide
MBR 12325
potassium (EZ)-N-[5-( 1,1,1 -trifluoromethanesulfonamido)-2,4-
xylyl]acetamide
7V-[2,4-dimethyl-5-[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide
monopotassium salt
83601-83-6
EMBARK 1-L (RegJ 2217-765), EMBARK 2-L (RegJ 2217-766)
Plant growth regulators
None
2.3 Physical and Chemical Properties
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TABLE 2.3.a Physicochemical Properties (Mefluidide)
Parameter
Molecular Weight
Melting point/range
pH
Density
Water solubility (25 °C)
Solvent solubility (temperature not
specified)
Vapor pressure (25°C)
Dissociation constant, pKa
Octanol/water partition coefficient,
Log(Kow) (25 °C)
UV/visible absorption spectrum
Value
310.3
183-185 °C
4.6 @25°C(1% aqueous
dispersion)
Not available
0.18g/Lat25°C
N-Octanol.
= 17g/L
<1.0E-4mmHg @25°C
pKa =4.6
Remain outstanding
Max at 287 nm
Reference
RED memo of 3/1 3/89, A.
Smith. Accession No.
259274. RGB No. 126
129
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TABLE 2.3b. Physicochemical Properties (Diethanolamine Mefluidide)
Parameter
Molecular Weight
Melting point/range
pH
Density
Water solubility (20 °C)
Solvent solubility (temperature not
specified)
Vapor pressure (25°C)
Dissociation constant, pKa
Octanol/water partition coefficient,
Log(Kow) (25 °C)
UV/visible absorption spectrum
Value
413.3
106-108 °C
6.98 @25°C(1% aqueous
dispersion)
0.69 g/cm3 typical @ 25°C
566 mg/g at 25°C
N-Octanol.
= 22 mg/g
<1.0E-7mmHg@25°C
100% dissociates in aqueous
solution. Mefluidide pKa =4.6
3.2 xlO'2
Max at 254 nm
Reference
RED memo of 3/2/93, C.
Olinger, D 166847 and
D179233. MRIDs 41913301
and 02, 422513 01 through
04,42309901,42283301
through 03, 42331401 and 02.
RED memo of W. Smith,
2/16/93,0183266. MRID
Nos: 42355501.
RED memo of 3/2/93, C.
Olinger, D 166847 and
D179233. MRIDs 41913301
and 02, 4225 13 01 through
04,42309901,42283301
through 03, 42331401 and 02.
130
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TABLE 2.3c. Physicochemical Properties (Potassium Mefluidide)
Parameter
Molecular Weight
Melting point/range
pH
Density
Water solubility (25 °C)
Solvent solubility (temperature not
specified)
Vapor pressure (25°C)
Dissociation constant, pKa
Octanol/water partition coefficient,
Log(Kow) (25 °C)
UV/visible absorption spectrum
Value
348.4
118- 120 °C
8.6@25°C(l%aqueous
dispersion)
0.85 g/cm3 typical @ 25°C
510mg/g
N-Octanol.
= 57 mg/g
< 1.0E-7mmHg@25°C
100% dissociates in aqueous
solution. Mefluidide pKa =4.6
Not available
Not available
Reference
RED memo of 1 1/24/92, F.
Toghrol, D 179244. MRIDs:
4225 1401 through 05,
42282001,42282002,
42302301, and 42323501.
Based on the structural activities of mefluidide and its DEA and potassium salts, where they
all have similar structures (identical benzene ring and functional groups, i.e., share the same
anion- anilide), and the above physical and chemical properties of the salts where they
dissociate 100% back to free mefluidide in aqueous environment, the risk assessment team
determined that mefluidide DEA and potassium salts are biologically equivalent to mefluidide
and thus they share the same toxicity as the free mefluidide. Therefore, it is reasonable to
bridge mefluidide toxicity data to mefluidide salts and vice versa.
3.0 METABOLISM ASSESSMENT
3.1 Rat Metabolic Profile
Mefluidide was almost completely absorbed following oral ingestion (approximately 96%)
and rapidly eliminated within 24 hours. A majority of dose was eliminated in urine (86-89 %)
and remainder in feces after a single oral dose in 24 hours. Residue consisted of mefluidide
(97%) and 2 unidentified metabolites (1.2% and 0.5%) and unidentified polar material (0.7%).
Excretion of the radioactivity in expired air was not detected. The chemical is unlikely to
accumulate in body since it was excreted almost completely within 24 hrs and steadily
declined thereafter.
3.2 Nature of the Residue in Foods
131
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Not applicable. There are no food uses.
3.3 Environmental Degradation
The only identified degradation product was 5-amino-2, 4-
dimethyltrifluoromethanesulfonilide. It was found at a maximum daily concentration of 2.8%
of applied dose (MRID 43162201, aerobic soil). The risk assessment team concluded that this
degradate is not of concern based on its structure (structurally similar to the parent, there fore
it is not likely to be significantly more toxic than the parent), and the fact that it is a minor
degradate (<10% of the applied dose). The residue of concern for drinking water assessment
is parent only.
4.0 HAZARD CHARACTERIZATION/ASSESSMENT
4.1 Hazard characterization
Mefluidide has shown low acute toxicity by the oral, dermal and inhalation routes (Toxicity
Category III and IV). It is a weak eye or dermal irritant (Toxicity Category III and IV).
However, the precursor of mefluidide (S-15733: manufacturing starting material) caused eye
irritation (Toxicity Category II). Mefluidide did not cause dermal sensitization in the guinea
pig. In rats and rabbits, critical effects of acute oral toxicity (occurring at doses of 100
mg/kg/day and above) were tremors, hunched posture, salivation, reduced body weight and
body weight gain.
Mefluidide and its diethanolamine salt subchronic and chronic toxicity are manifested by
decreased body weight and body weight gain in several species tested (rats, rabbits and dogs).
Dogs are most sensitive to these effects, which occur at doses as low as 15 mg/kg/day in diets
fed for one year. In addition, dogs fed with mefluidide for one year exhibited chronic cortical
nephrosis at doses of 150 mg/kg/day. Increased incidence of liver hyperplastic nodules in both
sexes was observed in mice fed with mefluidide at doses of 270 mg/kg/day and higher, but
there was no oncogenic response in mice at doses as high as 900 mg/kg/day. Rats fed with
mefluidide at doses up to 300 mg/kg/day did not exhibit any carcinogenic response either.
Based on lack of carcinogenic response in both rats and mice, mefluidide is considered as not
likely to be carcinogenic to humans.
Mefluidide exhibited a negative response in various genotoxicity screening assays (bacterial
reverse mutation, in vitro mouse lymphoma gene mutation, in vitro mammalian chromosome
aberration, in vivo sister chromatid exchange, unscheduled DNA synthesis).
Mefluidide and its DEA salt were not dermally toxic when tested in rabbits at limit doses of
1000 mg/kg/day for 21 days. Effects were limited to slight erythema at the application site at
the 1000 mg/kg/day dose.
132
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Mefluidide or its DEA salt has not been tested for subacute or subchronic inhalation toxicity.
However, both of them are in category IV for acute inhalation toxicity.
Developmental effects of Mefluidide in rats included increased number of early resorptions
and mean postimplantation loss. These effects were observed at the same dose that caused
maternal toxicity indicating there was no increased susceptibility to fetuses. The maternal
toxicity included tremors, decreased body weight, weight gain and mortality. In rabbit, the
LOAEL/NOAEL for developmental toxicity were above the highest dose tested (60
mg/kg/day). In the 3-generation reproduction toxicity study in rats, the offspring toxicity was
characterized by decreased body weights in both sexes and both litters in all generations. The
reproductive LOAEL was not observed (NOAEL = 346/604 mg/kg bw/day). The offspring
toxicity was observed at the highest dose tested (346 mg/kg/day) that also produced maternal
toxicity indicating there was no increased post-natal susceptibility for the mefluidide.
There is no evidence of increased pre- or post-natal susceptibility in the developmental study
or in the multi-generation reproduction study in rat. Although the LOAEL/NOAEL for
developmental toxicity in the rabbits were not established, the concern is low for the increased
susceptibility to the rabbit fetuses since the developmental effects were not seen at the highest
dose tested (60 mg/kg/day) which is above the developmental NOAEL in rat (58 mg/kg/day)
and well above (40X) the dose that is used to establish chronic RfD (1.5 mg/kg/day).
Therefore, there is no residual uncertainty for pre- and/or post natal susceptibility.
The toxicology profile of mefluidide does not indicate a potential concern for estrogens,
androgen and/or thyroid mediated toxicity.
The toxicology profile of mefluidide and its DEA salt is adequate for the purposes of hazard
and dose response assessment.
Table 4.1a. Acute Toxicity of Mefluidide and its salts (114001, 114002, 114003)
Guideline
No.
870.1100
(81-1)
870.1100
(81-1)
870.1100
(81-1)
870.1100
(81-1)
870.1200
(81-2)
870.1300
(81-3)
Study Type
Acute Oral (female rat)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Acute Oral (dog)
Mefluidide tech
Acute Dermal (female
rabbit)
Mefluidide tech
Acute inhalation - rat
DEA salt of Mefluidide
Results (LDso/LCso)
MRID
>4000 mg/kg
MRID 00047 118
1920.2 mg/kg
MRID 00047 117
829.8 mg/kg
MRID 00047 116
Not established
MRID 00049627; emesis precluded evaluation at
100, 500, 2000 mg/kg doses
>4000 mg/kg
MRID 00047122 & 00049628 & 00083817
>5.2 mg/L
MRID 41888801
Toxicity Category
III
III
III
III
IV
IV
133
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870.1300
(81-3)
870.2400
(81-4)
870.2400
(81-4)
870.2500
(81-5)
87.2600
(81-6)
87.2600
(81-6)
Acute inhalation - rat
Mefluidide tech.
Primary Eye Irritation
(rabbit) Mefluidide tech
Primary Eye Irritation
(rabbit) DBA Mefluidide
Primary Skin Irritation
(rabbit), Mefluidide tech
Dermal Sensitization
(guinea pig), Mefluidide
Dermal Sensitization
(guinea pig), Mefluidide
>5.4 mg/L
MRID 41964601
minimal irritation
MRID 00047126, 00049630
minimal irritation
MRID43481203
Not a dermal irritant
MRID 00047124, 00049629, 00083819
Not a dermal sensitizer
MRID 41887701
Not a dermal sensitizer
MRID 00082076
IV
III
III
IV
N/A
N/A
134
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Table 4.1b Toxicity Profile of Mefluidide and its salts (114001,114002,114003)
Guideline No./
Study type
MRID No.(year)/Doses/ classification
Results
Non-guideline
21-day Oral-dog
00047137, (1975)
0, 1000, 3000, 10000 ppm Vistar tech,
93% a.i./d (0, 25, 75, 250 mg/kg/d)
One dog/sex/dose
range finding
Acceptable/non-guideline
LOAEL = not established.
NOAEL > 250 mg/kg/d,
Non-guideline
5-week - mouse
00082072, (1976)
0, 1800, 6000 ppm Vistar tech, 93%
a.i./d (0, 270, 900 mg/kg/d)
(Dietary 5/sex/dose)
range finding
Acceptable/non-guideline
LOAEL = not established
NOAEL =900 mg/kg/d,
None-guideline
28-Day oral dietary
[rat]
00047135, (1973),
0, 1000, 3000 or 10000 ppm Vistar tech,
93% a.i. (0, 100, 300, 1000 mg/kg/d)
(Dietary 5 rats/sex/dose)
range finding
Acceptable/non-guideline
LOAEL = not established.
NOAEL > 1000 mg/kg/d,
870.3100
(82-la)
90-Day oral dietary
[rat]
00047136, (1975),
0, 300, 1000 or 6000 ppm Vistar tech,
93% a.i. (0, 15, 50, 300 mg/kg/d) (10
rats/sex/dose)
00047140 (1975)
0, 300, 1000, 3000 ppm (0, 15, 50, 150
mg/kg/day). (10 females/dose)
Acceptable/Guideline
LOAEL = 300 mg/kg/d, based on decreased body
weight, body weight gain and food consumption in
the females.
NOAEL =150 mg/kg/d (in conjunction with
MRID #00047140),
870.3150
82-l(b)
90-Day oral dietary
[dog]
00047141, (IBT Study, 1977),
0, 300, 1000 or 6000 ppm Vistar tech,
93% a.i. (0, 7.5, 25, 150 mg/kg/d)
(4/sex/dose)
Unacceptable/guideline (LOAEL was
not observed)
LOAEL = not established.
NOAEL = 150 mg/kg/d.
870.3200
82-2
21-Day Dermal
toxicity - rabbit
00082073, (1977)
0, 1, 3, 10 ml of 2S formulation/kg/day
(Formulation containing 24% a.i.,
equivalent to 0, 240, 720, or 2400 mg
mefluidide/kg/day)
(4 rabbits/sex/dose)
Acceptable/Non-guideline
(NOAEL was not observed)
Dermal LOAEL = 240 mg/kg/day, based on
irritation, inflammation and necrosis at test sites.
Systemic LOAEL = 240 mg/kg/day, based on
clinical chemistry (increased alkaline phosphatase
and alanine aminotransferase) and organ weights
(decreased spleen weight in females and increased
liver weights in males). Edema and swelling with
myelin loss in sciatic nerve was seen in 720 and
2400 mg/kg/day dose group. Dehydration observed
135
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Table 4.1b Toxicity Profile of Mefluidide and its salts (114001,114002,114003)
Guideline No./
Study type
MRID No.(year)/Doses/ classification
Results
Note: This study assessed the dermal
toxicity of 24 % formulation mefluidide
at 2400 mg/kg/day dose.
Dermal and systemic NOAELs were not
established.
870.3200
82-2
21-Day Dermal
toxicity - rabbit
42029601 (1991)
0, 100. 500 or 1000 mg a.i./kg/d
Mefluidide 58.2% a.i.
(5/rabbits/sex/dose)
Acceptable/guideline
Dermal toxicity LOAEL = 1000 mg/kg/day based
on erythema at the test site.
Dermal toxicity NOAEL = 500 mg/kg/day
Systemic toxicity LOAEL was not established.
Minor hematological and clinical chemistry
findings at 1000 mg/kg/day dose reported, that
were within normalbiological variation and did not
correlate to histopathological findings.
Systemic toxicity NOAEL = 1000 mg/kg/day
Dermal and systemic toxicity LOAEL was no)
870.3200
82-2
21-Day Dermal
toxicify - rabbit
41972901 (1991)
0, 100, 500 or 1000 mg a.i./kg/d
Mefluidide DBA salt 28.78% a.i.
(5/rabbits/sex/dose)
Acceptable/ guideline
Dermal and systemic toxicity LOAEL was not
established. Minor incidences of erythema at 500
mg and 1000 mg/kg/day dose. Increased liver
weight (absolute and relative) noted at 1000 mg/kg
dose but no correlating histopathological findings.
Minor statistical increases in liver enzymes AST
and ALT.
Dermal and systemic NOAEL = 1000 mg/kg/day
Non-guideline
1-year feeding (Rat)
00132993, (1981)
0, 60, 200, 600 ppm Vistar tech, 93% a.i.
(0, 3, 10, 30 mg/kg/d)
(20 rats/sex/dose)
Addendum to 2-year feeding study.
Acceptable/non-guideline
LOAEL = not established
NOAEL = 30 mg/kg/d,
870.4100b
83-lb
Chronic Oral
Feeding [dog]
00132995, (1982)
0, 60, 600, 6000 ppm Vistar tech, 93%
a.i. (0, 1.5, 15, 150 mg/kg/d)
(6 dogs/sex/dose)
Acceptable/guideline
LOAEL =15 mg/kg/d, based on decreased body
weight (15%) and body weight gain (50%) in the
males. Chronic cortical nepnrosis was observed at
150 mg/kg/day dose.
NOAEL = 1.5 mg/kg/d,
870.4100b
83-2b
Carcinogenicity
Dietary [mouse]
00082747, (1979)
0, 600, 1800, 6000 ppm Vistar tech, 93%
a.i. (0, 90, 270, 900 mg/kg/d)
(60 mice/sex/dose)
Acceptable/guideline
LOAEL = 270 mg/kg/day, based on increased
incidence of liver hyperplastic nodules in both
sexes.
NOAEL = 90 mg/kg/day.
No oncogenicity up to and including the highest
dose tested.
870.4300
83-5
2-year
feeding/carcinogenic
ity [rat]
00061930, 00082737 (1979)
0, 600, 1800, 6000 ppm Vistar tech, 93%
a.i. (0, 30, 90, 300 mg/kg/d)
(50 rats/sex/dose)
Acceptable/guideline
LOAEL = 30 mg/kg/d, based on body weight loss.
NOAEL < 30 mg/kg/d,
No oncogenicity up to and including the highest
dose tested.
870.3700a
83-3 (a)
Developmental
00132992, (1981)
0, 15, 30, 60 mg/kg/d
Unacceptable/guideline
Maternal LOAEL = not established.
Maternal NOAEL > 60 mg/kg/day,
Developmental NOAEL > 60 mg/kg/day,
136
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Table 4.1b Toxicity Profile of Mefluidide and its salts (114001,114002,114003)
Guideline No./
Study type
MRID No.(year)/Doses/ classification
Results
Toxicity, gavage
[rat]
(LOAEL was not observed)
Developmental LOAEL = not established.
870.3700a
83-3 (a)
Developmental
Toxicity
Gavage [rat]
42097201 (range finding)
42097701 (teratology), 1991
Range finding: 0, 100, 200, 400, 600 or
800mga.i./kg/d
Teratology study: 0, 50, 200 or 400 mg
a.i./kg/d
Mefluidide technical 58.2% a.i.
Acceptable/Guideline
Maternal LOAEL = 400 mg/kg/d based on
reduced gain and food consumption. Higher dose
in the range finding study of 600 mg/kg/day
produced excessive mortality.
Maternal NOAEL = 200 mg/kg/d
Developmental LOAEL = 4t)0 mg/kg/d based on
slight fetal toxicity as indicated by a slight
nonstatistical increase in 14 rib.
Developmental NOAEL = 200 mg/kg/d
Non-guideline
Range Finding
Developmental
Toxicity,
gavage[rat]
42026101, (1991)
0, 100, 200, 400, 600or 800 mg
diethanolamine salt of mefluidide
(28.78%)/kg/d
(6 female rats/dose)
Range finding
Acceptable/non-guideline
Maternal LOAEL: 115 mg a.i./kg/day based on
clinical signs (tremors, hunched posture, and
salivation), maternal body weight gain and food
consumption.
Maternal NOAEL: 58 mg a.i./kg/day;
Developmental LOAEL: 230 mg a.i. /kg/day
based on significantly decreased fetal body weight.
Developmental NOAEL: 173 mg a.i. /kg/day,
The dosage levels of 0, 50, 200 and 400 mg of the
28.78% formulation/kg/day were selected for the
definitive developmental study.
870.3700a
83-3 (a)
Developmental
Toxicity, gavage
[rat]
42026102, (1991)
0, 50, 200 400 mg diethanolamine salt
of mefluidide (28.78%)/kg/d
(25 females/dose)
Doses adjusted for 100 % purity were 0,
14, 58, or 115 mg/kg/day.
Acceptable/guideline
Maternal LOAEL = 115 mg a.i./kg/day based on
mortality, clinical signs (tremors, stained nose,
urine and vaginal discharge), decreased body
weight and weight gain.
Maternal NOAEL = 58 mg a.i./kg/day),
Developmental LOAEL = 115 mg a.i./kg/day
based on increased number of early resorptions and
mean post-implantation loss.
Developmental NOAEL: 58mg a.i./kg/day
Non-guideline
14-Day Oral gavage
[rabbit]
00047138, (1975)
0, 100, 200, 400, 800 mg/kg/d Vistar
tech, 93% a.i.
4 females/dose
range finding
Acceptable/non-guideline
LOAEL = < 100 mg/kg/day (females), based on
mortality (1/3 deaths) at 100 mg/kg/d. Tremors
and 100% mortality were noted at the levels of 200
mg/kg/d and above. Histopathology not reported.
NOAEL: not established,
870.3700b
83-3(b)
Developmental
Toxicity, gavage
[rabbit]
00047139, (1975)
0, 15, 30, 60 mg technical MBR
12325/kg/d (purity not reported).
Unacceptable by itself, however, if
combined with the 14-day oral study
(00047138), it is acceptable.
Maternal LOAEL = not established.
Maternal NOAEL = 60 mg/kg/day,
Developmental LOAEL = not established.
Developmental NOAEL = 60 mg/kg/day,
870.3800
(83-4)
00082748, (1979)
The parental systemic LOAEL = 346/604 mg/kg
bw/day (M/F), based on decreased body weights.
137
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Table 4.1b Toxicity Profile of Mefluidide and its salts (114001,114002,114003)
Guideline No./
Study type
MRID No.(year)/Doses/ classification
Results
3-generation
reproduction [rat]
0, 600, 1800, 6000 ppm, 93% a.i. (M/F:
0/0, 34/60, 102/183, 346/604 mg/kg/d)
Acceptable/guideline
The parental systemic NOAEL = 102/183 mg/kg
bw/day in males/females.
The offspring LOAEL = 346/604 mg/kg bw/day
in males/females, based on decreased body weights
in both sexes and both litters in all generations.
The offspring NOAEL = 102/183 mg/kg bw/day
in males/females.
The reproductive LOAEL was not observed.
The reproductive NOAEL = 346/604 mg/kg
bw/day in males/females.
870.5100
84-2
Bacterial reverse
mutation
00132996, (1983)
EL-565 (Lily compound 151065:
mefluidide technical) tested at 0.1 - 1000
ug/ml
Acceptable/Guideline
No reverse mutations were noted in any of 8 tester
strains of Salmonella typhimurium and two
tryptophan autotrophs of E. coli with or without
metabolic activation
870.5100
84-2
Bacterial reverse
mutation
41888804, (1991)
0, 100, 333, 667, 1000, 3330, or 5000
ug/plate diethanolamine salt of
mefluidide (28.78%)/
Acceptable/guideline
DBA mefluidide did not increase the number of
histidine revertants per plate in any of the tester
strains with or without metabolic activation.
870.5300
84-2
In-vitro Mouse
lymphoma - gene
mutation
00132996, (1983)
EL-565 (Lily compound 151065:
mefluidide technical)0, 1, 25, 50, 100,
250, 500, 750 or 1000 ug/ml
Acceptable/guideline
There was no evidence of mutation in the presence
or absence of metabolic activation.
870.5375
84-2
In-vitro mammalian
chromosome
aberration test
41888803, (1991)
Diethanolamine salt of mefluidide
(28.8%)
500,- 5010 ug a.i. /ml (without S9 mix)
or 500, - 5000 (with S9 mix)
Acceptable/guideline
No significant increase in structural chromosomal
aberration with or without metabolic activation was
seen, however, the results were considered
equivocal.
184-2 In-vitro
mammalian
chromosome
aberration test
(1992)
concentrations of 1250 to 5000 Og/ml (w
S9 mix) or 200-1600 (wt S9 mix)
Not mutagenic in Chinese Hamster Ovary cells
870.5550
84-2
Unscheduled DNA
Synthesis
41888802, (1991)
Diethanolamine salt of mefluidide
(28.8%)
Concentrations of 100, 250, 500, 1000,
2000, 3000 ug/ml in trial 1; 1000, 1500,
2000, 3000, 3500 ug/ml in trial 2.
Acceptable/guideline
No unscheduled DNA synthesis response in the
absence of moderate to severe cytotoxicity.
870.5550
84-2
00132996, (1983)
EL-565 (Lily compound 151065:
138
No indication of DNA repair synthesis was
observed in cultured rat heapatocytes treated with
-------
Table 4.1b Toxicity Profile of Mefluidide and its salts (114001,114002,114003)
Guideline No./
Study type
MRID No.(year)/Doses/ classification
Results
Unscheduled DNA
Synthesis
mefluidide technical)
Tested at 0.5 to 1000 nmoles/mL
the test material (EL-565 (Lily compound 151065:
mefluidide technical))
870.5915
84-2
In-vivo Sister
Chromatid Exchange
00132996, (1983)
EL-565 (Lily compound 151065:
mefluidide technical)
(0, 12.5, 25, 50, or 100 mg/kg.
Acceptable/Guideline
Negative in sister chromatid exchange in in-vivo
bone marrow of Chinese hamster assay.
870.5915
85-1
Metabolism- male
rat
MRID is not known: Steifer, LJ (1978).
3M Company Report Number 852 (1-26-
78)
Dose: 1 or 10 mg/kg of C-14, labeled
mefluidide
Acceptable/None-Guideline
By 24 hrs of post-treatment, 86-89% of the dose
was found in urine with the remainder in the feces.
Residue consisted of mefluidide (97%) and 2
unidentified metabolites (1.2% and 0.5%) and
unidentified polar material (0.7%).
870.6200
81-8
Demyelination
study - Chicken
0097684(1977)
1000, 3000, 5000, 10,000 and 20,000
mg/kg/day.
Non-Acceptable/Non-Guideline
NOAEL< 1000 mg/kg/day; LOAEL: 1000
mg/kg/day based on clinical signs (hypoactivity,
ataxia, tremors, lethargy and dyspnea) that were
subsided by 48 hrs following dosing. The test
material did not induce delayed neurotoxicity in
hens at the LD 50 dosage of 8500 mg/kg. (Limit
dose - 1 g/kg).
M = Males; F = Females
139
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4.2 Hazard considerations For Women and Children
4.2.1. Adequacy of the Toxicity Database
The toxicology database for mefluidide is considered adequate. The following acceptable
studies are available:
- Developmental toxicity studies in rats
- Developmental toxicity studies in rabbits
- Two-generation reproduction study in rats
4.2. 2. Evidence of Neurotoxicity
Acute and subchronic neurotoxicity studies were not performed. Clinical signs of
neurotoxicity (such as tremors, ataxia, atonia, decreased limb tone, salivation) were seen in
several studies (14-day oral in rabbit at or above 200 mg/kg/day, demyelination study in
chickens at 1000 mg/kg/day and two developmental toxicity studies in rats at 115 mg/kg/day.
Edema and swelling with myelin loss in sciatic nerve was observed in a dermal toxicity study
in rabbits at doses of 720 mg/kg and above. However, these effects were not seen in an
additional dermal test of similar duration using a 58.2% mefluidide formulation or
diethanolamine salt of mefluidide 28.8%.
4.2.3. Developmental Toxicity Study Conclusions
Developmental Toxicity Study - Rabbits:
In a developmental toxicity study (MRIDs 00047139 and 00047138), technical MBR 12325
(Lot #9) in 4% gum acacia was administered to 16-20 New Zealand White rabbits/dose group
via gavage at dose levels of 0, 15, 30, or 60 mg/kg bw/day from gestation days (GD) 6-18.
There were no treatment-related effects on survival, clinical signs, body weight, food
consumption, or cesarean parameters.
The maternal LOAEL was not observed. The maternal NOAEL is 60 mg/kg bw/day
(the highest dose tested).
There were no effects of treatment on the numbers of litters, live fetuses, dead fetuses, or
resorptions, or on fetal body weights, sex ratio, or post-implantation loss. There were no
treatment-related external, visceral, or skeletal variations or malformations.
The developmental LOAEL was not observed. The developmental NOAEL is 60 mg/kg
bw/day (the highest dose tested).
140
-------
This developmental toxicity study in rabbits has a number of deficiencies: a LOAEL was not
observed; test material purity was not provided; no information on dose formulation
preparation or storage was provided; and no analyses of homogeneity, stability, or
concentration were reported. However, when combined with the 14-day oral gavage study in
rabbits (MRID 00047138), where a LOAEL of < 100 mg/kg bw/day based on mortality and
tremor was established, this developmental toxicity study is considered acceptable and
satisfies the guideline for a developmental toxicity study (OPPTS 870.3700b; OECD 414) in
rabbits.
Developmental Toxicity Study - Rats:
In a developmental toxicity study (MRID 42026102), Diethanolamine salt of Mefluidide
(28.78% a.i. Lot # JB0624) in distilled water was administered to pregnant Sprague Dawley
Crl:CD BR VAF/Plus (25/dose) by gavage at dose levels of 0, 50, 200 or 400 mg/kg bw/day
(adjusted doses for 100 % purity were 0, 14, 58, or 115 mg/kg/day, respectively) from days 6
through 15 of gestation.
Animals were checked daily for clinical signs, mortality. Body weights were measured on
gestation day 0, 6, 9, 12, 16 and 20. Unscheduled deaths, scheduled sacrifice and c-sections
were subjected to gross necropsy examination. Each fetus was examined for
external/visceral/skeletal anomalies, sexed and then weighed.
Evidence of maternal toxicity included transient clinical signs (tremors, dark material around
the nose, few feces, urine stain and reddish vaginal discharge), decreased body weight gain
(11-61%), decreased food consumption and mortality (2/25 females found dead on GD 11 and
16) observed at the 400 mg/kg/day levels. At the 400 mg/kg dose, the clinical signs of
toxicity appeared within 2 days after dosing in few animals, and after few days of dosing in
some others and more than half of the animals at this dose were free from clinical signs of
toxicity. No external malformations or developmental variations were observed associated
with any fetus. Fetal toxicity was manifested by increase in the number of early resorptions
which resulted in increase in mean postimplantation loss at 400 mg/kg/day dose.
After adjusting to the pure active ingredient, the maternal NOAEL is 58 mg/kg/day and
the LOAEL is 115 mg/kg/day based on clinical signs (tremors, dark material around the
nose, urine stain and reddish vaginal discharge), decreased body weight gain, decreased
food consumption and mortality (2/25 females). The developmental toxicity NOAEL is
also 58 mg/kg/day, the LOAEL is 115 mg/kg/day based on increase in the number of
early resorptions and increase in mean postimplantation loss.
This developmental toxicity study is classified acceptable/Guideline and it does
satisfy the guideline requirement for a developmental toxicity study (OPPTS 870.3700;
OECD 414) in the rat.
4.2.4. Reproductive Toxicity Study
141
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In a three-generation reproduction study (MRID 00082748), MBR 12325 (Mefluidide; 93%
a.i., Lot #25) was administered in the diet to 20 male and 40 female Charles River CD®
rats/dose group at dose levels of 0, 600, 1800, or 6000 ppm (equivalent to Males/Females -
0/0, 34/60, 102/183, and 346/604 mg/kg bw/day). When approximately 100 days old, the P
generation animals were mated (1 male: 2 females) for up to 15 days to produce the Fla litter.
Following weaning of the Fla litters, 50 Fla offspring/sex/dose were selected for a 2-year
chronic feeding study, and the remaining Fla offspring were discarded. The P generation was
reduced to 10 males/20 females per dose group. After a 10-day post-weaning rest period,
these P animals were mated again to produce the Fib litter. Upon weaning, 10 male and 20
female Fib offspring/dose group were selected to be parents of the F2 generation. This study
design was continued for three generations with 2 litters per generation.
There were no effects on food consumption, organ weights, gross pathology, or
histopathology.
Numerous absolute and relative (to bw) organ weights in the 6000 ppm parents were
significantly (p<0.05) different from the controls, however, none of these differences were
corroborated by any macroscopic or microscopic findings indicating these decreases were
most likely not related to treatment. Thus, it is likely that they were attributable to decreased
body weights at this dose.
The only deaths included one 6000 ppm Fl female, one 6000 ppm F2 male, and one 1800
ppm F2 female. It was stated that macroscopic and microscopic findings in these animals
were unremarkable. Therefore, these deaths were considered incidental and were not
treatment related.
At 6000 ppm, body weights were decreased by 1-8% in males and 1-12% in females
throughout the study in the P generation, attaining significance (p<0.05) at Week 18 in the
males and Weeks 8, 18, 19, and 27 in the females. In the Fl generation at this dose, body
weights were decreased throughout the study in the males (deer. 13-21%) and females (deer.
10-21%), attaining significance (p<0.01) at Weeks 27, 37, and 56 in both sexes. Similarly in
the F2 generation, body weights were decreased throughout the study in the 6000 ppm males
(deer. 14-21%) and females (deer. 11-23%), attaining significance (p<0.01) at Weeks 57, 66,
and 85 in both sexes.
At 1800 ppm, only minor and infrequent decreases in body weights were noted. There were
no treatment-related findings at 600 ppm.
The parental systemic LOAEL is 6000 ppm (346/604 mg/kg bw/day in males/females),
based on decreased body weights in both sexes in all generations. The parental systemic
NOAEL is 1800 ppm (102/183 mg/kg bw/day in males/females).
There were no effects of treatment on post-natal survival (i.e., viability and lactation) indices
in the pups at any dose. There were no treatment-related findings at 600 or 1800 ppm.
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At 6000 ppm, body weights were decreased by up to 27% compared to controls throughout
the post-natal period in both litters in each generation (i.e., Fla, Fib, F2a, F2b, F3a, and F3b
litters). These decreases attained significance in both sexes at PND 21.
The offspring LOAEL is 6000 ppm (346/604 mg/kg bw/day in males/females), based on
decreased body weights in both sexes and both litters in all generations. The offspring
NOAEL is 1800 ppm (102/183 mg/kg bw/day in males/females).
There were no effects of treatment on male or female fertility indices or gestation survival
index.
The reproductive LOAEL was not observed. The reproductive NOAEL is 6000 ppm
(346/604 mg/kg bw/day in males/females).
This study is acceptable/guideline and satisfies the guideline requirement for a three-
generation reproductive study (OPPTS 870.3800; OECD 416) in rats.
4.2.5. Additional Information from Literature sources
There was no published information on this subject.
4.3. Hazard Identification and Toxicity Endpoint Selection
4.3.1. Acute Reference Dose (aRfD)
Females age 13-49 : Acute dietary endpoint for child bearing females (females 13+ years old)
was determined from the developmental toxicity study in rat (MRID 42026102). A NOAEL
of 58 mg/kg/day was derived based on developmental toxicity (increased number of early
resorptions and mean post-implantation loss) at a LOAEL of 115 mg/kg/day. An UF of 100X
(10-fold for inter-species extrapolation, 10-fold for intra-species variability) was applied to
the NOAEL of 58 mg/kg/day to derive the aRfD.
Acute RfD (Females 13-50 years old) = 58 mg/kg (NOAEL) = 0.58 mg/kg
100 (UF)
Acute Reference Dose (aRfD) - General Population
The acute RfD for the general population including infants and children was determined from
the developmental toxicity study in rat (MRID 42026102). A NOAEL of 58 mg/kg/day was
derived based on maternal toxicity (clinical signs: tremors) at a LOAEL of 115 mg/kg/day.
An UF of 100X (10- fold for inter-species extrapolation, 10-fold for intra-species variability)
was applied. The selected endpoint of toxicity is appropriate for this exposure since clinical
signs of toxicity occurred within two days of dosing.
143
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Acute RfD (general population) = 58 mg/kg (NOAEL) = 0.58 mg/kg
100 (UF)
4.3.2. Chronic Reference Dose (cRfD)
The cRfD of 0.015 mg/kg/day was determined on the basis of the Chronic Oral Feeding - dog
(MRID 00132995); NOAEL of 1.5 mg/kg/day and LOAEL of 15.0 mg/kg/day based on
decreased body weight (15%) and body weight gain (50%) in the males. This study provided
the lowest NOAEL (1.5 mg/kg/d) in the database that provides the most protective limits for
human effects. An UF of 100X (10-fold for interspecies extrapolation, 10-fold for
intraspecies variability) was applied to the NOAEL of 1.5 mg/kg/day to derive the cRfD to
give and RfD of 0.015 mg/kg/day.
4.3.3. Incidental Oral Exposure (Short-and Intermediate-term durations: 1 day -
6 months)
Points of departure for these scenarios were based on the rat developmental study (MRID
42026102). NOAEL = 58 mg/kg bw/day, LOAEL =115 mg/kg bw/day based on mortality
and clinical signs. These data were also supported by the rabbit developmental study
(NOAEL = 60 mg/kg bw/day) and rabbit 14 day oral study (LOAEL =100 mg/kg bw/day
based on mortality). The level of concern for residential exposure is for MOEs =100 and for
occupational exposure is for MOEs =100.
4.3.4. Dermal Absorption Factor
A dermal penetration study is not available. A dermal absorption factor is derived by
extrapolation from the rabbit 21-day dermal (MRID 41972901) and rabbit 14 day oral (MRID
00082073) studies. The dermal systemic NOAEL in the 21-day study is 1000 mg/kg/day
based on minor increases in liver enzymes. In the 14 day rabbit oral study(MRID 00047138),
the LOAEL is less than 100 mg/kg/day based on mortality and clinical signs (tremors) and the
NOAEL is <100 mg/kg/day, therefore, the calculated dermal absorption factor would at the
most be (100/1000) x 100 = 10%.
4.3.5. Dermal Exposure (Short and Intermediate: (1-30 days and 30 d-180 days)
Three subacute (21-day) dermal toxicity studies were considered. The two more recent
studies (MRID 42029601 and 41972901) showed no systemic effects at the limit dose. Only
one study (MRID 00082073) with 24% active ingredient showed toxic effects (Edema and
swelling with myelin loss in sciatic nerve at 720 and 2400 mg/kg/day). These effects were not
seen in the more recent GLP dermal studies using a 58.2% mefluidide formulation (MRID
144
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42029601) or diethanolamine salt of mefluidide 28.8% (MRID 41972901). The risk
assessment team determined that no quantitative dermal assessment is needed due to the
following:
1) Two 21-day dermal toxicity studies with rabbits indicated no dermal systemic toxicity at
1000 mg/kg/day (the highest dose tested). The one study that showed toxicity indicated that
effects only occurred at high doses.
2) The rat developmental study indicated no developmental concern (developmental NOAEL
equals to maternal NOAEL),
3) The acute dermal toxicity of mefluidide, where the acute dermal LD50 is >4000 mg/kg, it
is not a skin irritant and is not a dermal sensitizer.
4.3.6. Inhalation (Short- and Intermediate-Term)
Endpoint for this scenario was determined from the rat developmental study. NOAEL = 58
mg/kg bw/day, LOAEL =115 mg/kg bw/day based on mortality and clinical sings. These
data were also supported by the rabbit developmental study (NOAEL = 60 mg/kg bw/day) and
rabbit 14 day oral study (LOAEL =100 mg/kg bw/day based on mortality). Since oral study
was selected for inhalation exposure assessment an inhalation-absorption factor of 100% oral
equivalent should be used.
4.3.7. Margins of Exposure
These are summarized in the following table:
Route
Duration
Short-Term
(1-30 Days)
Intermediate-Term
(1-6 Months)
Occupational (Worker) Exposure
Dermal
Inhalation
NA
100
NA
100
Residential (Non-Dietary) Exposure
Oral
Dermal
Inhalation
100
NA
100
100
NA
100
4.3.8. Classification of Carcinogenic Potential
Mefluidide was negative for carcinogenicity in mouse (MRID 00082747) and rat (MRID
00061930 7 00082737) bioassays. It was also evaluated for genotoxicity in several tests and
found negative. It is unlikely that mefluidide will pose a cancer risk to humans.
145
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146
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Table 4.3. Summary of Toxicological Dose and Endpoints for Mefluidide and its salt
(114001, 114002, 114003) Used in Human Risk Assessment
Exposure
Scenario
Acute Dietary
(general
population)
Acute Dietary
(Females 13+)
Chronic Dietary
(All populations)
Short-Term
Incidental Oral (1-
30 days)
Intermediate-Term
Incidental Oral (1-
6 months)
Short-Term
Dermal (1 to 30
days)
Intermediate-Term
Dermal (1 to 6
months)
Point of
Departure
NOAEL = 58
mg/kg/day
NOAEL = 58
mg/kg/day
NOAEL = 1.5
mg/kg/day
NOAEL = 58
mg/kg/day
Dermal NOAEL
= 1000
mg/kg/day
Uncertainty
Factors
UFA = 10X
UFH = 10X
UFA = 10X
UFH = 10X
UFA = 10X
UFH = 10X
UFA = 10X
UFH = 10X
UFA = 10X
UFH = 10X
Level of
Concern for
Risk Assessment
Acute RfD =
Maternal
NOAEL
UncertaintyFacto
r
= 0.58 mg/kg /day
Acute RfD =
Develop. NOAEL
UncertaintyFacto
r
= 0.58 mg/kg
Chronic RfD =
NOAEL
Uncertainty
Factor
= 0.015
mg/kg/day
Residential LOC
forMOE=100
No quantitative
dermal assessment
is needed.
Study and Toxicological
Effects
MRID 42026102
Developmental toxicity - rat;
LOAEL= 115.0 mg/kg/day
based on mortality(within 5
days of dosing) and clinical
signs (within 2 days of dosing),
and the NOAEL of 58
mg/kg/day.
MRID 42026102
Developmental toxicity - rat;
LOAEL= 115.0 mg/kg/day
based on increased number of
early resorptions and mean
postimplantation loss. NOAEL
= 58 mg/kg/day
MRID 00132995
Chronic Oral Feeding - dog;
LOAEL= 15.0 mg/kg/day based
on decreased body weight (15%)
and body weight gain (50%) in
the males at 15 mg/kg/day.
MRID 42026102
Developmental toxicity - rat;
NOAEL = 58 mg/kg bw/day,
LOAEL =115 mg/kg bw/day
based on mortality and clinical
sings. These data were also
supported by the rabbit
developmental study (MRID
00047139) (NOAEL = 60 mg/kg
bw/day) and rabbit 14 day oral
study (LOAEL = 100 mg/kg
bw/day based on mortality).
Three subacute (21 -day) dermal
toxicity studies were considered.
The risk assessment team
determined that no quantitative
dermal assessment is needed due
to the following:
1) Two 21 -day dermal toxicity
studies with rabbits indicated no
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Table 4.3. Summary of Toxicological Dose and Endpoints for Mefluidide and its salt
(114001, 114002, 114003) Used in Human Risk Assessment
Exposure
Scenario
Short-Term
Inhalation (1 to 30
days)
Intermediate-Term
Inhalation (1 to 6
months)
cancer
Point of
Departure
Oral NOAEL =
58 mg/kg/day
(inhalation-
absorption rate =
100% oral
equivalent)
Uncertainty
Factors
UFA = 10X
UFH = 10X
Level of
Concern for
Risk Assessment
Residential LOC
forMOE=100;
Occupational LOC
forMOE=100
Study and Toxicological
Effects
dermal systemic toxicity at 1000
mg/kg/day (the highest dose
tested). The one study that
showed toxicity indicated that
effects only occurred at high
doses.
2) the rat developmental study
indicated no developmental
concern (developmental
NOAEL = maternal NOAEL),
3) Acute toxicity of mefluidide,
where acute dermal LD50 is
>4000 mg/kg, not a skin irritant
and is not a dermal sensitizer.
MRID 42026102
Developmental toxicity - rat;
NOAEL = 58 mg/kg bw/day,
LOAEL - 115 mg/kg bw/day
based on mortality and clinical
sings. These data were also
supported by the rabbit
developmental study (NOAEL =
60 mg/kg bw/day) and rabbit 14
day oral study (LOAEL = 100
mg/kg bw/day based on
mortality).
Mefluidide was negative for carcinogenicity in mouse (MRID 00082747) and rat (MRID
00061930 7 00082737) bioassays. It was also evaluated for genotoxicity in several tests and
found negative.
Point of Departure (POD) = a data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant
human exposures. UF = uncertainty factor, UFA = extrapolation from animal to human (intraspecies), UFH =
potential variation in sensitivity among members of the human population (interspecies), NOAEL = no observed
adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c =
chronic), MOE = margin of exposure, LOC = level of concern, NA = Not Applicable. Safety Factor = UF = 100.
5.0 Public Health Data
5.1 Incident Reports
(RED memo of 07/25/06, M. Hawkins, D324824)
The following data bases have been consulted for the poisoning incident data on the active
ingredient Mefluidide and salts:
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1) OPP Incident Data System (IDS) - No reports for mefluidide or its salts in the Incident
Data System.
2) Poison Control Centers - No reports located in the Poison Control Center records from
1993 through 2003 involving mefluidide.
3) California Department of Pesticide Regulation - Detailed description of 1 case submitted
to the California Pesticide Illness Surveillance Program (1982-2003) was reviewed. In the
case, a worker reported a rash on the side of their face after several workers passed a vehicle
that sprayed the product.
4) National Pesticide Information Center (NPIC) - From 1984-1991 inclusively, mefluidide
was not reported to be involved in human incidents.
5) National Institute of Occupational Safety and Health's Sentinel Event Notification System
for Occupational Risks (NIOSH SENSOR) - Of 5,899 reported cases from 1998-2003, none
involved mefluidide.
In conclusion, there was only one report of an ill effect from exposure to mefluidide in the
available data bases.
6.0 EXPOSURE CHARACTERIZATION/ASSESSMENT
6.1 Dietary Exposure/Risk Pathway
6.1.1 Food Exposure/Risk Pathway
None. No food uses.
6.1.2 Water Exposure/Risk Pathway
Drinking water Assessment; James Hetrick (D334508, 03/08/07)
Possible routes of dissipation for mefluidide are photodegradation on soil surfaces and
microbial-mediated degradation. Mefluidide is not prone to abiotic hydrolysis or photolysis
in sterile buffer solutions within the environmentally relevant pH range of 4 to 9. There are
data showing mefluidide undergoes rapid photodegradation (ti/2 = 2 to 3 days) in natural well
water. On soil surfaces, mefluidide photodegraded with a half-life of 116.4 hours.
Mefluidide in aerobic soils degraded with a half-life of 12 days. The only degradation
product was 5-amino-2,4-dimethyltrifluoromethanesulfonilide. It was found at a maximum
daily concentration of 2.8% of applied dose (MRID 43162201, aerobic soil). Mefluidide
dissipated with a half-life of 2.0 to 3.3 days in warm-season turf soil in Georgia and 1.2 to
1.4 days in cool-season grass soil in Missouri. Mefluidide dissipated from grass foliage at
half-lives of 1.7 to 6.91 days (upper 90th percentile of mean half-life= 4.0414 day, k= 0.1715
days"1-*.
No surface or ground water monitoring data were found for mefluidide. Drinking water
assessment was conducted using Tier II (PRZM-EXAMS) for surface water modeling and
Tier 1 (SCI-GROW) for groundwater modeling. Because mefluidide use is associated with
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turf, the aquatic exposure assessment was conducted using the PA and FL turf scenarios.
These use scenarios were selected to represent of rights-of-way, residential turf, industrial
areas with turf (i.e., airports, etc.), and golf courses. The turf scenarios are expected to be
conservative estimate of mefluidide runoff potential because they assume 100% of the
watershed is treated with mefluidide as well as the runoff scenarios are located in areas with
high runoff potential. The mefluidide acid concentrations in surface water are not expected to
exceed 32 ug/L for the 1 in 10 year daily peak concentration, 10 ug/L for the 1 in 10 year
annual concentration, and 5 ug/L for the 30 year annual average concentration. Mefluidide
acid concentrations in ground water are not expected to exceed 1.0 ug/L. These concentrations
have not been adjusted for any crop area factor (CAP) because the crop area factors do not
account for non-agricultural uses such as turf, ornamentals, etc. Uncertainty in the assessment
is the persistence of mefluidide acid in aerobic aquatic environments. This assessment was
conducted using an estimated aerobic aquatic half-life of 72 days (Guidance for Chemistry
and Management Practice Input Parameters for Use in Modeling the Environmental Fate and
Transport of Pesticides, Version 2, 11/7/2000). Because this estimated half-life was designed
to approximate upper 90th percentile of the mean half-life, it is anticipated to be a conservative
estimate of mefluidide acid persistence in aquatic environments.
6.2 Dietary Exposure Estimates
Acute and chronic dietary risk assessments were conducted using the Dietary Exposure
Evaluation Model (DEEM-FCID™, Version 2.03) which uses food consumption data from
the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals
(CSFII) from 1994-1996 and 1998.
Acute Dietary Exposure from Drinking Water
An acute dietary exposure assessment was performed for mefluidide considering exposures
from surface water only, as there are no food uses for this chemical. An estimated drinking
water concentration (EDWC) for surface water (32 ppb) provided by the Environmental Fate
and Effects Division (EFED) was used in this assessment. Ground water sources were not
included, as the EDWCs for this water source are minimal in comparison to surface water.
The drinking water exposure analysis result in dietary risk estimates for surface water only are
below the Agency's level of concern for acute exposure. At the 95th percentile, the exposure
to U.S. population was 0.0017 mg/kg/day, which utilized <1% of the acute reference dose
(aRfD). The exposure for all infants, which was the most highly exposed population
subgroup, was 0.006 mg/kg/day, which utilized 1% of the aRfD. Conservative screening-
level drinking water estimates were used in this assessment (i.e., the highest peak surface
water level for a one in ten year concentration), therefore the dietary risk estimates were
reported at the 95th percentile of exposure.
Chronic Dietary Exposure from Drinking Water
A chronic dietary exposure from drinking water only was also performed using surface water
EDWC value (10 ppb). For the U.S. population the exposure was 0.0002 mg/kg/day, which
150
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utilized 1% of the chronic reference dose (cRfD). The exposure for all infants, which was the
most highly exposed population subgroup, was 0.0007mg/kg/day, which utilized 5% of the
cRfD.
Table 6.2. Summary of Drinking Water Exposure and Risk for Mefluidide
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Youth 13- 19 years old
Adults 20-49 years old
Adults 50+ years old
Females 13-49 years old
Acute Dietary
95th Percentile
aRfD
(mg/kg/day)
0.58
Dietary
Exposure
(mg/kg/day)
0.001672
0.006303
0.002623
0.002396
0.001668
0.001356
0.001549
0.001399
0.001558
% aRfD
<1
1
<1
<1
<1
<1
<1
<1
<1
Chronic Dietary
cRfD
(mg/kg/day)
0.015
Dietary
Exposure
(mg/kg/day)
0.000211
0.000691
0.000313
0.000293
0.000202
0.000152
0.000197
0.000207
0.000196
% cRfD
1
5
2
2
1
1
1
1
1
For detailed DEEM input and result files, please see Attachment I.
6.3 Residential (Non-Occupational) Exposure/Risk Pathway
Occupational and Residential Exposure Assessment; Yan Donovan, D324823, 2/28/07.
Mefluidide is intended for both occupational and residential uses. None of the labels prohibit
use by homeowners. The residential products are typically formulated as granules, or as liquid
concentrates, or ready- to- use sprinkler can sprays. Spot and broadcast treatments are both
included on the labels. Exposures are expected to be short term in duration.
6.3.1. Residential Handler Exposure and Risks
Residential Handler Scenarios, Data Sources and Assumptions
Scenarios
Based on the product labels, the following scenarios were assessed.
1. Load/Apply Granules with Belly Grinder
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2. Load/Apply Granules with a Broadcast Spreader
3. Mix/Load/Apply with a Hose-end Sprayer (Mix your own)
4. Mix/Load/Apply with Hand Held Pump Sprayer.
Data Sources
Exposure data for scenario #1 was taken from PHED because no unit exposure data
is available from ORETF for this specific scenario. Exposure data for scenarios #2 and
#3 were taken from the residential portion of the ORETF Handler Study. Exposure data
for scenario #4 was taken from MRID 44459801, a study involved low pressure
handwand and RTU trigger sprayer application of carbaryl to home vegetable plants.
This study was reviewed by Jeff Dawson in document D287251, has since been
purchased by ORETF.
Assumptions Regarding Residential Applicators
• Broadcast spreaders and hose end sprayers would be used for broadcast treatments and the other
application methods would be used for spot treatments only.
• The application rate of 1.0 Ib ai/acre is from mefluidide labels.
• An area of 0.023 acre (1000 square feet) would be treated per application during spot treatments and an
area of 0.5 acre would be treated during broadcast applications.
Residential Handler Exposure and Risk Estimates
A summary is included in Table 6.3.1. The MOEs are > 100 and the risks are below
EPA's level of concern.
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Table 6.3.1- Mefluidide Short Term MOEs for Homeowner Applications to Lawns
Scenario
Load/Apply granules with Belly
Grinder (spot treatment)
Load/Apply Granules with a
Broadcast Spreader
Mix/Load/Apply with a Hose-
end Sprayer (Mix your own)
Mix/Load/Apply with Hand Held
Pump Sprayer (use on turf)
Mix/Load/Apply with Hand Held
Pump Sprayer (use on
ornamentals)
Application
Rate
0.5 Ibai/acre
0.5 Ibai/acre
1 .0 ai/acre
1.0 Ib ai/acre
O.Ollbsai
/gallon
Area Treated
or Amount
Applied
0.023 acre/day
0.5 acre/day
0.5 acre/day
0.023 acre/day
5 gallons
Inhalation Unit
Exposure (per
Ibs ai handled)
62 Hg
(PHED)
0.91 ng
(ORETF)
16 jig
(ORETF)
9^g
(MPJD44459801)
9^g
(MPJD44459801)
Inhalation
Dose
(mg/kg/day)
l.OE-05
3.3E-06
1.1E-04
3.0E-06
6.0E-06
Inhalation
MOE
6,000,000
18,000,000
500,000
20,000,000
9,000,000
6.3.2. Residential Post Application Exposure and Risks
Residential Post Application Exposure Scenarios, Data Sources and Assumptions
Scenarios
The following exposure scenario was assessed for residential turf post application risks:
Short Term Incidental Oral Exposures of Toddlers Playing on Treated Turf
General Assumptions
The following general assumptions are taken from the Standard Operating Procedure (SOPs)
of December 18, 1997 and ExpoSAC Policy #12 "Recommended Revisions to the Standard
Operating Procedures for Residential Exposure Assessments of February 22, 2001.
• An assumed initial TTR value of 5% of the application rate is used for assessing hand to mouth
exposures.
• An assumed initial TTR value of 20% of the application rate is used for assessing object to mouth
exposures.
• Soil residues are contained in the top centimeter and soil density is 0.67 mL/gram.
• Three year old toddlers are expected to weigh 15 kg.
• Hand-to-mouth exposures are based on a frequency of 20 events/hour and a surface area per event of 20
cm2 representing the palmar surfaces of three fingers.
• Saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth
approximately l/i of the residues on the hand are removed.
• An exposure duration of 2 hours per day is assumed for toddlers playing on turf.
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Assumptions Specific to Mefluidide
The following assumptions that are specific to mefluidide are used for assessing residential
post application exposures.
• The application rate of 1.0 Ibs ai/acre as stated in the label was used. Although RTU product (EPA Reg
# 2217-788) has the highest application rate of 1.23 Ibs ai/acre, this product is considered to be used as
spot treatment. As a result, the 1.23 Ibs ai/acre is not considered a representative rate for turf use.
Calculation Methods
The above factors were used in the standard residential SOP formulas to calculate the
incidental oral exposures from hand- to- mouth, object- to- mouth and soil ingestion on treated
turf. These formulas are described in the cited ORE memo. The MOEs were calculated using
the short/intermediate term incidental oral endpoint which has a NOAEL of 58 mg/kg/day.
The MOEs are summarized in Table 6.3.2A. All of the MOEs exceeded 100. This means
that the risks are below EPA's level of concern.
Table 6.3.2A - Mefluidide MOEs for Residential Post Application Turf Exposures
(Application Rate = 1.0 Ib ai/acre)
Toddler Exposure Scenario
Hand to Mouth Ingestion
Object to Mouth Ingestion
Soil Ingestion
Total of Above
TTR and soil
Residue Levels
0.56 ug/cm
2.2 ug/cm
7.5 ppm
Dose
(mg/kg/day)
0.0150
0.0037
5.0E-05
0.019
MOE
4,000
16,000
1,000,000
3,000
The risk assessment for toddler turf exposures are conservative because it is based on day zero
TTRs and soil residues and does not account for dissipation. The combined MOE is
considered highly conservative since each of the single scenarios (hand-to-mouth, object-to-
mouth, or soil ingestion) is assessed based on conservative assumptions, and that the
likelihood of all three scenarios occur at the same time is very rare.
Residential Turf Granule Ingestion Exposure and Risks
Scenarios
The following exposure scenario was assessed
Acute Exposures of Toddlers from Incidental Oral Ingestion of Granules
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Assumptions
The following assumptions were used to assess the risk of incidental oral ingestion of
granules:
• The assumed ingestion rate is 0.3 gram/day based on the Residential SOP 2.3.1. This
is based on the assumption that if 150 Ibs of product were applied to a 1A acre lawn, the
2
amount of product per square foot would be 3 g/ft and a child would consume one-
tenth of the product available in a square foot.
• Three year old toddlers are expected to weigh 15 kg.
• The granules contain a maximum of 0.49 percent mefluidide ai based upon product #538-181.
Calculation Methods and Risks
The above factors were used to calculate the potential dose rate and the absorbed dose
using the Residential SOP 2.3.1 formulas as shown in Table 6.3.2B. MOEs were then
calculated using the acute dietary NOAEL of 58 mg/kg/day and they exceed 100. This means
that the risks for toddler exposures from granular ingestion are below EPA's level of concern.
Table 6.3.2B - Granule Ingestion Risks for Mefluidide
Percent ai
Potential Dose Rate
(nig/day)
i
Absorbed Dose"
(mg/kg/day)
2
Acute MOE
3
0.49
1.47
0.098
590
1. Potential Dose Rate (PDR) = 0.3 gram/day * (Percent ai/100)* 1000 mg/gram
2. Absorbed Dose = PDR/BW
3. MOE = NOAEL/Dose where the NOAEL = 58 mg/kg/day
7.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION
7.1 Aggregate Risk
Aggregate Risk Assessment (food + water + residential exposure)
Although an aggregate risk assessment is not required under current Agency policies for non-
food use chemicals, to ensure that the public health is adequately protected, a screening level
aggregate risk assessment was conducted for mefluidide. For acute and chronic aggregate
risks, the only exposure is from drinking water. As stated above, the dietary exposures
(drinking water only) do not exceed 1% of the aRfD/cRfD for adult and 5% of the aRfD/cRfD
for children. For short- term, no aggregate is needed for adults since there are no residential
post- application exposures to adults. When considering the dietary exposure (drinking water
only) as a background exposure to Children for short-term risk, the level of dietary exposure
(0.0007 mg/kg/day) is negligible when compared to the combined incidental oral exposure
155
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(0.019 mg/kg/day, Table 6.3.2A above) or the granule ingesting dose (0.098 mg/kg/day, Table
6.3.2B above). No intermediate-term residential post application exposure was identified.
Therefore, short- and intermediate- term aggregate is not of concern.
7.2 Cancer Risk
Based on lack of evidence of carcinogenicity in both rats and mice, mefluidide was considered
as not likely to be carcinogenic to humans. No cancer assessment is needed.
8.0 CUMULATIVE RISK CHARACTERIZATION/ASSESSMENT
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a
common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding
as to mefluidide and any other substances and mefluidide does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this action, therefore, EPA has
not assumed that mefluidide has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
9.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY
(Occupational and Residential Exposure Assessment; Yan Donovan, D324823, 2/28/07).
Mefluidide products are intended for both occupational and residential uses.
9.1 Short/Intermediate-Term Handler Risk
Based upon the application methods listed in Table , the following exposure scenarios were
identified and assessed.
Mix/Load Liquid Formulations
Groundboom Application
Turf gun Application
Right of Way Application
Mix/Load/Apply Liquids with a Backpack Sprayer
Mix/Load/Apply Liquids with a Turfgun
Load/Apply Granules with a Push Cyclone
Occupational Handler Exposure Assumptions and Data Sources
Exposure Assumptions
156
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The following assumptions and factors were used in order to complete the exposure and risk
assessments for occupational handlers/applicators:
• The daily acreages treated were taken from EPA Science Advisory Council for Exposure Standard
Operating Procedure #9 "Standard Values for Daily Acres Treated in Agriculture," Revised July 5,
2000.
• The maximum application rate for turf areas is 1.0 Ibs ai per acre as listed in the Mefluidide labels.
• The maximum application rate for ornamental trees is 0.01 Ibs ai per gallon based upon the Label
#2217-759.
• A body weight of 70 kg was assumed because the endpoint is not gender specific.
• The inhalation absorption rate is 100%.
• Baseline indicates that no respirator is worn.
Handler Exposure Data Sources
The handler exposure data were taken from the Pesticide Handler Exposure Database
(PHED) and the Outdoor Residential Exposure Task Force (ORETF). The PHED data were
used primarily for the golf course, ornamental trees, and rights- of - ways (ROW) scenarios
and the ORETF data were used for lawn care scenarios. The detailed values specific to each
exposure scenario can be found in the above cited ORE memo.
Occupational Handler Exposure and Risk Estimates
Daily inhalation doses and Margins of Exposure (MOEs) were calculated using standard FED
methodology. The MOEs for occupational handlers are summarized in Table 9.1. All of the
MOEs are > 100 with baseline PPE which means that the risks are not of concern and
respiratory protection is not needed.
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Table 9.1 - Mefluidide Inhalation MOEs for Occupational Handlers
Exposure Scenario
Use Site
Application
Rate
Daily
Amount
Treated or
Applied
Inhalation
Unit
Exposure
at Baseline
(ug/lb ai
handled)
MOE
at
Baseline
Level1
Mixer/Loader (M/L)
M/L Liquids for Turfgun (20
PCOs)
M/L Liquids for High
pressure Handwand
M/L Liquids for Groundboom
M/L Liquids for ROW
Sprayer
PCO2 Turf
Ornamental
trees
Golf Courses
Right of Way
A
Groundboom Application
ROW Sprayer Application
Turfgun Application
Golf Courses
Non Turf
Areas3
PCO Turf
1.0 Ib ai/acre
O.Ollb
ai/gallon
1.0 Ib ai/acre
0.067 Ib
ai/gallon
100 acres
1000
gallons
40 acres
1000
gallons
1.2
1.2
1.2
1.2
34,000
340,000
85,000
50,000
pplicator
1.0 Ib ai/acre
0.067 Ib
ai/gallon
1.0 Ib ai/acre
40 acres
1000
gallons
5 acres
0.74
3.9
1.0
140,000
16,000
812,000
Mixer/Loader/Applicator (M/L/A)
M/L/A Liquid Flowables with
Turfgun
M/L/A Liquids with
Backpack Sprayer
M/L/A Granules with Push
Cyclone
PCO Turf
Non Turf Areas
PCO Turf
1.0 Ib ai/acre
0.067 Ib
ai/gallon
0.5 Ib ai/acre
5 acres
40 gallons
5 acres
1.9
30
7.5
427,000
50,000
217,000
1 . Baseline PPE indicates no respirator.
2. PCO Turf includes residential lawns, commercial lawns and other lawn areas treated by a Pest Control Operator (PCO).
3. Non Turf Areas include roadsides, Rights of Way (ROW) and other similar non-crop areas.
Occupational Handler Risk Characterization
All the MOEs for occupational handlers are greatly above HED's level of concern (100), no
refinement is needed. However, HED recommends the level of PPE required on the current
labels are not to be changed as a result of this assessment.
9.2 Post-application Exposure and Risk
Occupational post application dermal risks were not assessed because there is not likely to
have occupational post-application scenario. In addition, no dermal endpoints were selected.
Mefluidide is only applied outdoors and it is not a volatile compound, inhalation exposures
are negligible (Vapor pressures are < l.OE-4 torr at 25° C for mefluidide, < l.OE-7 torr at 25°
C for mefluidide DEA salt and potassium salt).
158
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10.0 DATA NEEDS AND LABEL REQUIREMENTS
None.
159
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Attachment I
Filename: C:\Documents and Settings\ydonovan\DEEM
Files\Mefluidide\Mefluidide.R98
Chemical: Mefluidide and Salts
RfD(Chronic) : .015 mg/kg bw/day NOEL (Chronic) : 1.5 mg/kg bw/day
RfD(Acute): .58 mg/kg bw/day NOEL(Acute): 58 mg/kg bw/day
Date created/last modified: 03-22-2007/09:27:32/8 Program ver.
2.03
Comment: Acute Exposure from drinking water only
EPA Crop Def Res Adj.Factors
Comment
Code Grp Commodity Name (ppm) #1 #2
86010000 0 Water, direct, all sources 0.032000 1.000 1.000
86020000 0 Water, indirect, all sources 0.032000 1.000 1.000
160
-------
U.S. Environmental Protection Agency Ver. 2.02
DEEM-FCID ACUTE Analysis for MEFLUIDIDE AND SALTS (1994-98 data)
Residue file: Mefluidide.R98 Adjustment factor #2 NOT used.
Analysis Date: 03-22-2007/09:46:53 Residue file dated: 03-22-2007/09:44:59/8
NOEL (Acute) = 58.000000 mg/kg body-wt/day
Daily totals for food and foodform consumption used.
Run Comment: "Exposure from drinking water only"
Summary calculations (per capita):
95th Percentile 99th
Exposure % aRfD MOE Exposure
Percentile
% aRfD MOE
99.9th Percentile
Exposure % aRfD MOE
1.08
2.79
1.10
1.06
U.S. Population:
0.001672 0.29 34696 0.003140 0.54 18472 0.006282
All infants:
0.006303 1.09 9202 0.009035 1.56 6419 0.016185
Children 1-2 yrs:
0.002623 0.45 22112 0.004380 0.76 13240 0.006371
Children 3-5 yrs:
0.002396 0.41 24206 0.003756 0.65 15443 0.006130
Children 6-12 yrs:
0.001668 0.29 34771 0.002774 0.48 20912 0.003788
Youth 13-19 yrs:
0.001356 0.23 42768 0.002282 0.39 25420 0.004104
Adults 20-49 yrs:
0.001549 0.27 37449 0.002594 0.45 22362 0.004692
Adults 50+ yrs:
0.001399 0.24 41469 0.002000 0.34 28997 0.003244
Females 13-49 yrs:
0.001558 0.27 37238 0.002507 0.43 23137 0.004446
9232
3583
9104
9462
0.65 15312
0.71 14133
0.81 12362
0.56 17881
0.77 13046
161
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Filename: C:\Documents and Settings\ydonovan\DEEM
Files\Mefluidide\Mefluidide-Chronic.R98
Chemical: Mefluidide and Salts
RfD(Chronic) : .015 mg/kg bw/day NOEL (Chronic) : 1.5 mg/kg bw/day
RfD(Acute): .58 mg/kg bw/day NOEL(Acute): 58 mg/kg bw/day
Date created/last modified: 03-22-2007/09:44:59/8 Program ver.
2.03
Comment: Chronic Exposure from drinking water only
EPA Crop Def Res Adj.Factors
Comment
Code Grp Commodity Name (ppm) #1 #2
86010000 0 Water, direct, all sources 0.010000 1.000 1.000
86020000 0 Water, indirect, all sources 0.010000 1.000 1.000
162
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U.S. Environmental Protection Agency Ver. 2.00
DEEM-FCID Chronic analysis for MEFLUIDIDE AND SALTS (1994-98 data)
Residue file name: C:\Documents and Settings\ydonovan\DEEM
Files\Mefluidide\Mefluidide-Chronic.R98
Adjustment factor #2 NOT used.
Analysis Date 03-22-2007/10:15:37 Residue file dated: 03-22-2007/10:14:22/8
Reference dose (RfD, Chronic) = .015 mg/kg bw/day
COMMENT 1: Chronic Exposure from drinking water only
Total exposure by ]
Population
Subgroup
U.S. Population (total)
U.S. Population (spring season)
U.S. Population (summer season)
U.S. Population (autumn season)
U.S. Population (winter season)
Northeast region
Midwest region
Southern region
Western region
Hispanics
Non-hispanic whites
Non-hispanic blacks
Non-hisp /non-white /non-black
All infants (< 1 year)
Nursing infants
Non-nursing infants
Children 1-6 yrs
Children 7-12 yrs
Females 13-19 (not preg or nursing)
Females 20+ (not preg or nursing)
Females 13-50 yrs
Females 13+ (preg/not nursing)
Females 13+ (nursing)
Males 13-19 yrs
Males 20+ yrs
Seniors 55+
Children 1-2 yrs
Children 3-5 yrs
Children 6-12 yrs
Youth 13-19 yrs
Adults 20-49 yrs
Adults 50+ yrs
Females 13-49 yrs
population subgroup
Total
mg/kg
body wt/day
0.000211
0.000209
0.000226
0.000204
0.000204
0.000192
0.000213
0.000200
0.000241
0.000239
0.000206
0.000200
0.000258
0.000691
0.000256
0.000856
0.000294
0.000191
0.000148
0.000210
0.000204
0.000205
0.000292
0.000155
0.000189
0.000207
0.000313
0.000293
0.000202
0.000152
0.000197
0.000207
0.000196
Exposure
Percent of
Rfd
1.4%
1.4%
1.5%
1.4%
1.4%
1.3%
1.4%
1.3%
1.6%
1.6%
1.4%
1.3%
1.7%
4.6%
1.7%
5.7%
2.0%
1.3%
1.0%
1.4%
1.4%
1.4%
1.9%
1.0%
1.3%
1.4%
2.1%
2.0%
1.3%
1.0%
1.3%
1.4%
1.3%
163
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Appendix B: Review of Human Research
Studies reviewed for ethical conduct:
No MRID - PHED Surrogate Exposure Guide
00031050 Feldman, R.J., Maibach, H.I. (1974) Percutaneous penetration of some pesticides
and herbicides in man. Toxicology and Applied Pharmacology 28(7): 126-132. (Also In
unpublished submission received Apr 23, 1980 under 10279-7; submitted by Purdue Frederick
Co., Norwalk, Conn.; CLD:242321-R)
Studies reviewed by the Human Studies Review Board:
44416201 Gledhill, A. (1997) Dichlorvos: A Study to Investigate Erythrocyte Cholinesterase
Inhibition Following Oral Administration to Healthy Male Volunteers: Lab Project Number:
XH5170: Y09341: C05743. Unpublished study prepared by Zeneca Central Toxicology Lab.
104 p.
164
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Appendix K: Mefluidide Ecological and Fate and Effects Assessment
U. S. ENVIRONMENTAL PROTECTION AGENCY
Washington, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
Date: September 13, 2007
Chemical: Mefluidide, Mefluidide -DBA and Mefluidide-K
PC Code: 114001,114002, 114003
DP Barcode: D334512
MEMORANDUM
SUBJECT: Response to comments Phase III for Reregi strati on of
Mefluidide acid, Mefluidide -DBA and Mefluidide-K
Mefluidide acid (CAS Reg. No.53780-34-0)
Mefluidide-DEA (CAS Reg. No.53780-36-2)
Mefluidide-K (CAS Reg. No. 83601-83-6)
TO: Wilhelmena Livingston
Special Review and Re-Registration Division (7508P)
FROM: Marie Janson, Environmental Scientist
James Hetrick, Ph.D., Senior Scientist Advisor
Tom Bailey, Ph.D., Branch Chief
Environmental Risk Branch I
Environmental Fate and Effects Division (7507P)
Attached please find the Environmental Fate and Effects Division's (EFED) revised
environmental risk assessment, which is for response to comments Phase III.
Public comment: Drinking Water Risk Assessment Comments
Please remove mention of annual sales volume information from page 2 of the document.
EFED response:
EFED removed mention of annual sales volume information from page 2 of the drinking
water risk assessment.
Environmental Fate and Effects Chapter Comments
165
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Public comment:
Page 44, Terrestrial Plant
FBI-Gordon has submitted a new Seed Germination/Seedling Emergence Study (MRID
47190701), which should help to refine the risk assessment to non target terrestrial species.
EFED response:
EFED incorporated results of a- the preliminary review of the seedling emergence study MRID
47190701 in the revised risk assessment
Public comment:
Section 3.3.1.2 Terrestrial Animals
Avian -
' The LC50 of 3750 mg ae/Kg diet was selected for evaluating birds on a sub acute dietary
basis exposed to Mefluidide-K, Mefluidide-DEA, andMefluidide for the terrestrial risk
assessment'
FBI-Gordon Response -
The mefluidide-DEA and mefluidide-K forms dissociate in the spray tank within minutes
as supported by MRID 42283301 and 42282001, respectively. Therefore the compound
of concern for both animals and birds should be mefluidide acid. Instead of using an
LC50 value of 3750 mg ae/Kg based on mefluidide-DEA dietary study, the LC50 of >
5000 mg ae/kg (ppm) from the mefluidide acid dietary studies, MRID 41602102
(Bobwhite Quail) and MRID 41602103 (Mallard Duck), should have been used for the
risk assessment on birds. Both of these studies were listed as supplemental due to lack of
classification of the test material. The test material used in both studies was Lot 1094 of
technical mefluidide acid as characterized in MRID 41601601.
On page 63, the Agency stated "The LD50 value of 5000 mg ae/bw if applied to the above
modeled scenario would result in no acute LOC exceedances for birds. Based on the
mean Kanaga assessment, no acute LOC exceedances occurred for birds (1.0 Ib ae/A at 3
spray applications"
EFED response:
The risk assessment strategy is designed to bridge the environmental fate and effects data for
the mefluidide-K and mefluidide-DEA, mefluidide to mefluidide acid. Therefore, the most
sensitive endpoint for the three mefluidide compounds (mefluidide, mefluidide-K, mefluidide-
DEA) was selected to represent all mefluidide compounds for aquatic and terrestrial
organisms in each category.
EFED stated the following for mammals in the risk assessment: For mammal toxicity
assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have
been bridged because toxicity is expected to come from the benzene ring of mefluidide.
Therefore, the most sensitive Mefluidide endpoint was selected to represent mammals for all
application scenarios.
In addition, EFED concurs with the following statement from the HED risk assessment:
"Based on the structural similarities of mefluidide and its diethanolamine (DEA) and
potassium salts, where they all share the same anion- anilide, and the physical and chemical
166
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properties of the DEA and potassium salts, where they dissociate 100% back to free
mefluidide in aqueous environments, the risk assessment team concluded that mefluidide
DEA and potassium salts are biologically equivalent to mefluidide and thus they share the
same toxicity as the free mefluidide. Therefore, it is reasonable to bridge mefluidide toxicity
data to mefluidide salts and vice versa."
Public comment:
Mammals -
'The LD50 of 829.8 mg ae/kg bw was selected for evaluating mammals on a acute dietary
basis exposed to mefluidide-K, mefluidide-DEA, and mefluidide for the terrestrial risk
assessment.'
FBI-Gordon Response -
The acute oral study in mice, MRID 00047116, selected for the terrestrial risk assessment
on mammals was a preliminary study and never intended to be a definitive study. This
study was conducted with 5 animals/dose whereas the definitive mouse study, MRID
00047117, was conducted with 10 animals/dose and at higher dose levels. This latter
definitive study generated an LD50 of 1920.2 mg ae/kg bw. Both studies were conducted
with the same strain of mice, but with different test materials. The test material for the
preliminary study was prepared in the lab and was yellow colored while the test material
for the definitive study was prepared in a pilot plant and was a white color and would be
more representative of production material. In the definitive study there were no effects
at the low dose, 830 mg ae/kg bw and only 1 death out of 10 animals at 1260 mg ae/kg
Further evidence showing that the mouse LD50 should be 1920.2 mg ae/kg comes from
the mouse carcinogenicity dietary study, MRID 00082747, where levels of 0, 600, 1800,
and 6000 ppm (0, 90, 270, and 900 mg/kg/day) were fed for 78 weeks and resulted in a
NOAEL of 90 mg/kg/day with survival rates.
After feeding mice at 270 mg/kg/day for 3 days they would have been exposed to nearly
the LD50 level reported in MRID 00047116 above and yet there was still 70% +
combined species survival at the end of 78 weeks.
Based on the weight of evidence the mouse LD50 of 1920.2 mg ae/kg should be used in
the mammalian risk assessment instead of 829.8 mg ae/kg. By using the revised LD50
values of >2000 mg ae/kg-bw for birds and 1920.2 mg ae/kg-bw for mammals, the
NOAEC for birds would be revised to >51 mg ae/kg and the NOAEC for mammals
would be revised to >49 mg ae/kg. Additionally if one uses the LD50 of >4315 mg ae/kg
from acute avian oral study MRID 00073632, even greater safety could be demonstrated
for mefluidide acid.
EFED response:
EFED will use the most conservative endpoint. The color of the test material does not matter,
as long as it is the correct ingredient, especially when both studies were conducted in the same
way (with the same strain of mice). Even if one study was conducted a bit differently than
the other, to ensure that terrestrial organisms are adequately protected it is EFED's policy to
base the risk assessment on the most sensitive endpoint.
Public comment: FBI/Gordon - Proposed Label language for products containing Mefluidide
167
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After discussions with EPA SRRD personnel, to minimize off target movement of applied
product, the following label language is proposed for all products containing mefluidide.
Droplet Size
To minimize off-target movement of this product, please apply product using spray equipment
which produces a medium to coarse droplet spectrum.
EFED response:
Agdrift was recalculated for medium to course droplet size and incorporated into the risk
assessement with buffers and LOG exceedences.
Public comment:
We recieved a comment from region 9 commenting about the selection of propanil toxicity
data as a substitute for missing mefluidide data. Both herbicides are anilides, but their
structures are very different. Of more concern is that propanil is a photosynthesis inhibitor
while mefluidide is a growth regulator. The different structures and the different modes of
action suggest that propanil effects will not be good predictors of mefluidide effects.
EFED response:
Athough propanil and mefluidide have similar chemical structures, they have different mode
of action for plants. Propanil is a photosynthesis inhibitor in contrast to mefluidide which
inhibits plant cell division, stem elongation and seed head development. Also, propanil has
reported sublethal effects in fish and aquatic invertebrates where mefluidide does not at
similar or lower concentrations such as; surfacing (fish and invertebrates), erratic movement
(invertebrates), loss of equilibrium (fish), quiescent (fish), labored respiration (fish), lying on
side (fish), hypersensitivity to disturbances (fish) and lying on the bottom of test vessel (fish
and invertebrates). Even though propanil effects may not be good predictors of mefluidide
effects, in the absence of mefluidide data, EFED believes propanil data could be used to
estimate the acute to chronic ratio for mefluidide. Note that uncertainties exist with these
extrapolated endpoints and propanil data are not considered complete substitutes for missing
effects data for mefluidide. Other anilide herbicides such as Chloranocryl, Monalide and
Pentanochlor were also considered, however no information was available for these
chemicals.
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RE-REGISTRATION ELIGIBILITY DOCUMENT
ENVIRONMENTAL FATE AND EFFECTS SCIENCE CHAPTER
Environmental Fate and Ecological Risk Assessment
for
Mefluidide (PC Code 114001)
CAS # 53780-34-0
AND
Mefluidide-DEA (PC Code 114002)
CAS # 53780-36-2
AND
Mefluidide-K (PC Code 114003)
CAS #83601-83-6
Environmental Fate and Effects Division Team Members
Marie Janson, Environmental Scientist
James Hetrick, Ph.D., Senior Scientist Advisor
Branch Reviewers
Ed Odenkirchen, Senior Biologist
Branch Chief Approval
Tom Bailey, Ph.D., Branch Chief
169
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Date of Approval: 9/13/07
TABLE OF CONTENTS
1 EXECUTIVE SUMMARY
1.1 Nature of Chemical Stressor 4
1.2 Potential Risks to Non-target Organisms 5
1.3 Conclusions - Exposure Characterization 9
1.4 Conclusions - Effects Characterization 10
1.5 Uncertainties and Data Gaps 12
2 PROBLEM FORMULATION
2.1 Stressor Source and Distribution 13
2.1.1 Environmental Fate Summary 14
2.1.2 Pesticide Type, Class and Mode of Action 14
2.1.3 Use Characterization 14
2.2 Assessment Endpoints 15
2.2.1 Ecosystems at Risk 15
2.2.2 Ecological Effects 16
2.3 Conceptual Model 18
2.3.1 Conceptual Model Diagram 18
2.3.2 Terrestrial Environment 20
2.3.3 Aquatic Environment 20
2.4 Risk Hypotheses 21
3 ANALYSIS
3.1 Use Characterization 22
3.2 Exposure Characterization 22
3.2.1 Environmental Fate Summary 22
3.2.2 Measures of Aquatic Exposure 24
3.2.2.1 .Aquatic Exposure Modeling 24
3.2.3 Measures of Terrestrial Exposure 27
3.2.3.1 .Terrestrial Exposure Modeling 28
3.3 Ecological Effects Characterization 32
3.3.1 Aquatic and Terrestrial Effects Characterization 32
3.3.1.1 Aquatic Animals 35
3.3.1.2 Terrestrial Animals 39
4 RISK CHARACTERIZATION
4.1 Risk Estimation - Integration of Exposure and Effects Data 46
4.1.1 Non-target Aquatic Animals and Plants 49
4.1.1.1.. Freshwater Fish and Invertebrates 50
4.1.1.2. .Estuarine/Marine Fish and Invertebrates 50
170
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4.1.1.3 Aquatic Plants 51
4.1.2 Non-target Terrestrial Animals 52
4.1.2.1 Birds 53
4.1.2.2 Mammals 55
4.1.2.3 Plants 58
4.1.3 RQs Based on Mean Kenaga Residues 61
4.2 Risk Description- Interpretation of Direct Effects 62
4.2.1 Risks to Aquatic Organisms and Plants 62
4.2.2 Risks to Terrestrial Organisms and Plants 62
4.2.4 Federally Threatened and Endangered (Listed) Species 68
4.2.4.1 Action Area 68
4.2.4.2...Taxonomic Groups Potentially at Risks 68
4.3 Description of Assumptions, Limitations, Uncertainties, and Data Gaps 74
4.3.1 Assumptions and Limitations Related to Exposure for all Taxa 76
4.3.2 Assumptions and Limitations Related to Exposure for Aquatic Species 76
4.3.2 Assumptions and Limitations Related to Exposure for Terrestrial Species...77
References 84
APPENDIX A. Data Requirements for Mefluidide 85
APPENDIX B. Bibliography for Environmental Fate and Chemical Structures 86
APPENDIX C. Aquatic Exposure Modeling Assessment - PRZM/EXAMS Outputs..87
APPENDIX D. Terrestrial Exposure Modeling Assessment- TREX and TerrPlant 99
APPENDIX E. Ecological Effects Characterization for Mefluidide 115
APPENDIX F. Guideline Sequence Bibliography for Ecological Effects 140
APPENDIX G. Risk Quotient Method 144
APPENDIX H. ECOTOX Results 146
171
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1. Executive Summary
1.1 Nature of Stressor
Mefluidide is a post-emergent, anilide growth regulator used to control
ornamental and non-ornamental woody plants, ground cover, hedges trees, turf grasses,
grass and broadleaf weeds. It is also registered for growth control of low maintenance turf
on rights-of-ways, airports, and industrial sites. It is formulated as the mefluidide,
diethanolamine salt of mefluidide (mefluidide-DEA), and potassium salt of mefluidide
(mefluidide-K). Based on the ionic nature of mefluidide-K and mefluidide-DEA and two
unreviewed dissociation studies, mefluidide-K and mefluidide-DEA will dissociate rapidly
and completely to form mefluidide acid. The two unreviewed dissociation studies
(MRIDs 422833-01 and 42282001) indicated mefluidide-K completely dissociated in 7
minutes and mefluidide-DEA completely dissociated in 3 minutes. Mefluidide acid is in
equilibriuml with mefluidide (Figure 1). In order to assess the environmental fate and
effects of mefluidide-K, mefluidide-DEA, mefluidide, the risk assessment strategy was to
bridge the environmental fate and ecological toxicity data for the mefluidide, mefluidide-
K, and mefluidide-DEA to the formation of mefluidide acid. For purposes of this
assessment, mefluidide acid will be used as an analog for mefluidide, mefluidide-DEA
and mefluidide-K.
Figure 1. Enol-Keto Equilibrium of Mefluidide-K and Mefluidide
Dissociation with K+
Mefluidide-DEA a.i
Dissociation with DEA
Stressor
Dominant
Mefluidide
Reversible Dissociation
Mefluidide acid
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1 The acetamide functional group in mefluidide exhibits in a enol-keto equilibrium with
mefluidide acid . This equilibrium is expected to favor the formation of the keto form
(mefluidide) over the enol form (mefluidide acid) (Morrison and Boyd, 1976).
1.2 Potential Risk to Non Target Organisms
This screening-level (Level I) risk assessment focused on the use of mefluidide-K,
mefluidide-DEA, and mefluidide on ornamental and turf areas. Results suggest that levels of
mefluidide in the environment, when compared with measured toxicity for the most sensitive
organisms of selected taxa, are likely to result in direct risks to listed and non-listed species
from several different taxa. Indirect risks are also identified for listed and non-listed non-
target organisms.
For the aquatic assessment, estimated environmental concentrations (EECs) in surface
water were calculated for mefluidide acid using the Tier II PRZM/EXAMS models and
employing maximum label application rates for mefluidide, mefluidide-K, mefluidide-DEA.
Turf application scenarios in Florida and Pennsylvania were modeled for the exposure
assessment.
This screening level risk assessment shows that use of mefluidide is below the
Agency's level of concern for direct acute (listed and non-listed) and chronic toxic
exposure to aquatic freshwater and estuarine marine organisms and acute aquatic
plants In contrast, the use of mefluidide is above the Agency's level of concern for direct
acute (listed and nonlisted) and chronic toxic exposure to mammals, birds and acute
(listed and nonlisted) exposure to terrestrial and semi aquatic plants.
The following toxicity data was not available for Agency review3:
• Chronic freshwater fish (72-5)
• Chronic freshwater invertebrates (72-4 b)
• Chronic estuarine marine fish (72-4 a)
• Chronic estuarine marine invertebrates (72-4 b)
• Seedling emergence (123-1 a) A preliminary assessement was completed from a
recently submitted seedling emergence study (MRID47190701) however, these results
are uncertain until a full review of the study is performed.
• Chronic bird (74-1)
• (ECos or NOAEC) was not provided for vascular and nonvascular plants (123-2)
• In the absence of data, EFED:
o Used available toxicity data of propani!2 a structurally similar anilide herbicide
2 Other anilide herbicides considered were chloranocryl, monalide and pentanochlor, however
no ecotoxicity data were-available for these chemicals. The chemical structures of mefluidide
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o Assumed that Ł€25 toxicity values for terrestrial plants (vegetative vigor) are
equivalent to (seedling emergence) measurement endpoints
o Used available data from mefluidide mammal toxicity data to evaluate chronic
toxicity to birds.
The Tier I terrestrial plant model, TERRPLANT, was used to assess risks to terrestrial
and semi-aquatic plants. LOCs were exceeded for both terrestrial and semi-aquatic plants
(monocots and dicots) for both spray and granular applications. All the above modeled
scenarios with T-REX and TERRPLANT are summarized in APPENDIX D. Specific direct
risks of concern to non-target terrestrial organisms are summarized as follows:
• Mammalian Acute Listed LOCs were exceeded for 15 g and 35 g mammals
exposed to application rates for mefluidide-DEA and mefluidide-K (1.0 Ib ae/A at 3
applications) consuming short grass, broadleaf plants, or small insects and 1000 g
mammals that consume short grass.
• Mammalian Acute Listed LOCs were exceeded for the LD50s/sq-ft for 15g and 35 g
mammals based on one granular application of mefluidide at 0.5 Ibs ae/acre.
• Mammalian Acute Restricted Use LOCs were exceeded for 15 g and 35 g mammals
that consume short grass exposed to application rates for mefluidide-DEA and
mefluidide-K (1.0 Ib ae/A at 3 applications).
• Mammalian Acute Restricted Use LOCs were exceeded for the LD50s/sq-ft for small
and medium-sized mammals based on one granular application of mefluidide at O.Slbs
ae/acre.
• Mammalian Chronic LOCs (dose-based) were exceeded for 15 g mammals that
consume short grass exposed to application rates for mefluidide-DEA and mefluidide-
K (1.0 Ib ae/A at 3 applications)
• Avian Acute Listed LOCs were exceeded for 20 g birds that consume short grass,
tall grass and broadleaf plants and small insects and 100 g birds that consume short
grass for the 1.0 Ib ae/A modeled scenario. Non-definitive toxicity endpoints do not
allow for calculations of definitive RQs, however the ratio of non- definitive endpoints
(EECs) in this case results in acute RQs ranging from <0.0 to <0.25.
• Avian Acute Listed LOCs were exceeded for the LD50s/sq-ft for 20 g birds based on
one granular application of mefluidide at 0.5 Ibs ae/acre.
and propanil are provided in Appendix B.3 Submitted ecotoxicity data are summarized in
Appendix A.
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• Avian Acute Restricted Use LOCs were exceeded for 20 g birds that consume short
grass for the 1.0 Iba ae/A application rate modeled scenario. Non-definitive toxicity
endpoints do not allow for calculations of definitive RQs, however the ratio of non-
definitive endpoints (EECs) in this case results in acute RQs of < 0.25.
• Avian Acute Restricted Use LOCs were exceeded for the LD50s/sq-ft for 20 g birds
based on one granular application of mefluidide at 0.5 Ibs ae/acre.
• Avian Chronic LOCs (dietary-based) exceedances occurred for birds for the 1.0 Ib
ae/A modeled scenario. Non-definitive toxicity endpoints do not allow for calculations
of definitive RQs, however the ratio of non- definitive endpoints (EECs) in this case
results in acute RQs ranging from 2.9 to 6.32.
• Terrestrial and Semi-aquatic Plants (Listed Species and Non-Listed Species)
LOCs were exceeded for monocots and dicots with the 1.0 Ib ae/A spray applications
of mefluidide-K and mefluidide-DEA. LOCs were exceeded for dicots and monocots
(granular applications) with 0.5 Ib ae/acre of mefluidide. Dicots demonstrated more
sensitivity than monocots in all application scenarios.
A summary of the potential for direct and indirect effects to listed species, summarized
by taxonomic group, is provided in Table 1.1.
The results of this risk assessment suggest that the patterns of mefluidide use are such
that they coincide in time and space to areas frequented by avian and mammalian wildlife.
These areas have been demonstrated as use by wildlife as sources of food and cover. The
potentially problematic wildlife food items suggested by this risk assessment are likely to be
present in and around the treated areas. In addition, there is potential for indirect effects to all
taxonomic groups due to changes in habitat caused by vegetation changes. Some uses of
mefluidide may not pose a threat for avian and mammalian wildlife, such as industrial sites
that are not frequented by wildlife
Table 1. 1 Listed Species Risks Associated With Direct or Indirect Effects Due to Applications of
Mefluidide
Listed Taxonomy
Terrestrial and semi-
aquatic plants -
monocots
Terrestrial and semi-
-------
Table 1. 1 Listed Species Risks Associated With Direct or Indirect Effects Due to Applications of
Mefluidide
Listed Taxonomy
Terrestrial phase
amphibians
Reptiles
Mammals
Aquatic vascular plants
Aquatic non-vascular
plants a
Freshwater fish
Aquatic phase
amphibians
Freshwater crustaceans
Mollusks
Marine/estuarine fish
Direct Effects
Yes (acute estimated values),
Yes(chronic estimated values),
Yes (acute estimated values),
Yes(chronic estimated values),
Yes (acute and chronic)
None Acute and None (ECos
estimated values)
None Acute and None (ECos
estimated values)
None(acute), None(chronic
estimated values)
None(acute), Unknown(chronic)
b
None (acute), None (chronic
estimated values)
None (acute), None chronic
estimated values
None (acute), None (chronic
estimated values)
Indirect Effects
Yes c' e
Yesc'd'e
Yesc'd'e
Yesc
Yesc
Yesc
Yesc
Yesc
Yesc
Yesc
a At the present time no aquatic non-vascular plants are included in Federal listings of threatened and listed
species. The taxonomic group is included here for the purposes of evaluating potential contributions to indirect
effects to other taxonomy and as a record of exceedances should future listings of non-vascular aquatic plants
warrant additional evaluation of Federal actions.
b Terrestrial phase amphibians and reptiles estimated using birds as surrogates. Aquatic amphibians estimated
using freshwater fish as surrogates.
c Listed and Non-listed LOC exceeded for terrestrial and semi-aquatic plants.
d Listed, Restricted Use, and Acute LOC exceeded for some feeding guilds and size classes of birds.
e Listed, Restricted Use, and Chronic LOC exceeded for some feeding guilds and size classes of mammals.
1.
Conclusions Exposure Characterization
The risk assessment strategy is designed to bridge the environmental fate and effects
data for the mefluidide-K and mefluidide-DEA, mefluidide to mefluidide acid. Based on the
ionic nature of mefluidide-K and mefluidide-DEA and two unreviewed dissociation studies,
mefluidide-K and mefluidide-DEA will dissociate rapidly and completely to form mefluidide
acid. The two unreviewed dissociation studies (MRTDs 422833-01 and 42282001) indicated
mefluidide-K completely dissociated in 7 minutes and mefluidide-DEA completely
dissociated in 3 minutes. The reported pKa for mefluidide acid (4.6) occurs at pH~7, with
176
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50% or greater dissociation at pHs < 4.6. Mefluidide acid is in equilibriums with mefluidide
(Figure 1). The only degradation product identified for mefluidide was 5-amino-2,4-
dimethyltrifluoromethanesulfonilide. Mefluidide is moderately persistent and mobile in soil.
Estimated environmental concentrations (EECs) in surface water were calculated for
mefluidide acid using the Tier IIPRZM/EXAMS models with the maximum proposed
application rates for mefluidide, mefluidide-K, and mefluidide-DEA on turf. Estimated
concentrations are expressed in acid equivalence because mefluidide acid is a common
intermediate compound among mefluidide, mefluidide-K, and mefluidide-DEA. Peak (1-in-
10 year) surface water EECs were approximately 7.054 ug ae/L and 10.573 ug ae/L for the
Pennsylvania Turf and Florida turf scenarios, respectively.
Routes of exposure evaluated in this risk assessment focused on runoff and spray drift
from ground spray with mefluidide applied at application rates of mefluidide-K and
mefluidide-DEA and runoff from granular applications with mefluidide.
For the terrestrial assessment, EECs for mefluidide were calculated using the terrestrial
Tier I model T-REX using the maximum application rate for mefluidide, mefluidide-K, and
mefluidide-DEA. Modeling was based on a foliar half-life of 4 days, 3 applications per season
and 42 day interval. Upper bound dietary EECs for mefluidide-DEA and mefluidide-K
application rate of 1.0 Ib ae/A (spray application) were 240.17 mg ae /kg on short grass,
110.08 mg ae /kg on tall grass, 135.09 mg ae /kg on broadleaf plants, or small insects and
15.01 mg ae /kg for fruits, pods, seeds, and large insects.
For a single granular application of mefluidide at the maximum application rate, 0.5 Ibs
ae/acre, the EEC was calculated as 5.21 mg ae/sq ft. This LD50/ sq ft approach can only be
applied for single applications. Since the chemical is not incorporated into the soil
immediately after application, it is assumed that 100% of the material is available to birds and
mammals (USEPA 1992).
1.4 Conclusions Effects Characterization
The risk assessment strategy is designed to bridge the environmental fate and effects
data for the mefluidide-K and mefluidide-DEA, mefluidide to mefluidide acid. Therefore, the
most sensitive endpoint for the three mefluidide compounds (mefluidide, mefluidide-K,
mefluidide-DEA) was selected to represent all mefluidide compounds for aquatic and
terrestrial organisms in each category. Most of the toxicity endpoints are within one order of
magnitude when comparing the mefluidide and mefluidide-DEA. There was an incomplete
toxicity database on mefluidide-K to allow for comparisons of toxicity.
Table 1.2,1.3 and 1.4 provides a summary of acute and chronic toxicity data used for
risk quotient calculation for mefluidide-K, mefluidide-DEA and mefluidide application.
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Table 1.2: Summary of endpoints (LCso or ECso, mg ae/L) for Aquatic
Toxicity used in RQ calculations for Mefluidide l
TAXONOMIC GROUP
Acute freshwater fish
Chronic freshwater fish
Acute freshwater inverts
Chronic freshwater inverts
Acute estuarine/marine fish
Chronic estuarine/marine fish
Acute estuarine/marine inverts
Chronic estuarine/marine
inverts
Acute
endpoint
>68.47*
Rainbow
Trout
>77.25*
Daphnid
>84.75*
Sheepshead
minnow
67*
Eastern
oyster
Chronic
endpoint
>0.2672
>5.542
>0.2672
>5.542
MRID/
Estimated
value
MRID
418937-02
Estimated
value acute to
chronic ratio
MRID
418937-03
Estimated
value acute to
chronic ratio
MRID
425623-03
Estimated
value acute to
chronic ratio
MRID
425624-01
Estimated
value acute to
chronic ratio
For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged for
the terrestrial risk assessment. *most sensitive species tested
acute to chronic ratio from propanil extrapolation
Table 1.3: Summary of endpoints (LCso or ECso, nig ae/L aquatic organisms)
for Plant Toxicity used in RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute vascular plant
Vascular plant(ECos)
Acute
endpoint
0.515*
Lemna
NOAEC
or EC05
>0.292
MRID 435266-01
Tier I (8% growth
stimulation)
Used this value as ECso
Estimated value acute to
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Acute non-vascular
plant
Non-vascular
plant(EC05)
Terrestrial Plant:
Vegetative Vigor
Terrestrial Plant:
Seedling Emergence
0.629*
Navicula
Monocot:*
Sorghum
EC25 0.105
Ib ae/A
Dicot:*
Mustard
EC25
0.0054 Ib
ae/A
Monocot:
Sorghum
EC25 0.105
Ib ae/A
Dicot:*
Mustard
EC25
0.0054 Ib
ae/A
>0.7862
Monocot:
*
Sorghum
NOAEC
0.045 Ib
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
Monocot:
Sorghum
NOAEC
0.045 Ib
ae/A
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
chronic ratio
MRID 435266-05
Tier I (11. 5% growth
reduction)
Used this value as ECso
Estimated value acute to
chronic ratio
MRID 435496-01
Estimated value from
vegetative vigor study
MRID 435496-01
For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged for the terrestrial risk assessment.
2 acute to chronic ratio from propanil extrapolation
*most sensitive species tested
Table 1.4: Summary of endpoints (LD50 or LC50mg ae/kg) for Terrestrial
Toxicity data used in RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute Avian
Acute
endpoint
>1500*
Bob white
Chronic
endpoint
MRID 416019-01
Used this non-definitive
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Chronic Avian
Acute Dietary Avian
Acute mammal
Chronic mammal
quail
>3750*
829.8*
mouse
38
102*
rat
endpoint as LD50
Estimated value acute to
chronic ratio based on
mefluidide mammal data
MRID 00047 116
MRID 00082748
For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged for the terrestrial risk assessment.
2 acute to chronic ratio from propanil extrapolation
*most sensitive species tested
7.5. Uncertainties, Assumptions, Limitations, and Data Gaps
• Ecotoxicity data for chronic risks to birds exposed to mefluidide were not available.
Therefore, EFED calculated estimates for measurement endpoints for chronic toxicity
to birds by evaluating the available data from mammal toxicity data (acute and
chronic) and extrapolating the findings to available data for mefluidide, mefluidide-
DEA and mefluidide-K to estimate possible effects measurement endpoints. These
extrapolated endpoints are uncertain and are not considered complete substitutes for
missing effects data. Additional information on these estimated values are provided in
Appendix E. Submission of a chronic bird study would quantify risks associated with
exposure of mefluidide to birds.
• The magnitude of toxicity to terrestrial plants is uncertain because only one terrestrial
vegetative vigor plant study was available for full review and conducted on fresh
weight and not dry weight as required by EPA guidelines. . A preliminary review on a
recently submitted seedling emergence study (MRID 471907-01) was conducted.
These results are uncertain until a full review of the study is performed. The results of
the preliminary review are summarized in Appendix E. Therefore, to estimate
possible effects measurement endpoints for seedling emergence, EFED assumed that
EC25 toxicity values for terrestrial plants (vegetative vigor) are equivalent to (seedling
emergence) measurement endpoints for mefluidide, mefluidide-DEA and mefluidide-
K. These estimated endpoints are uncertain and are not considered complete
substitutes for missing effects data. Additional information on these estimated values
are provided in Appendix E.
• The available dietary toxicity studies on avian species failed to established definitive
acute LDso values (i.e., the lethality values exceed the highest dose tested). Therefore,
use of this value adds uncertainty and may overestimate risk to avian species.
Submission of an acute bird study with definitive LD50 values would quantify risks
associated with exposure of mefluidide to birds.
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• Exposure estimates for this screening level risk assessment focused on the mefluidide,
mefluidide-K and mefluidide-DEA. Information or data is not available to evaluate
degradates as a potentially significant contributor to aquatic risk and which may affect
the outcome of risk conclusions are not considered in this risk characterization.
Therefore, this assessment may require further analysis to evaluate degradates as a
potential contributor to aquatic risk.
• In all cases, EFED concluded that resulting estimated risk quotients, had they been
based on definitive effects measurement endpoints, would not trigger concerns for
acute or chronic risks to freshwater fish, chronic estuarine marine fish, chronic
estuarine marine invertebrates, chronic freshwater invertebrates, vascular plants (ECos
or NOAEC) and non-vascular plants (ECos or NOAEC). In contrast, EFED concluded
that resulting estimated risk quotients for terrestrial organisms would trigger concerns
for chronic risks to birds and (listed and nonlisted) terrestrial and semi aquatic plants.
2. Problem Formulation
Problem formulation is used to establish the direction and scope of an ecological risk
assessment. According to the Guidelines for Ecological Risk Assessment (USEPA, 1998),
problem formulation consists of defining the problem and purpose for the assessment, and
developing a plan for analyzing and characterizing risk. The critical components of the
problem formulation are selection of the assessment endpoints, formulation of risk hypotheses
and the conceptual model, and development of an analysis plan. The analysis plan and
supporting rationale are aimed at determining whether the uses of mefluidide as a growth
regulator to control ornamental and non-ornamental woody plants, ground cover, hedges trees,
turf grasses, grass and broadleaf weeds, turf on rights-of-ways, airports, and industrial sites
could result in exposures that cause unreasonable adverse effects (risk) to non-target
organisms including those federally listed as threatened or endangered (hereafter referred to as
"listed"). The maximum application rate for mefluidide applied as ground spray is 1.0 Ib ae/A
for mefluidide-K and mefluidide-DEA. The maximum application rate for mefluidide, as a
granular formulation, is 0.5 Ib ae/A. Mefluidide, mefluidide-K, mefluidide-DEA can be
applied 3 times per season.
2.1 Stressor Source and Distribution
2.1.1 Environmental Fate Summary
Based on the review of the environmental fate data, mefluidide is moderately persistent
and mobile in terrestrial environments. Possible routes of dissipation for mefluidide are
photodegradation on soil surfaces, microbial mediated degradation, leaching, and runoff.
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There are no aerobic aquatic metabolism data to assess the environmental fate of mefluidide
in aquatic environments.
Because a bridging strategy was employed to link mefluidide-K, mefluidide-DEA,
mefluidide to mefluidide acid, exposure estimates for this screening level risk assessment
focused on mefluidide acid. Environmental fate data were not available to evaluate exposure
for mefluidide degradation products.
2.1.2 Pesticide Type, Class and Mode of Action
Mefluidide is an herbicide in the anilide chemical class. The mode of action is through
inhibiting plant cell division, stem elongation and seed head development.
2.1.3 Use Characterization
Mefluidide is used to control ornamental and non-ornamental woody plants, ground
cover, hedges trees, turf grasses, grass and broadleaf weeds. It is also registered for growth
control of low maintenance turf on rights-of-ways, airports, and industrial sites. There are
multiple active ingredient products that contain an additional plant growth regulator and
herbicides such as, paclobutrazol, imazapyr, and imazethapyr. Current formulations include;
granular, liquid-ready to use, and soluble concentrate/liquid. Mefluidide can be applied as a
band treatment, broadcast, spot treatment, and spray. The equipment used to apply mefluidide
includes; backpack sprayer, boom sprayer, ground equipment, hand held sprayer, handgun,
hose-end sprayer, power sprayer, pressure sprayer, and spreader.
The highest use areas for mefluidide include South Carolina, North Carolina,
Virginia, West Virginia, California, Nevada, Arizona, and New Mexico. The maximum
application rate for mefluidide applied as ground sprays is 1.0 Ib ae/A for mefluidide-K and
mefluidide-DEA. The maximum application rate for mefluidide, as a granular formulation, is
0.5 Ib ae/A. Mefluidide, mefluidide-K, mefluidide-DEA can be applied 3 times per season.
The uses that will be included in the re-registration assessment are; agricultural/farm
structures/buildings and equipment, agricultural/nonagricultural uncultivated areas/soils,
airports/landing fields, commercial industrial lawns, commercial institutional/industrial
premises/equipment (indoor/outdoor), golf course turf, hospitals/medical institutions premises
(human veterinary), household domestic dwellings outdoor premises, industrial areas
(outdoor), nonagricultural outdoor buildings/structures, nonagricultural rights-of-
way/fencerows/hedgerows, ornamental and or shade trees, ornamental ground cover,
ornamental herbaceous plants, ornamental lawns and turf, ornamental non-flowering plants,
ornamental woody shrubs and vines, paths/patios, paved area (private roads/sidewalks),
recreational areas, and residential lawns.
2.2 Assessment Endpoints
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2.2.1 Ecosystems Potentially at Risk
Ecosystems potentially at risk are expressed in terms of the selected assessment
endpoints. The typical assessment endpoints for screening-level pesticide ecological risks are
reduced survival and reproductive and growth impairment for both aquatic and terrestrial
animal species. Aquatic animal species of potential concern include freshwater fish and
invertebrates, estuarine/marine fish and invertebrates, and amphibians. Terrestrial animal
species of potential concern include birds, mammals, and beneficial insects. For both aquatic
and terrestrial animal species, direct acute and direct chronic exposures are considered. In
order to protect threatened and listed species, all assessment endpoints are measured at the
individual level. Although endpoints are measured at the individual level, they provide
insight about risks at higher levels of biological organization (e.g. populations and
communities). For example, pesticide effects on individual survivorship have important
implications for both population rates of increase and habitat carrying capacity.
For terrestrial and semi-aquatic plants, the screening assessment endpoint is the
perpetuation of populations of non-target species (crops and non-crop plant species). Existing
testing requirements have the capacity to evaluate emergence of seedlings and vegetative
vigor. The endpoints of seedling emergence (estimated endpoint) and vegetative vigor may
not address all terrestrial and semi-aquatic plant life cycle components, it is assumed that
impacts at emergence and in active growth have the potential to impact individual ability to
compete and reproductive success.
For aquatic plants, the assessment endpoint is the maintenance and growth of standing
crop or biomass. Measurement endpoints for this assessment endpoint focus on vascular
plants (Lemna gibba) and non-vascular plants (i.e., green algae) growth rates and biomass
measurements.
The ecological relevance of selecting the above-mentioned assessment endpoints is as
follows: (1) complete exposure pathways exist for these receptors; (2) the receptors may be
potentially sensitive to pesticides in affected media and in residues on plants, seeds, and
insects; and (3) the receptors could potentially inhabit areas where pesticides are applied, or
areas where runoff and/or spray drift may impact the sites because suitable habitat is
available.
2.2.2 Ecological Effects
Each assessment endpoint requires one or more "measures of ecological effect," which are
defined as changes in the attributes of an assessment endpoint itself or changes in a surrogate
entity or attribute in response to exposure to a pesticide. Ecological measurement endpoints
for the screening level risk assessment are based on a suite of registrant-submitted toxicity
studies performed on a limited number of organisms in the following broad groupings:
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Birds (mallard duck and bobwhite quail), also used as a surrogate
for terrestrial phase amphibians and reptiles (no chronic data submitted on birds),
Mammals (chronic data on laboratory rat, acute data on laboratory mouse),
Freshwater Fish (bluegill sunfish and rainbow trout), also used as a surrogate
for aquatic phase amphibians, (no chronic data submitted on freshwater fish)
Freshwater invertebrates (waterflea) (no chronic data submitted on freshwater
invertebrates),
Estuarine/marine fish (no chronic data on estuarine/marine fish submitted),
Estuarine/marine invertebrates (no chronic data on estuarine/marine invertebrates
submitted),
Aquatic plants (freshwater and estuarine/marine).
Terrestrial Plants (vegetative vigor, preliminary review seedling emergence study)
Within each of these very broad taxonomic groups, an acute and chronic endpoint is selected
from the available test data, as the data sets allow. Additional ecological effects data were
available for other taxa and have been incorporated into the risk characterization as other lines
of evidence, including acute contact and oral toxicity on honeybees and acute risk to
earthworm.
A complete discussion of all toxicity data available for this risk assessment and the resulting
measurement endpoints selected for each taxonomic group are included in Section 3 of this
document. A summary of the assessment and measurement endpoints selected to characterize
potential ecological risks associated with exposure to mefluidide is provided in Table 2.2.
Table 2.2 Summary of Assessment Endpoints and Measures of Effect for
Mefluidide, Mefluidide-DEA1 and Mefluidide-K1
Assessment Endpoint
Measures of Effect
1. Abundance (i.e., survival,
reproduction, and growth) of individuals
and populations of birds
la. Bobwhite quail acute oral LD50
Ib. Bobwhite quail and mallard duck
subacute dietary LCso
Ic. NOAEC estimated value
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2. Abundance (i.e., survival,
reproduction, and growth) of individuals
and populations of mammals
2a. Laboratory mouse acute oral LD50
2b. Laboratory ratLDso
2c. Laboratory rat chronic NOAEC
3. Survival of individuals and
communities of freshwater fish and
invertebrates
3a. Rainbow trout and bluegill sunfish
acute LCso
3b. Water flea acute ECso
3. NOAEC estimated values
4. Survival of individuals and
communities of estuarine/marine fish and
invertebrates
4 a. Sheepshead minnow LCso
4 b. Eastern oyster ECso
4 d. NOAEC estimated values
5. Survival of beneficial insect
populations
5a. Honeybee acute contact
'50
6. Maintenance and growth of individuals
and populations of aquatic plants from
standing crop or biomass
6a. Vascular plant (i.e., Lemna)
values for growth rate and biomass
measurements
6b. Non-vascul ar pi ant (i.e., Naviculd)
ECso values for growth rate and biomass
measurements
6c.EC05s estimated values for vascular
and non-vascular plants
7. Maintenance and growth of individuals
and populations of terrestrial plants from
standing crop or biomass
7a. Vegetative Vigor EC25 values for
growth rate and biomass measurements
7. Seedling Emergence EC25 estimated
values for growth rate and biomass
measurements
LD50 = Lethal dose to 50% of the test population.
LC50 = Lethal concentration to 50% of the test population.
EC5o/EC25 = Effect concentration to 50%/25% of the test population.
NOAEC = No observed adverse effect level.
LOAEC = Lowest observed adverse effect level.
1 The risk assessment strategy is designed to bridge the environmental fate and effects data for the mefluidide-K and
mefluidide-DEA to mefluidide. Therefore, the most sensitive endpoint for the three mefluidide compounds (mefluidide,
mefluidide-K, mefluidide-DEA) was selected to represent all mefluidide compounds for aquatic and terrestrial organisms in
each category.
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2.3 Conceptual Model
In order for a chemical to pose an ecological risk, it must reach ecological receptors in
biologically significant concentrations. An exposure pathway is the means by which a
contaminant moves in the environment from a source to an ecological receptor. For an
ecological exposure pathway to be complete, it must have a source, a release mechanism, an
environmental transport medium, a point of exposure for ecological receptors, and a feasible
route of exposure. In addition, the potential mechanisms of transformation (i.e., which
degradates may form in the environment, in which media, and how much) must be known,
especially for a chemical whose metabolites/degradates are of greater toxicological concern.
In this assessment, mefluidide is only assessed. The assessment of ecological exposure
pathways, therefore, includes an examination of the source and potential migration pathways
for constituents, and the determination of potential exposure routes (e.g., ingestion, inhalation,
and dermal absorption).
The source and mechanism of release of mefluidide and its salts is ground application
(spray and granular) and is an herbicide growth regulator used to control ornamental and non-
ornamental woody plants, ground cover, hedges trees, turf grasses, grass and broadleaf weeds.
It is also registered for growth control of low maintenance turf on rights-of-ways, airports, and
industrial sites. The conceptual model and subsequent analysis of exposure and effects are all
based on mefluidide. Surface water runoff from the areas of application is assumed to follow
topography. Additional release mechanisms include spray drift, and wind erosion, which may
potentially transport site-related contaminants to the surrounding air. Potential emission of
volatile compounds is not considered as a viable release mechanism for mefluidide of because
of a low Henry's Constant (2.27E"7 atm mVmol). The conceptual model shown in Figure 2.1
generically depicts the potential source of mefluidide, release mechanisms, abiotic receiving
media, and biological receptor types.
2.3.1 Conceptual Model Diagram
The conceptual model employs a bridging strategy to account for the dissociation of
mefluidide-K and mefluidide-DEA with the formation of form mefluidide acid. Additionally,
mefluidide is in a keto-enol equilibrium with mefluidide acid. Therefore, the conceptual
model is focused on the fate and disposition of mefluidide acid in the environment, and mode
of application (e.g., ground spray and granular application). A conceptual model (Figure 2.1)
was developed that represents the possible relationships between the stressor, ecological
endpoints, and the measurement endpoints. Risk to non-target animals is also possible from
dermal contact or inhalation, but because these are not considered in the risk assessment, they
are not shown in the diagram below.
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Figure 2.1) Conceptual Model1
Mefluidide applied by ground spray and granular applications
]
Leaching
(Infiltration/
Perolation)
Direct
Ingestion
Dietary
uptake
— 1
Terrestrial Animals
Birds, Mammals, Reptiles
Tefrestrial-phase
Afl^phibians, Bees
Individual Terrestrial
Animals
Reduced Survival
Reduced Growth
Reduced Reproduction
Individual Terrestrial
Plants
Seedling Emergence
Vegetative Vigor
Perturbing Forage or
Prey Availability
Aquatic Invertebrates
Aquatic Vertebrates
Aquatic Plants
Individual Aquatic
Vertebrates and
Invertebrates
Reduced Survival
Reduced Growth
Reduced Reproduction
Bioaccumulation
Habitat Alteration: impacting nesting
ability, ability to seek cover, etc.
Shaded areas in the conceptual model are not assessed in the risk assessment.
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2.3.2 Terrestrial Environment
The highest mefluidide residue levels are expected to be located on the surface soil and
on foliage (e.g., short and tall grasses, broadleaf weeds), seeds, and insects on the treated
agriculture field immediately following ground spraying.
While spray drift may result in transport of mefluidide to off-target field surface soil,
foliage, and insects, the highest concentrations for these media are still expected to be those in
the treated field. Birds, mammals, reptiles, and amphibians that ingest foliage, insects and/or
soil invertebrates from either the treated area or from spray drift impacted areas are potentially
exposed to mefluidide residues in their diet. Endpoints were included that represented
reduced survival, growth, and reproduction in these taxonomic groups from dietary exposure.
Because toxicity data for reptiles and terrestrial-phase amphibians are rarely available, risk
assessment results for birds were used as surrogates to assess risks to reptiles and terrestrial-
phase amphibians (USEPA 2004).
These animals may also be exposed to mefluidide by other exposure routes not
accounted for in this risk assessment, such as incidental ingestion of the soil; dermal contact
with the surface of the foliage or soil, direct impingement of sprayed material on the body at
time of application , residues on dust particulates; and/or ingestion of residues in drinking
water sources such as dew that form on plants and soil, puddles on the field or in spray drift
impacted areas at the time of application or which form after a rain event, and/or surface water
in spray drift and runoff impacted areas. Because of the low octanol/water partitioning
coefficient (log Kow=1.97; Kow=94.5) and a low Henry's Constant of (2.27E"7 atm m3/mol)
concerns for dermal and inhalation exposure would be minimal. Additional exposure
pathways and routes following application includes uptake of mefluidide by plants from soil
which can then be ingested by wildlife and which can then be ingested by other wildlife (i.e.,
food chain transfer).
Mefluidide may reach off-field terrestrial or riparian/wetland vegetation environments in
spray drift at the time of application. Following a rain event mefluidide, may also reach off-
field terrestrial or riparian/wetland vegetation environments in sheet and channel flow runoff.
2.3.3 Aquatic Environment
Direct application of mefluidide to streams, lakes, and ponds is forbidden by the
product label. The highest mefluidide residue levels are expected to be located in surface
waters adjacent to treated agricultural fields at the time of application due to spray drift and/or
from runoff after a rain event.
Because mefluidide is moderately persistent in soils and has a low soil: water partition
coefficient, there is high likelihood of transport by runoff. Exposure estimates for this
screening level risk assessment focused on mefluidide. Information or data was not available
to evaluate degradates as a potentially significant contributor to aquatic risk and is not
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considered in this risk characterization. Fish, amphibians, and aquatic invertebrates that live
in aquatic environments are potentially exposed to mefluidide residues in surface water by
direct contact of their integument (covering of the body or a part such skin, gill membranes,
cuticle, etc.) and via uptake through their gills or integument. Assessment endpoints were
selected to assess reduced survival, growth, and reproduction in these taxonomic groups from
combined direct contact with integument and uptake across the gill or integument. Because
toxicity data for amphibians are rarely available, addressing risks for fish were used as a
surrogate to assess risks to amphibians (USEPA 2004). Aquatic plants may be potentially
exposed by contact with mefluidide residues in surface water or through sorption and uptake
through roots from water compartments or across cell walls.
Leaching (infiltration/percolation) may result in transport of mefluidide through the soil
column into groundwater which may, in some circumstances, flow into a surface water body.
However, groundwater and surface water interactions are not in the exposure estimates for
evaluating ecological risks.
Bioaccumulation of mefluidide in fish tissue is not expected due to a low octanol
water partitioning coefficient (log Kow=1.97; Kow=94.5). Mefluidide was not found to
substantially accumulate (BCF = 0 to 1.11) in catfish tissues during bioconcentration studies
(Accession Number 226851).
2.4 Risk Hypothesis
• Terrestrial vertebrates (birds, mammals, reptiles, terrestrial-phase amphibians) are
subject to adverse direct effects such as reduced survival, growth, and reproduction
when exposed to mefluidide residues as a result of labeled use of the pesticide.
• Non-target terrestrial plants are subject to adverse effects such as reductions in
vegetative vigor and seedling emergence when exposed to mefluidide residues as a
result of labeled use of the pesticide.
• Aquatic invertebrates, fish, and amphibians in surface waters (freshwater or saltwater)
receiving spray drift or runoff from treated fields following mefluidide application are
subject to adverse effects such as reduced reproduction, growth, and survival when
exposed to mefluidide residues as a result of labeled use of the pesticide. Aquatic
plants may be potentially exposed by contact with mefluidide residues in surface water
or through sorption and uptake through roots from water compartments or across cell
walls.
3 ANALYSIS
3.1 Use Characterization
Mefluidide is used to control ornamental and non-ornamental woody plants, ground
cover, hedges trees, turf grasses, grass and broadleaf weeds. It is also registered for growth
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control of low maintenance turf on rights-of-ways, airports, and industrial sites. There are
multiple active ingredient products that contain an additional plant growth regulator and
herbicides such as, paclobutrazol, imazapyr, and imazethapyr. Current formulations include;
granular, liquid-ready to use, and soluble concentrate/liquid. Mefluidide can be applied as a
band treatment, broadcast, spot treatment, and spray. The equipment used to apply mefluidide
includes; backpack sprayer, boom sprayer, ground equipment, hand held sprayer, hose-end
sprayer, power sprayer, pressure sprayer, and spreader.
The highest use areas for mefluidide include South Carolina, North Carolina, Virginia,
West Virginia, California, Nevada, Arizona, and New Mexico. The maximum application
rate for mefluidide applied as ground spray is 1.0 Ib ae/A for mefluidide-K and mefluidide-
DEA. The maximum application rates for mefluidide, as a granular formulation, is 0.5 Ib
ae/A. Mefluidide, mefluidide-K and mefluidide-DEA can be applied 3 times per season.
The uses that will be included in the reregi strati on assessment are: agricultural/farm
structures/buildings and equipment, agricultural/nonagricultural uncultivated areas/soils,
airports/landing fields, commercial industrial lawns, commercial institutional/industrial
premises/equipment (indoor/outdoor), golf course turf, hospitals/medical institutions premises
(human veterinary), household domestic dwellings outdoor premises, industrial areas
(outdoor), nonagricultural outdoor buildings/structures, nonagricultural rights-of-
way/fencerows/hedgerows, ornamental and or shade trees, ornamental ground cover,
ornamental herbaceous plants, ornamental lawns and turf, ornamental non-flowering plants,
ornamental woody shrubs and vines, paths/patios, paved area (private roads/sidewalks),
recreational areas, and residential lawns.
3.2 Exposure Characterization
3.2.1 Environmental Fate and Transport Characterization
The risk assessment strategy is designed to bridge the environmental fate data for the
mefluidide-K, mefluidide-DEA, mefluidide to mefluidide acid. Based on the ionic nature of
mefluidide-K and mefluidide-DEA and two unreviewed dissociation studies, mefluidide-K
and mefluidide-DEA will dissociate rapidly and completely to form mefluidide acid. The two
unreviewed dissociation studies (MRIDs 422833-01 and 42282001) indicated mefluidide-K
completely dissociated in 7 minutes and mefluidide-DEA completely dissociated in 3 minutes.
The reported pKa for mefluidide acid is 4.6. These data suggest complete dissociation of
mefluidide acid is expected to occur at pH~7 (Figure 2), with 50% or greater dissociation at
pHs < 4.6. Mefluidide exhibits an enol-keto equilibrium with mefluidide acid (Figure 1).
Figure 2: Fraction of Undissociated Mefluidide as a Function of pH
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Possible routes of dissipation for mefluidide are photodegradation on soil surfaces,
microbial mediated degradation, leaching, and runoff. Mefluidide is not prone to abiotic
hydrolysis or photolysis in sterile buffer solutions within the environmentally relevent pH
range of 4 to 9 (Accession No. 226846, MRID 42935401). There are data showing
mefluidide undergoes rapid photodegradation (ti/2 = 2 to 3 days) in natural well water
(Accession No. 226851). On soil surfaces, mefluidide photodegraded with a half-life of
4.85 days. Nine unidentified photodegradation products were detected in the soil (MRID
43040801).
Mefluidide in aerobic soils degraded with a half-life of 12 days (MRID 43162201). The
only degradation product was 5-amino-2,4-dimethyltrifluoromethanesulfonilide. It was found
at a maximum daily concentration of 2.8% of applied mefluidide at 22 days post-treatment.
Diethanolamine is a degradation product of mefluidide-DEA. Non-extractable radiolabeled
mefluidide residues accounted for 32 to 37% are 366 days post-treatment. Evolved CC>2
accounted for 20.9% at 366 days posttreatment mefluidide was stable (t 1/2 > 1 year) in
anaerobic environments (MRID 43120001).
Mefluidide has Freundlich adsorption coefficients of 0.22 (l/n=0.35) in sand, 0.14
(l/n=0.95) in silt loam soil, 0.083 (l/n=1.3) in clay soil, and 0.11 (l/n=1.0) in sand sediment
(MRID 42998201). There was no relationship of soil OC content and Kd. Aged residues of
mefluidide were detected in the leachate of aged residue soil column leaching studies (MRID
43020801).
Mefluidide dissipated with a half-life of 2.0 to 3.3 days in warm-season turf soil in
Georgia and 1.2 to 1.4 days in cool-season grass soil in Missouri (MRID 43276802 and
43276801). It was not detected in soil samples at depths greater than 6 inches. Degradation
products were not evaluated in the field dissipation studies. Mefluidide dissipated from grass
foliage at half-lives of 1.7 to 6.91 days (upper 90th percentile of mean half-life=4.0414 day,
k=0.1715days'1}-
Bioaccumulation of mefluidide in fish tissue is not expected due to a low octanol water
partitioning coefficient (log Kow=1.97; Kow=94.5). It also was not found to substantially
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accumulate (BCF = 0 to 1.11) in catfish tissues during bioaccumulation studies (Accession
Number 226851).
There are no environmental fate data on 5-amino-2, 4-dimethyltrifluoro-methane-
sulfonilide. Diethanolamine (DEA) degrades rapidly (ti/2= 1.7 to 5.8 days) in aerobic soil and
water environments (MRID 43685901, 43685902, 44439401). In contrast, DEA is persistent
(ti/2= 990 days) in anaerobic aquatic environments (MRID 43882901). Degradation products
of diethanolamine are glycine, ethanolamine, and CC>2.
3.2.2
Measures of Aquatic Exposure
5.2.2.1
Aquatic Exposure Modeling
PRZM (3.12 beta) and EXAM (2.97.5) using PE4V01.pl (August 13, 2003) were used
to estimate mefluidide residue concentrations in surface water. Because mefluidide use is
associated with turf, the aquatic exposure assessment was conducted using the PA and FL turf
scenarios. These use scenarios were selected to represent of rights-of-way, residential turf,
industrial areas with turf (i.e., airports, etc.), and golf courses. It is important to note that all
mefluidide uses (i.e., spot treatments, etc.) were expressed on a Ibs ae/A basis. This approach
is expected to be conservative because it assumes 100% of the watershed is treated with
mefluidide. Application rates of mefluidide are expressed in acid equivalence to address the
bridging of mefluidide-K, mefluidide-DEA, mefluidide to the assigned stressor (the two forms
of mefluidide: enol/keto; same molecular weight). Table 3.4 contains a summary of the
various tabled application rates which suggests that the maximum rate is that of mefluidide-
DEA. Foliar dissipation half-lives for mefluidide were estimated from field dissipation studies
for warm-season and cool season grasses (MRID 43276801 and MRID 43276802). PRZM
/EXAMS input parameters for mefluidide are shown in Table 3.1. Estimated environmental
concentrations are shown in Table 3.2.
Table 3.1. Input Parameters for Mefluidide Acid for PRZM/EXAMS
Modeling for Aquatic Exposure Assessment
Variable Description
Application date(s) (day/mo/yr)
Number of Applications
Application Interval (days)
Incorporation depth (cm)
Input
Value
15/05
3
42 days
Default=0
Source of Info/Reference
Product label
Label Recommendation
Label Recommendation
Product label
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Application rate (kg a.e. ha"1)
Application efficiency (fraction)
Spray drift fraction: For aquatic ecological
exposure assessment, use 0.05 for aerial spray;
0.01 for ground spray. For drinking water
assessment, use 0.16 for aerial 0.064 for ground
spray.
Foliar extraction (frac./cm rain)
Decay rate on foliage ( days-1)
Volatilization rate from foliage (day-1)
Plant uptake factor (frac. of evap)
Aerobic soil metabolism Half-life (days)
Anaerobic Aquatic Metabolism Half-life (days)
Aerobic Aquatic Metabolism Half-life (days)
Photodegradation in Water Half-life (days)
Adsorption Soil: Water Partitioning
Coefficients
Molecular Weight (grams/mole)
Henry's Constant (atm nrVmol)
Vapor Pressure (torr)
Solubility (mg/L)
Chemical Application Method
Acid- 0.56
DBA salt- 1.1 2
K salt- 1.12
0.99
0.01
0.5 is the
default unless
field data is
available
T1/2=4.0414
days
Rate constant
= 0.1715/day
0.0 is the
default unless
field data is
available
0.0
Ti/2 =36 days
Estimation = 3
X 12 days
Stable
72 days
Estimation= 2
X 36 days
Stable
0.073 (lowest
non-sand Kd)*
310.6
2.27E'7
1E-4
180
2
Bead Use Closure Memorandum
Spray Drift Task Force Data
Spray Drift Task Force Data
Default or field data
Derived as 90th percentile of the mean
foliar dissipation half-life from field
dissipation studies. This value also
used for terrestrial modeling (MRID
43276801 MRID 43276802).
Default or field data
Default
MRID 43 162201
MRID 43120001
No Data Available
MRID 42935401
MRID 42998201
Calculated for Mefluidide structure
EFED One Liner
EFED One Liner
EFED One Liner
Foliar Application
1 Acid equivalence was calculated using the following equations:
Mefluidide-DEA= 310 g/mole (MW mefluidide)/415.24 g/mole (MW mefluidide-DEA)=0.75*concentration of ai
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Mefluidide-K= 310 g/mole (MW mefluidide)/348.29 g/mole (MW mefluidide-K)=0.89*concentration of ai
Mefluidide = 310 g/mole (MW mefluidide)/310 g/mole (MW mefluidide acid)= 1.0* concentration of ai
*there was no relationship of soil OC content. Therefore the lowest non-sand Kd was used.
The 1 in 10 year peak concentration for mefluidide is not expected to exceed 10.573 ug/L.
The 1 in 10 year 21-day and 60-day average concentrations are not expected to exceed 9.623
ug/L and 8.448 ug/L, respectively. A major uncertainty in the assessment is the persistence of
mefluidide acid in aerobic aquatic environments. This assessment was conducted using an
estimated aerobic aquatic half-life of 72 days (Guidance for Chemistry and Management
Practice Input Parameters for Use in Modeling the Environmental Fate and Transport of
Pesticides, Version 2, 11/7/2000). Because this estimated half-life was designed to
approximate upper 90th percentile of the mean half-life, it is anticipated to be a conservative
estimate of mefluidide acid persistence in aquatic environments.
Table 3.2 Tier II Estimated Environmental Concentrations for Mefluidide Acid
Scenario
FLTurf
PA Turf
Chemical
Mefluidide
Mefluidide-DEA
Mefluidide-K
Mefluidide
Mefluidide-DEA
Mefluidide-K
1 in 10 year Concentration (ug ae/L)
Peak
4.835
10.573
10.573
3.031
7.054
7.054
21 day average
4.399
9.623
9.623
2.900
6.738
6.738
60 day average
3.890
8.448
8.448
2.638
6.265
6.265
3.2.2.1
Monitoring Data
NAWQA surface or ground water monitoring data were not found for mefluidide,
mefluidide-K and mefluidide-DEA.
3.2.3 Measures of Terrestrial Exposure
The measures of exposure for terrestrial receptors in Agency ecological risk
assessments can be obtained from monitoring data, field studies, GIS analysis, and exposure
modeling. The TREX (v. 1.3.1) model was used to generate measures of exposure for
terrestrial organisms that may come in contact with areas where mefluidide may be used. This
assessment focuses on all methods of exposure for terrestrial birds and mammals as a result of
spray and granular applications of mefluidide. Other routes of exposure, primarily dermal,
inhalation, and incidental soil ingestion were not evaluated in this assessment. The degree to
which these routes of exposure may be important compared to exposure from dietary
ingestion is an uncertainty. Even though these routes of exposure may be important to the
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overall risk assessment, they require more analyses and data than those available for a
screening-level assessment. However, inhalation is not likely to be an important exposure
pathway because of the low Henrys Constant of mefluidide (2.27E-7 atm m3/mole). Dermal
exposure is not likely to be an important exposure pathway because of the low octanol/water
partitioning coefficient (log Kow=l .97; Kow=94.5). Mammalian toxicity studies for both
inhalation and dermal exposure to mefluidide indicate low acute toxicity are summarized in
Appendix E. Incidental soil ingestion is another possible route of exposure; available data
suggests that up to 15% of the diet can consist of incidentally ingested soil depending on the
species and feeding strategy (Beyer et al, 1994). Because mefluidide is moderately persistent
in soils, incidental soil ingestion is a possible exposure pathway.
Exposure of free-ranging receptors is a function of the timing and extent of pesticide
application with respect to the location and behavior of identified receptors. EFED's
terrestrial exposure model generates exposure estimates assuming that the receptor is present
on the use site at the time that pesticide levels are their highest.
The maximum pesticide residue concentration on food items is calculated from both initial
applications and additional applications taking into account pesticide degradation between
applications. In this assessment, three applications of mefluidide per season are applied as
recommended by the label. Because mefluidide dissipates rapidly from turf foliage (ti/2 = 4
days) and the application intervals are long (42 days), the likelihood for carry-over of
mefluidide residues between applications is low.
The current approach to screening-level terrestrial exposure estimation does not directly
relate the timing of exposure to critical or sensitive population, community, or ecosystem
processes. Therefore, it is difficult to address the temporal and spatial co-occurrence of
mefluidide use based on application timing, application location and sensitive ecological
processes. However, it is worth noting that pesticides are frequently used from spring through
fall, which are times of active migrating, feeding, and reproduction for many wildlife species.
The increased energy demands associated with these activities (as opposed to hibernation, for
example) can increase the potential for exposure to pesticide contaminated food items since
agricultural areas can represent a concentrated source of relatively easily obtained, high-
energy food items. In this assessment, the spatial extent of exposure for terrestrial animal
species is limited to the use area only.
It is assumed that given the typically lower metabolic demands of reptiles and
amphibians compared to birds, exposure to birds would be greater due to higher relative food
consumption. While this assumption is likely true, there are no supported relationships
regarding the relative toxicity of a compound to birds and herpetofauna.
3.2.3.1 Terrestrial Exposure Modeling
Birds and Mammals
Estimated exposure concentrations for terrestrial receptors were determined using
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the standard screening-level exposure model, TREX (v. 1.3.1) (US EPA,2006). Maximum
exposure levels were calculated for spray applications of mefluidide using maximum
proposed application rates, maximum number of applications, and minimum application
intervals for all proposed uses (Table 3.3). These exposure estimates are based on a database
of pesticide residues on wildlife food sources associated with a specified application rate.
Essentially, for a single application, there is a linear relationship between the amount of
pesticide applied and the amount of pesticide residue present on a given food item. These
relationships for the various food items are determined from the Kenaga nomogram as
modified by Fletcher (Hoerger and Kenaga, 1972; Fletcher et al., 1994). TREX (v. 1.3.1) is a
simulation model that, in addition to incorporating the nomogram relationship, also includes
pesticide degradation in the estimation of EECs. These EEC values from the TREX model
are summarized in Appendix D
TREX calculates pesticide residues on each type of food item on a daily interval for one
year. A first order decay function is used to calculate the residue concentration at each day
based on the concentrations present from both the initial and additional applications. The
first-order rate equation is: Ct = Qe"11 Where Ct is concentration at time t (days; t= 0
initially), Ct is initial concentration after application, k is the foliar dissipation half-life, and t
is time in days. The initial concentration, Ct, is determined by multiplying the application rate
by a constant specific to a food item.
For the ornamental turf control application for mefluidide-DEA and mefluidide-K at 1.0
Ib a.e. of pesticide per acre the upper-bound, food item concentration (ppm) is: 240.17 for
short grass, 110.08 for tall grass, 135.09 for broadleaf plants and small insects, and 15.01 for
fruits, pods, and large insects.
The dose-based EECs (mg/kg-bw) derived above are compared with LD50 or NOAEL
(mg/kg-bw) values from acceptable or supplemental toxicity studies that are adjusted for the
size of the animal tested compared with the size of the animal being assessed (e.g., 20-gram
bird). These exposure values are presented as mass of pesticide consumed per kg body weight
of the animal being assessed (mg/kg-bw). EECs and toxicity values are relative to the
animal's body weight (mg residue/kg bw) because consumption of the same mass of pesticide
residue results in a higher body burden in smaller animals compared with larger animals. For
birds, only acute values (LD50s) are adjusted because dose-based risk quotients are not
calculated for the chronic risk estimation. Adjusted mammalian LD50s and reproduction
NOAELs (mg/kg-bw) are used to calculate dose-based acute and chronic risk quotients for 15
g, 35 g, and 1000 g mammals. The test weight value for the acute laboratory mouse (20 g),
(Lehman, A. J. 1975), replaced the (350 g) laboratory rat value in the TREX modeled equations.
Equations and calculations for adjusted LD50s (mammals and birds) are summarized in
Appendix D.
In many cases, an empirically determined foliar dissipation half-life value is not
available, in which case the default value of 35 days is used (Willis and McDowell, 1987).
However, a 4 day foliar dissipation half life was estimated from field dissipation studies on
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warm-season and cool season grasses (MRID 43276801 and 43276802). The food item
concentration on any given day is the sum of all concentrations up to that day taking into
account the first-order degradation. The initial application is on day 0 (t = 0) and runs for 365
days. Over the 365 day run, the highest residue concentration is used in calculations of the
RQ.
Table 3.3 lists exposure estimates for birds and animals obtained from TREX
simulations for all the proposed uses of mefluidide at maximum label rates. Importantly,
TREX considers exposure only in the area where mefluidide is applied. The underlying
assumption is that most, if not all, of the applied pesticide will settle in the use area.
However, depending on weather conditions and type of application, spray drift of pesticides
may occur, increasing the likelihood of wildlife exposure outside the use area.
Table 3.3 Estimates of Foliar residues of Mefluidide for proposed uses (dietary based
EECs)1
Use
Ornamental Turf
Ground sprays
(Mefluidide salts
only)
Application Rate Ibs.
ae/A Food Items
(# app / interval, days)
1.0
3 per season
42
Day interval
Short grass
Tall grass
Broadleaf plants/small insects
Fruits, pods, seeds, and large
insects
Upper Bound EEC
(mg/kg)
240.17
110.08
135.09
15.01
Predicted maximum residues for specified application rates are based on Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994).
The residues or estimated environmental concentrations (EECs) on food items may be
compared directly with subacute dietary toxicity data or converted to an ingested whole body
dose (single oral dose), as is the case for small mammals and birds. Single-oral dose estimates
represent, for many pesticides, an exposure scenario where absorption of the pesticide is
maximized over a single ingestion event. Subacute dietary estimates provide for possible
effects of the dietary matrix and more extended time of gut exposure on pesticide absorption
across the gut. However dietary exposure endpoints are limited in their utility because the
current food ingestion estimates are uncertain and may not be directly comparable from
laboratory conditions to field conditions. The EEC is converted to an oral dose by multiplying
the EEC by the percentage of body weight consumed as estimated through allometric
relationships. These consumption-weighted EECs (i.e. EEC equivalent dose) are determined
for each food source and body size for mammals (15, 35, and 1000 g) and birds (20, 100, and
1000 g).. The EEC equivalent doses, formulas and calculations for adjusted body weights for
birds and mammals based on 1.0 Ib ae/A from TREX for turf are summarized in Appendix
D
A second approach for calculation of acute RQs for birds and mammals is the LD50 per
ft2 method. This method is used to address the exposure from granular pesticides (i.e.,
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mefluidide). EECs for this approach are calculated from the application rate (Ibs ae/acre) and
converted to mg ae/sq ft using the formula:
Ibs ae/acre * (453590 mg/lb) * (acre/43560 sq ft) = mg ae/sq ft.
Because the chemical is not incorporated into the soil immediately after application, it is
assumed that 100% of the material is available to birds and mammals (USEPA 1992). For a
single application of mefluidide at 0.5 Ibs ae/acre, the EEC was calculated at 5.21 mg ae/sq ft.
This approach can only be applied for single applications.
Terrestrial Plants
Terrestrial and semi-aquatic plants may be exposed to pesticides from runoff, spray
drift or volatilization. Semi-aquatic plants are those that inhabit low-laying wet areas that
may be dry at certain times of the year. The runoff scenario in TERRPLANT 1.2.1 is: (1)
based on a pesticide's water solubility and the amount of pesticide present on the soil surface
and its top one centimeter, (2) characterized as "sheet runoff" (one treated acre to an adjacent
acre) for dry areas, (3) characterized as "channel runoff (10 acres to a distant low-lying acre)
for semi-aquatic or wetland areas, and (4) based on percent runoff values of 0.01, 0.02, and
0.05 for water solubilities of <10, 10-100, and >100 ppm, respectively. Spray drift is assumed
as (1) 1% for ground application, (2) 5% for aerial, airblast, forced air, and spray chemigation
applications, and (3) 0% for granular applications. Currently, EFED derives plant exposure
concentrations from a single, maximum application rate only. EECs are calculated using the
approach outlined in the text box below. The EECs for terrestrial plants for a single
application of Mefluidide at the maximum label rate for ornamental turf are presented in
Table 3.4
Table 3.4 EECs for Granular and Spray Applications to Terrestrial Plants Near
Mefluidide Use Areas from TerrPlant (v 1.2.1)1.
Application Rate,
Ibs a.e./A
1.0 Ib ae/A
Turf
0.5 Ib ae/A
Turf
EECs (Ibs. a.e A)
Application Total Loading to Adjacent
method Areas (sheet runoff + drift)
ground spray
0.06
granular
0.03
Total Loading to Semi-
Aquatic Areas (channelized
runoff + drift)
0.51
0.255
Drift EEC
0.01
0.0050
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1 For terrestrial plant (seedling emergence and vegetative vigor) toxicity assessments, data evaluating mefluidide-K, mefluidide-DEA and
mefluidide toxicity have been bridged. Therefore, the most sensitive Mefluidide endpoint was selected to represent terrestrial plants for all
application scenarios.
a
EECs for spray turf applications in this table were calculated for the maximum labeled application rates of (1.2 Ibs ae/acre) and (1.0 Ibs
ae/acre) for mefluidide-DEA and mefluidide-K respectively..
'The runoff factor of 0.05 was used based on solubility of 180
Because mefluidide is a spray applied herbicide, a more in-depth spray drift exposure
assessment utilizing Tier I AgDRIFT® (version 2.01) modeling is also provided to better
characterize potential exposure of terrestrial plants. AgDRIFT® utilizes empirical data to
estimate off-site deposition of aerial and ground applied pesticides, and acts as a tool for
evaluating the potential of buffer zones to protect sensitive habitats from undesired exposures.
AgDrift provided 90th percentiles estimates based on the distribution of field measurements at
10 to 900, feet distances from the edge of field. Table 3.5 contains EECs at several distances
from the edge of the field for fine to very fine droplet size and medium to course droplet size.
Table 3.5 Estimated environmental concentrations (EECs) Deposition (Ib ae./acre) at
Specified Buffer Distance From Edge of Field (feet) from off-target terrestrial
exposure to Mefluidide through spray
drift derived from Tier I AgDRIFT® (version 2.01) at varying distance from the edge
of field.
Buffer Distance
From Edge of Field (feet)
10
20
40
60
80
100
140
180
200
250
500
900
1.0lbae/A*
0.0923
0.0437
0.0218
0.0149
0.0115
0.0095
0.007
0.0056
0.0051
0.0042
0.0021
0.0011
1.0lbae/A**
0.0275
0.0149
0.0087
0.0064
0.0052
0.0044
0.0035
0.0029
0.0026
0.0022
0.0012
0.0007
* Ground application assumed conditions of low boom, ASAE very fine to fine droplet size,
and 90th
** Ground application assumed conditions of low boom, ASAE medium to course droplet
size, and 90
,th
3.3 Ecological Effects Characterization
3.3.1 Aquatic and Terrestrial Effects Characterization
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In screening-level ecological risk assessments, effects characterization describes the
types of effects a pesticide can produce in an animal or plant. This characterization is based
on registrant-submitted studies and an ECOTOX database search that describe acute and
chronic effects toxicity information for various aquatic and terrestrial animals and plants. In
addition, a review of Ecological Incident Information System (EIIS) was conducted to further
refine the characterization of potential ecological effects. Tables 3.6, 3.7,3.8, summarize the
most sensitive ecological toxicity endpoints for aquatic organisms, terrestrial organisms, and
aquatic and terrestrial plants, respectively, which were used for risk characterization.
Discussions of the effects of mefluidide-K, mefluidide-DEA and mefluidide on aquatic and
terrestrial taxonomic groups are presented below. Concentrations of mefluidide are expressed
in acid equivalence to address the bridging of mefluidide-K, mefluidide-DEA, mefluidide to
mefluidide acid.
Acid equivalence was calculated using the following equations:
Mefluidide-DEA= 310 g/mole (MW mefluidide)/415.24 g/mole (MW mefluidide-DEA)=0.75 * concentration of ai
Mefluidide-K= 310 g/mole (MW mefluidide)/348.29 g/mole (MW mefluidide-K)=0.89 * concentration of ai
Mefluidide acid = 310 g/mole (MW mefluidide)/310 g/mole (MW mefluidide acid)= 1.0 * concentration of ai
Appendix E summarizes the results of all of the registrant-submitted toxicity studies
for this risk assessment. Also, a search of the ECOTOX database was completed on
mefluidide. Results of Ecotox search are listed in Appendix H. For mammals, toxicity
studies are limited to the laboratory rat. Estuarine/marine testing is limited to a crustacean, a
mollusk, and a fish. Also, no available data was available for reptiles or amphibians. The
risk assessment assumes that avian and reptilian and terrestrial-phase amphibian toxicities are
similar. The same assumption is used for fish and aquatic-phase amphibians. The most
sensitive ecological toxicity endpoints for aquatic organisms, terrestrial organisms, and
aquatic and terrestrial plants were used for risk characterization.
. Table 3.6, .3.7 and 3.8 provides a summary of acute and chronic toxicity data used for risk quotient
calculation for mefluidide-K, mefluidide-DEA and mefluidide application.
Table 3.6: Summary of endpoints (LC50 or EC50, mg ae/L) for
Aquatic Toxicity used in RQ calculations for Mefluidide 1
TAXONOMIC GROUP
Acute freshwater fish
Acute
endpoint
>68.47*
Rainbow
Trout
Chronic
endpoint
MRID/
Estimated
value
MRID
418937-02
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Chronic freshwater fish
Acute freshwater inverts
Chronic freshwater
inverts
Acute estuarine/marine
fish
Chronic
estuarine/marine fish
Acute estuarine/marine
inverts
Chronic
estuarine/marine inverts
>77.25*
Daphnid
>84.75*
Sheepshead
minnow
67*
Eastern
oyster
>0.267
>5.54
>0.267
>5.54
Estimated
value acute to
chronic ratio
MRID
418937-03
Estimated
value acute to
chronic ratio
MRID
425623-03
Estimated
value acute to
chronic ratio
MRID
425624-01
Estimated
value acute to
chronic ratio
For fish and invertebrates data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged
for the runoff risk assessment.
* most sensitive species tested
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Table 3.7: Summary of endpoints (LC50 or EC50, mg ae/L) for Plant Toxicity used in RQ
calculations for Mefluidide1
TAXONOMIC GROUP
Acute vascular plant
Vascular plant(ECos)
Acute non-vascular
plant
Non-vascular
plant(ECos)
Terrestrial Plant:
Vegetative Vigor
Terrestrial Plant:
Seedling Emergence
Acute endpoint
0.515*
T
Lemna
0.629*
Navicula
Monocot:*
Sorghum
EC250.1051b
ae/A
Dicot:*
Mustard EC25
0.0054 Ib ae/A
Monocot:
Sorghum
EC250.1051b
ae/A
Dicot:*
Mustard EC25
0.0054 Ib ae/A
NOAEC or
EC05
>0.29
>0.786
Monocot:*
Sorghum
NOAEC
0.045 Ib ae/A
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
Monocot:
Sorghum
NOAEC
0.045 Ib ae/A
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
MPJD 43 5266-01
Tier I (8% growth stimulation)
Used this value as ECso,
Estimated value acute to chronic ratio
MPJD 43 5266-05
Tier 1(1 1.5% growth reduction)
Used this value as ECso,
Estimated value acute to chronic ratio
MPJD 43 5496-01
Estimated value from vegetative
vigor study MPJD 43 5496-01
'For aquatic and terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been
bridged for the terrestrial and runoff risk assessment.
*most sensitive species tested
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Table 3.8: Summary of endpoints (LD50 or LCsomg ae/kg) for Terrestrial
Toxicity data used in RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute Avian
Chronic Avian
Acute Dietary Avian
Acute mammal
Chronic mammal
Acute
endpoint
>1500*
Bob white
quail
>3750*
829.8* mouse
Chronic
endpoint
38
102* rat
MRID 416019-01
Used this non-definitive
endpoint as LD50
Estimated value acute to
chronic ratio based on
mammal data
MRID 000471 16
MRID 00082748
'For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged for the
terrestrial risk assessment.
*most sensitive species tested
3.3.1.1 Aquatic Animals
Acute Toxicity to Freshwater Fish
There are no acute toxicity studies for mefluidide-K or mefluidide for bluegill sunfish
(Lepomis macrochirus) (warm water species) or cold water species, rainbow trout
(Oncorhynchus my kiss).
Mefluidide-DEA is practically non-toxic to the cold water species, rainbow trout
(Oncorhynchus mykiss), with a non-definitive 96-hour LCso of >68.47 mg ae/L and aNOAEC
of 68.47 mg ae/L (MRID 418937-02). No mortalities or sublethal signs of toxicity in rainbow
trout were observed with test material in any of the tested concentrations. The mean measured
concentrations were 15.2, 12.5,24.4,45.2, and 91.3 mg ai/L. (11.4, 9.3, 18.3, 33.9 and 68.4
mg ae/L).
Mefluidide-DEA is practically non-toxic to the warm water species, bluegill sunfish
(Lepomis macrochirus) with a non-definitive 96-hour LCso of >70.80 mg ae/L and a NOAEC
of 70.80 mg ae/L (MRID 418937-01). No mortalities or sublethal signs of toxicity in bluegill
sunfish were observed with test material in any of the tested concentrations. The mean
measured concentrations were 14.6, 19.7, 32.4, 58.3 and 94.4 mg ai /L(10.9, 14.7, 24.3, 43.7
and 70.8 mg ae/L).
The most conservative non-definitive LCso of > 68.47 mg ae/L for mefluidide was
determined from the rainbow trout fish study with mefluidide-DEA. Both studies were
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classified as acceptable based on guidelines §72-1 (a) and §72-l(c) testing requirements. These
results are summarized in Table El.
The non-definitive LC50 of >68.47 mg ae/L was selected for evaluating freshwater
fish for the runoff risk assessment of mefluidide-K, mefluidide-DEA and mefluidide.
Acute Toxicity to Estuarine/Marine Fish
Mefluidide is practically non-toxic to sheepshead minnow (Cyprinodon variegatus),
with a non-definitive 96-hour LC50 of >130 mg ae/L and a NOAEC of 130 mg ae/L (MRTD
425624-03). No mortalities or sublethal signs of toxicity in sheephead minnow were observed
with test material in any of the tested concentrations. The mean measured concentrations were
19, 28, 45, 80, and 130 mg ae /L.
Mefluidide-DEA is practically non-toxic to sheepshead minnow (Cyprinodon
variegatus), with a non-definitive 96-hour LCso of >84.75 mg ae/L and a NOAEC of 84.75
mg ae/L (MRID 425623-03). No mortalities or sublethal signs of toxicity in sheephead
minnow were observed with test material in any of the tested concentrations. The mean
measured concentrations were 16, 28, 34, 68, and 113 mg ai /L (12, 21, 25.5, 51 and 84.7 mg
ae/L).
The non-definitive LC50 of >84.75 mg ae/L was selected for evaluating estuarine
marine fish exposed to mefluidide-K, mefluidide-DEA and mefluidide for the runoff risk
assessment.
Chronic Toxicity to Freshwater Fish and Estuarine/Marine Fish
No studies evaluating the chronic toxicity of mefluidide to freshwater or
estuarine/marine fish have been submitted to the Agency. Due to lack of submitted chronic
studies for freshwater fish estimated acute to chronic ratios (ACRs) were derived from the
propanil analog. Therefore, the chronic NOAEC of > 0.267 mg ae/L value for freshwater fish
was estimated from the propanil analog. Calculations and endpoints used to determine ACRs
are summarized in Appendix E
Mefluidide is practically non-toxic to estuarine marine fish and slightly toxic to estuarine
marine invertebrates on an acute basis. The lowest acute LCso values reported for estuarine
marine fish and invertebrates are >84.75 and (57.75 and 67 mg ae/L), respectively.
There are insufficient data to establish a definitive toxicity endpoint for estuarine/marine fish
and invertebrate chronic effects for mefluidide and DEA salt acid equivalents for mefluidide.
There is also little available data to compare to other anilide herbicides for this taxonomic
group For the purposes of this risk assessment, it was assumed that estuarine marine fish
were at least as sensitive as freshwater fish in terms of chronic toxicity. Therefore, the
estimated endpoint for freshwater fish (NOAEC >0.267 mg ae/L) was used to estimate a
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chronic effects endpoint for estuarine/marine fish. The multiple assumptions involving
extrapolations across species (fathead minnow and rainbow trout), data from a single analog
(propanil) and across freshwater and estuarine/marine conditions suggests that this estimate
maybe highly uncertain. (For more information, please see source data in Appendix E for
other anilide herbicide).
Acute Toxicity to Freshwater Invertebrates
Mefluidide-DEA is practically non-toxic to the waterflea (Daphnia magna), with a
non-definitive 48-hr EC50 >77.25mg ae/L and a NOAEC of 77.25mg ae/L (MRID 418937-
03). Mean measured concentrations were 16.2, 28.0, 41.8, 68.0 and 103 mg ai/L. (12.1, 21,
31.3,51 and 77.2 mg ae/L). One mortality for freshwater invertebrates occurred at the 5 Img
ae/L. This death was not considered treatment related due to 100% survival in the 77.2 mg
ae/L concentration. This study is classified as acceptable according to the §72-2 guideline
requirements.
The non-definitive LCso of 77.25 mg ae/L was selected for evaluating freshwater
invertebrates exposed to mefluidide-K, mefluidide-DEA, and mefluidide for the runoff risk
assessment.
The results of these tests are summarized in Appendix E, Table E2.
Acute Toxicity to Estuarine/Marine Invertebrates
Mefluidide is practically non-toxic to the estuarine marine mysid (Mysidopsis bahia),
with a 96-hr EC50 133 mg ae/L and a NOAEC of 47 mg ae/L (MRID 425624-02). Mean
measured concentrations were 16.2, 28.0, 47, 80 and 133 mg ae/L. One mortality for
estuarine marine invertebrates occurred at the 28 mg ae/L treatment level. However, this death
was not considered treatment related. By the end of the study 50% mortality had occurred in
the 133 mg ae/L treatment group. This study is classified as acceptable according to the §72-3
guideline requirements.
Mefluidide-DEA is practically non-toxic to the estuarine marine mysid (Mysidopsis
bahia), with a 96-hr EC50 >94.5mg ae/L and a NOAEC of 31.5 mg ae/L (MRID 425623-02).
Mean measured concentrations were 15, 26, 42, 75 and 126 mg ai/L
(11.25, 19.5, 31.5, 56.2 and 94.5 mg ae/L). One mortality to estuarine marine mysid occurred
at the 52.2 mg ae/L treatment level and 2 mortalities occurred in the 94.5 mg ae/L treatment
level. No other mortalities or sublethal effects occurred during the test. This study is
classified as acceptable according to the §72-3 guideline requirements.
Mefluidide is practically slightly toxic to the estuarine marine eastern oyster
(Crassostrea virginica) for shell deposition, with a 96-hr ECso 67 mg ae/L and a NOAEC of
<12 mg ae/L (MRID 425624-01). Mean measured concentrations were 12, 21, 34, 55 and 99
mg ae/L. There were no mortalities or observations of sublethal effects during the test. The
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length measurements indicated shell growth inhibition ranging from 16.7% in the 12 mg ae/L
group to 73% in the 99 mg ae/L This study is classified as acceptable according to the §72-3
guideline requirements.
Mefluidide-DEA is slightly toxic to the estuarine marine eastern oyster (Crassostrea
virginica) for shell deposition with a 96-hr ECso 57.75 mg ae/L and a NOAEC of <10.5 mg
ae/L (MRID 425623-01). Mean measured concentrations were 14, 23, 37, 61 and 98 mg
ai/L.(10.5, 17.25, 27.75, 45.75 and 73.5 mg ae/L). The length measurements indicated shell
growth inhibition ranging from 11% in the 10.5 mg ae/L group to 71% in the 73.5 mg ae/L.
This study had 3 study deficiencies which results in a supplemental study. There was less
than the recommended shell growth in the control animals, contamination was present in the
control groups and the flow rate in the test chambers was less than recommended. However,
adequate dose response occurred in the study. Contamination of the control solutions was
evident, but this contamination was intermittent and well below the NOEC. Also the results
of the study correlate well with the oyster shell deposition study done with TGAI (MRID
425624-01). This study is classified as supplemental according to the §72-3 guideline
requirements.
The EC50 of 67 mg ae/L was selected for evaluating estuarine marine invertebrates
exposed to mefluidide-K, mefluidide-DEA and mefluidide for the runoff risk assessment.
The most sensitive endpoint EC50 57.75 mg ae/L was not selected due to study deficiencies
as described above.
The results of these tests are summarized in Appendix E, Table E2.
(Chronic Toxicity to Estuarine/Marine Invertebrates
No studies were submitted to the Agency evaluating the chronic toxicity of
mefluidide-DEA, mefluidide-K and mefluidide to freshwater and estuarine marine
invertebrates. Due to lack of submitted chronic studies for freshwater invertebrates estimated
acute to chronic ratios (ACRs) were derived from the Propanil analog. Therefore, the chronic
NOAEC of >5.54 mg ae/L value for freshwater invertebrates was estimated from the propanil
analog. Calculations and endpoints used to determine ACRs are summarized in Appendix D
There are insufficient data to establish a definitive toxicity endpoint for estuarine/marine
invertebrate chronic effects for the acid and DEA salt acid equivalents for mefluidide. There is
also little available data to compare to other anilide herbicides for this taxonomic group For
the purposes of this risk assessment, it was assumed that estuarine marine invertebrates were
at least as sensitive as freshwater invertebrates in terms of chronic toxicity. Therefore, the
estimated endpoint for freshwater invertebrates (NOAEC >5.54 mg ae/L) was used to estimate
a chronic effects endpoint for estuarine/marine invertebrates. The multiple assumptions
involving extrapolations with data from a single analog (Propanil) and across freshwater and
estuarine/marine conditions suggests that this estimate maybe highly uncertain (see source
data in Appendix E for other anilide herbicide).
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\Aquatic Plant Toxicity
No studies were submitted to the Agency evaluating the acute toxicity of mefluidide-K and
mefluidide to aquatic plants. For mefluidide-DEA, the dosage tested for Lemna gibba
(freshwater vascular plant) was 0.515 mg ae/L with stimulation of 8% frond growth for a
Tier I study (MRID 435266-05). The dosage tested for Selenastrum capricornutum was 0.561
mg ae/L caused an 8% growth reduction in the exposed algal population for a Tier I study
(MRID 435266-03). For the other two species of freshwater non-vascular plants (i.e.,
Naviculapelliculosa andAnabaenaflos-aquae), Tier I studies resulted in (0.629 mg ae/L)
11.5% growth reduction and (0.543 mg ae/L) 4.3% growth reduction, respectively (MRIDs
435266-01 and 435266-04). For the estuarine/marine non-vascular plant (Skeletonema
costatum\ the dosage tested was 0.575 mg ae/L which resulted in no adverse effects for this
Tier I study (MRID 4435266-02). All of the above Tier I studies are classified as acceptable
according to the 122-2 guideline requirements.
The experimental procedures and dose calculation procedures for the range finding
tests, for the above Tier I studies are basically the same as are those for the final or definitive
studies. The results of the definitive or final aquatic plant tests are one order of magnitude
more toxic than the range finding tests. The results for both sets of studies do not show any
inhibition levels above 50%.
Due to lack of submitted aquatic plant studies for vascular and non-vascular plants, NOAEC
or ECos values were estimated acute to chronic ratios (ACRs) from the propanil analog. An
EC05 was estimated at >0.029 value for vascular plants and >0.786 mg ae/L for non-vascular
plants. The multiple assumptions involving extrapolations with data from a single analog
(propanil) suggests that this estimate maybe highly uncertain. Calculations and endpoints
used to determine ACRs are summarized in Appendix E.
Peak EECs from the PRZM/EXAMS turf modeled scenarios ranged from 0.003031 mg ae/L
to 0.010573 mg ae/L. The Tier I study for Navicula pelliculosa resulted in (0.629 mg ae/L)
11.5% growth reduction. In contrast, the Tier I study for Lemna gibba resulted in (0.515 mg
ae/L) 8% frond growth.
The results of the above studies and the range-finding tests are provided in Table E4.
3.3.1.2 Terrestrial Animals
Acute oral gavage bird
For mefluidide, an acute single-dose oral toxicity study was performed using the
bobwhite quail (Colinus virginianus). The 58.2% ai compound was adjusted to 100% ai at
dosing. Thirty birds were used at one dose level of 2000 mg ae/ kg. The LDso value was
>2000mg ae/kg-bw. The results of this study categorize mefluidide as practically non-toxic to
birds on a acute oral basis. However, this study is classified as Supplemental for an avian
dietary LD 50 study because it is unclear what material (TGAI, formulated product, or
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formulation intermediate) was tested. No statistics were performed due to lack of mortality
and no signs of toxicity were observed. (MRID 416021-01)
For mefluidide-DEA, an acute single-dose oral toxicity study was performed using the
bobwhite quail (Colinus virginianus). The 21.5% ai compound was adjusted to 100% ai at
dosing. Thirty birds were used at one dose level of 1500 mg ae/ kg. The LDso value was
>1500mg ae/kg-bw. The results of this study categorize mefluidide-DEA as practically non-
toxic to birds on an acute oral basis. However, this study does not fulfill the requirement in
support of registration and is classified as Supplemental for an avian dietary LD 50 study
because it is unclear what material (TGAI, formulated product, or formulation intermediate)
was tested. No statistics were performed due to lack of mortality and no signs of toxicity
were observed (MRID 416019-01).
The above studies are summarized in Table E5.
Sub a^ute (dietary) Toxicity to Birds
For mefluidide, one dietary toxicity study was performed using the mallard duck (Anas
platyrhynchos). The 58.2% ai compound was adjusted to 100% ai at dosing. Thirty birds were
used at one dose level of 5000 mg ae/ kg diet. In the mallard duck study, the non-definitive
LCso was >5000 mg ae/kg diet. The results of this study categorize mefluidide as practically
non-toxic to birds on a dietary basis. However, this study is classified as Supplemental for an
avian dietary LCso study because it is unclear what material (TGAI, formulated product, or
formulation intermediate) was tested. No statistics were performed due to lack of mortality
and no signs of toxicity were observed. (MRTD416021-03)
For mefluidide, one dietary toxicity study was performed using the bobwhite quail
(Colinus virginianus). The 58.2% ai compound was adjusted to 100% ai at dosing. Thirty
birds were used at one dose level of 5000 mg ae/ kg diet. In the bobwhite quail study, the
non-definitive LC50 was >5000 mg ae/kg diet. The results of this study categorize mefluidide
as practically non-toxic to birds on a dietary basis. However, this study is classified as
Supplemental for an avian dietary LCso study because it is unclear what material (TGAI,
formulated product, or formulation intermediate) was tested. No statistics were performed
due to lack of mortality and no signs of toxicity were observed. (MRID 416021-02).
For mefluidide-DEA, one dietary toxicity study was performed using the mallard duck (Anas
platyrhynchos). The 21.5% ai compound was adjusted to 100% ai at dosing. Thirty birds
were used at one dose level of 3750mg ae/ kg diet. In the mallard duck study, the non-
definitive LCso was >3750 mg ae/ kg diet. The results of this study categorize mefluidide as
practically non-toxic to birds on a dietary basis. However, this study is classified as
Supplemental for an avian dietary LCso study because it is unclear what material (TGAI,
formulated product, or formulation intermediate) was tested. No statistics were performed due
to lack of mortality and no signs of toxicity were observed. (MRTD416019-03)
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For mefluidide-DEA, one dietary toxicity study was performed using the bobwhite
quail (Colinus virginianus). The 21.5% ai compound was adjusted to 100% ai at dosing.
Thirty birds were used at one dose level of 3750 mg ae/ kg diet. In the bobwhite quail
study, the non-definitive LCso was >5000 mg ae/ kg diet. The results of this study categorize
mefluidide-DEA as practically non-toxic to birds on a dietary basis. However, this study is
classified as Supplemental for an avian dietary LCso study because it is unclear what material
(TGAI, formulated product, or formulation intermediate) was tested. No statistics were
performed due to lack of mortality and no signs of toxicity were observed. (MRID416019-02)
The LCso of 3750 mg ae/kg diet was selected for evaluating birds on a sub acute dietary
basis exposed to mefluidide-K, mefluidide-DEA and mefluidide for the terrestrial risk
assessment.
The above studies were classified as supplemental according to Guideline §71-2
requirement for subacute avian dietary testing and are summarized in Table E6.
Chronic Toxicity to Birds
No studies were submitted to the Agency evaluating the chronic toxicity of mefluidide-
DEA, mefluidide-K and mefluidide to birds. There are insufficient data to establish a
definitive toxicity endpoint for chronic effects to birds for the acid and DEA salt acid
equivalents for mefluidide. There is also no available chronic avian data from other anilide
herbicides for this taxonomic group to extrapolate acute to chronic ratios. For the purposes of
this risk assessment, it was assumed that birds are similar in toxicity responses as mammals in
terms of chronic toxicity. Therefore, acute to chronic ratios (ACRs) were derived from
mefluidide laboratory rat and laboratory mouse data to determine the estimated chronic
NOAEC of 38 mg ae/kg value for birds. Calculations and endpoints used to determine ACRs
are summarized in Appendix E. The assumptions involving extrapolations with data from
different terrestrial species suggests that this estimate maybe highly uncertain.
Acute Oral Toxicity to Mammals
Wild mammal testing is required on a case-by-case basis, depending on the results of
lower tier laboratory mammalian studies, intended use pattern and pertinent environmental
fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's
Health Effects Division (HED) substitute for wild mammal testing.
An acute oral toxicity study with the laboratory mouse for mefluidide resulted in a
LD50 value of 829.8 ae mg/kg bw (MRID 00047116). This study is acceptable and satisfies
guideline requirements for acute oral toxicity in rodents (81-1). Mefluidide is toxicity
Category II. The data are summarized in Table E9.
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Additional acute oral toxicity studies with the laboratory mouse and laboratory rat
resulted in LDso values based on mefluidide ranged from 1920.2 ae mg/kg bw to >4000 ae
mg/kg bw. Mefluidide toxicity was classified as Category III.
The LD50 of 829.8 mg ae/kg bw was selected for evaluating mammals on a acute
dietary basis exposed to mefluidide-K, mefluidide-DEA and mefluidide for the terrestrial risk
assessment.
The data are summarized in Table E9.
Subchronic and Developmental/Chronic Toxicity to Mammals
Multi-Generation Reproduction Laboratory Rat Toxicity Study
In a three-generation reproduction study (MRTD 00082748), MBR 12325 (Mefluidide;
93% a.i., Lot #25) was administered in the diet to 20 male and 40 female Charles River CD®
rats/dose group at dose levels of 0, 600, 1800, or 6000 ppm (equivalent to Males/Females -
0/0, 34/60, 102/183, and 346/604 mg ae/kg bw/day)
There were no effects on food consumption, organ weights, gross pathology, or
histopathology. Numerous absolute and relative (to bw) organ weights in the 6000 ppm
parents were significantly (p<0.05) different from the controls, however, none of these
differences were corroborated by any macroscopic or microscopic findings indicating these
decreases were most likely not related to treatment. Thus, it is likely that they were
attributable to decreased body weights at this dose.
The only deaths included one 6000 ppm Fl female, one 6000 ppm F2 male, and one
1800 ppm F2 female. It was stated that macroscopic and microscopic findings in these
animals were unremarkable. Therefore, these deaths were considered incidental and were not
treatment related. At 6000 ppm, body weights were decreased by 1-8% in males and 1-12%
in females throughout the study in the P generation, attaining significance (p<0.05) at Week
18 in the males and Weeks 8, 18, 19, and 27 in the females. In the Fl generation at this dose,
body weights were decreased throughout the study in the males (deer. 13-21%) and females
(deer. 10-21%), attaining significance (p<0.01) at Weeks 27, 37, and 56 in both sexes.
Similarly in the F2 generation, body weights were decreased throughout the study in the 6000
ppm males (deer. 14-21%) and females (deer. 11-23%), attaining significance (p<0.01) at
Weeks 57, 66, and 85 in both sexes. At 1800 ppm, only minor and infrequent decreases in
body weights were noted. There were no treatment-related findings at 600 ppm.
The parental systemic LOAEL is 6000 ppm (346/604 mg ae/kg bw/day in
males/females), based on decreased body weights in both sexes in all generations. The
parental systemic NOAEL is 1800 ppm (102/183 mg ae/kg bw/day in males/females). This
study is acceptable/guideline and satisfies the guideline requirement for a three-generation
reproductive study (OPPTS 870.3800; OECD 416) in rats.
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Developmental Toxicity Study in Laboratory Rats:
In a developmental toxicity study (MRID 42026102), mefluidide-DEA (28.78% a.i. Lot
# JB0624)) in distilled water was administered to pregnant Sprague Dawley Crl:CD BR
VAF/Plus (25/dose) by gavage at dose levels of 0, 50, 200 or 400 mg/kg bw/day (adjusted
doses for 100 % purity were 0, 14, 58, or 115 mg/kg/day, respectively) from days 6 through
15 of gestation. Animals were checked daily for clinical signs, mortality. Body weights were
measured on gestation day 0, 6, 9, 12, 16 and 20. Unscheduled deaths, scheduled sacrifice
and c-sections were subjected to gross necropsy examination. Each fetus was examined for
external/visceral/skeletal anomalies, sexed and then weighed. Evidence of maternal toxicity
included transient clinical signs (tremors, dark material around the nose, urine stain and
reddish vaginal discharge), decreased body weight gain (11-61%), decreased food
consumption and mortality (2/25 females) observed at the 400 mg ai/kg/day levels No
external malformations or developmental variations were observed associated with any fetus.
Fetal toxicity was manifested by increase in the number of early resorptions which resulted in
increase in mean postimplantation loss at 400 mg ai/kg/day dose.
The maternal NOAEL was 200 mg ai/kg/day (adjusted to 58 mg/kg/day) and the
LOAEL at 400 mg ai/kg/day (adjusted to 115 mg/kg/day) based on clinical signs (tremors,
dark material around the nose, urine stain and reddish vaginal discharge), decreased body
weight gain, decreased food consumption and mortality (2/25 females).
The developmental toxicity NOAEL was 200 mg/kg/day (adjusted to 58 mg/kg/day),
the LOAEL was 400 mg ai/kg/day (adjusted to 115 mg/kg/day) based on increase in the
number of early resorptions and increase in mean postimplantation loss.
The NOAEC of 102 mg ae/kg bw was selected for evaluating mammals on a
chronic/reproductive basis exposed to mefluidide-K, mefluidide-DEA and mefluidide for the
terrestrial risk assessment.
This developmental toxicity study is classified acceptable/Guideline and it does satisfy
the guideline requirement for a developmental toxicity study (OPPTS 870.3700; OECD 414)
in the rat.
Acute Toxicity to Non-target Insects (Honey Bee)
Acute contact toxicity of mefluidide-DEA on the honey bee (Apis melliferd) was tested
and the data are summarized in Table E8. In the acute contact test, the non-definitive LD50
value was >18.75 jig ae/bee and the NOAEC was 9.37|ig ae/bee. Mortality ranged between 6
and 14% with doses 1.6,3.1,6.3, 12.5 and 25 wgai/bee (1.2, 2.3, 4.7, 9.3, and 18.75 wgae
/bee). Mortality at the four lowest test levels was determined to be non-treatment related.
Mortality at the highest level was 14%. Mefluidide-DEA is categorized as practically non-
toxic to honeybees on an acute contact basis. This study is classified as acceptable according
to guideline 141-1 (MRID 425628-01).
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Acute contact toxicity of mefluidide-K on the honey bee (Apis melliferd) was tested and
the data are summarized in Table E8. In the acute contact test, the non-definitive LD50 value
was >22.25|ig ae/bee and the NOAEC was 22.25|ig ae/bee. Mortality ranged between 6 and
14% with doses 1.6,3.1,6.3, 12.5, 25 wg-ai/bee (1.4, 2.7, 5.6, 11.1 and 22.25 ug ae/bee).
Mortality at all treatment levels was determined not to be treatment related since clinical
observations were similar between control and treated bees and the surviving bees at the
lowest dosage appeared normal throughout the test. Mefluidide-K is categorized as
practically non-toxic to honeybees on an acute contact basis. This study is classified as
acceptable according to guideline 141-1 (MRID 425628-02).
Terrestrial Plant
A Tier II vegetative vigor study was conducted for ten species using mefluidide-DEA
and the data are summarized in Tables E12 and El3. For the vegetative vigor study, the most
sensitive monocot was sorghum with an Ł€25 of 0.105 Ibs ae/A and a NOAEC of 0.045 Ibs
ae/A, and the most sensitive dicot was mustard, with an Ł€25 of 0.00547 Ibs ae/A and a
NOAEC of 0.0029 Ibs ae/acre. For both monocots and dicots, the most sensitive parameter
was shoot fresh weight. Symptoms of toxicity included stunting, chlorosis, necrosis and
distortion. This study was originally classified as acceptable, however this study will be
reviewed for a possible classification of Supplemental because this study was based on fresh
weight instead of dry weight which is required according to guideline 123-1 (MRID 435496-
01).
Seedling emergence toxicity data was not available for a full review and data was not
available from other anilide analogs to derive EC25 values. . A preliminary review on a
recently submitted seedling emergence study (MRID 471907-01) was conducted. These
results are uncertain until a full review of the study is performed. The results of the
preliminary review are summarized in Appendix E. Therefore, to estimate possible effects
measurement endpoints for seedling emergence, EFED assumed that EC25 toxicity values for
vegetative vigor are equal to seedling emergence measurement endpoints for mefluidide,
mefluidide-DEA and mefluidide-K. Therefore, the most sensitive seedling emergence EC25
estimated values are 0.105 and 0.0054 Ib ae/acre for monocots and dicots, respectively. The
NOEC estimated values for seedling emergence are 0.045 and 0.0029 Ib ae/acre for monocots
and dicots, respectively.
Earthworms
No earthworm studies were submitted to the Agency. However, Ecotox data indicates
that mefluidide is non-toxic to earthworms (Ref #39542 Potter DA; Spicer PG;Redmond CT;
Powell AJ (1994) Toxicity of Pesticides to Earthworms in Kentucky Bluegrass Turf). Two
evaluations were conducted in the spring and the fall of 1992. Earthworm populations were
sampled at 1 and 3 weeks after treatment. The application rate of mefluidide applied to the
212
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plots were 0.56 ai/ha of Embark 2S which resulted in 0% and 17 % reduction of earthworms
in the spring and fall respectively after the 3 week treatments.
Review of Incident Data
A review of the EIIS database for ecological incidents involving mefluidide,
mefluidide-DEA and mefluidide-K was completed on December 28, 2006. There were no
incidences reported for mefluidide, mefluidide-DEA and mefluidide-K in the EIIS database.
Incident reports submitted to EPA since approximately 1994 have been tracked by
assignment of I #s in an Incident Data System (IDS), microfiched, and then entered to a
second database (in EFED), the Ecological Incident Information System (EIIS). An effort
has also been made to enter information to EIIS on incident reports received prior to
establishment of current databases. Incident reports are often not received in a consistent
format (e.g., states and various labs usually have their own formats), may involve multiple
incidents involving multiple chemicals in one report, and may report on only part of a given
incident investigation (e.g., residues).
It is believed that the EFED database contains reports of only a small portion of plant
and animal wildlife incidents that actually occur as a result of pesticide use. Mortality
incidents must be seen, reported, investigated, and had investigation reports submitted to EPA
to have the potential to get entered into a database. Incidents often are not seen, especially if
the affected organisms are inconspicuous or few people are systematically looking, for
example. Incidents seen may not get reported to appropriate authorities capable of
investigating the incident because the finder may not know of the importance of reporting
incidents, may not know who to call, or may not feel they have the time or desire to call, for
example. Incidents reported may not be investigated if resources are limited or may not get
investigated thoroughly. Reports of investigated incidents often do not get submitted to EPA,
since reporting by states is voluntary and some investigators may believe that they don't have
the resources to submit incident reports to EPA.
Review ofECOTOXData
A search of the ECOTOX from a Duluth review was completed on II 5/06 for
mefluidide. Six studies were reviewed with reference numbers 39542, 71019, 74741, 82489,
82719 and 82721. Studies with reference numbers 71019, 74741, 82489 were not incorporated
in the assessment. The references to the above referenced studies and studies that were not
accepted by OPP are posted in Appendix H.
Ecotox data indicates that mefluidide is non-toxic to earthworms (Ref #39542 Potter
DA; Spicer PG; Redmond CT; Powell AJ (1994) Toxicity of Pesticides to Earthworms in
Kentucky Bluegrass Turf). Two evaluations were conducted in the spring and the fall of 1992.
Earthworm populations were sampled at 1 and 3 weeks after treatment. The application rate
of mefluidide applied to the plots were 0.56 ai/ha of Embark 2S which resulted in 0% and 17
213
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% reduction of earthworms in the spring and fall respectively after the 3 week treatments.
(ref#39542)
Ecotox data indicates that mefluidide is non-toxic to grazing cattle based on weight
gain. Twelve Hereford heifers were used in a grazing experiment to determine intake and
digestibility of tall fescue forage treated with mefluidide. Additionally, steer and heifer
performance were evaluated after grazing tall fescue pastures or consuming hay harvested
from pastures treated with mefluidide. Two forage plots were sprayed with 0.28kg ai/ha when
tall fescue herbage was 10 cm in height. Steers grazing mefluidide-treated herbage had
greater total weight gains than untreated fields during a 168 d study (86 vs 69 kg). Heifers fed
hay harvested from mefluidide treated pastures also exhibited similar improvements in gain
(49 vs 38 kg) because of increased forage consumption (8.3 vs. 7.3 kg/d) greater forage OM
digestibility (65 vs. 61%). Greater weight gains were attributed to a increased nitrogen
content, lowered NDF neutral detergent fiber content (NDF) and increased OM digestibility
from herbage available( ref#82719) A similar study (ref#82721) for effects of mefluidide on
grazing cow-calf performance on smooth brome pastures also resulted in improved calf
performance on treated mefluidide fields with 0.28kg ai/ha of mefluidide. Mefluidide sprayed
on fields produced 26 kg/ha more cow gain than the controlled smooth brome pastures.
RISK CHARACTERIZATION
Risk characterization is the integration of exposure and effects characterization to determine
the ecological risk from the use of mefluidide and the likelihood of effects on aquatic life,
wildlife, and plants based on varying pesticide-use scenarios. The risk characterization
provides a estimation and a description of the risk; articulates risk assessment assumptions,
limitations, and uncertainties; synthesizes an overall conclusion; and provides the risk
managers with information to support regulatory decision making.
4.1. Risk Estimation - Integration of Exposure and Effects Data
Results of the exposure and toxicity effects data are used to evaluate the likelihood of
adverse ecological effects on non-target species. For the assessment of mefluidide risks, the
risk quotient (RQ) method is used to compare exposure and toxicity values. Estimated
environmental concentrations (EECs) are divided by acute and chronic toxicity values. The
resulting RQs are compared to the Agency's levels of concern (LOCs). These LOCs are the
Agency's interpretive policy and are used to analyze potential risk to non-target organisms
and the need to consider regulatory action. These criteria are used to indicate when a
pesticide's use as directed on the label has the potential to cause adverse effects on non-target
organisms.
A summary of toxicity values used to calculate RQs is provided in Table 4.1 and 4.2
and 4.3 more detailed discussion of mefluidide toxicity can be found in section 3.3 and
Appendix D.
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Table 4.1: Summary of endpoints (LCso or ECso, mg ae/L) for
Aquatic Toxicity used in RQ calculations for Mefluidide 1
TAXONOMIC GROUP
Acute freshwater fish
Chronic freshwater fish
Acute freshwater inverts
Chronic freshwater
inverts
Acute estuarine/marine
fish
Chronic
estuarine/marine fish
Acute estuarine/marine
inverts
Chronic
estuarine/marine inverts
Acute
endpoint
>68.47*
Rainbow
Trout
>77.25*
Daphnid
>84.75*
Sheepshead
minnow
67*
Eastern
oyster
Chronic
endpoint
>0.267
>5.54
>0.267
>5.54
MRID/
Estimated
value
MRID
418937-02
Estimated
value acute to
chronic ratio
MRID
418937-03
Estimated
value acute to
chronic ratio
MRID
425623-03
Estimated
value acute to
chronic ratio
MRID
425624-01
Estimated
value acute to
chronic ratio
1 For fish and invertebrates data evaluating mefluidide-K, mefluidide-DEA and mefluidide have been bridged
for the runoff risk assessment.
*most sensitive species
Table 4.2: Summary of endpoints (LCso or ECso, mg ae/L) for Plant Toxicity
used in RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute vascular plant
Acute
endpoint
0.515*
Lemna
NOAEC
or EC05
MRID 435266-01
Tier 1(8% growth
stimulation)
Used this value as EC50,
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Vascular plant (ECos )
Acute non-vascular
plant
Non-vascular plant (
ECos
Terrestrial Plant:
Vegetative Vigor
Terrestrial Plant:
Seedling Emergence
0.629*
Navicula
Monocot:*
Sorghum
EC25 0.105
Ib ae/A
Dicot:*
Mustard
EC25
0.00541b
ae/A
Monocot:
Sorghum
EC25 0.105
Ib ae/A
Dicot:*
Mustard
EC25
0.00541b
ae/A
>0.29
>0.786
Monocot:
*
Sorghum
NOAEC
0.045 Ib
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
Monocot:
Sorghum
NOAEC
0.045 Ib
ae/A
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
Estimated value acute to
chronic ratio
MRID 435266-05
Tier 1(1 1.5% growth
reduction)
Used this value as ECso,
Estimated value acute to
chronic ratio
MRID 435496-01
Estimated value from
vegetative vigor study
MRID 435496-01
'For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have
been bridged for the terrestrial risk assessment. *most sensitive species tested
Table 4.3: Summary of endpoints (LDso or LCsomg ae/kg) for Terrestrial
Toxicity data used in RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute Avian
Chronic Avian
Acute
endpoint
>1500*
Bob white
quail
Chronic
endpoint
38
MRID 416019-01
Used this non-definitive
endpoint as LDSO
Estimated value acute to
216
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Acute Dietary Avian
Acute mammal
Chronic mammal
>3750*
829.8*
mouse
102*
rat
chronic ratio based on
mammal data
MRID 00047 116
MRID 00082748
'For terrestrial plants data evaluating mefluidide-K, mefluidide-DEA and mefluidide have
been bridged for the terrestrial risk assessment. *most sensitive species tested
4.1.1 Non-target Aquatic Animals and Plants
Routes of exposure evaluated in this risk assessment focused on runoff and/or spray
drift for mefluidide-K, mefluidide-DEA and mefluidide. Tier IIPRZM/EXAM modeling was
used to estimate mefluidide acid concentrations in surface water. The runoff assessment
considered the maximum label application rates. Because the mefluidide can be used on
general turf areas including residential and agricultural areas, the runoff modeling was
conducted using the PA turf and FL turf scenarios. More importantly, mefluidide labels
allow broadcast applications as well as spot treatments. Application rates, therefore, were
expressed on Ibs ae/A regardless of the recommend application treatment. This approach is
expected to be conservative because it assumes 100% of the watershed is treated with
mefluidide. Concentrations of mefluidide are expressed in acid equivalence to address the
bridging of mefluidide-K, mefluidide-DEA, mefluidide to mefluidide acid. Foliar dissipation
half-lives were incorporated in the modeling to address mefluidide dissipation from the
foliage of warm-season and cool season grasses. PRZM /EXAMS input parameters for
mefluidide are shown in Table 3.1. Estimated environmental concentrations are shown in
Table 3.2.
The l-in-10 year peak EECs were compared to acute toxicity endpoints to derive acute
RQs for mefluidide. For aquatic vascular and non-vascular plants, l-in-10 year peak EECs
were compared to acute EC50 values to derive acute non-listed species RQs. NOAEC values
for vascular and non-vascular plants were estimated to derive listed species RQs for these
taxonomic groups. RQs for listed and non-listed aquatic vascular and non-vascular plants are
summarized in Table 4.2.
4.1.1.1
Freshwater Fish and Invertebrates
Risk quotients for mefluidide-K, mefluidide-DEA and mefluidide were <0.0001 for
acute freshwater fish and invertebrates based on the non-definitive EC50 of >68.47 mg ae/L
for freshwater fish and >77.25 mg ae/L for freshwater invertebrates. Acute risk quotients for
freshwater fish and invertebrates are summarized in TABLE 4.4.
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Risk quotients for mefluidide-K, mefluidide-DEA and mefluidide were <0.001 for
chronic freshwater fish and invertebrates based on the non-definitive estimated NOAEC
values of >0.267 mg ae/L for freshwater fish and >5.54 mg ae/L for freshwater invertebrates.
Chronic RQs for mefluidide freshwater fish and invertebrates were derived from estimated
values due to lack of toxicity data and are summarized in Appendix D.
No LOG exceedances occurred for acute and chronic risks to freshwater fish and
invertebrates for all application scenarios.
Table 4.4. Aquatic acute freshwater fish and Invertebrate RQs for Mefluidide-K,
Mefluidide-DEA and Mefluidide applications by Ground (G) Spray and Granular(GR) for
the aquatic runoff assessment1'2'3
Application Scenario
Ornamental Turf
(FLTurf PRISM scenario)
3 applications per season ( interval of 6
weeks apart)
Ornamental Turf
( PA Turf PRISM scenario)
3 applications per season ( interval of 6
weeks apart)
mefluidide (GR)
mefluidide-K and
mefluidide-DEA (G)
mefluidide (GR)
mefluidide-K and
mefluidide-DEA (G)
Acute
EECs mg
ae/L
0.004835
0.010573
0.003031
0.007054
Fresh water
Invertebrates
Acute RQs
(EC50 >77.25
mg ae/L)2
0.0000625
0.0001368
0.0000392
0.0000913
Freshwater
Fish
Acute RQs
(EC50 >68.47
mg ae/L)2
0.0000706
0.0001544
0.0000442
0.000103
The below notation will be used to denote values that exceed the Levels of Concern (LOG)
* exceeds LOG for acute risk to listed fish or invertebrate species (RQ > 0.05)
* * exceeds LOCs for acute risk to listed fish or invertebrate species and restricted use (RQ > 0.1)
4.1.1.2 Estuarine'/Marine Fish and Invertebrates
Risk quotients for mefluidide-K, mefluidide-DEA and mefluidide were <0.0001 for
acute estuarine marine fish aquatic-phase amphibians based on the non-definitive ECso of
>84.75 mg ae/L. No LOG exceedances occurred for acute risks to estuarine/ marine
invertebrates with an EC50 of 67 mg ae/L and RQs <0.0001 for all application scenarios.
Acute risk quotients for estuarine marine fish and invertebrates are summarized in TABLE
4.5.
There are insufficient data to establish a definitive toxicity endpoint for
estuarine/marine fish and invertebrate chronic effects for mefluidide and mefluidide-DEA.
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For the purposes of this risk assessment, it was assumed that estuarine marine fish were at
least as sensitive as freshwater fish in terms of chronic toxicity. Therefore, the estimated
endpoint for freshwater fish (NOAEC >0.267 mg ae/L) was used to estimate a chronic effects
endpoint for estuarine/marine fish. Therefore, based on the estimated NOAEC of >0.267 mg
ae/L no exceedances occurred for chronic estuarine marine fish and invertebrates. These
estimated RQ values are summarized in Appendix D.
Table 4.5. Aquatic Estuarine Marine fish and Invertebrate RQs for Mefluidide-K,
Mefluidide-DEA and Mefluidide applications by Ground (G) Spray and Granular(GR)
for the aquatic runoff assessment1'2'3
Application Scenario
Ornamental Turf
(FLTurf PRISM scenario)
3 applications per season ( interval of 6
weeks apart)
Ornamental Turf
( PA Turf PRISM scenario)
3 applications per season ( interval of 6
weeks apart)
mefluidide (GR)
mefluidide-K and
mefluidide-DEA (G)
mefluidide (GR)
mefluidide-K and
mefluidide-DEA (G)
Acute
EECs mg
ae/L
0.004835
0.010573
0.003031
0.007054
E/M
Invertebrates
Acute RQs
(EC50 67 mg
ae/L)2
0.0000721
0.0001578
0.0000452
0.0001052
E/M
Fish
Acute RQs
(EC50 >84.75
mg ae/L)2
0.000057
0.0001247
0.0000357
0.0000832
1 The below notation will be used to denote values that exceed the Levels of Concern (LOG)
* exceeds LOG for acute risk to listed fish or invertebrate species (RQ > 0.05)
* * exceeds LOCs for acute risk to listed fish or invertebrate species and restricted use (RQ > 0.1)
4.1.1.3
Aquatic Plants
Although no ECso values were available from aquatic plant studies, RQs were calculated
for aquatic plants based on a ECso values >0.515 mg ae/L for vascular plants and >0.629 mg
ae/L for non-vascular plants. RQ values were <0.1 for all modeled scenarios.
Risk quotients for mefluidide-K, mefluidide-DEA and mefluidide were <0.1 for
vascular and non-vascular plants based on the non-definitive estimated ECos values of >0.029
mg ae/L for vascular plants and >0.786 mg ae/L for non-vascular plants.
No LOG exceedances occurred for acute listed and non-listed risks to vascular and non-
vascular plants for all application scenarios.
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Table 4.6 lists the RQs for aquatic vascular and non-vascular plants potentially
exposed to mefluidide-K, mefluidide-DEA and mefluidide. No LOG exceedances (RQs
<0.1) occurred for vascular and non-vascular plants.
Table 4.6. Aquatic Plant RQs for Mefluidide-K, Mefluidide-DEA and Mefluidide
applications by Ground (G) Spray and Granular(GR) for the aquatic runoff
assessment1
Application Scenario
Ornamental
Turf
(FLTurf
PRZM
scenario)
3 applications
,
per season (
interval of 6
weeks apart)
Ornamental
Turf
( PA Turf
PRZM
scenario)
3 applications
per season (
interval of 6
weeks apart)
mefluidide
ff~*T)\
(GR)
mefluidide-
K and
mefluidide-
DEA (G)
mefluidide
(GR)
mefluidide-
K and
mefluidide-
DEA (G)
EECs to
calculate
Acute
RQsmg
ae/L
0.004835
0.010573
0.003031
0.007054
Vascular
Plants
RQs(
EC50
>0.515
mg ae/L)
0.0093883
0.02053
0.0058854
0.013697
Vascular
Plants
(listed)
RQs
(EC05>0.29
mg ae/L)
0.0166724
0.0364586
0.0104517
0.0243241
Non-
vascular
Plants RQs
ECso
(>0.629 mg
ae/L)2
0.0076868
0.0168092
0.0048187
0.0112146
Non-
vascular
Plants RQs
(EC05>0.786
mg ae/L) 2
0.0061513
0.0134516
0.0038562
0.0089745
The below notation will be used to denote values that exceed the Levels of Concern (LOG)
* exceeds LOG for acute risk to aquatic plant species (RQ > 1.0, calculated as acute EEC /EC50 )
"exceeds LOG for acute risk to listed aquatic plant species (RQ > 1.0, calculated as acute EEC /NOAEC)
***exceeds LOG for acute risk to listed aquatic plant species (RQ > 1.0, calculated as acute EEC /NOAEC),
However, currently there are no listed non-vascular plants.
EC50 or NOAEC estimated calculations are summarized in Appendix E
4.1.2 Non-target Terrestrial Animals
EECs were calculated for all ornamental turf labeled uses with application rates
ranging from 0.5 to 1.0 Ib ae/A. Risk quotients are based on the most sensitive studies that
yielded the lowest toxicity values. For this assessment, the lowest LD50 and NOAEC values
220
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were used for birds and the lowest LD50 and NOAEL were used for mammals (based on lab
rat and mouse studies).
4.1.2.1 Birds
Avian Risk
The EEC's for terrestrial exposure were derived from the Kenaga nomograph, as
modified by Fletcher et al. (1994), based on a large set of field residue data. The EECs were
calculated by the T-REX Version 1.3.1 model and corresponding avian acute and chronic risk
quotients are based on the most sensitive subacute dietary LC50, single oral dose LD50, and
NOAEC for birds.
Calculations for single-oral dose risk quotients are based on a Northern bobwhite quail
oral acute LD50 of 1500 mg ae/kg-bw. RQs for oral dose-based scenarios are calculated by
dividing the consumption-weighted equivalent dose by the body weight-adjusted LD50. The
avian LD50 is adjusted for body weight according to the following equation:
Adjusted Avian LD50(mg/kgbw) = LD50 (mg/kgbw)*
g
(USEPA, 2006)
The assessed weight (AW) is the body weight of the wildlife species of concern. An adjusted
LDso is calculated for three weight classes of birds (20, 100, and 1000 g). The test weight
(TW) is the body weight of the species used in the toxicity study. In this case, the weight of
the bobwhite quail is estimated to be 178 g. The adjusted LD50 is 1080, 1375, and 1943 mg
ae/kg-bwt for the weight classes 20, 100, and 1000 g birds, respectively.
Foliar Summary for Mefluidide-K and Mefluidide-DEA
1. Acute RQs were calculated for birds based on the non-definitive LD50 value of
>1500 mg ae/kg-bw. No mortality occurred at the single dose treatment level
(1500 mg ae/kg-bw) for the Tier I Acute Toxicity to Bobwhite quail study
MRID 416019-01. RQ values ranged 0 to 0.25 for the 1.0 Ib ae/A ornamental
turf modeled scenario. RQs are summarized in Appendix D. summarizes the
avian dietary-based chronic RQs for foliar uses of mefluidide-K and mefluidide-
DEA. Chronic RQs were estimated for birds based on the non-definitive LD50
value of 38 mg ae/kg. Chronic dietary-based exceedances occurred for birds for
the 1.0 Ib ae/A modeled scenario with risk quotients ranging from 2.9 to 6.32.
Chronic estimated NOAEC values and calculations are summarized in
Appendix E.
Table 4.7 summarizes the avian dose-based acute RQs for foliar uses of mefluidide-K
and mefluidide-DEA.
221
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For mefluidide-DEA and mefluidide-K, acute restricted use and/or listed species risk
LOCs are exceeded for 20 g birds that consume short grass, tall grass, and broadleaf plants
and small insects for the 1.0 ae/A application rate modeled scenario with acute RQs of <0.25.
For mefluidide-DEA and mefluidide-K, acute risk to listed species LOCs are exceeded
for 20 g birds that consume short grass, tall grass, and broadleaf plants and small insects and
100 g birds that consume short grass for the 1.0 Ib ae/A application rate modeled scenario
with acute RQs ranging from <0.11 to <0.25.
Table 4.8 summarizes the avian dietary-based chronic RQs for foliar uses of
mefluidide-K and mefluidide-DEA. Chronic dietary-based exceedances occurred for birds for
the 1.0 Ib ae/A modeled scenario with risk quotients ranging from 2.9 to 6.32. Risk quotients
based on dietary exposure levels are provided for comparison purposes.
Table 4.7. Avian dose-based acute RQ values for proposed uses of Mefluidide-K,
Mefluidide-DEA and Mefluidide based on a bobwhite quail LD50 > 1500 mg ae/kg
-bw and upper-bound Kenaga values1.
Use
Application
Mammalian Acute Risk Quotients (upper-bound Kenaga residues)
Kaie IDS. ae/A
(# app /
interval, days) Body Short
Weight, g Grass Tall Grass
Ornamental
Turf
(mefluidide
salts only)
Ground spray
1.0
3 per season
42
day interval
20
100
1000
<0.25**
<0.11*
<0.04
<0.12*
<0.05
<0.02
Broadleaf
Plants/Small
Insects
<0.14*
<0.06
<0.02
Fruits/pods/
seeds
large insects
<0.02
<0.01
<0.00
1 For avian toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have been bridged because toxicity
is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was selected to represent avian
for all application scenarios.
* exceeds LOG for acute risk to listed species (RQ > 0.1)
* * exceeds LOCs for acute risk to listed species and restricted use (RQ > 0.2)
Table 4.8. Avian dietary-based chronic RQ values for Mefluidide-K and Mefluidide-DEA
based on an estimated NOAEC of 38.0 mg/ ae kg and upper-bound Kenaga residues1.
Use
Ornamental Turf
(mefluidide salts
only)
Ground spray
Application Rate
Ibs. ai/A Food Items
(# app / interval,
days)
1.0
3 per season
42
day interval
Short grass
Tall grass
Broadleaf plants/small
insects
Upper Bound
EEC(mg/kg)2
240.17
110.08
135.09
Chronic RQ
(EEC/
NOAEC)
6.32*
2.90*
3.56*
222
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Table 4.8. Avian dietary-based chronic RQ values for Mefluidide-K and Mefluidide-DEA
based on an estimated NOAEC of 38.0 mg/ ae kg and upper-bound Kenaga residues1.
Use
Application Rate
Ibs. ai/A
(# app / interval,
days)
Food Items
Fruits, pods, seeds, and
large insects
Upper Bound
EEC(mg/kg)2
15.01
Chronic RQ
(EEC/
NOAEC)
0.40
1 For avian toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have been bridged because
toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was selected to
represent avian for all application scenarios.
* exceeds LOG for chronic risk to listed species (RQ > 1.0)
LD50/sq ft Summary
Mefluidide is the only proposed granular application. Based on one application of mefluidide at 0.51bs ae/acre,
LOG exceedances occurred for small-sized 20 g birds for acute restricted use and/or listed species (RQ=0.24).
LD50s/sq-ft can be interpreted as the number of lethal doses (LD50s) that are available within one square foot
immediately after application. EFED does not currently assess chronic risks to birds from granular applications.
The acute RQs for LD50/sq ft based on a single application of mefluidide are summarized in Appendix D
4.1.2.2 Mammals
Mammalian Risk
EECs and corresponding mammalian acute and chronic RQs for Mefluidide
application were determined using the T-REX Version 1.3.1 model. Calculations for
mammalian organisms oral dose-based risk quotients were based on an acute laboratory
mouse LDso value of 829.8 mg ae/kg bw and a chronic reproductive effect (NOAEC)
observed at 102 mg ae/kg bw/day . Oral dose-based RQ values were calculated by dividing
the consumption-weighted equivalent dose by the body weight-adjusted LD50. The
mammalian LD50 is adjusted for body weight according the following equation:
Adjusted Mammalian LD50 (mg/kg bw) = LD
TW(g)
,0.25
(USEPA, 2006)
The assessed weight (AW) is the body weight of the wildlife species. An adjusted LD50 is
calculated for each weight class of mammal (15, 35, and 1000 g). The test weight (TW) is the
weight of the species used in the toxicity study. In this case, the average weight of the
laboratory mouse was 20 g; however, T-REX assumes the average weight is 350 g.
Therefore, the TW was adjusted to a mouse weighing 20 g in the model instead of 350 g rat
weight. However, the assumed 350 g TW for the rat was used for the chronic oral dose-
based RQ calculations, the NOAEC (102 mg ae/kg bw/day) was converted to a NOAEL (2040
mg ae/kg diet) based on a standard FDA lab rat conversion.
223
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Foliar Summary for Mefluidide-K and Mefluidide-DEA
Table 4.9 summarizes the mammalian dose-based acute RQs for foliar uses of
mefluidide-K and mefluidide-DEA.
For mefluidide-DEA and mefluidide-K, acute restricted use and/or listed species acute
risk LOCs are exceeded for 15 g and 35 g mammals that consume short grass for the 1.0 Ib
ae/A application rate modeled scenario with acute RQs ranging from 0.22 to 0.26.
Acute risk to listed species are exceeded for 15 and 35 g sized mammals that consume
short grass, tall grass, broadleaf plants and small insects and 1000 g mammals that consume
short grass for the 1.0 Ib ae/A application rate modeled scenario with acute RQs ranging from
0.10 to 0.26.
Table 4.10 summarizes the mammalian dose-based chronic RQs for foliar uses of
mefluidide-K and mefluidide-DEA. The chronic LOG is exceeded for 15 g mammals that
consume short grass with an RQ of 1.02 for the 1.0 Ib ae/A modeled scenario.
Table 4.11 summarizes the mammalian dietary-based chronic RQs for foliar uses of
mefluidide-K and mefluidide-DEA. No chronic dietary-based exceedances occurred for
mammals for thel.O Ib ae/A modeled scenario. Risk quotients based on dietary exposure
levels are provided for comparison purposes.
Table 4.9. Mammalian
Mefluidide-DEA based
Use
Ornamental
Turf
(mefluidide
Application
Rate Ibs. ae/A
(# app /
interval,
days)
1.0
3 per season
42
dose-based acute RQ values for proposed uses of Mefluidide-K and
on a mouse LD50 = 829.8 mg ae/kg -bw and upper-bound Kenaga values1.
Body
Weight,
g
15
35
Mammalian
Short
Grass
0.26**
0.22**
Acute Risk Quotients (upper-bound Kenaga residues]
Tall Grass
0.12*
0.10*
Broadleaf
Plants/Small
Insects
0.14*
0.12*
Fruits/pods/
seeds
large insects
0.02
0.01
Seeds
(granivore)
0.00
0.00
224
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Table 4.9. Mammalian
Mefluidide-DEA based
Use
salts only)
Ground spray
Application
Rate Ibs. ae/A
(#app/
interval,
days)
day interval
dose-based acute RQ values for proposed uses of Mefluidide-K and
on a mouse LD50 = 829.8 mg ae/kg -bw and upper-bound Kenaga values1.
Body
Weight,
9
1000
Mammalian
Short
Grass
0.12*
Acute Risk Quotients (upper-bound Kenaga residues]
Tall Grass
0.05
Broadleaf
Plants/Small
Insects
0.07
Fruits/pods/
seeds
large insects
0.01
Seeds
(granivore)
0.00
1 For mammal toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have been bridged because
toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was selected to
represent mammals for all application scenarios.
* exceeds LOG for acute risk to listed species (RQ > 0.1)
* * exceeds LOCs for acute risk to listed species and restricted use (RQ > 0.2)
Table 4.10. Mammalian dose-based chronic RQ values for proposed uses of Mefluidide-
K and Mefluidide-DEA based on a rat reproductive NOAEC of 102 mg ae/kg-bw/day
and upper-bound Kenaga residues1.
Use
Ornamental
Turf
(mefluidide
salts only)
Ground spray
Application
Rate Ibs. ae/A
(# app /
interval,
days)
1.0
3 per season
42
day interval
Body
Weight,
9
15
35
1000
Mammalian
Short
Grass
1.02*
0.87
0.47
Acute Risk Quotients (upper-bound Kenaga residues)
Tall Grass
0.47
0.40
0.21
Broadleaf
Plants/Small
Insects
0.57
0.49
0.26
Fru its/pods/see
ds
large insects
0.06
0.05
0.03
Seeds
(granivore)
0.01
0.01
0.01
For mammal toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have been bridged because
toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was selected to
represent mammals for all application scenarios.
'exceeds the chronic risk LOG (RQ > 1.0) for non-listed and listed species.
Table 4.1 1 . Mammalian dietary-based chronic RQ values for Mefluidide-K and Mefluidide-
DEA based on a rat reproductive NOAEC of 2040 mg/kg-diet and upper-bound Kenaga
residues1.
Use
Ornamental Turf
(mefluidide salts
only)
Ground spray
Application Rate
Ibs. ai/A Food Items
(# app / interval,
days)
1.0
3 per season
42
day interval
Short grass
Tall grass
Broadleaf plants/small
insects
Upper Bound
EEC(mg/kg)2
240.17
110.08
135.09
Chronic RQ
(EEC/
NOAEC)
0.12
0.05
0.07
225
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Table 4.11. Mammalian dietary-based chronic RQ values for Mefluidide-K and Mefluidide-
DEA based on a rat reproductive NOAEC of 2040 mg/kg-diet and upper-bound Kenaga
residues1.
Use
Application Rate
Ibs. ai/A
(# app / interval,
days)
Food Items
Upper Bound
EEC(mg/kg)2
Chronic RQ
(EEC/
NOAEC)
Fruits, pods, seeds, and
large insects
15.01
0.01
For mammal toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and Mefluidide toxicity have been bridged because
toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was selected to
represent mammals for all application scenarios.
estimated chronic diet concentration equivalent based on reported chronic dose
*exceeds the chronic risk LOG (RQ > 1.0) for non-listed and listed species.
LD1(/sqft Summary
Mefluidide is the only proposed granular application. Based on one application of mefluidide at 0.51bs
ae/acre, acute restricted use and/or listed species acute risk LOG exceedances occurred for the LD50s/sq-ft for
small and medium-sized mammals. The RQs are 0.39 and 0.21 for small and medium mammals, respectively.
LD50s/sq-ft can be interpreted as the number of lethal doses (LD50s) that are available within one square foot
immediately after application. EFED does not currently assess chronic risks to mammals from granular
applications. The acute RQs for LD50/sq ft based on a single application of mefluidide are summarized in
Appendix D. Calculations for LD50/sq ft are based on the acute laboratory mouse LD50 value of 829.8 mg ae/kg
bw, adjusted to an average weight of 20 g. The calculations for food intake for a 20 gram size class mouse are
summarized in Appendix D. The LD50 approach is only applied to a single application.
4.1.2.3 Plants
Non-target Terrestrial Plants in Dryland and Semi-aquatic Areas
An analysis indicates exceedance of the Acute Risk LOG for listed and non-
endangered monocots and dicots in dryland and semi-aquatic areas located adjacent to treated
areas, both as a result of combined runoff and spray drift, and from spray drift alone for
mefluidide-DEA and mefluidide-K.
For terrestrial plants, only one vegetative vigor toxicity study was submitted for plants
based on fresh weight exposed to mefluidide-DEA. These data were bridged with mefluidide
and mefluidide-K.
Risk to terrestrial plants from spray drift alone is evaluated by comparing the
estimated exposure from drift to the most sensitive Ł€25 calculated from vegetative vigor
laboratory tests. The most sensitive vegetative vigor EC25 values were 0.105 and 0.0054 Ib
ae/acre for monocots and dicots, respectively. The NOAEC values were 0.045 and 0.0029 Ib
ae/acre for monocots and dicots, respectively. Wet weight was the most sensitive endpoint for
monocots and dicots in the vegetative vigor studies used to evaluate risk to terrestrial plants.
226
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Seedling emergence toxicity data was not available for full review and data was not
available from other anilide analogs to derive EC25 values. A preliminary review on a recently
submitted seedling emergence study (MRID 471907-01) was conducted. These results are
uncertain until a full review of the study is performed. The results of the preliminary review
are summarized in Appendix E. Therefore, to estimate possible effects measurement
endpoints for seedling emergence, EFED assumed that EC25 toxicity values for vegetative
vigor are equal to seedling emergence measurement endpoints for mefluidide, mefluidide-
DEA and mefluidide-K. Therefore, the most sensitive seedling emergence Ł€25 estimated
values are 0.105 and 0.0054 Ib ae/A for monocots and dicots, respectively. The NOEC
estimated values for seedling emergence are 0.045 and 0.0029 Ib ae/A for monocots and
dicots, respectively. These values are used to calculate risk quotients for exposure from
combined runoff and spray drift to adjacent fields.
Because RQs based on the EC25 values exceed the acute LOG, and exposure can be
expected which would cause greater than a 25% effect, risk to listed plants is also a concern.
Because RQs based on the NOAEC values exceed the acute LOG, and exposure can be
expected which would cause potential risks to listed plants. Risk quotients with which to
evaluate listed plant risks from a result of combined runoff and spray drift, and from spray
drift alone for mefluidide, mefluidide-DEA and mefluidide-K were calculated with the above
NOAEC values from the vegetative vigor studies.
Spray applications with l.Olb ae/A demonstrated the highest RQ exceedances followed
by granular applications with 0.5 Ib ae/A. Dicots demonstrated more sensitivity than
monocots in most application scenarios with exposure to mefluidide, mefluidide-DEA and
mefluidide-K.
(Table 4.12) summarizes vegetative vigor and seedling emergence terrestrial plant
RQs for foliar and granular uses of mefluidide-K, mefluidide-DEA and mefluidide from a
result of combined runoff and spray drift, and from spray drift alone. Risk quotients were
exceeded for ground spray (1.0 Ib ae/A) and granular applications (0.5 Ib ae/A) for monocots
and dicots. Dicots demonstrated more sensitivity than monocots in all application scenarios
with exposure to mefluidide-K and mefluidide-DEA with all TERR Plant modeled scenarios.
Table 4.12. Summarized Terrestrial Plant Risk Quotients for Mefluidide, Mefluidide-DEA
andMefluidide-Ka'b'c'd
Scenario
Acute Non-endangered RQs
adjacent to
treated
sites
Ground spray application (1.0
Monocot
0.571
semi-aquatic
areas
drift
Acute listed RQs
adjacent to
treated
sites
Ibs ae/acre)
4.86** 0.10 1.33*
semi-aquatic
areas
11.33*
Drift
0.22
227
-------
Table 4.12. Summarized Terrestrial Plant Risk Quotients for Mefluidide, Mefluidide-DEA
andMefluidide-Ka'b'c'd
Scenario
Dicot
Acute Non-endangered RQs
adjacent to
treated
sites
11.11**
semi-aquatic
areas drift
Acute listed RQs
adjacent to
treated
sites
94.44** 1.85* 20.69*
semi-aquatic
areas
175.86*
Drift
3.45*
Granular ground application (0.5 Ibs ae/acre)e
Monocot
Dicot
0.24
4.63**
2.38** n/a 0.56
46.3** n/a 8.62*
5.56*
86.21*
n/a
n/a
1 For terrestrial plant (seedling emergence and vegetative vigor) toxicity assessments, data evaluating Mefluidide-K, Mefluidide-DEA and
Mefluidide toxicity have been bridged. Therefore, the most sensitive Mefluidide endpoint was selected to represent terrestrial plants for all
application scenarios.
RQs for spray turf applications in this table were calculated for the maximum labeled application rates of (1.2 Ibs ae/acre) and (1.0 Ibs
ae/acre) for mefluidide-DEA and mefluidide-K respectively..
b Acute non-endangered toxicity thresholds (EC25) were (0.105, 0.0054, 0.105, 0.0054)ae/acre for seedling emergence monocot, seedling
emergence dicot, vegetative vigor monocot, and vegetative vigor dicot, respectively. EFED assumed that EC25 toxicity values for terrestrial
plants (vegetative vigor) are equal to (seedling emergence) measurement endpoints for Mefluidide, Mefluidide-DEA and Mefluidide-K due
to lack of submitted data.
c Acute listed toxicity thresholds (NOAEC) were (0.045, 0.0029, 0.045, 0.0029) Ib ai/acre for seedling emergence monocot, seedling
emergence dicot, vegetative vigor monocot, and vegetative vigor dicot, respectively. EFED assumed that NOAEC toxicity values for
terrestrial plants (vegetative vigor) are equal to (seedling emergence) measurement endpoints for Mefluidide, Mefluidide-DEA and
Mefluidide-K due to lack of submitted data.
* indicates an exceedance of the listed Species Level of Concern (LOG).
"indicates an exceedance of the Acute Risk LOG.
dRQs for ground granular applications in this table were calculated for the maximum labeled application rate of O.Slbs ae/acre. Drift RQs are
not applicable for granular applications.
Spray drift is an important factor in characterizing the risk of Mefluidide to non-
target plants. Spray drift exposure from ground application is assumed to be 1% of the
application rate and the EECs and RQs were calculated using EFED's TerrPlant.xls model
(Version 1.2.1). The AgDrift Tier 1 model (ground application, very fine to fine droplet size,
medium to course droplet size and low boom height for turf application) was used to
determine what conditions are represented by a 1% spray drift exposure from ground
application. AgDrift provided 90th percentile estimates based on the distribution of field
measurements at 10 to 900 feet distances from the edge of field (Table 3.5). The 90th
percentile drift estimates from AgDrift for 1.0 Ib ae/A ground application was 0.51% of
applied at a distance of 200 ft from the edge of the field for turf applications (very fine to fine
droplet size). The 90th percentile drift estimates from AgDrift for 1.0 Ib ae/A ground
application was 0.26% of applied at a distance of 200 ft from the edge of the field for turf
applications (medium to course droplet size). LOG exceedences did not occur with a 80 foot
or above buffer size for both listed and non-listed dicots for the 1.0 Ib ae/A application
scenario with the medium to course droplet size. LOG exceedences did not occur with a 200
foot or above buffer size for both listed and non-listed dicots for the 1.0 Ib ae/A application
228
-------
scenario with the very fine to fine droplet size. RQs were calculated for buffers from 10 to
900 feet are summarized in Appendix D.
4.1.3 RQs Based on Mean Kenaga Residues
For this risk assessment, the RQ that were compared to the LOCs were calculated using
maximum EECs derived from the Kenaga nomograph. Risk quotients were also calculated
using mean EECs to determine the extent of the risk to mammals. RQs were based on both
single oral dose and dietary studies for mammals.
Birds
Acute RQs were calculated for birds based on the non-definitive LD50 value of >1500
mg ae/kg-bwt. No mortality occurred at the single dose treatment level (1500 mg ae/kg-bw)
for the Tier I Acute Toxicity to Bobwhite quail study MRID 416019-01. When mean residues
were assumed, RQ values ranged from 0 to <0.09 for the 1.0 Ib ae/A ornamental turf modeled
scenario. Based on the mean kenaga assessment, no acute LOG exceedances occurred for
birds for the 1.0 Ib ae/A application scenario.
Based on the chronic estimated value of NOAEC of 38 mg/ ae kg diet, when mean
residues were assumed, RQ values ranged from 0.18 to 2.23 for the 1.0 Ib ae/A ornamental
turf modeled scenario. Based on the mean Kenaga assessment, chronic LOG exceedances for
birds occurred for thel.O Ib ae/A ornamental turf modeled scenario. RQs are summarized in
APPENDIX D.
Mammals
When mean residues were assumed:
• Mammalian Acute listed LOCs were no longer exceeded for the 1 Ib ae/A modeled
scenario.
• Mammalian Acute Restricted Use LOCs were no longer exceeded for 15 g and 35 g
mammals for the 1.0 Ib ae/A modeled scenario.
• Mammalian Chronic LOCs (dose-based) were no longer exceeded for the 15 g and
35 g size mammals for the 1.0 Ib ae/A application scenario.
4.2. Risk Description - Interpretation of Direct Effects
4.2.1 Risks to Aquatic Organisms and Plants
229
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Based on the risk hypothesis terrestrial organisms (birds, mammals, reptiles, terrestrial-
phase amphibians and plants) and aquatic organisms (invertebrates, fish, amphibians and
plants) in surface waters (freshwater or saltwater) are subject to adverse effects when exposed
to mefluidide residues as a result of labeled use of the pesticide. Routes of exposure evaluated
in this risk assessment focused on runoff and spray drift from ground spray with mefluidide
applied at application rates of 1.0 Ib ae/A (mefluidide-K and mefluidide-DEA) and runoff
from granular applications with 0.5 Ib ae/A mefluidide.
No LOCs were exceeded for acute effects on freshwater and estuarine marine fish,
aquatic invertebrates, non-vascular and vascular aquatic plants in water bodies adjacent to
ornamental turf in areas treated with mefluidide DBA, mefluidide K and mefluidide.
No LOG exceedances occurred for chronic freshwater fish, chronic estuarine marine
fish, chronic estuarine marine invertebrates, chronic freshwater invertebrates, vascular plants
and non-vascular plants.
4.2.2 Risks to Terrestrial Organisms and Plants
Direct application of mefluidide-K, mefluidide-DEA, and mefluidide to the field leads
to the conclusion that exposure is likely to terrestrial organisms that are foraging or nesting in
or near the treated field. Birds and mammals in treated fields may be exposed to spray and
granular applications of pesticides by ingesting material directly with the diet. When
pesticides are applied as a granular formulation, the exposure estimate is assumed to account
for all methods of exposure. They may also be exposed by other routes, such as incidental
ingestion of contaminated soil, dermal contact with treated plant surfaces and soil during
activities in the treated areas, direct impingement of sprayed material on the body at the time
of application, preening activities, inhalation of pesticide vapor and contaminated paniculate,
and ingestion of drinking water contaminated by the pesticide.
1. Birds
Six acute dietary studies were considered in determining the risk for birds following
applications of mefluidide, mefluidide-K, and mefluidide-DEA to ornamental turf. Also, no
mortality occurred at the highest levels for all six dietary studies. No toxic effects were
identified for the above studies. Acute RQs were calculated for birds based on the non-
definitive LDso value of >1500 mg ae/kg-bw. RQ values ranged from 0 to <0.25 for the 1.0
ae/A ornamental turf modeled scenario. The available dietary toxicity studies on avian species
failed to establishe definitive acute LDso values (i.e., the lethality values exceed the highest
dose tested). Therefore, use of this value adds uncertainty and may overestimate risk to avian
species. Therefore, when the LD50 value of >1500 mg ae/kg-bw was applied to the TREX
model it resulted in LOG exceedances for acute listed for 20 and lOOg birds and restricted use
for 20 g birds for mefluidide-DEA and mefluidide-K (1.0 Ib ae/A at 3 spray applications).
The LD50 value of 5000 mg ae/bw if applied to the above modeled scenario would result in no
acute LOG exceedances for birds. Based on the mean kenaga assessment, no acute LOG
exceedances occurred for birds (1.0 Ibae/A at 3 spray applications).
230
-------
Chronic RQs were estimated for birds based on the non-definitive NOAEC value of
38 mg ae/kg. Chronic dietary-based exceedances occurred for birds for the 1.0 Ib ae/A
modeled scenario with risk quotient exceedances ranging from 2.90 to 6.32. Chronic
estimated NOAEC values and calculations are summarized in Appendix E.
Due to the high degree of uncertainty based on the estimated NOAEC value 38 mg
ae/kg and the non-definitive LD50 value of >1500 Ib ae/A. Acute and chronic avian studies
with definitive LD50 and NOAEC values would quantify the uncertainties of avian risk.
LD50/sq ft Summary
Mefluidide is the only proposed granular application. Based on one application of mefluidide at 0.51bs ae/acre,
acute restricted use and/or listed species acute risk LOG exceedances occurred for the LD50s/sq-ft for small and
medium-sized mammals. The RQs are 0.39 and 0.21 for small and medium mammals, respectively. LD50s/sq-ft
can be interpreted as the number of lethal doses (LD50s) that are available within one square foot immediately
after application. EFED does not currently assess chronic risks to birds from granular applications. The acute
RQs for LD50/sq ft based on a single application of mefluidide are summarized in Appendix D
2. Mammals
Two dietary studies were considered in determining the risk for mammals following
the application of mefluidide, mefluidide-K and mefluidide-DEA.
Based on this analysis, it is likely that listed and non-listed mammals that feed on
grasses and broadleaf plants and small insects are at risk from acute exposure due to spray
applications of mefluidide-K and mefluidide-DEA residues for turf modeled scenarios. Also,
it is likely that listed and non-listed mammals that feed on grasses and broadleaf plants or
small insects are at risk from chronic exposure due to mefluidide-DEA and mefluidide-K
residues based on the ornamental turf (1.0 Ib ae/A) modeled scenario.
Based on one granular application of mefluidide (0.5 Ib ae/A) acute listed and restricted
use LOCs were exceeded for small and medium sized mammals.
3. Non-Target Insects and Earthworms
EFED currently does not quantify risks to terrestrial non-target insects. Risk quotients,
therefore, are not calculated for these organisms. Because mefluidide, mefluidide-K and
mefluidide-DEA are practically non-toxic to honey bees (96-hr acute contact LDso > 18.75 jig
ae/bee, MRID 425628-01, LD50 > 22.25 |ig ae/bee, MRID 425628-02), the risk are not likely
to have adverse effects on pollinators and other beneficial insects.
Ecotox data indicates that mefluidide is non-toxic to earthworms (Ref #39542 Potter
DA; Spicer PG; Redmond CT; Powell AJ (1994) Toxicity of Pesticides to Earthworms in
Kentucky Bluegrass Turf). Two evaluations were conducted in the spring and the fall of 1992.
Earthworm populations were sampled at 1 and 3 weeks after treatment. The application rate
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of mefluidide applied to the plots were 0.56 ai/ha of Embark 2S which resulted in 0% and 17
% reduction of earthworms in the spring and fall respectively after the 3 week treatments.
3. Terrestrial Plants
Ground spray and granular applications were modeled for both monocots and dicots
from combined runoff and drift and drift only scenarios. Only one vegetative vigor toxicity
study was submitted for terrestrial plants based on fresh weight basis exposed to mefluidide-
DEA. These data were bridged with mefluidide and mefluidide-K. Seedling emergence
toxicity data were not available for a full review to evaluate exposure of terrestrial plants to
mefluidide from combined runoff and drift. In addition, data were not available from other
anilide analogs to derive estimated Ł€25 values. To estimate possible effects measurement
endpoints for seedling emergence, EFED assumed that Ł€25 toxicity values for vegetative
vigor are equal to seedling emergence measurement endpoints for mefluidide, mefluidide-
DEA and mefluidide-K.
Levels of concerns are exceeded for acute non-listed and listed monocots and dicots for
ground applications for turf modeled scenarios. For the ornamental turf (1.0 Ib ae/A) modeled
scenario, RQs ranged from 0.10 to 175.86 (ground spray applications) for monocots and
dicots from combined runoff and spray drift. For the ornamental turf (0.5 Ib ae/A) modeled
scenario, RQs ranged from 0.24 to 86.21 (granular applications) for monocots and dicots from
runoff.
For the ornamental turf (1.0 Ib ae/A) modeled scenario RQs ranged from 0.1 to 3.45
(ground spray applications) for monocots and dicots from spray drift only.
Levels of concerns are exceeded for acute non-listed and listed monocots and dicots
from granular turf applications. For the ornamental turf (0.5 Ib ae/A) modeled scenario, RQs
were 46.3 for non-listed dicots, 86.2 for listed dicots, 2.38 for non-listed monocots and 5.56
for listed monocots.
An analysis of the results indicates exceedance of the Acute Risk LOG for listed and
non-listed monocots and dicots in dryland and semi-aquatic areas located adjacent to treated
areas, both as a result of combined runoff and spray drift, and from spray drift alone for
mefluidide, mefluidide-DEA and mefluidide-K.
Spray applications with 1.0 Ib ae/acre demonstrated the highest RQ exceedances
followed by granular applications with 0.5 Ib ae/A. Dicots demonstrated more sensitivity than
monocots in most application scenarios with exposure to mefluidide, mefluidide-DEA and
mefluidide-K. A preliminary review on a recently submitted seedling emergence study
(MRID 471907-01) was conducted. These results are uncertain until a full review of the study
is performed. The results of the preliminary review are summarized in Appendix E.
5. Endocrine Disruption Assessment
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No studies were submitted for mefluidide-K, mefluidide-DEA and mefluidide that
indicated endocrine disruption.
The degradates of mefluidide-K, mefluidide-DEA and mefluidide have not been
identified as possessing the potential for endocrine disruption. In addition, the registrant has
not submitted, nor has the Agency requested, studies on the potential for endocrine disruption
for any of these degradates resulting from the use of mefluidide. Until such time as the
Agency determines that any of these degradates have the potential to be an endocrine
disrupter, this risk assessment has not included an evaluation of the relative risk of
mefluidide-K, mefluidide-DEA and mefluidide, degradates for endocrine disruption and as
such is a source of uncertainty in this assessment.
EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (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 Disrupter 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 The Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, mefluidide-K, mefluidide-DEA and mefluidide may be subjected
to additional screening and/or testing to better characterize effects related to endocrine
disruption.
6. Potential for Avian and Mammalian Exposure in Space and Time
In order for chemical residues in potential wildlife food items to result in direct adverse
effects in a mammalian population, the organisms must be exposed to those food items at
locations and at times when the residues are present. There are a number of important
questions that must be considered:
1. Are the residues present at locations where wildlife might feed?
2. Are the residues present in food items at times when wildlife might use the
areas?
3. Are the residues likely to be around long enough to result in exposure
sufficient to trigger the expected adverse responses?
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Mefluidide formulations are for use on: agricultural/farm structures/buildings and
equipment, agricultural/nonagricultural uncultivated areas/soils, airports/landing fields,
commercial industrial lawns, commercial institutional/industrial premises/equipment
(indoor/outdoor), golf course turf, hospitals/medical institutions premises (human veterinary),
household domestic dwellings outdoor premises, industrial areas (outdoor), nonagricultural
outdoor buildings/structures, nonagri cultural rights-of-way/fencerows/hedgerows, ornamental
and or shade trees, ornamental ground cover, ornamental herbaceous plants, ornamental lawns
and turf, ornamental nonflowering plants, ornamental woody shrubs and vines, paths/patios,
paved area (private roads/sidewalks), recreational areas, and residential lawns.
One category of ornamental turf that mefluidide is used on is golf courses. Golf courses
are recognized as having strong potential for providing quality habitat to many wildlife
species (Stangel and Distler 2002). For example, Audubon International has more than 2,200
golf courses enrolled in its Audubon Cooperative Sanctuary System Program for Golf Courses
providing education and assistance to golf course managers promoting environmental
stewardship, conservation of biological diversity, and sustainable resource management.
Audubon International has also been awarded a grant from Wildlife Links to create a database
for information on wildlife habitat on golf courses.
Across 24 golf courses in the northern coast of South Carolina, a total of 5,362 birds, 82
species, and 30 neotropical migratory birds species were recorded at 599 point count stations
over a two year study (Crum et al. 2003). Crum et al. (2003) report that the majority of birds
associated with less developed landscapes (i.e. golf courses with less habitat disturbance)
were woodland breeding species, while urban breeding species were found primarily on golf
courses in which the majority of native vegetation had either been removed or replaced with
ornamental vegetation, or contained a high level of human disturbance including residential
and non-residential structures. The large number of species observed on golf courses in this
small geographic area of the US indicates that a wide variety of birds will utilize golf courses.
Because of the large number of species represented, it is likely that some population of birds
will be on the golf course year-round and that bird breeding seasons will be spread throughout
much of the year. In another study, Merola-Zwartjes and DeLong (2005) compared a number
of golf courses in the Albuquerque, New Mexico, area with paired natural areas to see
whether golf courses have the potential of acting as surrogate riparian habitats for
Southwestern birds. They concluded that golf courses do have the potential to support riparian
bird communities, but that their conservation potential can be enhanced through the addition
of habitat complexity and structure utilizing native plants.
Sod farms are also registered for application with mefluidide-K, mefluidide-DEA,
mefluidide. One example of a bird species that utilizes sod farms is the mountain plover who
is attracted to manmade landscapes (e.g., sod farms and cultivated fields) that mimic their
natural habitat associations, or sites with little vegetative cover (e.g., other agricultural lands
and alkali flats) (http://www.epa.gov/fedrgstr/EPA-IMPACT/2002/December/Day-
05/130801.htm, accessed 01 October 2006). Land management practices on cultivated fields
may include periods when fields are fallow, idle, or barren. If these fields remain fallow, idle,
234
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or barren during April and May, mountain plovers may choose these fields for nesting. Sod
farms are often listed as popular sites for birding enthusiasts.
(e.g.,http://home.comcast.net/~ehoward24/localbirdingsites.html,
http://www.crbo.net/SpecialtyBirds.html, accessed on 01 October 2006).
An example of wildlife use of roadsides is provided by the Minnesota Department of Natural
Resources (http://www.dnr.state.mn.us/roadsidesforwildlife/index.html, accessed on 01 October 2006).
Researchers have found that over 40 species of birds and mammals utilize roadsides for shelter,
nesting, and food. Roadsides receive almost continuous nesting use from April through August.
Roadsides also provide the right combination of abundant food and cover for birds that nest in cavities
or in trees near roads. Examples of birds and mammals documented to use roadsides in Minnesota
are: cottontail rabbit, white-tailed jackrabbit, short-tailed shrew, woodchuck, meadow vole, meadow
jumping mouse, ring-necked pheasant, gray (Hungarian) partridge, mallard, blue-winged teal, pintail,
and upland sandpiper. Disturbance of roadside cover by early mowing, farm tillage, grazing, "blanket"
spraying, or vehicle and tractor encroachment during the peak nesting months (May, June, July) will
significantly lower production for species that use roadsides for nesting.
Based on a 4 day foliar half-life with LOG exceedances for mammals and birds for the 1.0 and
0.5 Ib ae/A application scenarios, residues are likely to result in exposure sufficient to trigger the
expected adverse responses.
This analysis suggests that the patterns of mefluidide uses are such that they coincide in
time and space to areas frequented by mammalian wildlife. These areas have been of
demonstrated use by wildlife as sources of food and cover. Finally, the potentially problematic
wildlife food items suggested by the risk assessment of mefluidide are likely to be present in
and around the treated areas.
4.2.4 Federally Threatened and Endangered (Listed)
Species Concerns
4.2.4.1 Action Area
For listed species assessment purposes, the action area is considered to be the area
affected directly or indirectly by the Federal action and not merely the immediate area
involved in the action. At the initial screening-level, the risk assessment considers broadly
described taxonomic groups and so conservatively assumes that listed species within those
broad groups are collocated with the pesticide treatment area. This means that terrestrial
plants and wildlife are assumed to be located on or adjacent to the treated site and aquatic
organisms are assumed to be located in a surface water body adjacent to the treated site. The
assessment also assumes that the listed species are located within an assumed area which has
the relatively highest potential exposure to the pesticide, and that exposures are likely to
decrease with distance from the treatment area.
4.2.4.2 Taxonomic Groups Potentially at Risk
Based on available screening level information, the greatest concerns for direct
Mefluidide ecological risks lie with effects to terrestrial and semi-aquatic plants as well as
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acute and chronic effects to birds and mammals. The screening-level risk assessment for
Mefluidide has identified potential concerns for direct effects on the following listed species
categories: birds, mammals, and terrestrial and semi-aquatic plants (both monocots and
dicots). Since birds are used as a surrogate for reptiles and terrestrial phase amphibians, they
are also considered to be of concern.
The LOCATES database was not used for this assessment to identify specific listed
and threatened species at risk from exposure to Mefluidide. Because of its widespread use on
non-crop areas and because it is used throughout the United States, the search of the database
could not be restricted by crop or geographic area. Therefore, all species within each of the
categories listed above would be identified as being at risk through the LOCATES database.
Probit Slope Analysis
Screening-level acute listed LOCs are exceeded for terrestrial organisms potentially
exposed to residues by Mefluidide applications. The Agency uses the dose response
relationship from the toxicity study used for calculating the RQ to estimate the probability of
acute effects associated with an exposure equivalent to the EEC. This information serves as a
guide to establish the need for and extent of additional analysis that may be performed using
Services-provided "species profiles" as well as evaluations of the geographical and temporal
nature of the exposure to ascertain if a "not likely to adversely affect" determination can be
made. The degree to which additional analyses are performed is commensurate with the
predicted probability of adverse effects from the comparison of the dose response information
with the EECs. The greater the probability that exposures will produce effects on a taxa, the
greater the concern for potential indirect effects for listed species dependant upon that taxa,
and therefore, the more intensive the analysis on the potential listed species of concern, their
locations relative to the use site, and information regarding the use scenario (e.g., timing,
frequency, and geographical extent of pesticide application).
The Agency uses the probit dose response relationship as a tool for providing
additional information on the listed animal species acute levels of concern. The acute listed
Species LOCs of 0.1 and 0.05 are used for terrestrial and aquatic animals, respectively. As
part of the risk characterization, an interpretation of acute LOCs for listed species is
discussed. This interpretation is presented in terms of the chance of an individual event (i.e.,
mortality or immobilization) should exposure at the estimated environmental concentration
actually occur for a species with sensitivity to Mefluidide on par with the acute toxicity
endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the
slope of the dose response relationship available from the toxicity study used to establish the
acute toxicity measurement endpoints for each taxonomic group. The individual effects
probability associated with the LOCs is based on the mean estimate of the slope and an
assumption of a probit dose response relationship. In addition to a single effects probability
estimate based on the mean, upper and lower estimates of the effects, probabilities are also
provided to account for variance in the slope. The upper and lower bounds of the effects
probability are based on available information on the 95% confidence interval of the slope.
Confidence in the applicability of the assumed probit dose response relationship for predicting
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individual event probabilities is also relevant. Studies with good probit fit characteristics (i.e.,
statistically appropriate for the data set) are associated with a high degree of confidence.
Conversely, a low degree of confidence is associated with data from studies that do not
statistically support a probit dose response relationship. In addition, confidence in the data set
may be reduced by high variance in the slope estimate (i.e., large 95% confidence intervals),
despite good probit fit characteristics.
The individual effect probabilities for aquatic organisms were calculated based on an
Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) The model
allows for such calculations by entering the mean slope estimate (and the 95% confidence
bounds of that estimate) as the slope parameter for the spreadsheet. For all species event
probability was calculated for the exceeded LOG based on a default slope assumption of 4.5
due to studies that do not statistically support a probit dose response relationship with
confidence intervals of 2 and 9 as per original Agency assumptions of typical slope cited in
Urban and Cook (1986).
The corresponding estimated chance of individual mortality associated with the
terrestrial listed Species LOG 0.10 for terrestrial species located near ornamental turf (1.0 Ib
ae/A) areas exposed to mefluidide is approximately 1 in 2.94E+05 for mammals. Probit
analysis was not conducted for birds because the LD50 was greater than 1500 mg ae/kg-bw in
the Bobwhite quail study (MRID 416019-01) and there were no mortalities reported.
However, based on the screening level assessment, the acute risk quotients for mammals are
as high as 0.26, above the acute listed LOG of 0.05. The probability of individual mortality
based on the calculated RQs is 1 in 236 for potentially exposed mammals (based on the LD50
study). Table 4.7 summarizes information on the Probability of Individual Mortality for
Mammals and Birds.
Table 4.7 Probability of Individual Mortality for Birds and Mammals at the Highest RQs and
Application Rate (l.Olb ae/A) Mefluidide
Species
Bob whit
e quail
LD50
Lab
mouse
LD50
Type of
applicatio
n
Ornamenta
1
Turf
Ornamenta
1
Turf
EC50
LD50
>1500
829.8
RQ
0.26**
Probit
Slope
n/a
default
= 4.5
95%
Confiden
ce
Interval
default 2-
9
Probability of
Individual
Mortality at the
RQ in this
Assessment
1 in 236
(95% confidence
interval 1 in 8.27
and 1 in 1.43 E+
07)
MRID
Source of
Probit
Slope
416019-01
00047116
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For terrestrial avion toxicity assessments, data evaluating toxicity data have been bridged. Therefore, the most sensitive mefluidide endpoint for birds
was selected to represent all three Mefluidide formulations for birds for all application scenarios For terrestrial mammal toxicity assessments, data
evaluating toxicity data have been bridged. Also the most sensitive mefluidide endpoint for mammals was selected to represent all three Mefluidide
formulations for mammals for all application scenarios.
* exceeds LOC for acute risk to listed species (aquatic LOC = 0.05, terrestrial LOC = 0.10)
** exceeds LOCs for acute risk to listed species and restricted use (aquatic LOC = 0.1, terrestrial LOC = 0.20)
*** exceeds LOCs for acute risk, acute risk to listed species, and restricted use (LOC = 0.5)
The corresponding estimated chance of individual mortality associated with the aquatic
species listed Species LOC of 0.05 for potentially exposed estuarine marine invertebrates
located near ornamental turf (1.0 Ib ae/A) is approximately 1 in 4.18E*8. Probit analysis was
not conducted for freshwater fish because the LCso was greater than 68.47 mg ae/L in the
rainbow trout study (MRID 418937-02) and there were no mortalities reported. Probit analysis
was not conducted for freshwater invertebrates because the LCso was greater than 77.25 mg
ae/L in the Daphnia study (MRID 418937-03) and there were no mortalities reported.
Based on the screening level assessment, the highest acute risk quotient for estuarine marine
invertebrates is 0.0001, two orders of magnitude below the acute listed LOC of 0.05. The
probability of individual mortality based on the calculated RQs is 1 in 1.03E+72 for
potentially exposed invertebrates (based on the LC50 study) Table 4.8 summarizes information
on the Probability of Individual Mortality for fish and aquatic invertebrates.
Table 4.8 Probability of Individual Mortality for fish and aquatic invertebrates at the Highest
RQs and Application Rate (1.0 ae/A) Mefluidide
Species
FW
Rainbo
w trout
FW
Daphnid
EM
Sheepsh
ead
minnow
EM
Eastern
oyster
Type of
Applicati
on
Ornament
al turf
Ornament
al turf
Ornament
al turf
Ornament
al turf
LC50
LD50
EC50
>68.4
7
>77.2
5
>84.7
5
67
RQ
0.00
01
Probit
Slope
n/a
n/a
n/a
defaul
t = 4.5
95%
Confidence
Interval
default 2-9
Probability of
Individual
Mortality at the RQ
in this Assessment
linl.03E+72
(95% confidence
interval 1 in
1.61E+15andl in
2.39E+283)
MRID
Source of
Probit
Slope
418937-02
418937-03
425623-03
425624-01
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For terrestrial avion toxicity assessments, data evaluating toxicity data have been bridged. Therefore, the most sensitive mefluidide endpoint for birds
was selected to represent all three Mefluidide formulations for birds for all application scenarios For terrestrial mammal toxicity assessments, data
evaluating toxicity data have been bridged. Also the most sensitive mefluidide endpoint for mammals was selected to represent all three Mefluidide
formulations for mammals for all application scenarios.
* exceeds LOC for acute risk to listed species (aquatic LOC = 0.05, terrestrial LOC = 0.10)
** exceeds LOCs for acute risk to listed species and restricted use (aquatic LOC = 0.1, terrestrial LOC = 0.20)
*** exceeds LOCs for acute risk, acute risk to listed species, and restricted use (LOC = 0.5)
Indirect Effects Analysis
The Agency acknowledges that pesticides have the potential to exert indirect effects
upon the listed organisms by, for example, perturbing forage or prey availability, altering the
extent of nesting habitat, etc. In conducting a screen for indirect effects, direct effect LOCs for
each taxonomic group are used to make inferences concerning the potential for indirect effects
upon listed species that rely upon non-endangered organisms in these taxonomic groups as
resources critical to their life cycle. There are acute and chronic direct effects for mammals,
birds and acute direct effects for terrestrial plants (monocot and dicot).
Indirect effects are possible for terrestrial animals that are dependent on terrestrial
monocots and dicot plants for food and/or shelter. Therefore, there is potential for adverse
effects to those species that rely either on a specific plant species or multiple plant species.
Also, plant indirect effects may be limited to general habitat modification, host plant loss, and
competition. If the available plant material is impacted due to the effects of mefluidide, this
may have negative effects not only on the herbivorous animals, but throughout the food chain.
Also, depending on the severity of impact to the plant communities (edge and riparian
vegetation), community assemblages and ecosystem stability may be altered (i.e. reduced bird
and mammal populations in edge habitats; reduced riparian vegetation resulting in increased
light penetration and temperature in aquatic habitats).
Acute listed LOCs were exceeded for 20 g and 100 g birds and acute restricted use
LOCs were exceeded for 20 g birds that were exposed to and consumed various feed items.
Consequently, there may be a concern for potential indirect effects to listed species dependent
upon birds that consume feed items (short and tall grasses, broadleaf plants, and small insects)
contaminated with mefluidide residues; such as predatory birds and mammals.
Acute listed and acute restricted use LOCs were exceeded for mammals (15 g and
35 g) and acute listed LOCs were exceeded for 1000 g mammals that consumed various feed
items. The results of the probit dose analysis for mouse indicated a 1 in 236 for mammals
chance of mortality based on the maximum use scenario and RQ of 0.26 for small mammals
consuming mefluidide. Consequently, there may be a concern for potential indirect effects to
listed species dependent upon mammals that consume feed items (short and tall grasses,
broadleaf plants, and small insects) contaminated with mefluidide residues; such as predatory
birds and mammals.
There are potential concerns for indirect effects on aquatic organisms (fish,
invertebrates, and plants) due to the potential for changes in the habitat adjacent to water
bodies. Shading of water bodies that provides temperature regulation of the water could be
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reduced, thus altering the habitat by increasing water temperature. This change in temperature
could affect the abundance and/or diversity of aquatic plants and organisms in the adjacent
water bodies. Furthermore, the reduction of upstream riparian vegetation that would otherwise
supply downstream habitats could result not only in a loss of a significant component of food
for aquatic herbivores and detritivores, but also of habitat (i.e. leaf packs, materials for case-
building for invertebrates). These concerns are not only for freshwater systems, but also for
estuarine/marine systems. As an example, many golf courses are located on or near coastal
areas.
Again, the LOCATES database was not used for this assessment to identify specific
listed and threatened species at risk from indirect effects to Mefluidide-K, mefluidide-DEA
and mefluidide. Because of its widespread use on non-crop areas and because it is used
throughout the United States, the search of the database could not be restricted by crop or
geographic area. Therefore, further co-location analysis is recommended once the locations of
mefluidide use can be identified.
Critical Habitat for Listed Species
In the evaluation of pesticide effects on designated critical habitat, consideration is
given to the physical and biological features (constituent elements) of a critical habitat
identified by the U.S Fish and Wildlife and National Marine Fisheries Services as essential to
the conservation of a listed species and which may require special management considerations
or protection. The evaluation of impacts for a screening level pesticide risk assessment
focuses on the biological features that are constituent elements and is accomplished using the
screening-level taxonomic analysis (RQs) and listed species levels of concern (LOCs) that are
used to evaluate direct and indirect effects to listed organisms.
The screening-level risk assessment for mefluidide has identified potential concerns for
direct effects on the following listed species categories: small and medium birds, small,
medium and large mammals, and terrestrial and semi-aquatic plants (both monocots and
dicots). Since birds are used as a surrogate for reptiles and terrestrial phase amphibians, they
are also considered to be of concern. In light of the potential for both direct effects, the next
step for EPA and the Service(s) is to identify which listed species and critical habitat are
potentially implicated.
Analytically, the identification of such species and critical habitat can occur in either of
two ways. First, the Agencies could determine whether the action area overlaps critical
habitat or the occupied range of any listed species. If so, EPA would examine whether the
pesticide's potential impacts on non-endangered species would affect the listed species
indirectly or directly affect a constituent element of the critical habitat. Alternatively, the
Agencies could determine which listed species depend on biological resources, or have
constituent elements that fall into the taxa that may be directly or indirectly impacted by a
pesticide. Then EPA would determine whether or not use of the pesticide overlaps the critical
habitat or the occupied range of those listed species. At present, the information reviewed by
EPA is not sufficient to permit use of either analytical approach to make a definitive
240
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identification of species that are potentially impacted indirectly or critical habitats that are
potentially impacted directly by the use of pesticides. EPA and the Service(s) are working
together to conduct the necessary analysis.
Because of the large number of species that are potentially impacted, critical habitats will not
be analyzed in this assessment. Therefore, it is the continued responsibility of the EPA and the
Service(s) to make these assessments before final regulatory decisions are made.
Species with identified critical habitats are listed at:
http://ecos.fws.gov/tess_public/CriticalHabitat.do?listings=0&nmfs=l
(Fish and Wildlife Service)
http://ecos.fws.gov/tess_public/CriticalHabitat.do?listings=0&nmfs=2
(National Oceanic and Atmospheric Administration). A critical habitat mapper for a
subset of listed species is available at: http://ecos.fws.gov/imf/imfjsp?site=ecos.
4.3. Description of Assumptions, Limitations, Uncertainties, Strengths and
Data Gaps
1. Uncertainties and data gaps associated with the environmental fate
and toxicity data
Exposure estimates for this screening level risk assessment focused on the
mefluidide, mefluidide-K and mefluidide-DEA. Degradation products were not
considered in the exposure assessment. There are no environmental fate data on the
degradation products of mefluidide, mefluidide-K and mefluidide-DEA. More
importantly, 5-amino-2,4-dimethyltrifluoromethane-sulfonilide is a minor degradation
product of mefluidide. Diethanolamine (DEA) degrades rapidly (ti/2= 1.7 to 5.8 days) in
aerobic soil and water environments (MRTD 43685901, 43685902, 44439401). In
contrast, DEA is persistent (ti/2= 990 days) in anaerobic aquatic environments (MRID
43882901). Degradation products of diethanolamine are glycine, ethanolamine, and CCh.
Therefore, the potential mechanisms of transformation (i.e., which degradates may form in
the environment, in which media, and how much) must be known, especially for a
chemical whose metabolites/degradates such as DEA are of greater toxicological concern.
Additional uncertainty results from the lack of information and/or data in several components
of this ecological risk assessment as follows:
Ecotoxicity data for chronic risks to freshwater fish and freshwater invertebrates exposed to
mefluidide were not available. However, estimated values were derived from only one anilide
(propanil) herbicide to obtain effects measurement endpoints. A range of anilide herbicides
was not available to extrapolate endpoints.
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• Although propanil has a similar chemical structure as mefluidide, the anilide
(propanil) has a different mode of action for plants. Propanil is a photosynthesis
inhibitor in contrast to mefluidide which inhibits plant cell division, stem elongation
and seed head development. Also propanil has reported sublethal effects in fish and
aquatic invertebrates where mefluidide does not at similar or lower concentrations
such as; surfacing, loss of equilibrium, quiescent, labored respiration, fish lying on
their side, hypersensitivity to disturbances and fish lying on the bottom of test vessel.
Even though propanil effects may not be good predictors of mefluidide effects, in the
absence of mefluidide data, EFED believes propanil data could be used to estimate the
acute to chronic ratio for mefluidide. Note that uncertainties exist with these
extrapolated endpoints and propanil data are not considered complete substitutes for
missing effects data for mefluidide. Other anilide herbicides such as Chloranocryl,
Monalide and Pentanochlor were also considered, however no information was
available for these chemicals. Additional information on these estimated values are
provided in Appendix E. However, EFED concluded that resulting estimated risk
quotients, had they been based on definitive effects measurement endpoints, would not
trigger concerns for chronic risks to these taxonomic groups.
• Ecotoxicity data for chronic risks to estuarine marine fish and estuarine marine
invertebrates exposed to mefluidide were not available. However, assuming ACRs
from the freshwater fish and invertebrates are similar to the estuarine marine species.
No chronic exceedances would occur for estuarine marine fish or invertebrates with
RQs <0.01. These extrapolated endpoints are uncertain and are not considered
complete substitutes for missing effects data. RQ calculations for chronic risks to
estuarine marine fish and estuarine marine invertebrates are summarized in Appendix
E. However, EFED concluded that resulting estimated risk quotients, had they been
based on definitive effects measurement endpoints, would not trigger concerns for
chronic risks to these taxonomic groups.
• Ecotoxicity data for chronic risks to birds exposed to mefluidide were not available.
Therefore, EFED calculated estimates for measurement endpoints for chronic toxicity
to birds by evaluating the available data from mammal toxicity data (acute and
chronic) and extrapolating the findings to available data for mefluidide, mefluidide-
DEA and mefluidide-K to estimate possible effects measurement endpoints. These
extrapolated endpoints are uncertain and are not considered complete substitutes for
missing effects data. Additional information on these estimated values are provided in
Appendix E. Submission of a chronic bird study would quantify risks associated with
exposure of mefluidide to birds.
• The magnitude of toxicity to terrestrial plants is uncertain because only one terrestrial
vegetative vigor plant study was available and conducted on fresh weight and not dry
weight as required by EPA guidelines. A preliminary review on a recently submitted
seedling emergence study (MRID 471907-01) was conducted. These results are
uncertain until a full review of the study is performed. The results of the preliminary
review are summarized in Appendix E. Ecotoxicity data for terrestrial plants (seedling
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emergence) exposed to mefluidide were not available Therefore, to estimate possible
effects measurement endpoints for seedling emergence, EFED assumed that EC25
toxicity values for terrestrial plants (vegetative vigor) are equivalent to (seedling
emergence) measurement endpoints for mefluidide, mefluidide-DEA and mefluidide-
K. These estimated endpoints are uncertain and are not considered complete
substitutes for missing effects data. Additional information on these estimated values
are provided in Appendix E.
NOAEC or ECos values were not available to calculate (listed) aquatic vascular plants
exposed to mefluidide. However, estimated values were derived from only one anilide
herbicide to obtain effects measurement endpoints. A range of anilide herbicides was
not available to extrapolate endpoints. Although propanil has a similar chemical
structure as mefluidide, the anilide (propanil) has a different mode of action for plants.
Propanil is a photosynthesis inhibitor in contrast to mefluidide which inhibits plant cell
division, stem elongation and seed head development. Therefore, these extrapolated
endpoints are uncertain and are not considered complete substitutes for missing effects
data. Additional information on these estimated values are provided in Appendix E.
However, EFED concluded that resulting estimated risk quotients, had they been based
on definitive effects measurement endpoints, would not trigger concerns for chronic
risks to these taxonomic groups
The available dietary toxicity studies on avian species failed to established definitive
acute LDso values (i.e., the lethality values exceed the highest dose tested). Therefore,
use of this value adds uncertainty and may overestimate risk to avian species.
Therefore, when the LD50 value of >1500 mg ae/kg-bw was applied to the TREX
model it resulted in LOG exceedances for Acute listed (20 and 100 g birds) and
Restricted Use (100 g birds) for mefluidide-DEA and mefluidide-K (1.0 Ib ae/A at 3
applications). The LD50 value of 5000 mg ae/bw if applied to the above modeled
scenario would result in no acute LOG exceedances for birds.
4.3.1 Assumptions and Limitations Related to Exposure to All Taxa
There are a number of areas of uncertainty in the aquatic and terrestrial risk
assessments. The toxicity assessment for terrestrial and aquatic animals is limited by the
number of species tested in the available toxicity studies. Use of toxicity data on
representative species does not provide information on the potential variability in
susceptibility to acute and chronic exposures.
4.3.2. Assumptions and Limitations Related to Exposure to Aquatic
Species
PRZM/EXAMS standard runoff model
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Although there are uncertainties and limitations with the use of the PRZM/EXAMS
standard runoff scenario for a regional aquatic exposure assessment, it is designed to represent
pesticide exposure from an agricultural watershed impacting a vulnerable aquatic
environment. Extrapolating the risk conclusions from this standard small water body scenario
may either underestimate or overestimate the potential risks.
Major uncertainties with the standard runoff scenario are associated with the physical
construct of the watershed and representation of vulnerable aquatic environments for different
geographic regions. The phyisco-chemical properties (pH, redox conditions, etc.) of the
standard small water body are based on a Georgia farm pond. These properties are likely to be
regionally specific because of local hydrogeological conditions. Any alteration in water
quality parameters may impact the environmental behavior of the pesticide. The small water
body represents a well mixed, static water body. Because the small water body is a static
water body (no flow through); it does not account for pesticide removal through flow through
or accidental water releases. However, the lack of water flow in the small water body provides
an environmental condition for accumulation of persistent pesticides. The assumption of
uniform mixing does not account for stratification due to thermoclines (e.g., seasonal
stratification in deep water bodies). Additionally, the physical construct of the standard runoff
scenario assumes a watershed water body area ratio of 10. This ratio is recommended to
maintain a sustainable pond in the Southeastern United States. The use of higher watershed
water body ratios (as recommended for sustainable ponds in drier regions of the United
States) may lead to higher pesticide concentrations when compared to the standard watershed
water body ratio.
The standard small water body scenario assumes uniform environmental and management conditions exist
over the standard 10 hectare watershed. Soils can vary substantially across even small areas, and thus, this
variation is not reflected in the model simulations. Additionally, the impact of unique soil characteristics (e.g.,
fragipan) and soil management practices (e.g., tile drainage) are not considered in the standard runoff scenario.
The assumption of uniform site and management conditions is not expected to represent some site-specific
conditions. Extrapolating the risk conclusions from the standard small water body scenario to other aquatic
habitats (e.g., marshes, streams, creeks, and shallow rivers, intermittent aquatic areas) may either underestimate
or overestimate the potential risks in those habitats.
Currently, crop sites for PRZM/EXAMS modeling are chosen to represent sites which
produce high-end, but not unrealistic or worst-case, EECs for that crop. The EECs in this
analysis are accurate only to the extent that the site represents a hypothetical high-end
exposure site. It should be remembered that while the standard pond would be expected to
generate lower EECs than shallow water bodies near agricultural fields that receive most of
their water as runoff from use sites that have been treated with mefluidide.
4.3.3 Assumptions and Limitations Related to Exposure to Terrestrial
Species
Residue concentration
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The data available to support the exposure assessment for mefluidide is substantially
complete, with the exception of a chronic bird study, which is an input variable for Tier 1
modeling of risks to birds and mammals (i.e., T-REX Model). EFED is confident that the
estimated foliar half-life of 4 days derived from the two field dissipation studies on warm and
cool season turf soil are acceptable (MRID 43276802 and 43276801). Therefore, EFED used
the 4 day half-life for aquatic and terrestrial modeling in this assessment.
EFED also identified alternative foliar half lives and applications to identify LOG
exceedances. To assess risks to terrestrial animals, the Tier I terrestrial model, T-REX, was
used with maximum application rates (1 and 3 applications), foliar half-lives (4 day and 35
day) and values derived from upper bound and mean kenaga assessments.
To obtain an upper and lower bound estimates, both the estimated foliar half-life (4 days) and
the default foliar half-life (35 days) with 1 and 3 applications resulted in acute LOG
exceedances for both mammals and birds from both the upperbound and mean kenaga
assessments. Chronic dose based exceedances for mammals did not exceed from the mean
kenaga assessment for the 1.0 Ib ae/A application scenario. The 35 day foliar half life with 3
applications resulted in RQ values approximately 61% higher than the single application rates
for mammals. EFED is confident that the estimated foliar half-life of 4 days derived from the
two field dissipation studies on warm and cool season turf soil is acceptable (MRID 43276802
and 43276801). Therefore, EFED will use the 4 day half-life for aquatic and terrestrial
modeling in this assessment. Based on acute RQ values for the upper bound kenaga values for
mammals, LOG exceedances for acute mammals would occur for the 1.0 Ib ae/A modeled
scenario. However, acute exceedences for mammals did not exceed from the mean kenaga
assessment for the 1.0 Ib ae/A application scenario. These RQ values are summarized in
Appendix D.
Variation in habitat and dietary requirements
For screening terrestrial risk assessments, a generic bird or mammal is assumed to
occupy either the treated field or adjacent areas receiving pesticide at a rate commensurate
with the treatment rate on the field. The habitat and feeding requirements of the modeled
species and the wildlife species may be different. It is assumed that species occupy,
exclusively and permanently, the treated area being modeled. This assumption leads to a
maximum level of exposure in the risk assessment.
The acute studies have a fixed exposure period, not allowing for the differences in
response of individuals to different durations of exposure. Further, for the acute oral study,
Mefluidide is administered in a single dose which does not mimic wild birds' exposure
through multiple feedings. Also, it does not account for the effect of different environmental
matrices on the absorption rate of the chemical into the animal. Because exposure occurs over
several days, both the accumulated dose and elimination of the chemical from the body for the
duration of the exposure determine the exact exposure to wildlife, however they are not taken
into account in the screening assessment. There was also no assumption of an effect of
repeated doses that change the tolerance of an individual to successive doses. EFED is
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confident based on the acceptable bird and mammal toxicity studies and conservative
modeling procedures that the above assumptions pertaining to variations in habitat and dietary
requirements do not effect the certainty of the risk conclusions.
Variation in diet composition
The risk assessment and calculated RQs assume 100% of the diet is relegated to single
food types foraged only from treated fields. The assumption of 100% diet from a single food
type may be realistic for acute exposures based on this assessment, but diets are likely to be
more variable over longer periods of time. This assumption is likely to be conservative and
will tend to overestimate potential risks for chronic exposure. These large animals (e.g., deer
and geese) will tend to forage from a variety of areas and move on and off of treated fields.
Small animals (e.g., mice, voles, and small birds) may have home ranges smaller than the size
of a treated area and will have little or no opportunity to obtain foodstuffs that have not been
treated with mefluidide. Even if their home range does cover area outside the treated field,
mefluidide may have drifted or runoff to areas adjacent to the treated area.
Exposure routes other than dietary
Screening-level risk assessments for spray applications of pesticides consider dietary
exposure to terrestrial organisms. Other exposure routes are possible for animals residing in
or moving through treated areas. These routes include ingestion of contaminated drinking
water, ingestion of contaminated soils, preening/grooming, and dermal contact. Preening
exposures, involving the oral ingestion of material from the feathers remains an unquantified,
but potentially important, exposure route. If toxicity is expected through any of these other
routes of exposure, then the risks of a toxic response to mefluidide is underestimated in this
risk assessment. Other routes of exposure, not considered in this assessment, are discussed
below:
Incidental soil ingestion exposure
This risk assessment does not consider incidental soil ingestion. Available data suggests
that up to 15% of the diet can consist of incidentally ingested soil depending on the species
and feeding strategy (Beyer et al, 1994). Because mefluidide is moderately persistent in soils,
incidental soil ingestion is a possible exposure pathway.
Inhalation exposure
The screening risk assessment does not consider inhalation exposure however, due to the
low Henrys Constant of mefluidide (2.27E-7 atm mVmole) inhalation is not likely to be an
246
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important exposure pathway. Also, mammalian toxicity studies for inhalation exposure to
mefluidide indicate low acute toxicity Appendix E.
Based on the acceptable mammal toxicity studies and low Henrys Constant of
mefluidide the above assumptions pertaining to inhalation exposure do not effect the certainty
of the risk conclusions.
Dermal Exposure
The screening assessment does not consider dermal exposure. Dermal exposure may
occur through three potential sources: (1) direct application of spray to terrestrial wildlife in
the treated area or within the drift footprint, (2) incidental contact with contaminated
vegetation, or (3) contact with contaminated water or soil.
The low octanol/water partitioning coefficient with a Kow value of (log Kow=1.97;
Kow=94.5 indicates the potential for mefluidide to be absorbed via dermal exposure is not
likely to be an important exposure pathway. Also, mammalian toxicity studies for mefluidide
indicate low acute toxicity by dermal exposure routes Appendix E.
The available measured data related to wildlife dermal contact with pesticides are
extremely limited. The Agency is actively pursuing modeling techniques to account for
dermal exposure via direct application of spray and by incidental contact with vegetation.
EFED is confident based on the acceptable mammal toxicity studies and low octanol/water
partitioning coefficient of mefluidide that the above assumptions pertaining to dermal
exposure do not effect the certainty of the risk conclusions.
Drinking Water Exposure
Drinking water exposure to a pesticide active ingredient may be the result of consumption of surface
water or consumption of the pesticide in dew or other water on the surfaces of treated vegetation. Given that
Mefluidide is soluble in water there exists the potential to dissolve in runoff and puddles on the treated field may
contain the chemical. Consumption of drinking water would appear to be inconsequential if water
concentrations were equivalent to the concentrations from PRZM/EXAMS; however, concentrations in puddled
water sources on treated fields may be higher than concentrations in modeled small water body. Given that this
exposure route is not included in the assessment, overall risk may be underestimated.
Dietary Intake - Differences between Laboratory and
Field Conditions
There are several aspects of the dietary test that introduce uncertainty into calculation of
the LC50 value (Mineau, Jobin, and Baril, 1996; ECOFRAM, 1999). The endpoint of this test
is reported as the concentration mixed with food that produces a response rather than as the
dose ingested. Although food consumption sometimes allows for the estimate of a dose,
calculations of the mg/kg/day are confounded by undocumented spillage of feed and how
247
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consumption is measured over the duration of the test. Usually, if measured at all, food
consumption is estimated once at the end of the five-day exposure period. Further, group
housing of birds undergoing testing only allows for a measure of the average consumption per
day for a group; consumption estimates can be further confounded if birds die within a
treatment group. The exponential growth of young birds also complicates the estimate of the
dose; controls often nearly double in size over the duration of the test. Since weights are only
taken at the initiation of the exposure period and at the end, the dose per body weight (mg/kg)
is difficult to estimate with any precision. The interpretation of this test is also confounded
because the response of birds is not only a function of the intrinsic toxicity of the pesticide,
but also the willingness of the birds to consume treated food.
Further, the acute and chronic characterization of risk rely on comparisons of wildlife
dietary residues with LCso or NOAEC values expressed in concentrations of pesticides in
laboratory feed. These comparisons assume that ingestion of food items in the field occurs at
rates commensurate with those in the laboratory. Although the screening assessment process
adjusts dry-weight estimates of food intake to reflect the increased mass in fresh-weight
wildlife food intake estimates, it does not allow for gross energy and assimilative efficiency
differences between wildlife food items and laboratory feed. On gross energy content alone,
direct comparison of a laboratory dietary concentration- based effects threshold to a fresh-
weight pesticide residue estimate would result in an underestimation of field exposure by food
consumption by a factor of 1.25 - 2.5 for most food items. Only for seeds would the direct
comparison of dietary threshold to residue estimate lead to an overestimate of exposure.
Differences in assimilative efficiency between laboratory and wild diets suggest that
current screening assessment methods do not account for a potentially important aspect of
food requirements. Depending upon species and dietary matrix, bird assimilation of wild diet
energy ranges from 23 - 80%, and mammal's assimilation ranges from 41 - 85% (U.S.
Environmental Protection Agency, 1993). If it is assumed that laboratory chow is formulated
to maximize assimilative efficiency (e.g., a value of 85%), a potential for underestimation of
exposure may exist by assuming that consumption of food in the wild is comparable with
consumption during laboratory testing. In the screening process, exposure may be
underestimated because metabolic rates are not related to food consumption.
Finally, the screening procedure does not account for situations where the feeding rate
may be above or below requirements to meet free living metabolic requirements. Gorging
behavior is a possibility under some specific wildlife scenarios (e.g., bird migration) where
the food intake rate may be greatly increased. Kirkwood (1983) has suggested that an upper-
bound limit to this behavior might be the typical intake rate multiplied by a factor of 5. In
contrast is the potential for avoidance, operationally defined as animals responding to the
presence of noxious chemicals in their food by reducing consumption of treated dietary
elements. This response is seen in nature where herbivores avoid plant secondary compounds.
In the absence of additional information, the acute oral LD50 test provides the best
estimate of acute effects for chemicals where exposure can be considered to occur over
relative short feeding periods, such as the diurnal feeding peaks common to avian species
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(ECOFRAM, 1999). EFED is confident based on the acceptable bird and mammal toxicity
studies that the above assumptions pertaining laboratory and field conditions do not effect the
certainty of the risk conclusions.
Assumptions and Limitations Related to Effects Assessment
EFED has identified gaps in the effects dataset for mefluidide, mefluidide-DEA and
mefluidide-K. These data gaps prevent the establishment of definitive effects measurement
endpoints for the following taxonomic groups for mefluidide, mefluidide-DEA and
mefluidide-K: Chronic freshwater fish, chronic estuarine marine fish, chronic estuarine
marine invertebrates, chronic freshwater invertebrates, vascular plants (EC0s or NOAEC) and
non-vascular plants (ECos or NOAEC). Therefore, EFED calculated estimates for
measurement endpoints for these taxonomic groups by evaluating the available data from
other anilide herbicides (Propanil) and extrapolating the findings to available data for
mefluidide, mefluidide-DEA and mefluidide-K to estimate possible effects measurement
endpoints. Other anilide herbicides that were considered for data were Chloranocryl,
Monalide and Pentanochlor, however no information was available for these chemicals.
Therefore, Propanil was used to estimate acute to chronic ratios for mefluidide. EFED then
compared estimated environmental concentrations for surface waters with these endpoints. In
all cases, EFED concluded that resulting estimated risk quotients, had they been based on
definitive effects measurement endpoints, would not trigger concerns for acute or chronic
risks to these taxonomic groups. In fact, the RQ estimates are multiple orders of magnitude
below Agency LOCs. However, estimated values were derived from only one anilide
herbicides to obtain effects measurement endpoints. A range of anilide herbicides was not
available to extrapolate endpoints. Although propanil has a similar chemical structure as
mefluidide, the anilide (propanil) has a different mode of action for plants. Propanil is a
photosynthesis inhibitor in contrast to mefluidide which inhibits plant cell division, stem
elongation and seed head development. Also propanil has reported sublethal effects in fish
and aquatic invertebrates where mefluidide does not at similar or lower concentrations such
as; surfacing (fish and invertebrates), erratic movement( invertebrates), loss of equilibrium
(fish), quiescent (fish), labored respiration (fish), lying on side (fish), hypersensitivity to
disturbances (fish) and lying on the bottom of test vessel (fish and invertebrates). Therefore,
these extrapolated endpoints are uncertain and are not considered complete substitutes for
missing effects data.
EFED has identified gaps in the effects dataset for mefluidide, mefluidide-DEA and
mefluidide-K. These data gaps prevent the establishment of definitive effects measurement
endpoints for the following taxonomic groups for mefluidide, mefluidide-DEA and
mefluidide-K: birds (chronic) and terrestrial plants (seedling emergence). Therefore, EFED
calculated estimates for measurement endpoints for chronic toxicity to birds by evaluating the
249
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available data from mammal toxicity data (acute and chronic) and extrapolating the findings
to available data for mefluidide, mefluidide-DEA and mefluidide-K to estimate possible
effects measurement endpoints.
To estimate possible effects measurement endpoints for seedling emergence, EFED
assumed that Ł€25 toxicity values for terrestrial plants (vegetative vigor) are equivalent to
(seedling emergence) measurement endpoints for mefluidide, mefluidide-DEA and
mefluidide-K. Therefore, these estimated endpoints are uncertain and are not considered
complete substitutes for missing effects data.
Age class and sensitivity of effects thresholds
It is generally recognized that test organism age may have a significant impact on the
observed sensitivity to a toxicant. The screening risk assessment acute toxicity data for fish
are collected on juvenile fish between 0.1 and 5 grams. Aquatic invertebrate acute testing is
performed on recommended immature age classes (e.g., first instar for daphnids, second instar
for amphipods, stoneflies and mayflies, and third instar for midges). Similarly, acute dietary
testing with birds is also performed on juveniles, with mallard being 5-10 days old and quail
10-14 days old.
Testing of juveniles may overestimate toxicity of older age classes for pesticidal active
ingredients, such as Mefluidide, that act directly (without metabolic transformation) because
younger age classes may not have the enzymatic systems associated with detoxifying
xenobiotics. The screening risk assessment has no current provisions for a generally applied
method that accounts for this uncertainty. In so far as the available toxicity data may provide
ranges of sensitivity information with respect to age class, the risk assessment uses the most
sensitive life-stage information as the conservative screening endpoint. However, EFED is
confident based on all the acceptable aquatic and terrestrial toxicity studies that the above
assumptions pertaining to age sensitivity does not effect the certainty of the risk conclusions.
Use of the Most Sensitive Species Tested
Although the screening risk assessment relies on a selected toxicity endpoint from the
most sensitive species tested, it does not necessarily mean that the selected toxicity endpoint
reflect sensitivity of the most sensitive species existing in a given environment. The relative
position of the most sensitive species tested in the distribution of all possible species is a
function of the overall variability among species to a particular chemical. In the case of listed
species, there is uncertainty regarding the relationship of the listed species' sensitivity and the
most sensitive species tested.
The Agency is not limited to a base set of surrogate toxicity information in establishing
risk assessment conclusions. The Agency also considers toxicity data on non-standard test
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species when available. EFED is confident based on the acceptable aquatic and terrestrial
toxicity studies that the above assumptions pertaining to the most sensitive species tested
does not effect the certainty of the risk conclusions.
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REFERENCES
Beyer, W.N. 1994. Estimates of soil ingestion by wildlife. J Wildlife Manage 58(2):375-382.
Crum, J. R., F. W. Thomas, and J. N. Rogers III. 2003. Agronomic and engineering properties
of USGA putting greens. USGA Turfgrass and Environmental Research Online 2(15): 1-9.
ECOFRAM. 1999. ECOFRAM Terrestrial Draft Report. Ecological Committee on FIFRA
Risk Assessment Methods. USEPA, Washington, DC.
Fletcher, J.S., I.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of
the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on
plants. Environ. Tox. Chem. 13:1383-1391.
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of
representative data as a basis for estimation of their magnitude in the environment. In F.
Coulston and F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and
Technology, Georg Thieme Publ, Stuttgart, West Germany, pp. 9-28.
Gibson, L. R. and M. Liebman. 2002. Course Material for Principles of Weed Science,
Agronomy 317, Iowa State University. Website accessed 17 July 2006,
http://www.agron.iastate.edu/courses/Agron317/Herbicide_mode_of_action.htm.
Kirkwood JK. 1983. Minireview. A limit to metabolisable energy intake in mammals and
birds. Comp Biochem Physiol A 75(1): 1-3.
Lehman, A. J.I 975. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Association of Food and Drug Officials of the United States
Merola-Zwartjes, M., and J. P. DeLong. 2005. Southwestern golf courses provide needed
riparian habitat for birds. USGA Turfgrass and Environmental Research Online 4(14): 1-18
Mineau, P., B. T. Collins, and A. Baril. 1996. On the use of scaling factors to improve
interspecies extrapolation of acute toxicity in birds. Regulatory Toxicology and
Pharmacology. 24:24-29.
Stangel, P., and K. Distler. 2002. Golf courses for wildlife: Looking beyond the turf. USGA
Turfgrass and Environmental Research Online 1(2): 1-6.
Urban DJ & Cook NJ (1986) Hazard Evaluation Division Standard Evaluation Procedure:
Ecological risk assessment. EPA 540/9-85-001. Office of Pesticide Programs, United States
Environmental Protection Agency, Washington, D.C
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Appendix A Ecological Data Requirements
Ecological Effects Data Requirements for Mefluidide1
Guideline #
71-1 850.2100
71-2 850.2200
71-4 850.2300
81-1
83-4
72-1 850.1075
72-2 850.1010
72-3(a) 850.1075
72-3(b) 850.1025
72-4(a) 850.1400
72-4(b) 850.1300
850.1350
72-5 850.1500
123-l(a) 850.4225
123-l(b) 850.4250
123-2 850.4400
123-2 850.4400
141-1 850.3020
Data Requirement
Avian Oral LD50
Avian Dietary LC50
Avian Reproduction
Acute Mammal
Chronic Mammal
Freshwater Fish LC50
Freshwater Invertebrate Acute
LC50
Estuarine/Marine Fish LC50
Estuarine/Marine Invertebrates
EC50
Fish Early Life-Stage
Aquatic Invertebrate Life-
Cycle
Freshwater Fish Full Life-
Cycle
Seedling Emergence
Vegetative Vigor (Tier II)
Aquatic Plant Growth (Tier II)
Aquatic Plant Growth (Tier II)
Honey Bee Acute Contact
LD50
Species / MRID
Northern Bobwhite Quail (416019-01 )
Mallard duck Not submitted
Northern Bobwhite Quail (416019-02)
Mallard duck (416019-03)
Not submitted
Laboratory mouse (000471 16)
Laboratory rat (00082748)
Rainbow Trout Coldwater species Freshwater fish
(418937-02)
Bluegill sunfish Warmwater species Freshwater fish
(418937-01)
Water flea
Freshwater Invertebrate (418937-03)
Sheepshead minnow
(425623-03)
Eastern Oyster (425624-01)
Not submitted
Not submitted
Not submitted
Not submitted
Most sensitive monocot: Onion
Most sensitive dicot: cabbage, lettuce
(435496-01 )
Navicula pelliculosa Tier I Nonvascular Plant(435266-
05 )
Lemna gibba Tier I Vascular Plantf 435266-01 )
Honeybee (425628-01 )
Study Classification
Supplemental
Supplemental
Supplemental
Estimated
values
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Estimated values
Estimated values
Estimated values
Estimated values
Supplemental
Acceptable
Acceptable
Acceptable
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Appendix B Bibliography for Environmental Fate and Selected Chemical
Structures
Bibliography
,rd
Morrison Robert T. and R. N. Boyd. 1973. Organic Chemistry 3 edition. Allyn and
Bacon, Inc., Boston.
Chemical Stuctures for Mefluidide
CH2 C
\
F — C - S — N
F O
CH,
CH,
F — C - S — N
F O
CH,
CH,
CH2—C
F—C S—N
F O
[DEA]
CH,
CH,
Mefluidide a.i
Mefluidide-K a.i
Mefluidide-DEA a.i
\
F—C S—N
F O
CH,
CH,
F — C - S — N
F O
CH,
CH,
Mefluidide acid (Enol form)
Mefluidide (Keto form)
CH,
Propanil analog
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Appendix C Aquatic Exposure Modeling Assessment PRZM-
EXAMS model outputs
PRZM-EXAMS SIMULATIONS
FL TURF mefluidide-DEA
stored as MefluDEA.out
Chemical: Mefluidide
PRZM environment: FLturfC.txt modified Monday, 16 June 2003 at 13:48:06
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 16:33:30
Metfile: w!2834.dvf modified Wedday, 3 July 2002 at 09:04:28
Water segment concentrations (ppb)
Year
1961
1962
1963
1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
Pe
6 .
2.
10
3.
1.
16
3 .
8.
5.
2.
6 .
2.
2 .
5 .
^
12
1.
1.
1.
5.
1.
5 .
2 .
10
1.
1.
2.
1.
1.
1.
ak
522
048
.33
237
479
.06
069
56
46
4
952
756
109
179
035
. 62
88
602
461
023
565
846
743
. 6
841
867
407
338
267
281
96
6 .
2.
10
3.
1.
15
^
8.
5 .
2.
6 .
2.
2 .
5 .
2 .
12
1.
1.
1.
4 .
1.
5 .
2 .
10
1.
1.
2.
1.
1.
1.
hr
393
006
.1
164
45
T
035
38
357
345
81
706
069
102
971
. 39
837
565
427
929
529
753
703
. 4 2
806
84
354
309
239
251
21
5 .
1.
9 .
3.
1.
14
2 .
~->
5.
2.
6 .
2.
1.
4 .
2 .
11
1.
1.
1.
4 .
1.
5 .
2 .
9 .
1.
1.
2.
1.
1.
1.
Day
844
904
353
003
332
. 25
896
675
124
128
223
502
968
72
726
. 53
714
421
304
5
387
376
492
653
697
67 9
14
194
126
198
60
4 .
1.
7 .
2.
1.
11
2 .
6.
4 .
1.
5 .
2.
1.
^
2 .
9 .
1.
1.
1.
3.
1.
4 .
2 .
8.
1.
1.
1.
1.
0 .
0.
Day
781
621
649
477
139
.58
614
287
396
816
131
233
866
909
251
825
619
337
145
632
276
844
398
537
559
404
739
038
9689
9955
90
4 .
1.
6 .
2.
1.
10
2 .
5 .
3.
1.
4 .
2.
1.
3 .
2 .
8.
1.
1.
1.
3.
1.
4 .
2 .
8.
1.
1.
1.
1.
0 .
0.
Day
142
473
617
159
112
.03
409
45
892
765
881
031
792
396
01
995
523
278
04
132
222
576
317
545
529
239
515
003
9342
953
Yearly
1. 629
1. 009
2.702
1.513
0. 679
4.671
1.701
2 . 273
1. 956
1. 048
2 . 576
1.15
0. 9159
1.445
1.233
4.192
1.118
0. 6743
0. 5849
1. 623
0.7967
2.162
1.295
3. 988
1.038
0. 6823
0. 7955
0. 5808
0. 4958
0.5079
orted results
rob. Peak 96 hr
.032258064516129
.0645161290322581
.0967741935483871
.129032258064516
.161290322580645
.193548387096774
.225806451612903
.258064516129032
.290322580645161
.32258064516129
.354838709677419
.387096774193548
255
-------
. 419354838709677
. 451612903225806
. 483870967741936
.516129032258065
.548387096774194
.580645161290323
. 612903225806452
.645161290322581
. 67741935483871
.709677419354839
.741935483870968
.774193548387097
. 806451612903226
. 838709677419355
.870967741935484
. 903225806451613
. 935483870967742
.967741935483871
3.
3.
2.
2.
2 .
2 .
2 .
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
9 .
. 069
. 035
. 756
743
.407
. 4
.109
. 048
. 88
. 867
. 841
. 602
.565
.479
.461
.338
.281
.267
. 623
3.
2.
2.
2.
2 .
2 .
2 .
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
8.
. 035
. 971
. 706
703
.354
.345
.069
.006
. 84
. 837
. 806
.565
. 529
.45
. 427
.309
.251
.239
.4482
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
8
A-
. 896
.726
.502
4 92
.14
.128
. 968
. 904
.714
. 697
. 67 9
. 421
.387
332
.304
.198
.194
.126
.3522
veraae
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
0
0
3
0
. 477
.398
.251
233
. 866
.816
.739
. 621
. 619
.559
. 404
.337
. 276
.145
.139
. 038
. 9955
. 9689
. 8594
f vea
2.
2.
2.
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
0 .
0 .
ri^
.317
.159
. 031
01
.792
.765
. 529
.523
.515
. 473
.278
.239
. 222
.112
.04
.003
. 953
. 9342
/ aver;
1
1
1
1
1
1
1
1
0
0
o
0
0
0
0
0
0
0
ac
. 445
.295
.233
. 15
.118
.048
.038
.009
. 9159
. 7 967
. 7 955
. 6823
. 679
.6743
.5849
.5808
. 5079
. 4958
ies: 1.5678366666666
Data used for this run:
Output File: MefluDEA
Metfile: w!2834.dvf
PRZM scenario: FLturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight
Henry's Law Const.
Vapor Pressure vapr
Solubility sol
Kd Kd 0.073
Koc Koc
Photolysis half-life
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.01
Application Date Date
Interval 1 interval
Interval 2 interval
Record 17: FILTRA
IPSCND 1
UPTKF
PLVKRT
0.1715
0.5
Flaq for Index Res. Run
Flaq for runoff calc. RUNOFF
Value Units Comments
mwt 310.6
henry 2.27E-7
1E-4 torr
180 mg/L
mg/L
mg/L
kdp
kbacw
kbacs
asm
days Half-life
integer See PRZM manual
cm
1.12 kg/ha
APPEFF 0.99 fraction
fraction of application rate applied to pond
1-4
4 2
42
Half-life
days Halfife
days Halfife
Halfife
Record 18:
PLDKRT
FEXTRC
IR
none
256
-------
FL TURF mefluidide-K
stored as MefluK.out
Chemical: Mefluidide
PRZM environment: FLturfC.txt modified Monday, 16 June 2003 at 13:48:06
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 16:33:30
Metfile: w!2834.dvf modified Wedday, 3 July 2002 at 09:04:28
Water segment concentrations (ppb)
Drted results
rob. Peak 96 hr
.032258064516129
.0645161290322581
.0967741935483871
.129032258064516
.161290322580645
.193548387096774
.225806451612903
.258064516129032
.290322580645161
.32258064516129
.354838709677419
.387096774193548
.419354838709677
.451612903225806
.483870967741936
.516129032258065
.548387096774194
.580645161290323
.612903225806452
.645161290322581
.67741935483871
.709677419354839
.741935483870968
. 774193548387097
21
5 .
1.
9 .
3.
1.
14
2 .
^
5 .
2.
6 .
2.
1.
4 .
11
1.
1.
1.
4 .
1.
5 .
9
1.
1.
2.
1.
1.
1.
21
16
12
10
10
8.
6.
6.
5 .
5 .
5 .
5.
3.
3.
3 .
2 .
2 .
2 .
2.
2.
2.
1.
1.
1.
1.
Day
844
904
353
003
332
. 25
896
675
124
128
223
502
968
7 2
726
. 53
714
421
304
5
387
376
4 92
653
697
67 9
14
194
126
198
Day
.06
. 62
. 6
.33
56
952
522
846
46
179
023
237
069
035
756
743
407
4
109
048
88
867
841
602
60
4 .
1.
7 .
2.
1.
11
2 .
6.
4 .
1.
5.
2.
1.
3 .
9
1.
1.
1.
3.
1.
4 .
8.
1.
1.
1.
1.
0 .
0.
60
15
12
10
10
8.
6.
6.
5 .
5 .
5.
4 .
3.
3.
2 .
2 .
2 .
2 .
2.
2.
2.
1.
1.
1.
1.
Day
781
621
649
477
139
.58
614
287
396
816
131
233
866
909
251
825
619
337
145
632
276
844
398
537
559
404
739
038
9689
9955
Day
•-J
.39
. 42
.1
38
81
393
753
357
102
929
164
035
971
706
703
354
345
069
006
84
837
806
565
90
4 .
1.
6 .
2.
1.
10
2 .
5 .
^
1.
4 .
2.
1.
^
8.
1.
1.
1.
3.
1.
4 .
8.
1.
1.
1.
1.
0 .
0.
90
14
11
9 .
9 .
7 .
6.
5 .
5 .
5 .
4 .
4 .
3.
2.
2 .
2 .
2 .
2 .
2.
1.
1.
1.
1.
1.
1.
Day
142
473
617
159
112
.03
409
45
892
765
881
031
792
396
01
995
523
278
04
132
222
576
317
545
529
239
515
003
9342
953
Day
. 25
.53
653
353
675
223
844
376
124
72
5
003
896
726
502
492
14
128
968
904
714
697
679
421
Y
1
1
2
1
0
4
1
2
1
1
2
1
0
1
1
4
1
0
0
1
0
2
1
^
1
0
o
0
0
0
Y
1
9
8
7
6
5
4
4
4
3
3
2
2
2
2
2
1
1
1
1
1
1
1
1
early
. 629
. 009
.702
.513
.679
.671
.701
273
. 956
. 048
. 576
.15
. 9159
.445
.192
.118
. 6743
.5849
. 623
. 7 967
.162
.295
. 988
. 038
. 6823
. 7955
.5808
. 4958
.5079
early
1.58
. 825
.537
. 649
.287
.131
.844
.781
.396
. 909
. 632
. 614
. 477
.398
.251
233
. 866
. 816
.739
. 621
. 619
.559
.404
. 337
10
8.
8.
6 .
5 .
4 .
4 .
4 .
3 .
3.
3.
2.
2.
2 .
2 .
2 .
1.
1.
1.
1.
1.
1.
1.
1.
.03
995
545
617
45
881
576
142
892
396
132
409
317
159
031
01
792
765
529
523
515
473
278
239
257
-------
0.806451612903226
0.838709677419355
0.870967741935484
0.903225806451613
0.935483870967742
0.967741935483871
Inputs generated by pe4.pl - 8-August-2003
Data used for this run:
Output File: MefluK
Metfile: w!2834.dvf
PRZM scenario: FLturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight mwt
Henry's Law Const. henry
Vapor Pressure vapr 1E-4
Solubility sol
Kd Kd 0.073
Koc Koc
Photolysis half-life
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.01
Value
310. 6
2.27E-7
torr
mg/L
Comments
Half-life
Application Dat
Interval 1
Interval 2
Record 17:
IPSCND
UPTKF
Record 18:
PLDKRT
FEXTRC
e Date 1-4
interval 42
interval 42
FILTRA
1
PLVKRT
0.1715
0 . 5
days Halfife
days Halfife
36 days Halfife
Half-life
integer See PRZM manual
cm
1.12 kg/ha
APPEFF 0.99 fraction
fraction of application rate applied to pond
dd/mm or dd/mmm or dd-mm or dd-mmm
days Set to 0 or delete line for single app.
days Set to 0 or delete line for single app.
Flag for Index Res. Run
Flag for runoff calc. RUNOFF
258
-------
FL TURF mefluidide
stored as Mefluacidi.out
Chemical: Mefluidide
PRZM environment: FLturfC.txt modified Monday, 16 June 2003 at 13:48:06
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 16:33:30
Metfile: w!2834.dvf modified Wedday, 3 July 2002 at 09:04:28
Water segment concentrations (ppb)
Year Peak 96 hr 21 Day
1961 2.705 2.623 2.395
1962 0.4867 0.4819 0.4621
1963 4.628 4.521 4.186
1964 1.063 1.039 0.9768
1965 0.2023 0.2004 0.1923
1966 7.509 7.344 6.666
1967 1.435 1.419 1.354
1968 3 711 3 633 3 3?4
1969 2.254 2.212 2.
1970 0. 6738 0. 6621 0.
1971 2.902 2.842 2.
1972 0.8825 0.8664 0.
1973 0.7281 0.7167 0.
1974 1.999 1.973 1.
1975 0.9183 0.8987 0.
1976 5.849 5.746 5.
1977 0.7792 0.773 0.
1978 0.3362 0.3306 0.
1979 0. 209 0. 2042 0.
1980 1.927 1.886 1.
1981 0.3447 0.3422 0.
1982 2.621 2.58 2.
1983 0.9113 0.8994 0.
1984 4 . 858 4.774 4 .
1985 0.6437 0.6381 0.
1986 0.3765 0.3696 0.
1987 0.6123 0.5988 0.
1988 0.1109 0.1099 0.
1989 0.029120.028660.
1990 0. 08553 0. 083
Sorted results
Prob. Peak 96 hr
0.
0 .
0 .
0 .
0 .
0.
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
. 032258064516129
. 0645161290322581
. 0967741935483871
.129032258064516
.161290322580645
.193548387096774
.225806451612903
.258064516129032
.290322580645161
.32258064516129
.354838709677419
.387096774193548
. 419354838709677
. 451612903225806
. 483870967741936
.516129032258065
.548387096774194
.580645161290323
. 612903225806452
. 645161290322581
. 67741935483871
.709677419354839
.741935483870968
.774193548387097
55 0.
.11
. 6153
.597
. 8012
. 6819
.825
.8271
.348
.7472
.3074
.1856
.725
.3319
. 411
.8361
. 423
.615
. 3383
.544
. 1057
. 02658
. 07587
21 Day
•-j
5.
4 .
4 .
3.
2 .
2 .
2 .
2 .
1.
1.
1.
1.
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
.509
. 849
. 858
. 628
.711
. 902
.705
. 621
.254
.999
. 927
. 435
. 063
. 9183
. 9113
. 8825
.7792
.7281
. 6738
. 6437
. 6123
. 4867
.3765
.3447
60 Day
1. 959
0. 4172
3. 424
0. 8114
0.1746
5.416
1.222
2 794
1.
0 .
2.
0.
0 .
1.
0.
4 .
0.
0 .
0 .
1.
0 .
2.
0.
-^
0.
0.
0 .
0 .
0 .
0 .
90 Day
1.697
0.3845
2. 962
0. 7087
0.1613
4 . 692
1.126
? 361
.748 1.
.5286 0.
.132 1.
.6593 0.
.5861 0.
.513 1.
.6841 0.
.478 4 .
.6889 0.
.2628 0.
.1521 0.
.393 1.
.306 0.
.08 1.
.7669 0.
. 942 3.
.5619 0.
.2763 0.
.4412 0.
. 09663 0.
. 02215 0.
. 0616
60 Day
^
5 .
4 .
4 .
3.
2 .
2 .
2 .
2 .
1.
1.
1.
1.
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
.344
.746
.774
.521
. 633
. 842
. 623
.58
.212
. 973
. 886
. 419
. 039
. 8994
. 8987
. 8664
.773
.7167
. 6621
. 6381
.5988
.4819
.3696
.3422
0 .
Yearly
0.6036
0. 2598
1.119
0.5198
0. 0877
2.106
0.6051
0 . 896?
.51 0.
. 4994 0.
.999 1 .
.5722 0.
.5181 0.
.314 0.
.5946 0.
.143 1.
.6377 0.
.2355 0.
.1322 0.
.199 0 .
.2846 0.
.908 0.
.7557 0.
.914 1.
.5184 0.
.2394 0.
.3805 0.
. 08981 0.
. 01923 0.
. 05313 0.
90 Day
6.
5.
4 .
4 .
3.
2 .
2 .
2 .
2 .
1.
1.
1.
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
. 666
.348
. 423
.186
.324
. 597
.411
. 395
.11
.825
.725
.354
. 9768
. 8361
.8271
. 8012
.7472
. 6819
. 6153
. 615
.544
. 4621
. 3383
.3319
.7417
.2943
. 053
.3381
.2195
. 4854
.3775
. 863
.3198
.1042
. 05641
.5759
.157
. 8387
.396
. 755
.2808
.09841
. 1559
. 04412
009001
. 01983
Yearly
5 .
4 .
3.
3.
2.
2 .
2 .
1.
1.
1.
1.
1.
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
.416
. 478
. 942
. 424
.724
.132
.08
. 959
.748
.513
.393
.222
. 8114
. 7669
. 6889
.6841
.6593
.5861
.5619
.5286
. 4412
. 4172
.306
.2763
4 .
4 .
3.
2.
2.
1.
1.
1.
1.
1.
1.
1.
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
. 692
.143
. 914
. 962
.361
.999
. 908
. 697
.51
.314
.199
.126
.7557
. 7087
. 6377
.5946
. 5722
.5184
.5181
.4994
.3845
.3805
.2846
.2394
2 .
1.
1.
1.
1.
0.
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
.106
. 863
.755
.119
. 053
. 8962
.8387
.7417
.6051
. 6036
. 5759
.5198
. 4854
.396
.3775
.3381
.3198
.2943
.2808
.2598
.2195
.157
.1559
.1042
259
-------
0.806451612903226
0.838709677419355
0.870967741935484
0.903225806451613
0.935483870967742
0.967741935483871
Inputs generated by pe4.pl - 8-August-2003
Data used for this run:
Output File: Mefluacidi
Metfile: w!2834.dvf
PRZM scenario: FLturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight mwt
Henry's Law Const. henry
Vapor Pressure vapr 1E-4
Solubility sol
Kd Kd 0.073
Koc Koc
Photolysis half-life
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.0
Value
310. 6
2.27E-7
torr
mg/L
Comments
Half-life
Application Dat
Interval 1
Interval 2
Record 17:
IPSCND
UPTKF
Record 18:
PLDKRT
FEXTRC
e Date 1-4
interval 42
interval 42
FILTRA
1
PLVKRT
0.1715
0 . 5
days Halfife
days Halfife
36 days Halfife
Half-life
integer See PRZM manual
cm
0.56 kg/ha
APPEFF 1.00 fraction
fraction of application rate applied to pond
dd/mm or dd/mmm or dd-mm or dd-mmm
days Set to 0 or delete line for single app.
days Set to 0 or delete line for single app.
Flag for Index Res. Run
Flag for runoff calc. RUNOFF
260
-------
PA TURF mefluidide-DEA
stored as MefluDEA.out
Chemical: Mefluidide
PRZM environment: PAturfC.txt modified Satday, 12 October 2002 at 16:27:02
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 16
Metfile: w!4737.dvf modified Wedday, 3 July 2002 at 09:06:12
Water segment concentrations (ppb)
Year
1961
1962
1963
1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
Peak
1.
1.
1.
1.
1.
1.
3.
1.
10
5 .
2 .
10
4 .
^
5 .
2.
5 .
2.
1.
2 .
2 .
1.
6 .
2.
2.
3.
2 .
3 .
2 .
508
894
689
64
606
618
188
823
.34
302
679
. 43
838
102
928
329
93
673
753
388
107
87
622
641
182
103
9
313
244
96
1.
1.
1.
1.
1.
1.
3.
1.
10
5.
2 .
10
4 .
•-j
5.
2.
5.
2.
1.
2 .
2 .
1.
6 .
2.
2.
3.
2 .
^
2 .
hr
481
864
663
616
582
591
478
157
795
.26
247
641
9 R
7 92
045
872
298
872
634
726
359
078
84
507
607
148
066
866
275
208
21 Day
1.
1.
1.
1.
1.
1.
3.
1.
9 .
5 .
2 .
9
4 .
6.
5 .
2.
5 .
2.
1.
2 .
1.
1.
6 .
2.
2.
2.
2 .
3 .
2 .
.375
.74
.549
.507
.477
. 472
. 31
. 052
. 677
. 907
. 022
. 464
. 455
.605
.814
. 64
.172
.592
. 47
.601
. 239
. 943
.719
. 052
. 468
. 018
. 944
.718
.116
.074
60 Day
1.
1.
1.
1.
1.
1.
2.
1.
9 .
4 .
2 .
T
4 .
6.
5.
2.
5.
2.
1.
2 .
1.
1.
5 .
2.
1.
2.
2 .
2 .
1.
.288
. 627
. 395
.342
.306
.321
. 014
. 893
.549
.204
.55
.311
. 943
.369
.374
.283
. 051
. 087
.386
.465
.1
.781
.599
.134
.323
. 904
. 855
.551
.887
. 949
90 Day
1.
1.
1.
1.
1.
1.
1 .
2.
1.
8.
4 .
2 .
^
4 .
5 .
4 .
2.
4 .
2.
1.
1.
1.
1.
4 .
2.
1.
2.
2 .
2 .
1.
.184
. 567
. 353
.309
977
.274
. 848
. 82
.499
. 608
.182
.18
. 066
.183
. 981
. 982
. 021
.753
.27
.403
. 963
.701
. 527
. 63
.243
. 816
. 755
.358
. 683
.867
Ye
0 .
1.
0.
0.
0.
0.
1 .
1.
1.
4 .
2.
1.
-^
2.
3.
2.
1.
2.
1.
0.
1.
1.
0.
2.
1.
1.
1.
1.
1.
1.
sarly
.6653
. 027
. 9127
.861
. 8369
.8173
. 149
. 641
. 083
.205
.656
. 537
655
. 896
.199
. 834
. 455
. 412
. 662
. 9518
.108
.123
. 9895
. 621
. 695
.182
.587
.403
.541
. 252
Drted results
rob. Peak 96 hr
.032258064516129
.0645161290322581
.0967741935483871
.129032258064516
.161290322580645
.193548387096774
.225806451612903
.258064516129032
.290322580645161
.32258064516129
.354838709677419
.387096774193548
.419354838709677
.451612903225806
.483870967741936
.516129032258065
.548387096774194
.580645161290323
.612903225806452
.645161290322581
.67741935483871
.709677419354839
261
-------
0.741935483870968
0. 774193548387097
0.806451612903226
0.838709677419355
0.870967741935484
0.903225806451613
0.935483870967742
0.967741935483871
Data used for this run:
Output File: MefluDEA
Metfile: w!4737.dvf
PRZM scenario: PAturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight mwt
Henry's Law Const. henry
Vapor Pressure vapr 1E-4
Solubility sol 180
Kd Kd 0.073 mg/L
Koc Koc mg/L
Photolysis half-life kdp
Aerobic Aguatic Metabolism
Anaerobic Aguatic Metabolism
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.01
Application Date Date
Half-life
days Halfife
days Halfife
Halfife
Half-life
integer See PRZM manual
cm
1.12 kg/ha
APPEFF 0.99 fraction
fraction of application rate applied to pond
Interval 1
Interval 2
Record 17:
IPSCND
UPTKF
Record 18:
PLDKRT
FEXTRC
interval
interval
FILTRA
1
IR
Flag for runoff calc. RUNOFF none
262
-------
PA TURF mefluidide-K
stored as MefluK.out
Chemical: Mefluidide
PRZM environment: PAturfC.txt modified Satday, 12 October 2002 at 15:27:02
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 15:33:30
Metfile: w!4737.dvf modified Wedday, 3 July 2002 at 08:06:12
Water segment concentrations (ppb)
Year Peak 96 hr
1961 1 . 508 1.481
1962 1.894 1.864
1963 1.689 1.663
1964 1.64 1.616
1965 1.606 1.582
1966 1.618 1.591
1967 2.52 2.478
1968 3.188 3.157
1969 1.823 1.795
1970 10.34 10.26
1971 5.302 5.247
1972 2.679 2.641
1973 10.43 10.25
1974 4.838 4.792
1975 7.102 7.045
1976 5.928 5.872
1977 2 . 329 2.298
1978 5 93 5 872
1979 2.673 2.634
1980 1.753 1.726
1981 2.388 2.359
1982 2.107 2.078
1983 1.87 1.84
1984 6.622 6.507
1985 2.641 2.607
1986 2.182 2.148
1987 3.103 3.066
1988 2.9 2. 866
1989 3.313 3.275
1990 2.244 2.208
Sorted results
Prob. Peak 96 hr
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0 .
0.
0.
0.
0.
. 032258064516129
. 0645161290322581
. 0967741935483871
.129032258064516
.161290322580645
.193548387096774
.225806451612903
.258064516129032
.290322580645161
.32258064516129
.354838709677419
.387096774193548
. 419354838709677
. 451612903225806
. 483870967741936
.516129032258065
.548387096774194
. 580645161290323
. 612903225806452
.645161290322581
. 67741935483871
21
1 .
1.
1.
1.
1.
1.
2.
3.
1.
9
5 .
9 .
4 .
6 .
5
1.
2.
1.
1.
6 .
2.
^
2.
21
10
10
•-j
6.
5 .
5.
5 .
4 .
3 .
^
3 .
2 .
2.
2.
2.
2.
2.
9
2.
2 .
2 .
Day
375
74
549
507
477
472
31
052
677
907
022
464
455
605
814
64
172
592
47
601
239
943
719
052
468
018
944
718
116
074
Day
.43
. 34
102
622
93
928
302
838
313
188
103
9
67 9
673
641
52
388
329
244
182
107
60
1 .
1.
1.
1.
1.
1.
2.
2.
1.
9 .
4 .
7 .
4 .
6 .
5 .
s
1.
2.
1.
1.
2.
1.
1.
60
10
10
•-J
6.
5.
5 .
5.
4 .
3 .
3 .
^
2 .
2.
2.
2.
2.
2.
0
2.
2 .
2 .
Day
288
627
395
342
306
321
014
893
549
204
55
311
943
369
374
283
051
087
386
465
1
781
599
134
323
904
855
551
887
94 9
Day
. 2 6
2 5
045
507
872
872
247
792
275
157
066
866
641
634
607
478
359
298
208
148
078
90 Day
1.184
1.
1.
1.
1.
1.
1.
2.
1.
8.
4 .
7 .
4 .
5 .
4 .
4 .
1.
1.
1.
1.
4 .
2.
1.
1.
.567
. 353
.309
.277
.274
. 848
. 82
.499
. 608
.182
.18
.066
.183
. 981
. 982
.021
. 753
.403
. 963
.701
.527
. 63
.243
.816
. 755
.358
.683
. 867
90 Day
9 .
9
6.
6.
5 .
5.
5 .
4 .
3 .
^
2 .
2 .
2.
2.
2.
2.
2.
0
2.
2 .
1.
. 907
. 455
.814
.052
. 64
.592
. 022
. 605
.116
.052
. 944
.718
. 47
. 468
. 464
.31
.239
172
.074
.018
. 943
Yearly
0 6653
1.
0.
0.
0 .
0 .
1.
1.
1.
4 .
1.
3.
2.
3.
2.
1.
1.
0.
1.
1.
0 .
2.
1.
1.
1.
1.
1.
1.
Ye
9
T
6.
5 .
5.
5 .
4 .
4 .
2 .
2 .
2 .
2 .
2.
2.
2.
2.
2.
0
1.
1.
1.
.027
. 9127
.861
. 8369
. 8173
.149
. 641
. 083
.205
.656
. 537
. 655
. 896
.199
. 834
.455
. 412
. 662
. 9518
.108
.123
. 9895
. 621
.695
.182
.587
.403
.541
.252
sarly
.204
. 943
.374
.283
.134
. 087
.55
.369
.893
. 887
.855
.551
.386
.323
.311
.1
. 051
014
. 949
. 904
.781
8.
~->
5 .
4 .
4 .
4 .
4 .
4 .
2 .
2 .
2 .
2 .
2.
2.
2.
2.
1.
1 .
1.
1.
1.
.608
. 066
. 981
. 982
.753
. 63
.183
.182
. 82
. 755
. 683
.358
.27
.243
.18
. 021
. 963
. 867
.848
.816
.701
4 .
-^
3 .
2 .
2.
2.
2.
2.
1.
1.
1.
1.
1.
1.
1.
1.
1.
1 .
1.
1.
1.
.205
655
.199
.896
. 834
.656
. 621
. 412
. 695
. 662
.641
.587
.541
.537
. 455
. 403
.252
. 182
.149
.123
.108
263
-------
0.709677419354839
0.741935483870968
0.774193548387097
0.806451612903226
0.838709677419355
0.870967741935484
0.903225806451613
0.935483870967742
0.967741935483871
Value
310.6
2.27E-7
torr
mg/L
Data used for this run:
Output File: MefluK
Metfile: w!4737.dvf
PRZM scenario: PAturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight mwt
Henry's Law Const. henry
Vapor Pressure vapr 1E-4
Solubility sol
Kd Kd 0.073
Koc Koc
Photolysis half-life
Aerobic Aguatic Metabolism kbacw
Anaerobic Aguatic Metabolism kbacs
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.01
Application Date Date
Interval 1 interval
Interval 2 interval
Record 17: FILTRA
IPSCND 1
UPTKF
Record 18:
PLDKRT
FEXTRC
Flag for Index Res. Run IR
Flag for runoff calc. RUNOFF none
Half-life
days Halfife
days Halfife
Halfife
Half-life
integer See PRZM manual
cm
1.12 kg/ha
APPEFF 0.99 fraction
fraction of application rate applied to pond
264
-------
PA TURF mefluidide
stored as Mefluacid.out
Chemical: Mefluidide
PRZM environment: PAturfC.txt modified Satday, 12 October 2002 at 16:27:02
EXAMS environment: pond298.exv modified Thuday, 29 August 2002 at 16:33:30
Metfile: w!4737.dvf modified Wedday, 3 July 2002 at 09:06:12
Water segment concentrations (ppb)
Sorted results
Prob. Peak 96 hr
0.032258064516129
0.0645161290322581
0.0967741935483871
0.129032258064516
0.161290322580645
0.193548387096774
0.225806451612903
0.258064516129032
0.290322580645161
0.32258064516129
0.354838709677419
0.387096774193548
0.419354838709677
0.451612903225806
0.483870967741936
0.516129032258065
0.548387096774194
0.580645161290323
60
4 .
4 .
3 .
2 .
2.
2.
1.
1.
1.
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0.
0.
0.
0.
Day
666
414
059
513
481
287
952
943
053
9843
9672
8088
7858
6705
6321
5865
5415
5042
4126
4043
3007
90
4 .
4 .
2 .
2 .
2.
2.
1.
1.
1.
0.
0.
0.
0 .
0 .
0 .
0 .
0 .
0.
0.
0.
0.
Day
505
073
958
382
339
179
868
868
014
9364
9291
7976
7451
6519
5955
5663
5138
4697
3863
3805
291
Y
4
3
2
2
1
1
1
1
0
0
0
0
0
o
0
0
0
0
0
0
0
early
.108
. 421
.691
.164
. 984
. 926
. 697
. 635
. 9196
.8587
.8137
.7681
. 6441
. 6315
.5166
.5151
. 4424
.4045
.3501
.3328
.265
3.
3 .
2 .
1.
1.
1.
1.
1.
0.
0.
0.
0.
0 .
0 .
0 .
0 .
0 .
0.
0.
0.
0.
.775
.043
.461
. 981
.775
. 768
.565
. 465
. 8384
.7887
.7392
.7298
. 6109
. 5769
.5046
. 4622
.3929
.3667
.3269
.2998
.243
265
-------
.709677419354839
.741935483870968
.774193548387097
.806451612903226
.838709677419355
.870967741935484
.903225806451613
.935483870967742
0.003507
.967741935483871
0.0007252
0.2013 0.1977 0.1837 0.1753 0.17 0.09462
0.184 0.1834 0.1809 0.1572 0.141 0.06874
0.06957 0.06934 0.06838 0.06625 0.06425 0.03723
0.024590.0244 0.023650.021810.0201 0.01287
Data used for this run:
Output File: Mefluacid
Metfile: w!4737.dvf
PRZM scenario: PAturfC.txt
EXAMS environment file:
Chemical Name: Mefluidide
Description Variable Name
Molecular weight mwt
Henry's Law Const. henry
Vapor Pressure vapr 1E-4
Solubility sol
Kd Kd 0.073
Ko c Ko c
Photolysis half-life
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Aerobic Soil Metabolism
Hydrolysis: pH 7
Method: CAM 2
Incorporation Depth: DEPI
Application Rate: TAPP
Application Efficiency:
Spray Drift DRFT 0.00
Application Date Date
Value Units
310.6 g/mol
2.27E-7 atm-m"3/mol
torr
180 mg/L
mg/L
mg/L
kdp
kbacw
kbacs
asm
days Half-life
integer See PRZM manual
cm
0.56 kg/ha
APPEFF 1.00 fraction
fraction of application rate applied to pond
Half-life
days Halfife
days Halfife
Halfife
Interval 1
Interval 2
Record 17:
interval
interval
FILTRA
IPSCND 1
UPTKF
Record 18:
PLDKRT
FEXTRC
Flag for Index Res. Run
Set to 0 or delete line for single app.
IR
Flag for runoff calc. RUNOFF none
Pond
none.
monthly or total(average of entire run)
266
-------
Appendix D Terrestrial Exposure Modeling TREX and Terrplant
TREX MODEL OUTPUTS
TREX (Version 1.3.1)
2006
As part of the terrestrial assessment, EFED modeled exposure concentrations of Mefluidide,
Mefluidide-K and Mefluidide-DEA to non-target animals following the proposed application
rates provided by the registrant. For terrestrial birds and mammals, estimates of initial levels
of Mefluidide, Mefluidide-K and Mefluidide-DEA residues on various food items, which
may be contacted or consumed by wildlife, were determined using the Kenega-Fletcher
nomogram followed by a first order decline model TREX 1.3.1. Upper bound and Mean
Kenega-Fletcher values were used for RQ calculations.
T-REX Calculations and Results
Risk Estimation Based on Dietary Residue Concentrations (Foliar Spray)
The methods used by T-REX to estimate risk from consumption of selected contaminated
food items is described below. For this analysis, T-REX calculates EECs and risk quotients
based on both the upper bound and mean residue concentrations as presented by Hoerger and
Kenaga (1972) and modified by Fletcher et al. (1994). These concentrations are determined
using nomograms that relate application rate of a pesticide to residues remaining on dietary
items of terrestrial organisms. The results of the upper bound and mean residue levels are
presented in separate tabs ("upper bound Kenaga" and "mean Kenaga"); however, the
methods used to calculate EECs and risk quotients are equivalent. Based on the estimated
dietary residue concentrations from the upper bound and mean Kenaga values, T-REX
calculates the associated doses for various size classes of birds and mammals.
T-REX estimates the following: (1) residue concentrations on selected food items (mg/kg-
dietary item); (2) dose-based EECs (mg/kg-bw) from dietary concentrations on selected food
items; (3) adjusted toxicity values; and (4) risk quotients.
Calculation of dietary concentrations on selected food items
The spreadsheet calculates the pesticide residue concentrations on each selected food item on
a daily interval for one year. When multiple applications are modeled, residue concentrations
resulting from the final application and remaining residue from previous applications are
summed. The maximum concentration calculated out of the 365 days is returned as the EEC
used to estimate potential risk to birds and mammals as described below. Dissipation of a
chemical applied to foliar surfaces for single or multiple applications is calculated assuming a
first order decay rate from the following first order rate equation:
267
-------
C/-i -kt
t = Co6
or in log form:
ln(Ct) = ln(Co)(-kT)
Where:
Ct = concentration, parts per million (ppm), at time T.
Co = concentration (ppm), present initially (on day zero) on the surface of selected
food items. Co is calculated by multiplying the application rate, in pounds
active ingredient per acre, by 240 for short grass, 110 for tall grass, and 135 for
broad-leafed plants/small insects and 15 for fruits/pods/large insects for upper
bound residue levels. Mean residue levels are derived by multiplying the
application rate by 85 for short grass, 36 for tall grass, and 45 for broad-leafed
plants/small insects and 7 for fruits/pods/seeds/large insects. Residue levels
are based on work by Hoerger and Kenaga (1972) as modified by Fletcher et
al. (1994). Additional applications are converted from pounds active
ingredient per acre to ppm on the plant surface and the additional mass added
to the mass of the chemical still present on the surfaces on the day of
application.
k = Exponential rate constant = In 2 + foliar dissipation half-life. This value is in
cell Q16 of the upper bound and mean Kenaga worksheets of TREX. If the
foliar dissipation data submitted to EFED are found scientifically valid and
statistically robust for a specific pesticide, the 90% upper confidence limit of
the mean half-lives should be used. When scientifically valid, statistically
robust data are not available, EFED recommends the using a default foliar
dissipation half-life value of 35 days. The use of the 35-day half-life is based
on the highest reported value (36.9 days), as reported by Willis and McDowell
(1987). However in this assessment a 4 day foliar half life was used.
t = time, in days, since the start of the simulation. The initial application is on day 0.
The simulation is designed to run for 365 days.
The dietary concentrations estimated using the above methodology may be used directly to
calculate risk quotients, but may also be used to calculate dose-based EECs (mg/kg-bw) for
various size classes of mammals and birds .
Calculating EEC Equivalent Doses based on Estimated Dietary Concentrations on
Selected Bird and Mammal Food Items
EECs (mg/kg-bw) for various size classes of mammals and birds may be calculated based on
the dietary residue concentrations derived using the equations presented above. To allow for
this type of analysis, the EECs and toxicity values are adjusted based on food intake and body
268
-------
weight differences so that they are comparable for a given weight class of animal. The size
classes assessed are small (20-gram), medium (100-gram), and large (1000-gram) birds, and
small (15-gram), medium (35-gram), and large (1000-gram) mammals. Equations used to
calculate food intake (grams/day) and to adjust toxicity values for dose-based risk quotients
are presented below.
Calculating Food Intake for Different Size Classes of Birds and Mammals:
Daily food intake (g/day) is assumed to correlate with body weight using the following
empirically derived equation (U.S. EPA, 1993):
Avian consumption
0.648 * BW°-651
F= (l-W)
where:
F = food intake in grams of fresh weight per day (g/day)
BW= body mass of animal (g)
W = mass fraction of water in the food (EFED value = 0.8 for birds and herbivorous
mammals, 0.1 for granivorous mammals)
Based on this equation, a 20-gram bird would consume 22.8 grams of food daily (114% of its
body weight), a 100-gram bird would consume 65 grams of food daily (65% of its body
weight daily), and 1000-gram bird would consume 290 grams of food daily (29% of its body
weight). These data, together with the residue concentrations (mg/kg-food item) on selected
food items calculated from the Kenaga nomogram, are used to estimate the dose (mg/kg-bw)
of residue consumed by the three size classes of birds as discussed below. Using a small (20-
gram) bird as an example, a dietary concentration of 100 mg/kg-diet (ppm) x 1.14 kg diet/kg
bw (114%) would result in an equivalent dose-based EEC of 114 mg/kg-bw. T-REX
calculates food intake based on dry weight and wet weight of food items. The dose-based
assessment uses the wet weight food consumption values by assuming that dietary items are
80% water by weight. However, if dietary items of a species being assessed are known, then
a refined dose-based EEC can be calculated using appropriate water fractions of the food
items.
A similar relationship between body weight and food intake has been derived for mammals
(U.S. EPA 1993):
Mammalian food consumption (g/day)
0.621* BW0564
F =
(l-W)
where:
F = food intake in grams of fresh weight per day (g/day)
BW= body mass of animal (g)
269
-------
W = mass fraction of water in the food (EFED value = 0.8 for birds and herbivorous
mammals, 0.1 for granivorous mammals)
The scaling factors result in a percent body weight consumed presented in the following table
for each weight class of mammal. These values are used in the same manner described for
birds to calculate dose-based EECs (mg/kg-bw). Note the difference in food intake of
grainivores compared with herbivores and insectivores. This is caused by the difference in the
assumed mass fraction of water in their diets.
Organism and
body weight
15 g
35 g
1000 g
Food intake
(g day V
14.3/3.2
23/5.1
150/34
Percent body
weight
consumed (day *)
a
95/21
66/15
15/3
a The first number in this column is specific to herbivores/insectivores. The second
number is for granivores. These groups have markedly different consumption
requirements.
T-REX calculates food intake based on dry weight and wet weight of food items (wet weight
is used for RQ calculations). The dose-based assessment uses the wet weight food
consumption values by assuming that dietary items are 80% water by weight (10% for
granivores). However, if dietary items of a species being assessed are known, then a refined
dose-based EEC can be calculated using appropriate water fractions of the food items.
Calculating Adjusted Toxicity Values
The dose-based EECs (mg/kg-bw) derived above are compared with LD50 or NOAEL (mg/kg-
bw) values from acceptable or supplemental toxicity studies that are adjusted for the size of
the animal tested compared with the size of the animal being assessed (e.g., 20-gram bird).
These exposure values are presented as mass of pesticide consumed per kg body weight of the
animal being assessed (mg/kg-bw). EECs and toxicity values are relative to the animal's body
weight (mg residue/kg bw) because consumption of the same mass of pesticide residue results
in a higher body burden in smaller animals compared with larger animals. For birds, only
acute values (LDsos) are adjusted because dose-based risk quotients are not calculated for the
chronic risk estimation. Adjusted mammalian LDsoS and reproduction NOAELs (mg/kg-bw)
are used to calculate dose-based acute and chronic risk quotients for 15-, 35-, and 1000-gram
mammals. The following equations are used for the adjustment (U.S. EPA 1993):
(AW\ (x~l)
(TWJ
Adjusted avian LD50: Adj.LD50 = LD50
where:
270
-------
Adj. LD50 = adjusted LD50 (mg/kg-bw) calculated by the equation
LDso = endpoint reported from bird study (mg/kg-bw)
TW= body weight of tested animal (178g bobwhite; 1580g mallard; 350g rat)
AW= body weight of assessed animal (avian: 20g, lOOg, and lOOOg)
x = Mineau scaling factor for birds; EFED default 1.15
Adjusted mammalian NOAELs and LD50s (note that the same equation is used to adjust the
(a25)
NOAEL): Adj. NOAEL or LD,n = NOAEL or LDJ -
' J 50 50\AW
where:
Adj. NOAEL or LD50 = adjusted NOAEL or LD50 (mg/kg-bw)
NOAEL or LDso = endpoint reported from animal study (mg/kg-bw)
TW= body weight of tested animal (350g for chronic mammal based on the rat ) TREX does
not incorporate in the model different mammal TW. Therefore, the above calculation was
used and incorporated in model (replaced the 350 g to 20 g in the formula equations) with the
TW of 20 g for acute mammal based on the laboratory mouse with 829. 8mg ae/kg bw LDso to
derive the adjusted toxicity values for acute mammals for each body weight class.
AW= body weight of assessed animal (15g, 35g, lOOOg)
Calculating Risk Quotients
Two types of risk quotients are calculated by T-REX based on the estimated dietary residue
concentrations determined from the Kenaga nomogram: (1) dietary based RQs; and (2) dose
based RQs. These RQs are not equivalent. Dietary risk quotients are calculated by directly
comparing the concentration of a pesticide administered (or estimated to be administered) to
experimental animals in the diet in a toxicity study to the concentration estimated to be on
selected food items. These risk quotients do not account for the fact that smaller-sized
animals need to consume more food relative to their body weight than larger animals or that
differential amounts of food are consumed depending on the water content and nutritive value
of the food. The dose-based risk quotients do account for these factors. The dose-based RQs
incorporate the ingestion rate-adjusted exposure from the various food items to the different
weight classes of birds and the weight class-scaled toxicity endpoints. Formulas presented in
Table 1 are used to calculate dose-based and dietary based risk quotients:
Table 1. Formulas used to calculate dose- and dietary-based risk quotients.
Duration
Acute
Dose or
Dietary
RQ
Dose-based
Dietary-
Surrogate
Organism
Birds and
mammals
Birds
Equation
Acute Daily Exposure (mg/kg-bw) / adjusted
LD50 (mg/kg-bw)
Kenaga EEC (mg/kg-food item) / LCso (mg/kg-
271
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Chronic
based
Dietary-
based
Dose-based
Birds and
mammals
Mammals
only
diet)
EEC (mg/kg-food item) / NOAEC (mg/kg-diet)
EEC (mg/kg-bw) / Adjusted NOAEL (mg/kg-bw)
These risk quotients are compared to the Agency's LOCs to determine if risk is greater than
EFED's concern level.
Granular LD50 per square foot
Mammalian LD50 per Square Foot 0.5 Ibs ae
A
Based on acute mouse LD50 829.8 mg /kg bw, 4
day half life, 42 day interval and 3 applications
per season
Size Class
(grams)
15
35
1000
Broadcast
LD50 per Square Foot
0.39
0.21
0.02
Upper Bound and Mean Kenaga 1.0 Ibs ae/A application Rate based on
acute mouse LD50 829.8 mg/kg bw, 4 day half life, 42 day interval and 3
applications per season
Upper 90th Percentile Kenaga, Acute Mammalian Dose-Based Risk Quotients 1.0 Lbs ae/A
Based on acute mouse LD50 829. 8, 4 day half life, 42 day interval and 3 applications per season
Size
Class
(grams)
15
35
1000
Adjusted
LD50
891.68
721.46
312.05
EECs and RQs
Short Grass
EEC
228.98
158.26
36.69
RQ
0.26
0.22
0.12
Tall Grass
EEC
104.95
72.53
16.82
RQ
0.12
0.10
0.05
Broadleaf
Plants/
Small
Insects
EEC
128.80
89.02
20.64
RQ
0.14
0.12
0.07
Fruits/Pods/
Seeds/
Large
Insects
EEC
14.31
9.89
2.29
RQ
0.02
0.01
0.01
Granivore
EEC
3.18
2.20
0.51
RQ
0.00
0.00
0.00
272
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Mean Kenaga, Acute Mammalian Dose-Based Risk Quotients 1.0 Lbs ae/A
Based on acute mouse LD50 829. 8, 4 day half life, 42 day interval and 3 applications per season
Size
Class
(grams)
15
35
1000
Adjusted
LD50
891.68
721.46
312.05
EECs and RQs
Short Grass
EEC
80.81
56.14
12.76
RQ
0.091
0.078
0.041
Tall Grass
EEC
34.22
23.78
5.40
RQ
0.038
0.033
0.017
Broadleaf
Plants/
Small
Insects
EEC
42.78
29.72
6.75
RQ
0.048
0.041
0.022
Fruits/Pods/
Seeds/
Large
Insects
EEC
6.65
4.62
1.05
RQ
0.007
0.006
0.003
Granivore
EEC
1.47
1.05
0.21
RQ
0.00
0.00
0.00
Upper Bound and Mean Kenaga 1.0 Ibs ae/A application Rate based on
Chronic rat NOAEL 102 mg ae/A, 4 day half life, 42 day interval and 3
applications per season
Upper 90th Percentile Kenega, Chronic Mammalian Dietary Based Risk
Quotients
1.0 Ibs ae/A application Rate based on Chronic rat NOAEL 102 mg ae/A, 4 day half life, 42 day interval and 3 applications
per season
NOAEC
(ppm)
2040
EECs and RQs
Short Grass
EEC
240.17
RQ
0.12
Tall Grass
EEC
110.08
RQ
0.05
Broadleaf
Plants/
Small Insects
EEC
135.09
RQ
0.07
Fruits/Pods/
Seeds/
Large Insects
EEC
15.01
RQ
0.01
Size class not used for dietary risk quotients
Upper 90th Percentile Kenega, Chronic Mammalian Dose-Based Risk Quotients
1.0 Ibs ae/A application Rate based on Chronic rat NOAEL 102 mg ae/A, 4 day half life, 42 day interval and 3 applications per season
Size
Class
(grams)
15
35
1000
Adjusted
NOAEL
224.18
181.38
78.45
EECs and RQs
Short Grass
EEC
228.98
158.26
36.69
RQ
1.02
0.87
0.47
Tall Grass
EEC
104.95
72.53
16.82
RQ
0.47
0.40
0.21
Broadleaf
Plants/
Small Insects
EEC
128.80
89.02
20.64
RQ
0.57
0.49
0.26
Fruits/Pods/
Seeds/
Large Insects
EEC
14.31
9.89
2.29
RQ
0.06
0.05
0.03
Granivore
EEC
3.18
2.20
0.51
RQ
0.01
0.01
0.01
273
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Mean Kenega, Chronic Mammalian Dietary Based Risk Quotients
1.0 Ibs ae/A application Rate based on Chronic rat NOAEL 102 mg ae/A, 4 day half life, 42 day interval and 3
applications per season
NOAEC
(ppm)
2040
EECs and RQs
Short Grass
EEC
85.06
RQ
0.04
Tall Grass
EEC
36.02
RQ
0.018
Broadleaf
Plants/
Small
Insects
EEC
45.03
RQ
0.022
Fruits/Pods/
Seeds/
Large Insects
EEC
7.00
RQ
0.003
Size class not used for dietary risk quotients
Mean Kenega, Chronic Mammalian Dose-Based Risk Quotients
1.0 Ibs ae/A application Rate based on Chronic rat NOAEL 102 mg ae/A, 4 day half life, 42 day interval and 3 applications per season
Size
Class
(grams)
15
35
1000
Adjusted
NOAEL
224.18
181.38
78.45
EECs and RQs
Short Grass
EEC
80.81
56.14
12.76
RQ
0.36
0.31
0.163
Tall Grass
EEC
34.22
23.78
5.40
RQ
0.153
0.131
0.069
Broadleaf Plants/
Small Insects
EEC
42.78
29.72
6.75
RQ
0.191
0.164
0.086
Fruits/Pods/
Seeds/
Large Insects
EEC
6.65
4.62
1.05
RQ
0.030
0.025
0.013
Granivore
EEC
1.47
1.05
0.21
RQ
0.01
0.01
0.00
Avian Granular LD50 per square foot
Avian LD50 per Square Foot 0.5 Ibs ae A
Based on acute bird LD50 >1500 mg ae /kg bw, 4 day half
life, 42 day interval and 3 applications per season
Size Class
(grams)
20
100
1000
Adjusted
LD50
1080.64
1375.71
1943.25
Broadcast
LD50 per Square Foot
0.24
0.04
0.00
Upper Bound and Mean Kenaga 1.0 Ibs ae/A application Rate based on
acute avian LD50 >1500 mg/kg bw, 4 day half life, 42 day interval and 3
applications per season
Upper 90th Percentile Kenaga, Acute Avian Dose-Based Risk Quotients
1.0 Ibs ae/A application Rate based on acute bird LD50 >1500 mg ae/kg bw, 4 day half life, 42 day interval and 3 applications
per season
274
-------
Size
Class
(grams)
20
100
1000
Adjusted
LD50
1080.64
1375.71
1943.25
EECs and RQs
Short Grass
EEC
273.52
155.98
69.83
RQ
0.25
0.11
0.04
Tall Grass
EEC
125.37
71.49
32.01
RQ
0.12
0.05
0.02
Broadleaf
Plants/
Small
Insects
EEC
153.86
87.74
39.28
RQ
0.14
0.06
0.02
Fruits/Pods/
Seeds/
Large Insects
EEC
17.10
9.75
4.36
RQ
0.02
0.01
0.00
Upper 90th Percentile Kenega, Subacute Avian Dietary Based Risk
Quotients
1.0 Ibs ae/A application
LC50
3750
EECs and RQs
Short Grass
EEC
240.17
RQ
0.06
Tall Grass
EEC
110.08
RQ
0.03
Broadleaf Fruits/Pods/
Plants/ Seeds/
Small Insects Large Insects
EEC
135.09
RQ EEC
0.04 15.01
RQ
0.00
Mean Kenaga, Acute Avian Dose-Based Risk Quotients
1.0 Ibs ae/A application Rate based on acute bird >1500 mg ae/kg bw, 4 day half life, 42 day interval and 3 applications per season
Size
Class
(grams)
20
100
1000
Adjusted
LD50
1080.64
1375.71
1943.25
EECs and RQs
Short Grass
EEC
96.97
55.29
24.67
RQ
0.090
0.040
0.013
Tall Grass
EEC
41.07
23.42
10.45
RQ
0
0
0
.038
.017
.005
Broadleaf
Plants/
Small
Insects
EEC
51.34
29.27
13.06
RQ
0
0
0
048
021
007
Fruits/Pods/
Seeds/
Large Insects
EEC RQ
7.99 0.007
4.55 0.003
2.03 0.001
Mean Kenega, Subacute Avian Dietary Based Risk Quotients
1.0 Ibs ae/A application
LC50
EECs and RQs
275
-------
3750
Short
EEC
85.06
Grass
RQ
0.023
Tall Grass
EEC
36.02
RQ
0.010
Broadleaf
Plants/
Small
Insects
EEC
45.03
RQ
0.012
Fruits/Pods/
Seeds/
Large
Insects
EEC
7.00
RQ
0.002
Upper Bound and Mean Kenaga 1.0 Ibs ae/A application Rate based on
Chronic bird NOAEL= 38 mg ae/kg, 4 day half life, 42 day interval and 3
applications per season
Upper 90th Percentile Kenega, Chronic Avian Dietary Based Risk
Quotients
1.0 Ibs ae/A application Rate based on chronic bird = 38 mg ae/kg , 4 day half life, 42 day interval and 3
applications per season
NOAEC
(ppm)
38
EECs and RQs
Short Grass
EEC
240.17
RQ
6.32
Tall Grass
EEC
110.08
RQ
2.90
Broadleaf
Plants/
Small
Insects
EEC
135.09
RQ
3.56
Fruits/Pods/
Seeds/
Large
Insects
EEC
15.01
RQ
0.40
Mean Kenega, Chronic Avian Dietary Based Risk Quotients
1.0 Ibs ae/A application Rate based on Chronic bird = 38 mg ae/A, 4 day half life, 42 day interval and 3
applications per season
NOAEC
(ppm)
38
EECs and RQs
Short
EEC
85.06
Grass
RQ
2.238
Tall Grass
EEC
36.02
RQ
0.948
Broadleaf
Plants/
Small
Insects
EEC
45.03
RQ
1.185
Fruits/Pods/
Seeds/
Large
Insects
EEC
7.00
RQ
0.184
TERRPLANT MODEL
276
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(November 9, 2005; version 1.2.1)
Terrestrial plant exposure characterization employs runoff and spray drift scenarios contained
in OPP's Terrplant model. Exposure calculations are based on a pesticide's water solubility
and the amount of pesticide present on the surface soil within the first inch of depth. For dry
areas, the loading of pesticide active ingredient or acid equivalent from runoff to an adjacent
non-target area is assumed to occur from one acre of treatment to one acre of non-target area.
For terrestrial plants inhabiting semi-aquatic (wetland) areas, runoff is considered to occur
from a larger source area with active ingredient loading originating from 10 acres of treated
area to a single acre of non-target wetland. Default spray drift assumptions are 1% for ground
applications and 5% for aerial, forced air (i.e., air pressure within a spray tank that forces the
spray liquid through the boom nozzles), and chemigation applications. Predicted EECs
resulting from spray drift and aerial applications are derived for non-granular applications
only.
TERRPLANT
MEFLUIDIDE-K, MEFLUIDIDE-DEA (1.0 Ibs ae/A)
GROUND SPRAY ONLY
Terrestrial Plant EECs and Acute Non Endangered RQs
(November 9, 2005; version 1.2.1)
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if chemical
solubility <10,
10-100, or>100
ppm,
respectively)
1.0
0.05
Estimated Environmental Concentrations (EECs)
for NON-GRANULAR formulation applications
(Ibs a.i./acre)
Applica
tion
Method
Total
Loading to
Adjacent
Areas (EEC
= Sheet
Runoff
+Drift)
Total Loading
to Semi-
aquatic Areas
(EEC =
Channelized
Runoff +
Drift)
DRIFT
EEC*
Risk Quotients (RQs) for NON-GRANULAR formulation applications
Emergence RQs,
Adjacent Areas
RQ =
EEC/Seedling
Emergence EC25
Emergence RQs,
Semi-aquatic Areas
RQ = EEC/Seedling
Emergence EC25
Drift RQs
RQ = Drift EEC/
Vegetative Vigor
EC25
277
-------
Minimum
Incorporation
Depth (cm)
Seed Emerg
Monocot EC25
(Ib a.e./acre)
Seed Emerg
Dicot EC25(lb
a.e./acre)
Veg Vigor
Monocot EC25
(Ib a.e./acre)
Veg Vigor Dicot
EC25 (Ib
a.e./acre)
0
0.105
0.0054
0.105
0.0054
Ground
Unincor
P-
Ground
Incorp
0.600
0.600
0.5100
0.5100
0.100
0.100
Monocot
0.571
0.571
Dicot
11.11
11.11
Monocot
4.86
4.86
Dicot
94.44
94.44
Monocot
0.10
0.10
Dicot
1.85
1.85
TERRPLANT
MEFLUIDIDE-K, MEFLUIDIDE-DEA (1.0 Ibs ae/A)
GROUND SPRAY ONLY
Terrestrial Plant EECs and Acute Endangered RQs
(November 9, 2005; version 1.2.1)
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if chemical
solubility <10,
10-100, or>100
ppm,
respectively)
Minimum
Incorporation
Depth (cm)
Seed Emerg
Monocot EC05
orNOAEC (Ib
a.e./acre)
1.0
0.05
0
0.105
Estimated Environmental Concentrations (EECs)
for NON-GRANULAR formulation applications
(Ibs a.i./acre)
Applica
tion
Method
Ground
Unincor
P-
Ground
Incorp
Total
Loading to
Adjacent
Areas (EEC
= Sheet
Runoff
+Drift)
0.600
0.600
Total Loading
to Semi-
aquatic Areas
(EEC =
Channelized
Runoff + Drift)
0.5100
0.5100
DRIFT
EEC*
0.100
0.100
Risk Quotients (RQs) for NON-GRANULAR formulation applications
Emergence RQs,
Adjacent Areas
RQ =
EEC/Seedling
Emergence EC05
or NOAEC
Monocot
1.333
1.333
Dicot
20.69
20.69
Emergence RQs,
Semi-aquatic areas
RQ =
EEC/Seedling
Emergence EC05 or
NOAEC
Monocot
11.33
11.33
Dicot
175.86
175.86
Drift RQs
RQ = EEC/
Vegetative Vigor EC05 or
NOAEC
Monocot
0.22
0.22
Dicot
3.45
3.45
278
-------
Seed Einerg
Dicot ECOSor
NOAEC (lb
a.e./acre)
Veg Vigor
Monocot EC05
or NOAEC (Ibs
a.e./acre)
Veg Vigor Dicot
EC05 or
NOAEC (lb
a.e./acre)
0.0054
0.105
0.0029
TERRPLANT
MEFLUIDIDE (0.5 Ibs ae/A) GRANULAR
APPLICATION ONLY
Terrestrial Plant EECs and Acute Non Endangered RQs
(November 9, 2005; version 1.2.1)
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if chemical
solubility <10,
10-100, or>100
ppm,
respectively)
Minimum
Incorporation
Depth (cm)
Seed Emerg
Monocot EC25
(lb a.e./acre)
Seed Emerg
Dicot EC25(lb
a.e./acre)
Veg Vigor
Monocot EC25
(lb a.e./acre)
Veg Vigor Dicot
EC25 (lb
a.e./acre)
0.5
0.05
0
0.105
0.0054
0.105
0.0054
Estimated Environmental Concentrations (EECs)
for NON-GRANULAR formulation applications
(Ibs a.i./acre)
Applica
tion
Method
Ground
Unincor
P-
Total
Loading to
Adjacent
Areas (EEC
= Sheet
Runoff)
0.0250
Total Loading
to Semi-
aquatic Areas
(EEC =
Channelized
Runoff)
0.2500
DRIFT
EEC*
N/A
Risk Quotients (RQs) for NON-GRANULAR formulation applications
Emergence RQs,
Adjacent Areas
RQ =
EEC/Seedling
Emergence EC25
Monocot
0.24
Dicot
4.63
Emergence RQs,
Semi-aquatic Areas
RQ = EEC/Seedling
Emergence EC25
Monocot
2.38
Dicot
46.30
Drift RQs
RQ = Drift EEC/
Vegetative Vigor
EC25
Monocot Dicot
N/A N/A
279
-------
TERRPLANT
MEFLUIDIDE (0.5 Ibs ae/A) GRANULAR
APPLICATION ONLY
Terrestrial Plant EECs and Acute Endangered RQs
(November 9, 2005; version 1.2.1)
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if chemical
solubility <10,
10-100, or>100
ppm,
respectively)
Minimum
Incorporation
Depth (cm)
Seed Emerg
Monocot EC05
orNOAEC (Ib
a.e./acre)
Seed Emerg
Dicot ECOSor
NOAEC (Ib
a.e./acre)
Veg Vigor
Monocot EC05
or NOAEC (Ibs
a.e./acre)
Veg Vigor Dicot
EC05 or
NOAEC (Ib
a.e./acre)
0.5
0.05
0
0.105
0.0054
0.105
0.0029
Estimated Environmental Concentrations (EECs)
for NON-GRANULAR formulation applications
(Ibs a.i./acre)
Applica Total Total Loading DRIFT
tion Loading to to Semi- EEC*
Method Adjacent aquatic Areas
Areas (EEC (EEC =
= Sheet Channelized
Runoff) Runoff)
Ground 0.0250 0.2500 N/A
Unincor
P-
Risk Quotients (RQs) for NON-GRANULAR formulation applications
Emergence RQs, Emergence RQs, Drift RQs
Adjacent Areas Semi-aquatic areas RQ = EEC/
RQ= RQ = Vegetative Vigor EC05 or
EEC/Seedling EEC/Seedling NOAEC
Emergence EC05 Emergence EC05 or
or NOAEC NOAEC
Monocot Dicot Monocot Dicot Monocot Dicot
0.56 8.62 5.56 86.21 N/A N/A
DRIFT RQs for Buffers from 10 to 900 ft RQs= (EEC/EC25)
EECs derived from AGDRIFT Table 3.5 for very fine to fine
droplet size*
Buffer distance
10
1.0 Ib ae/A
0.0923
RQs
Monocot (EC25 0.105)
0.879
RQs
Dicot (EC25
0.0054)
17.093
280
-------
20
40
60
80
100
140
180*
200
250
500
900
0.0437
0.0218
0.0149
0.0115
0.0095
0.007
0.0056
0.0051
0.0042
0.0021
0.0011
0.416
0.208
0.142
0.110
0.905
0.067
0.053
0.049
0.040
0.020
0.011
8.093
4.037
2.759
2.130
1.759
1.296
1.037
0.944
0.778
0.389
0.204
* dicots exceed LOCs for spray drift (very fine to fine droplet
size)
DRIFT RQs for Buffers from 10 to 900 ft RQs= (EEC/EC25 )
EECs derived from AGDRIFT Table 3.5 for medium to course
droplet size*
Buffer distance
10
20
40
60*
80
100
140
180
200
250
500
900
1.0 Ib ae/A
0.0275
0.0149
0.0087
0.0064
0.0052
0.0044
0.0035
0.0029
0.0026
0.0022
0.0012
0.0007
RQs
Monocot(EC25 0.105)
0.262
0.142
0.083
0.061
0.05
0.042
0.033
0.028
0.025
0.021
0.011
0.006
RQs
Dicot (EC25
0.0054)
4.8
2.8
1.61
1.18
0.96
0.82
0.65
0.54
0.481
0.41
0.22
0.13
* dicots exceed LOCs for spray drift (medium to course
droplet size)
Appendix E
281
-------
APPENDIX E. Ecological Effects Characterization for Mefluidide,
Mefluidide-DEA and Mefluidide-K
310=Molecular Weight of Mefluidide acid
415.24 = Molecular Weight of Mefluidide-DEA
348.29=Molecular Weight of Mefluidide-K
The following tables present measures of effect both in terms of active ingredient and acid
equivalents. Conversion from active ingredient to acid equivalents was made in accordance
with molecular weight differences (MW acid/ MW salt = AE). One gram mole of Mefluidide
acid has a mass of 310.0 and one gram mole of Mefluidide-DEA has a mass of 415.24 grams;
therefore one unit of salt would be equivalent to 0.75 units of the acid. Hence, the LC50
values from the toxicity tests with Mefluidide-DEA were converted to acid equivalents by
multiplying the values by 0.75. The same conversion scenario was made Mefluidide-K with
one gram mole of Mefluidide-K equal to 348.29. Therefore, 310 MW acid/348.29MW
potassium salt is equivalent to 0.89. Hence, the LC50 values from the toxicity tests with
Mefluidide-K were converted to acid equivalents by multiplying the values by 0.89.
Table E-l: Acute Toxicity of Mefluidide to Freshwater Fish
Species
%
a.i. /
%ae
96-hr LC50,
mg/L
(confid. int.)
a.i.
a.e.
NOEC
(mg/L)
a.i.
a.e.
Study
Properties3
Toxicity
Classification
(based on
a.e.)
MRID
Status
Freshwater fish studies were submitted for 114001-Mefluidide and are in review
MRIDs 73635, 80027, 80028 , 87475, 41893801 and 41893802 with LCSOs ranging from >
96.4 mg/L to 1720 mg/L
No freshwater fish studies were submitted for 114003 -Mefluidide potassium salt
114002- Mefluidide-DEA
Rainbow
trrmt
Bluegill
sunfish
28.8
28.8
>91.3
>94.4
>68.47
>70.80
91.3
94.4
68.47
70.80
F-T, M
F-T, M
Slightly-toxic
Slightly-toxic
418937-
02
418937-
01
Acceptable
Acceptable
Table E-2: Acute Toxicity of Mefluidide to Freshwater Invertebrates
282
-------
Species
% a.i.
48-hr ECso, mg/L
(confid. int.)
a.i.
a.e.
NOEC
(mg/L)
a.i.
a.e.
Study
Properties"
Toxicity
Classification
(based on
a.e.)
MRID
Status
Freshwater invertebrate study was submitted for 114001-Mefluidide and is in review
with MRID 41893803 with and EC50 of >111
No freshwater invertebrate studies were submitted for 114003 -Mefluidide potassium
salt
114002- Mefluidide-DEA
Daphnia
28.8%
>103
>77.25
103
77.25
F-T, M
Slightly-toxic
418937-
03
Acceptable
a M=mean-measured chemical concentrations, N=nominal chemical concentrations; F-
T=flow-through; S=static.
Table E-3: Chronic (Early-life) Toxicity of Mefluidide to Invertebrates
Species
% a.i.
NOEC
(mg/L)
a.i.
a.e.
LOEC
(mg/L)
a.i.
a.e.
Study
Properties3
Most sensitive
parameter
MRID
Status
No Chronic invertebrate studies were submitted for 114001-Mefluidide , 114002
Mefluidide-DEA and 114003 - Mefluidide-K
a M=mean-measured chemical concentrations, N=nominal chemical concentrations; F-
T=flow-through; S=static.
Table E-l: Acute Toxicity of Mefluidide to Estuarine marine Fish
283
-------
Species
%
a.i. /
%ae
96-hr LC50,
mg/L
(confid. int.)
a.i.
a.e.
NOEC
(mg/L)
a.i.
a.e.
Study
Properties3
Toxicity
Classification
(based on
a.e.)
MRID
Status
114001-Mefluidide
Sheepshead
minnow
58.2
>130
>130
130
130
F-T, M
Practically
non-toxic
425624-
03
Acceptable
114002- Mefluidide-DEA
Sheepshead
minnow
28.8
>113
>84.75
113
84.75
F-T, M
Slightly-toxic
425623-
03
Acceptable
Table E-2: Acute Toxicity of Mefluidide to Estuarine marine Invertebrates
Species
%
a.i.
EC50, mg/L
(confid. int.)
a.i.
a.e.
NOEC
(mg/L)
a.i.
a.e.
Study
Properties"
Toxicity
Classification
(based on
a.e.)
MRID
Status
114001-Mefluidide
Mysid
(Mysidopsis
bahia) (96
HR)
Eastern
Oyster
(Crassostrea
virginica)(96
HR)
58.2
58.2
133
(113-
204)
67
133
67
47
<12
47
<12
F-T, M
F-T,M
Practically
non-toxic
Slightly toxic
425624-
02
425624-
01
Acceptable
Acceptable
114002- Mefluidide-DEA
Mysid
(Mysidopsis
bahia) (96
777?)
28.8
>126
>94.5
42
31.5
F-T,M
Practically
non-toxic
425623-
02
Acceptable
284
-------
Table E-2: Acute Toxicity of Mefluidide to Estuarine marine Invertebrates
Species
Eastern
Oyster
(Crassostrea
virginica)
%
a.i.
28.8
EC50, mg/L
(confid. int.)
a.i.
77
a.e.
57.75
NOEC
(mg/L)
a.i.
<14
a.e.
<10.5
Study
Properties3
F-T,M
Toxicity
Classification
(based on
a.e.)
Slightly toxic
MRID
425623-
01
Status
Supplemental
a M=mean-measured chemical concentrations, N=nominal chemical concentrations; F-
T=flow-through; S=static.
285
-------
Table E-3: Acute Toxicity of Mefluidide to Aquatic Plants
Species
%a.i.
Definitive test
a.i.
a.e.
Most
sensitive
paramet
er
Initial/mea
n
measured
concentrat
ions
MRID
Status
114002- Mefluidide-DEA
Navicula pelliculosa
Tier I (120 Hr)
Skeletonema costatum
Tierl(120Hr)
Lemna gibba
Tier I (14day)
Anabaena flos-aquae
Tier 1(120 Hr)
Selenastrum
capricornutum
Tier I (120 Hr)
28.8
28.8
28.8
28.8
28.8
83 lug
ai/L
767ug ai/L
687 ug
ai/L
(8%
growth
stimulatio
n)
725 ug
ai/L
749 ug
ai/L
.629mg
ae/L
.575 mg
ae/L
0.515 mg
ae/L
0.543 mg
ae/L
0.561 mg
ae/L
11.5%
growth
reduction
no
adverse
effects
8%
growth
stimulati
on
4.3%
growth
reduction
8%
growth
reduction
mean
mean
mean
mean
mean
435266-
01
435266-
02
435266-
05
435266-
04
435266-
03
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
286
-------
Table E-4: Acute Toxicity of Mefluidide to Aquatic
Plants
Species
Endpoints
definitive
tests
Endpoints
range
finding
tests
MRID
114002- Mefluidide-DEA Definitive and Range finding
Tessts for Tier I studies for aquatic plants
Navicula pelliculosa
Tier I (120 Hr)
83 lug
ai/L
11.5%
growth
reduction
1131 ug
ai/L
5.10%grow
th
stimulation
435266-
01
Skeletonema costatum
Tierl(120Hr)
767ug ai/L
no adverse
effects
1117ugai/L
2.5%
growth
stimulation
435266-
02
Lemna gibba
Tierl (14day)
687 ug
ai/L8%
growth
stimulatio
1084ug
ai/L 2.6%
growth
reduction
435266-
05
Anabaena flos-aquae
Tier 1(120 Hr)
725 ug
ai/L
4.3%
growth
reduction
1077ug
ai/L
26.5%grow
th
stimulation
435266-
04
287
-------
Table E-4: Acute Toxicity of Mefluidide to Aquatic
Plants
Species
Selenastrum
capricornutum
Tier I (120 Hr)
Endpoints
definitive
tests
749 ug
ai/L
4.3%
growth
reduction
Endpoints
range
finding
tests
1117ug
ai/L 8.5%
growth
stimulation
MRID
435266-
03
Table E-5: Acute Toxicity of Mefluidide to Birds (oral administration)
Species
%
a.i.
LD50, mg
ai/kg-bw
(conf.
interval)
a.i.
a.e.
NOEC, mg
ai/kg-diet
a.i.
a.e.
Effects
Toxicity
Classification
(based on
a.e.)
MRID
114001-Mefluidide*
Bob white
quail
Tier I
58.2
>2000
>2000
>2000
>2000
Practically
non-toxic
416021-
01
114002- Mefluidide DEA
Bob white
quail
Tier I
28.8
>2000
>1500
>2000
>1500
Practically
non-toxic
416019-
01
Status
Supplemental
Supplemental
* Avian acute oral studies were submitted for 114001-Mefluidide and are in review MRIDs
7362 with LD 50 4640 mg/kg bw
Table E-6: Acute Toxicity of Mefluidide to Birds (dietary administration)
288
-------
Species
% a.i.
LCso, mg
ai/kg-diet
(conf.
interval)
a.i.
a.e.
NOEC, mg
ai/kg-diet
a.i.
a.e.
Effects
Toxicity
Classification
(based on
a.e.)
MRID
114001-Mefluidide*
Mallard
duck
(Tier I or
limit test)
Bob white
quail
(Tier I or
limit test)
58.2%
(adjusted
to
100%ai)
58.2%
(adjusted
to
100%ai)
>5000
>5000
>5000
>5000
>5000
>5000
>5000
>5000
No
mortality
No
mortality
Practically
non- toxic
Practically
non- toxic
416021-
03
416021-
02
114002- Mefluidide Diethanolamine salt
Mallard
duck
(Tier I or
limit test)
Bob white
quail
(Tier I or
limit test)
00 QO/
Z o . o /o
(adjusted
to
100%ai)
28.8%
(adjusted
to
100%ai)
>5000
>5000
>3750
>3750
>5000
>5000
>3750
>3750
No
mortality
No
mortality
Practically
non- toxic
Practically
non- toxic
416019-
03
416019-
02
Status
Supplemental
Supplemental
Supplemental
Supplemental
* Avian acute dietary studies were submitted for 114001-Mefluidide and are in review
MRIDs, 7633 and 7634 with LC50s of >10,000 mg/kg diet
I Table E-7: Chronic Toxicity of Mefluidide to Birds
289
-------
Table E-7: Chronic Toxicity of Mefluidide to Birds
NOEC(mg LOEC(mg
ai/kg-diet) ai/kg-diet)
Species
a.i. a.i. a.e.
a.i.
a.e. Effects
MRID Status
No Chronic bird studies were submitted for 114001-Mefluidide , 114002 Diethanolamine
salt and 114003 -Mefluidide potassium salt
Table E-8: Acute Contact Toxicity of Mefluidide to Non-target Insects
Species
% a.i.
Toxicity endpoint
a.i.
a.e.
NOEL
Toxicity
classification
(based on
a.e.)
MRID
Status
114002- Mefluidide Diethanolamine salt
Honey bee
28.8
>25
>18.75
12.5
Practically
non-toxic
425628-
01
Acceptable
114003- Mefluidide Potassium salt
Honey bee
28.8
>25
>22.25
25
Practically
non-toxic
425628-
02
Acceptable
Table E 9 Acute Toxicity of Mefluidide a
Guideline
No.
870.1100
(81-1)
870.1100
(81-1)
870.1100
(81-1)
Study Type
Acute Oral (female
rat)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Acute Oral (mouse)
Mefluidide tech
Results (LDso/LCso)
MRID
>4000 mg/kg
MRID 000471 18
1920.2 mg/kg
MRID 000471 17
829.8 mg/kg
MRID 000471 16
Toxicity Category
III
III
III
Status (acceptability) based on HEDs guidelines.
Table E 10 Toxicity Profile of Mefluidide sub chronic and developmental toxicity and its salts
(114001,114002,114003)a
290
-------
Guideline No./
Study type
MRID No.(year)/Doses/
classification
Results
870.3200
82-2
21-Day Dermal
toxicity - rabbit
00082073, (1977)
0, 1,3, 10 ml of 2S
formulation/kg/day (Formulation
containing 24% a.i., equivalent to
0, 240, 720, or 2400 mg
meflui di de/kg/day)
(4 rabbits/sex/dose)
Acceptable/Non-guideline
(NOAEL was not observed)
Note: This study assessed the
dermal toxicity of 24 %
formulation mefluidide
Dermal LOAEL = 240 mg/kg/day, based
on irritation, inflammation and necrosis at
test sites.
Dermal a NOAELs were not established.
Maternal LOAEL = 4uy mg/kg/d based
on reduced gam and foodxon sumption.
Higher dose, in the range, rinding study of
600 mg/kg/day produced excessive
prtality, ^ A „ .,
laternal NOAEL = 200 mg/kg/d
Jevelopmental LOAEL = 400 mg/kg/d
)ased,on, slight fetal toxicity as indicate^l
).y a slight nonstatistical increase in 14
Developmental NOAEL = 200 mg/kg/d
,
evelopmental
[pxicity
javage [rat]
mm
/teflurai
iccepta
range .tin
;teraiolo
ing: 0, i:
mga.i./
400,
'•8^200 or
caJ 58.2% a.i.
elme
870.3700a
83-3 (a)
Developmental
Toxicity, gavage
[rat]
42026102,(1991)
0, 50, 200 400 mg
diethanolamine salt of
mefluidide (28.78%)/kg/d
(25 females/dose)
Doses adjusted for 100 % purity
were 0, 14, 58, or 115 mg/kg/day.
Acceptable/guideline
Maternal LOAEL = 115 mg a.i./kg/day
based on mortality, clinical signs (tremors,
stained nose, urine and vaginal discharge),
decreased body weight and weight gain.
Maternal NOAEL = 58 mg a.i./kg/day),
Developmental LOAEL = 115 mg
a.i./kg/day based on increased number of
early resorptions and mean post-
implantation loss.
Developmental NOAEL: 200 mg/kg/day
(adjusted to 58 mg/kg/day),
Non-guideline
14-Day Oral
gavage [rabbit]
00047138,(1975)
0, 100, 200, 400, 800 mg/kg/d
Vistartech, 93% a.i.
4 females/dose
range finding
A rrpntn hi P/II 011-011 iHpli IIP
LOAEL = < 100 mg/kg/day (females),
based on mortality (1/3 deaths) at 100
mg/kg/d. Tremors and 100% mortality
were noted at the levels of 200 mg/kg/d
and above. Histopathology not reported.
NDAF.T,- not
870.3700b
83-3(b)
Developmental
00047139,(1975)
0, 15, 30, 60 mg technical MBR
12325/kg/d
Maternal LOAEL = not established.
Maternal NOAEL = 60 mg/kg/day,
Developmental LOAEL = not
291
-------
Table E 10 Toxicity Profile of Mefluidide sub chronic and developmental toxicity and its salts
(114001,114002,114003) a
Guideline No./
Study type
MRID No.(year)/Doses/
classification
Results
Toxicity, gavage
[rabbit]
Unacceptable by itself, however,
if combined with the 14-day oral
study (00047138), it is acceptable.
established.
Developmental NOAEL = 60 mg/kg/day,
870.1300
(81-3)
Acute inhalation - rat
DBA salt of Mefluidide
>5.2 mg/L
MRID 41888801
870.1300
(81-3)
Acute inhalation - rat
Mefluidide tech.
>5.4 mg/L
MRID 41964601
870.3800
(83-4 )
3-generation
reproduction [rat]
00082748, (1979)
0, 600, 1800, 6000 ppm, 93% a.i.
(M/F: 0/0, 34/60, 102/183,
346/604 mg/kg/d)
Acceptable/guideline
The parental systemic LOAEL =
346/604 mg/kg bw/day (M/F), based on
decreased body weights.
The parental systemic NOAEL =
102/183 mg/kg bw/day in males/females.
The offspring LOAEL = 346/604 mg/kg
bw/day in males/females, based on
decreased body weights in both sexes and
both litters in all generations. The
offspring NOAEL = 102/183 mg/kg
bw/day in males/females.
The reproductive LOAEL was not
observed.
The reproductive NOAEL = 346/604
mg/kg bw/day in males/females.
M = Males; F = Females
a Status (acceptability) based on HEDs guidelines.
Table E-ll: Toxicity of Mefluidide to Terrestrial Plants (vegetative vigor)1
Most Sensitive
Species
%
a.i.
EC25, Ibs
ai/acre
a.i.
a.e.
NOEC (Ibs
ai/acre)
a.i.
a.e.
Most
sensitive
parameter
MRID
Status
114002- Mefluidide Diethanolamine salt
Monocot -
Sorghum
29.5
0.14
0.06
Shoot fresh
weight
435496-
01
Supplemental
292
-------
Table E-ll: Toxicity of Mefluidide to Terrestrial Plants (vegetative vigor)1
Most Sensitive
Species
Dicot - Mustard
%
a.i.
29.5
EC25, Ibs
ai/acre
a.i.
0.0073
a.e.
NOEC (Ibs
ai/acre)
a.i.
0.0039
a.e.
Most
sensitive
parameter
Shoot fresh
weight
MRID
Status
1 Seedling emergence studies were not available for Mefluidide formulations
Additional preliminary reviews were conducted on the following submitted studies to
determine the most sensitive species for endpoint selection. The results of the preliminary
reviews concluded that the most sensitive endpoints will remain the same in all cases as well
as in all risk conclusions.
MRID 73633 Fink, Robert. 1975. Final Report: Acute Dietary LC50 of MBR 12325 in Mallard
Ducks. Unpublished study performed by Truslow Farms, Incorporated, Chestertown, MD.
Laboratory report number 136-102. Study sponsored by Riker Laboratories, Inc., Sterling, VA.
Study completed April 3, 1975.
MRID 73634 Fink, Robert. 1975. Final Report: Acute Dietary LC50 of MBR 12325 in
Bobwhite Quail. Unpublished study performed by Truslow Farms, Incorporated, Chestertown,
MD. Laboratory report number 136-101. Study sponsored by Riker Laboratories, Inc., Sterling,
VA. Study completed April 3, 1975.
MRID 73632 Fink, Robert. 1975. Final Report: Acute Oral LD50 of MBR 12325 in Mallard
Ducks. Unpublished study performed by Truslow Farms, Incorporated, Chestertown, MD.
Laboratory report number 136-103. Study sponsored by Riker Laboratories, Inc., Sterling, VA.
Study completed April 3, 1975
MRID 73635 Rausima, Gary. 1975. Four-Day Static Aquatic Toxicity Studies with MBR
12325 Technical and MBR 12325-4S in Rainbow Trout and Bluegills. Unpublished study
performed by Industrial Bio-Test Laboratories, Inc. Laboratory report number 621-07032.
Study submitted by Riker Laboratories, Inc. Final report issued July 21, 1975.
MRID 80027 Rhuberick, John C. 1980. Acute Toxicity of MBR 12325 (Technical) to the
Rainbow Trout (Salmo gairdnerf). Unpublished study conducted by Biospherics Incorporation,
Rockville, MD. Study sponsored by Agrichemicals 3M Company, St. Paul, MN. Study
completed on February 23, 1980.
MRID 87475 Rhuberick, John C. 1980. Acute Toxicity of MBR 12325 (Technical) to the
Bluegill Sunfish (Lepomis macrochirus). Unpublished study conducted by Biospherics
Incorporation, Rockville, MD. Laboratory report number 80-PL-14-AQ. Study sponsored by
Agrichemicals 3M Company, St. Paul, MN. Study completed on March 12, 1980.
293
-------
MRID 41893801 Murphy, Daniel and G.T. Peters. 1991. Mefluidide: A 96-Hour Flow-
Through Toxicity Test with the Bluegill (Lepomis macrochirus). Unpublished study performed
by Wildlife International, Ltd., Easton, Maryland. Laboratory report number 281 A-l 12. Study
sponsored by FBI Gordon, Kansas City, Missouri. Study completed May 23, 1991.
MRID 41893802 Murphy, Daniel and G.T. Peters. 1991. Mefluidide: A 96-Hour Flow-
Through Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Unpublished study
performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number 281A-
111. Study sponsored by FBI Gordon, Kansas City, Missouri. Study completed May 23, 1991
MRID 41893803 Holmes, Catherine M. and G.T. Peters. 1991. Mefluidide: A 48-Hour Flow-
Through Acute Toxicity Test with the Cladoceran (Daphnia magnd). Unpublished study
performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number 281A-
110. Study sponsored by FBI Gordon, Kansas City, Missouri. Study completed May 23, 1991.
Seedling emergence test (MRID 471907-01) preliminary review results
A preliminary review was conducted on the submitted seedling emergence test MRID 471907-01
to determine if LOG exceedences would decrease with additional toxicity data. Based on the
reported results of the author the most sensitive dicot is mustard with an EC25 of 0.0625 and a
NOEC of 0.0625. The most sensitive monocot is is oat with an EC25 of 0.034 and a NOEC of
0.031. It is unclear however the determination of the EC25 of 0.0625 and a NOEC of 0.0625 for
dicots since 30 percent inhibition occurred at 0.0078 and 20 percent inhibition occurred at
0.0039. In addition, results were reported using pooled controls. The blank or solvent controls
were not clearly identified in the raw data. Therefore, control -1.00000 and 0.00000 need to be
identified as to which one is the solvent and blank control. In reported controls there are
differences of one order of magnitude. If the identified blank controls in this study have
magnitudes of order differences in the reported responses, this study would be considered
unacceptable.
Therefore, EFED used the nuthatch statistical program on mustard dry weight using the assumed
blank control with response values of 0.88, 0.55, 0.58 and 0.33 which resulted in an EC25 of
0.0032 and a NOEC of 0.0156 for the most sensitive dicot (mustard).
EFED also used the nuthatch statistical program on oat dry weight using the assumed blank
control with response values of 1.09, 1.14, 0.83 and 1.15 which resulted in an EC25 of 0.080 and
a NOEC of 0.03125 for the most sensitive monocot (oat).
After a full review of the above seedling emergence study for validity and review of statistics,
higher LOG exceedences may result for granular and ground spray applications based on EC25
and NOEC values than in existing estimated values in the assessment. Based on EC25 of 0.0032
and a NOEC of 0.0156 for dicots (mustard) the highest RQs were 159 (ground spray) nonlisted
species, 33 (ground spray) listed species 78 (granular) nonlisted species and 16 (granular) for
listed species.
294
-------
Dicots continued to show more sensitivity than monocots. Based on EC25 of 0.080 and aNOEC
of 0.03125 for monocots (oat), RQ exceedences for monocots ranged from 1.65 to 8.06 for
granular and spray applications. Refer to Appendix D for all calculations from the preliminary
review of the seedling emergence test.
After full review of the above seedling emergence test if considered acceptable, the following
risk conclusion remains the same in the assessment based on preliminary review of the seedling
emergence test:
Terrestrial and Semi-aquatic Plants (Listed Species and Non-Listed Species) LOCs were
exceeded for monocots and dicots with the 1.0 Ib ae/A spray applications of mefluidide-K and
mefluidide-DEA. LOCs were exceeded for dicots and monocots (granular applications) with 0.5
Ib ae/acre of mefluidide. Dicots demonstrated more sensitivity than monocots in all application
scenarios.
Acute Non- Endangered granular and spray applications (preliminary review of seedling
emergence test)
TERRPLANT
MEFLUIDIDE-K, MEFLUIDIDE-DEA (1.0 Ibs ae/A)
GROUND SPRAY ONLY
Terrestrial Plant EECs and Acute Non Endangered RQs
(November 9, 2005; version 1.2.1)
295
-------
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if
chemical
solubility <10,
10-100, or
>100 ppm,
respectively)
Minimum
Incorporation
Depth (cm)
Seed Emerg
Monocot EC25
(Ib a.e./acre)
Seed Emerg
Dicot EC25
(Ib a.e./acre)
1.0
0.05
0
0.08
0.0032
Estimated Environmental Concentrations (EECs) for
NON-GRANULAR formulation applications (Ibs
a.i./acre)
Applicati
on
Method
Ground
Unincorp
Ground
Incorp
Total
Loading to
Adjacent
Areas (EEC
= Sheet
Runoff
+Drift)
0.06
0.06
Total Loading
to Semi-
aquatic Areas
(EEC =
Channelized
Runoff +
Drift)
0.51
0.51
DRIFT
EEC*
0.01
0.01
Risk Quotients (RQs) for NON-GRANULAR
formulation applications
Emergence RQs,
Adjacent Areas
RQ =
EEC/Seedling
Emergence EC25
Monocot
0.750
0.75
Dicot
18.75
18.75
Emergence RQs, Semi-
aquatic Areas
RQ = EEC/Seedling
Emergence EC25
Monocot
6.38
6.38
Dicot
159.38
159.38
EECs for GRANULAR formulation applications (Ibs
a.i./acre) O.SIb ae/A Terrestrial Plant EECs and Acute Non
Endangered RQs (November 9, 2005; version 1.2.1)
Application
Method
Unincorp.
Incorp.
Total Loading to
Adjacent Areas
(EEC = Sheet
Runoff)
0.0250
0.0250
Total Loading to
Semiaquatic Areas
(EEC = Channelized
Runoff)
0.2500
0.02500
RQs for GRANULAR formulation applications
Emergence RQs, Adjacent
Areas RQ =
EEC/Seedling Emergence
EC25
Monocot
0.31
0.31
Dicot
7.81
7.81
Emergence RQs,
Semiaquatic Areas
RQ = EEC/Seedling
Emergence EC25
Monocot
3.13
0.31
Dicot
78.13
7.81
Acute Endangered granular and spray applications (preliminary review of seedling
emergence test)
296
-------
TERRPLANT
MEFLUIDIDE-K, MEFLUIDIDE-DEA (1.0 Ibs ae/A)
GROUND SPRAY ONLY
Terrestrial Plant EECs and Acute Endangered RQs
(November 9, 2005; version 1.2.1)
Input
Values
Application
Rate(lb
a.e./acre)
Runoff Value
(0.01, 0.02, or
0.05 if chemical
solubility <10,
10-100, or>100
ppm,
respectively)
Minimum
Incorporation
Depth (cm)
Monocot
NOAEC
Divot
NOAEC
1.0
0.05
0
0.31
0.0156
Estimated Environmental Concentrations (EECs)
for NON-GRANULAR formulation applications
(Ibs a.i./acre)
Applica
tion
Method
Ground
Unincor
P-
Ground
Incorp
Total
Loading to
Adjacent
Areas (EEC
= Sheet
Runoff
+Drift)
0.06
0.06
Total Loading
to Semi-
aquatic Areas
(EEC =
Channelized
Runoff +
Drift)
0.51
0.51
DRIFT
EEC*
0.01
0.01
Risk Quotients (RQs) for NON-
GRANULAR formulation applications
Emergence RQs,
Adjacent Areas
RQ =
EEC/Seedling
Emergence EC25
Monocot
0.194
0.19
Dicot
3.85
3.85
Emergence RQs,
Semi-aquatic Areas
RQ = EEC/Seedling
Emergence EC25
Monocot
1.65
1.65
Dicot
32.69
32.69
EECs for GRANULAR formulation applications (Ibs
a.i./acre) O.SIb ae/A Terrestrial Plant EECs and Acute
Endangered RQs (November 9, 2005; version 1.2.1)
Application
Method
Unincorp.
Total Loading
to Adjacent
Areas (EEC =
Sheet Runoff)
0.0250
Total Loading to
Semiaquatic Areas
(EEC = Channelized
Runoff)
0.2500
RQs for GRANULAR formulation applications
Emergence RQs, Adjacent
Areas RQ =
EEC/Seedling Emergence
EC25
Monocot
0.81
Dicot
1.60
Emergence RQs, Semiaquatic
Areas RQ =
EEC/Seedling Emergence EC25
Monocot
8.06
Dicot
16.03
Calculations for Estimated Endpoints
297
-------
Seedling emergence toxicity data was not available for full review and data was not available
from other anilide analogs to derive EC25 values. To estimate possible effects measurement
endpoints for seedling emergence, EFED assumed that Ł€25 toxicity values for vegetative vigor
are equal to seedling emergence measurement endpoints for Mefluidide, Mefluidide-DEA and
Mefluidide-K. Therefore, the most sensitive seedling emergence Ł€25 estimated values are 0.105
and 0.0054 Ib ae/acre for monocots and dicots, respectively. The NOEC estimated values for
seedling emergence are 0.045 and 0.0029 Ib ae/acre for monocots and dicots, respectively.
These values are used to calculate risk quotients for exposure from combined runoff and spray
drift to adjacent fields.
There are insufficient data to establish a definitive toxicity endpoint for freshwater fish chronic
effects for the acid and DEA salt acid equivalents for mefluidide. To estimate a potential chronic
freshwater fish endpoint for mefluidide the relationship between established acute and chronic
endpoints for mefluidide and propanil were considered (see source data in Appendix E). A ratio
was determined between the 96h acute freshwater fish endpoints and the chronic freshwater fish
endpoints used for RQ calculation for mefluidide (>68.47 mg/L acute freshwater fish) and
propanil (2.3mg /L/0.009 mg /L = 256 mg/L). The largest ratio between acute endpoint and
chronic endpoint was applied to the Mefluidide acute freshwater fish value to derive an estimated
chronic endpoint of 0.267 mg/L (>68.47mg/L/256 = >0.267 mg/L).
There are insufficient data to establish a definitive toxicity endpoint for freshwater invertebrate
chronic effects for the acid and DEA salt acid equivalents for mefluidide. To estimate a potential
chronic freshwater fish endpoint for mefluidide the relationship between established acute and
chronic endpoints for mefluidide and propanil were considered (see source data in Appendix E).
A ratio was determined between the 48 h acute freshwater invertebrate endpoints and the chronic
freshwater invertebrate endpoints used for RQ calculation for mefluidide (>77.25 mg/L acute
freshwater invertebrate) and propanil (1.2mg /L acute freshwater invertebrate/0.086 mg /L
chronic freshwater invertebrate = 13.95). The largest ratio between acute endpoint and chronic
endpoint was applied to the Mefluidide acute freshwater fish value to derive an estimated chronic
endpoint of 5.54 mg/L (>77.25 mg/L/13.95= >5.54 mg/L).
There are insufficient data to establish a definitive toxicity endpoint for estuarine/marine fish and
invertebrate chronic effects for the acid and DEA salt acid equivalents for mefluidide. There is
also little available data to compare to other anilide herbicides for this taxonomic group For the
purposes of this risk assessment, it was assumed that estuarine marine fish and invertebrates
were at least as sensitive as freshwater fish and invertebrates in terms of chronic toxicity.
Therefore, the estimated endpoint for freshwater invertebrates (>5.54 mg/L) was used to
estimate a chronic effects endpoint for estuarine/marine invertebrates and >0.267 mg/L was used
to estimate chronic effect endpoint for estuarine marine fish.
There are insufficient data to establish a definitive toxicity endpoint for a NOAEC or EC05 value
for vascular plant effects for the acid and DEA salt acid equivalents for mefluidide. To estimate
a potential EC05 endpoint for mefluidide the relationship between established acute and EC05
endpoints for mefluidide and propanil were considered (see source data in Table 1 Appendix E).
Comparisons were made between the acute mefluidide endpoint and the propanil EC05 endpoint
for vascular plant RQ calculation for mefluidide (>0.515 mg/L acute vascular plant) and propanil
298
-------
(0.1 Img /L acute vascular plant/0.0063 mg /L EC05 vascular plant= 17.46). The largest ratio
between acute endpoint and EC0s was applied to the Mefluidide acute vascular plant value to
derive an estimated EC05 endpoint of >0.029 mg/L (>5.15 mg/L/17.46= >0.029 mg/L).
There are insufficient data to establish a definitive toxicity endpoint for a chronic
(NOAEC) value for bird effects for the acid and DBA salt acid equivalents for mefluidide. To
estimate a potential chronic endpoint for mefluidide the relationship between established acute
and chronic endpoints for mefluidide mammals were considered (see source data in Appendix
E). Chronic NOAEC values for the most sensitive mammal (mouse) were not available.
Therefore, to derive a chronic value for the mouse the acute mefluidide endpoint and the chronic
mefluidide endpoint from rat toxicity endpointswere used to derive a chronic mouse value for
mefluidide (829.8 mg ae/kg acute mouse) and mefluidide (>4000mg ae /kg acute (rat)/102 mg ae
/kg chronic (rat)) = 39.2). The largest ratio between acute endpoint and chronic endpoint was
applied to the mefluidide acute mouse value to derive an estimated chronic mouse endpoint of
NOAEC>21 mg ae/kg bw (829.8 mg ae/kg bw /39.2= NOAEC >21mg ae/kg bw (mouse)). The
acute mefluidide endpoint for bird and the acute and chronic endpoints for the mouse were used
to derive a ratio for the chronic bird RQ calculation for mefluidide (>1500 mg ae/kg acute bird)
and mefluidide (829.8 mg ae /kg acute (mouse)/ >21mg ae /kg chronic (mouse) = 39.5). The
largest ratio between acute endpoint and chronic endpoint was applied to the mefluidide acute
bird value to derive an estimated chronic endpoint of NOAEC 38 mg ae/kg bw
(>1500mg/L/39.5= NOAEC 38 mg ae/kg bw).
Calculations for Estimated Endpoints
Table #1 Summary of Calculations for Estimated Endpoints
ENDPOINT
DESIRED
For
Mefluidide
Chronic Fish
Chronic
Invertebrate
Chronic Bird
(used mammal
rat and mouse
toxdata body
weight)
EC05 vascular
plant
Acute/Chronic
mefluidide =ratio
>4000 mefluidide rat
/102mefuidide rat =39.2
(829.8 mg ae/kg bw (mouse)
139.2= NOAEC >21mg ae/kg
bw (mouse)).
829.8 mg ae /kg acute
(mouse)/ >21mg ae /kg
chronic (mouse) = 39.5
Acute/Chronic
Propanil =ratio
2.3/0.009=256
1.2/0.086=13.95
0.11/0.0063=17.46
Acute Endpoint
Mefluidide/ratio= Estimated
endpoint Endpoint
>68.47/256=>0.267
>77.25/13.95=>5.54
>1 500/39.5=38
>0.515/17.46=>0.029
299
-------
EC05 non-
vascular plant
Seedling
emergence
ECOSand EC25
0.016/0.02=0.80
>0.629/0.80=>0.786
EC05 and
EC25 values
are equal to
vegetative vigor
values
Due to data gaps for chronic studies for freshwater and estuarine marine fish and invertebrates
and chronic studies for birds EFED reviewed the analog Propanil to obtain estimated LD50 and
LC50 values for Mefluidide from acute to chronic ratios
Also for the most sensitive estuarine marine invertebrate Propanil is 2 orders more toxic than
Mefluidide and no chronic estuarine marine studies were available for Propanil.
No chronic studies for birds were submitted for Propanil.
Tables #2 to #4 summarize endpoints from mefluidide and propanil considered for estimated
values. Bolded values were used in endpoint selection for acute and chronic ratios.
300
-------
Table#2 Summary of Aquatic and Terrestrial Plant Toxicity Data used for Risk
Quotient Calculation Mefluidide and Propanil Application(bolded values were
used in acute to chronic ratios)
Species
Aquatic Plant: Navicula
Tier I
Nonvascular
Freshwater diatom
Aquatic Plant: Lemna
gibba Tier I
Vascular
Terrestrial Plant:
Vegetative Vigor
Terrestrial Plant:
Seedling Emergence
Mefluidide
EC5o=>0.629mgae/L
NOAEC N/A due to Tier one study
EC50= 0.515 mgae/L
NOAEC N/A due to Tier one study
Most sensitive endpoint:
( N/Afor Propanil)
Fresh Weight
Most sensitive monocot: Sorghum
NOAEC 0.045 Ib ae/A; EC25 0.105 Ib
ae/A
Most sensitive dicot: Mustard
NOAEC 0.0029 Ib ae/A; EC25
0.00541b ae/A
(No studies submitted) Vegetative
Vigor enpoints from mefluidide were
used for this data gap.
Propanil
0.016 mgai/L
EC05 0.02
.11 mgai/L
EC05 0.0063
N/A for Propanil
EC25 1.41bai/Afor
Propanil
Table#3 Summary of Terrestrial Acute and Chronic Toxicity Data used for Risk Quotient Calculation
for Mefluidide and Propanil Application (bolded values were used in acute to chronic ratios)
Species
Acute Toxicity
Mefluidide
LD50
mg ae/kg-bw
Propanil
LD50
mg ae/kg-
bw
Mefluidid
e
Propanil
LC5n
Chronic Toxicity
Mefluidide
NOAEC
Propanil
NOAEC
Laboratory rat
>4000 Rat
Used to calculate
chronic bird
enpoint
1080
102
Used to calculate
chronic bird
enpoint
300
Laboratory mouse
829.8
Used to calculate
chronic bird
enpoint
301
-------
Table#4 Summary of Acute and Chronic Aquatic Toxicity Data used for Risk Quotient Calculation for
Mefluidide and Propanil Application (bolded values were used in acute to chronic ratios)
Species
Rainbow Trout
Oncorhynchus mykiss
Coldwater species
Freshwater fish
Fathead minnow
Freshwater fish
Water flea
Daphnia magna
Freshwater
Invertebrate
Sheepshead
minnow
Estuarine marine
fish
Mysid shrimp
Estuarine marine
invertebrate
Eastern oyster
Estuarine marine
Invertebrate
Acute Toxicity
Mefluidid
e
96-hr
LCso
(mg/L ae)
>68.47
>84.75
Mefluidid
e
48-hr
ECso
(mg/L ae)
>77.25
67
Propanil
96-hr
LC50(mg
ai/L)
2.3
4.6
Propani
1
48-hr
ECso
(mg ai/L
)
1.2
.400
Chronic Toxicity
Mefluidide
NOAEC /
LOAEC
(mg/L)
No studies
submitted
No studies
submitted
No studies
submitted
No studies
submitted
No studies
submitted
No studies
submitted
Northern Bobwhite Quail , ,„.,
fr, ,. ... ^ >1500
(Lohnus virgimanus) ,-, ,.
Limit study(Tierl) Used to >3750 2311 No Studies
calculate chronic Submitted
bird enpoint
Propanil
NOAEC /
LOAEC
(mg/L)
No studies
submitted
.009
.086
No studies
submitted
No studies
submitted
No studies
submitted
No studies submitted
302
-------
Summary of Endpoints (LCgn or ECgn, mg ae/L) for Aquatic and Terrestrial
Toxicitv used in RQ calculations for Mefluidide 1
Summary of endpoints (LCso or ECso, mg ae/L) for Aquatic
Toxicity used in RQ calculations for Mefluidide 1
TAXANOMIC GROUP
Acute freshwater fish
Chronic freshwater fish
Acute freshwater inverts
Chronic freshwater
inverts
Acute estuarine/marine
fish
Chronic
estuarine/marine fish
Acute estuarine/marine
inverts
Chronic
estuarine/marine inverts
Acute
endpoint
>68.47*
Rainbow
Trout
>77.25*
Daphnid
>84.75*
Sheepshead
minnow
67*
Eastern
oyster
Chronic
endpoint
>0.267
>5.54
>0.267
>5.54
MRID/
Estimated
value
MRID
418937-02
Estimated
value acute to
chronic ratio
MRID
418937-03
Estimated
value acute to
chronic ratio
MRID
425623-03
Estimated
value acute to
chronic ratio
MRID
425624-01
Estimated
value acute to
chronic ratio
1 For fish and invertebrates data evaluating Potassium Mefluidide, Diethanolamine Mefluidide and Mefluidide have been bridged for the
runoff risk assessment.
Summary of endpoints (LCso or ECso, mg ae/L) for Plant Toxicity used in
RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute vascular plant
Acute
endpoint
0.515*
Lemna
EC05 and
NOAEC
MRID 435266-01
Tier 1(8% growth
stimulation)
303
-------
Vascular plant (EC05)
Acute non-vascular
plant
Non-vascular
plant(ECOS)
Terrestrial Plant:
Vegetative Vigor
Terrestrial Plant:
Seedling Emergence
0.629*
Navicula
Monocot:*
Sorghum
EC250.105
Ib ae/A
Dicot:*
Mustard
EC25
0.00541b
ae/A
>0.29
>0.786
Monocot:*
Sorghum
NOAEC
0.045 Ib
ae/A
Dicot:*
Mustard
NOAEC
0.0029 Ib
ae/A
Used this value as
ECso,
Estimated value acute to
chronic ratio
MRID 435266-05
Tier 1(1 1.5% growth
reduction)
Used this value as
ECso,
Estimated value acute to
chronic ratio
MRID 435496-01
N/A
Summary of endpoints (LDso mg ae/L) for Terrestrial Toxicity data used in
RQ calculations for Mefluidide1
TAXONOMIC GROUP
Acute Avian
Chronic Avian
Acute mammal
Chronic mammal
Acute
endpoint
>1500*
Bob white
quail
829.8*
mouse
Chronic
endpoint
MRID 416019-01
Used this non-definitive
endpoint as LDSO
38 Estimated value acute to
chronic ratio based on
mammal data
MRID 000471 16
MRID 00082748
102*
rat
'For terrestrial plants data evaluating Potassium Mefluidide, Diethanolamine Mefluidide and Mefluidide have been
bridged for the terrestrial risk assessment.
*most sensitive species tested
304
-------
Summary of Mammal and Avian RQS with both 35 day and 4 day
half lives
Mammalian dose-based acute RQ values for proposed uses of Mefluidide K and Mefluidide DEA
based on a mouse LD50 = 829.8 mg/kg -bw and upper-bound Kenaga values1. 35day half life (A 4day
half life with either 1 and 3 applications = 1 application at 35 day)
Use
Application
Mammalian Acute Risk Quotients (upper-bound Kenaga residues)
rtam ius. amn
(# app / Body Short Short
interval, Weight, Grass Grass
days) 9 ' (1app) (3 app)
Ornamental
Turf
(mefluidide
salts only)
Ground spray
1.0
15
35
1000
0.26
0.22
0.12
0.42
0.36
0.19
Tall
Grass(lapp)
0.12
0.10
0.05
uroadiea Broadleaf
Plants/S P'ants/Small
Tall mall lnsects(3
Grass(3app) fe'5" app)
0.19
0.16
0.09
0.14
0.12
0.07
0.23
0.20
0.11
1 For mammal toxicity assessments, data evaluating Potassium Mefluidide, Diethanolamine Mefluidide and Mefluidide toxicity have been
bridged because toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was
selected to represent mammals for all application scenarios.
Mammalian dose-based chronic RQ values for proposed uses of MefluidideK and
Mefluidide DEA based based on a rat reproductive NOAEC of 102 mg ae/kg-bw/day and
upper-bound Kenaga residues1 based on a 35day half life (4day half life with 1 and 3
application rates)= 1 application 35 day)
Use
Application
Mammalian Acute Risk Quotients (upper-bound Kenaga residues)
rtaie IDS. ae/M
(# app /
interval, Body Short Short
days) Weight, Grass Grass
g (1app) (3 app)
Ornamental
Turf
(mefluidide
salts only)
Ground spray
1.0
3 per season
42
day interval
15
35
1000
1.02
0.87
0.47
1.66
1.42
0.76
Tall
grass)
1app)
0.47
0.40
0.21
Tall
grass
(3
app)
0.76
0.65
0.35
Broadleaf
Plants/Sm
Broadleaf all
Plants/Small lnsects(3
Insects(lapp) app)
0.57
0.49
0.26
0.93
0.80
0.43
For mammal toxicity assessments, data evaluating Potassium Mefluidide, Diethanolamine Mefluidide and Mefluidide toxicity have been
bridged because toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was
selected to represent mammals for all application scenarios.
Avian dose-based acute RQ values for proposed uses of MefluidideK and Mefluidide DEA based on a
bobwhite quail LD50 >1500 mg/kg -bw and upper-bound Kenaga values1. 35day half life (4day half life with 1
and 3 application rates)= same as 1 application 35 day)
Use
Application
Body
Avian Acute Risk Quotients (upper-bound Kenaga residues)
305
-------
Short Short
Grass Grass
(1app) (3 app)
Ornamental
Turf
(mefluidide
salts only)
Ground spray
1.0
20
100
1000
0.25
0.11
0.04
0.41
0.18
0.06
Tall
Grass(lapp)
0.12
0.05
0.02
Broadlea Broadleaf
Plants/S P'ants/Small
Tall mall lnsects(3
Grass(Sapp) larfpf5" app)
0.19
0.08
0.03
0.14
0.06
0.02
0.23
0.10
0.03
1 For mammal toxicity assessments, data evaluating Potassium Mefluidide, Diethanolamine Mefluidide and Mefluidide toxicity have been
bridged because toxicity is expected to come from the benzene ring of mefluidide. Therefore, the most sensitive Mefluidide endpoint was
selected to represent mammals for all application scenarios.
Appendix F Guideline Sequence Bibliographies for Ecological
Effects
PC 14001-Mefluidide
Guideline: 71-1 Avian Single Dose Oral Toxicity
MRID: 41602101
Culotta, I; Campbell, S.; Hoxter, K.; et al. (1990) Mefluidide: An Acute Oral Toxicity Study
with the Northern Bobwhite: Wildlife Int. Project No. 281-106. Unpublished study prepared by
Wild-life International Ltd. 17 p.
Guideline: 71-2 Avian Dietary Toxicity
MRID: 41602102
Foster, I; Driscoll, C.; Hoxter, K.; et al. (1990) Mefluidide: A Dietary LC50 Study with the
Northern Bobwhite: Lab Project Number: 281-104. Unpublished study prepared by Wildlife
Inter-national Ltd. 17 p.
MRID: 41602103
Foster, I; Driscoll, C.; Hoxter, K.; et al. (1990) Mefluidide: A Dietary LC50 Study with the
Mallard: Lab Project No: 281-105. Unpublished study prepared by Wildlife International Ltd.
19 p.
Guideline: 72-3 Acute Toxicity to Estuarine/Marine Organisms
306
-------
MRID 425624-01
Graves, W.C. and J.P. Swigert. (1992) Technical Mefluidide: A 96-Hour shell deposition Test
with Eastern Oyster Project No. 281 A-121 Prepared by Wildlife International Ltd
MRID 425624-02
Graves, W.C. and J.P. Swigert. (1992) Technical Mefluidide: A 96-Hour flow through acute
toxicity test with the salt water mysid. Project No. 281 A-122a Prepared by Wildlife
International Ltd
PC 114002—Mefluidide-DEA
Guideline: 71-1 Avian Single Dose Oral Toxicity
MRID: 41601901
Culotta, I; Campbell, S.; Smith, G. (1990) Diethanolamine Salt of Mefluidide: An Acute Oral
Toxicity Study with the Northern Bob- white: Lab Project Number: 281-103. Unpublished study
prepared by Wildlife International Ltd. 17 p.
Guideline: 71-2 Avian Dietary Toxicity
MRID: 41601902
Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Diethanolamine Salt of Mefluidide: A Dietary
LC 50 Study with the Northern Bob- white: Lab Project Number: 281-101. Unpublished study
prepared by Wildlife International Ltd. 17 p.
MRID: 41601903
Foster, J.; Driscoll, C.; Hoxter, K.; et al. (1990) Diethanolamine Salt of Mefluidide: A Dietary
LC50 Study with the Mallard: Lab Project Number: 281-102. Unpublished study prepared by
Wildlife International Ltd. 19 p.
Guideline: 72-1 Acute Toxicity to Freshwater Fish
MRID: 41893701
Murphy, D.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 96-Hour Flow-Through
Acute Toxicity Test with the Bluegill (Lep- omis macrochirus): Final Report: Lab Project
Number: 281 A-l 14. Unpublished study prepared by Wildlife International Ltd. 56 p.
MRID: 41893702
307
-------
Murphy, D.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 96-Hour Flow-Through
Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report: Lab Project
Number: 281 A- 1113. Unpublished study prepared by Wildlife International Ltd. 56 p.
Guideline: 72-2 Acute Toxicity to Freshwater Invertebrates
MRID: 41893703
Holmes, C.; Peters, G. (1991) Diethanolamine Salt of Mefluidide: A 48-Hour Flow-Through
Toxicity Test with the Cladocern (Daphnia magna): Final Report: Lab Project Number: 281A-
109. Unpublished study prepared by Wildlife International Ltd. 54 p.
Guideline: 72-3 Acute Toxicity to Estuarine/Marine Organisms
MRID: 42562301
Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Shell Deposition
Test with the Eastern Oyster (Crassostrea virginica): Final Report: Lab Project Number: 281A-
124A. Unpublished study prepared by Wildlife International Ltd. 46 p.
MRID: 42562302
Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Flow-through
Acute Toxicity Test with Saltwater Mysid (Mysidopsis bahia): Final Report: Lab Project
Number: 281A-125. Unpublished study prepared by Wildlife International Ltd. 45 p.
MRID: 42562303
Graves, W.; Swigert, J. (1992) Diethanolamine Salt of Mefluidide: A 96-hour Flow-through
Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Final Report: Lab
Project Number: 281A-126. Unpublished study prepared by Wildlife International Ltd. 45 p.
Guideline: 122-2 Aquatic plant growth
MRID: 43526601
Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Navicula pelliculosa: Lab Project Number: 15-01-3. Unpublished study prepared
by Carolina Ecotox, Inc. 58 p.
MRID: 43526602
Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Skeletonema costatum: Lab Project Number: 15-01-4. Unpublished study
prepared by Carolina Ecotox, Inc. 60 p.
308
-------
MRID: 43526603
Hughes, 1; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DBA) Salt of
Mefluidide to Selenastrum capricornutum: Lab Project Number: 15-01-1. Unpublished study
prepared by Carolina Ecotox, Inc. 60 p.
MRID: 43526604
Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Anabaena flos-aquae: Lab Project Number: 15-01-2. Unpublished study prepared
by Carolina Ecotox, Inc. 62 p.
MRID: 43526605
Hughes, J.; Alexander, M.; Conder, L. (1995) The Toxicity of Diethanolamine (DEA) Salt of
Mefluidide to Lemna gibba: Lab Project Number: 15-01-5. Unpublished study prepared by
Carolina Ecotox, Inc. 59 p.
Guideline: 123-1 Seed germination/seedling emergence and vegetative vigor
MRID: 43549601
Crosby, K. (1995) Effect of DEA Mefluidide on Vegetative Vigor of Plants: Lab Project
Number: 6272-92-0223-BE-001. Unpublished study prepared by Ricerca, Inc. 213 p.
Guideline: 141-1 Honey bee acute contact
MRID: 42562801
Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey
Bee: Diethanolamine Salt of Mefluidide: Final Report: Lab Project Number: 281-111 A.
Unpublished study prepared by Wildlife Int'l Ltd. 16 p.
PC 114003 Mefluidide-K
Guideline: 141-1 Honey bee acute contact
MRID: 42562802
309
-------
Hoxter, K.; Bernard, W.; Smith, G. (1992) An Acute Contact Toxicity Study with the Honey
Bee: Potassium Salt of Mefluidide: Final Report: Lab Project Number: 281-112A. Unpublished
study prepared by Wildlife Int'l Ltd. 16 p.
Appendix G: The Risk Quotient Method and Levels of Concern
The Risk Quotient Method is the means used by EFED to integrate the results of exposure and
ecotoxicity data. For this method, risk quotients (RQs) are calculated by dividing exposure
estimates by ecotoxicity values (i.e., RQ = EXPOSURE/TOXICITY), both acute and chronic.
These RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used
by OPP to indicate potential risk to non-target organisms and the need to consider regulatory
action. EFED has defined LOCs for acute risk, potential restricted use classification, and for
endangered species.
The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on
nontarget organisms. LOCs currently address the following risk presumption categories:
(1) acute - there is a potential for acute risk; regulatory action may be warranted
in addition to restricted use classification;
(2) acute restricted use - the potential for acute risk is high, but this may be
mitigated through restricted use classification
(3) acute endangered species - the potential for acute risk to endangered species is
high, regulatory action may be warranted, and
(4) chronic risk - the potential for chronic risk is high, regulatory action may be
warranted.
Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks
to non-target insects, or chronic risk from granular/bait formulations to mammalian or avian
species.
The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk
quotients are derived from required studies. Examples of ecotoxicity values derived from short-
term laboratory studies that assess acute effects are: (1) LC50 (fish and birds), (2) LD50 (birds and
mammals), (3) ECso (aquatic plants and aquatic invertebrates), and (4) EC25 (terrestrial plants).
Examples of toxicity test effect levels derived from the results of long-term laboratory studies
that assess chronic effects are: (1) LOAEL (birds, fish, and aquatic invertebrates), and (2)
NOAEL (birds, fish and aquatic invertebrates). The NOAEL is generally used as the ecotoxicity
test value in assessing chronic effects.
Risk presumptions, along with the corresponding RQs and LOCs are summarized in Table E.
110
-------
Table F: Risk Presumptions and LOCs
Risk Presumption
RQ
LOC
Birds1
Acute Risk
Acute Restricted Use
EEC/LCso or LD50/sqft or LD50/day
Acute Endangered Species EEC/LC50 or LD50/sqft or LD50/day
Chronic Risk
Wild Mammals1
Acute Risk
Acute Restricted Use
EEC/NOAEC
EEC/LCso or LD50/sqft or LD50/day
Acute Endangered Species EEC/LCso or LDso/sqft or LDso/day
Chronic Risk EEC/NOAEC
Aquatic Animals2
Acute Risk EEC/LC50 or EC50
Acute Restricted Use EEC/LCso or ECso
Acute Endangered Species EEC/LCso or ECso
Chronic Risk EEC/NOAEC
Terrestrial and Semi-Aquatic Plants
Acute Risk EEC/EC25
Acute Endangered Species EEC/EC0s or NOAEC
Aquatic Plants2
Acute Risk EEC/EC50
Acute Endangered Species EEC/ECps or NOAEC
0.5
EEC/LCso or LD50/sqft or LD50/day (or LD50 < 50 0.2
mg/kg)
0.1
1
0.5
EEC/LCso or LD50/sqft or LD50/day (or LD50 < 50 0.2
mg/kg)
0.1
1
0.5
0.1
0.05
1
1
1
1
1
1 LDso/sqft = (mg/sqft) / (LD50 * wt. of animal)
LDso/day = (mg of toxicant consumed/day) / (LDso * wt. of animal)
2 EEC = (ppb or ug/L) in water
Appendix H
ECOTOX Results
in
-------
MEFLUIDIDE
Papers that were accepted for ECOTOX
Acceptable for ECOTOX and OPP
Agnello, A. M., Bradley, J. R. Jr., and Van Duyn, J. W. (1986). Plant-Mediated Effects of
Postemergence Herbicides on Epilachna varivestis (Coleoptera: Coccinellidae).
Environ.Entomol. 15: 216-220.
EcoReference No.: 71019
Chemical of Concern: MFD,FZFB,SXD; Habitat: T; Effect Codes:
REP,GRO,BEH,ENV; Rejection Code: LITE EVAL
CODED(SXD,MFD),OK(ALL CHEMS).
Griffin, J. L. and Harger, T. J. (1990). Red Rice (Oryza sativa) Control Options in
Soybeans (Glycine max). Weed Technol. 4 : 35-38.
EcoReference No.: 74045
User Define 2: WASH
Chemical of Concern: MTL,BT,FZFP,ACR,SXD,HFP,MFD,FZF,QZF; Habitat:
T; Effect Codes: POP; Rejection Code: NO CONTROL,TARGET(SXD).
Kwon, S. L., Smith, R. J. Jr., and Talbert, R. E. (1991). Red Rice (Oryza sativa) Control
and Suppression in Rice (O. sativa). Weed Technol. 5: 811-816.
EcoReference No.: 74741
Chemical of Concern: MLT,FNP,AMC,SXD,MFD; Habitat: A; Effect Codes:
PHY,POP; Rejection Code: LITE EVAL CODED(MFD),OK(ALL CHEMS).
Marini, R. P., Byers, R. E., and Sowers, D. L. (1989). Growth Regulators and Herbicides
for Delaying Apple Fruit Abscission. Hortscience 24: 957-959.
EcoReference No.: 76104
Chemical of Concern: BZO,TPR,DMB,PBZ,DMZ,FXP,PDM,MFD; Habitat: T;
Effect Codes: GRO: Rejection Code: OK(FXP,DMZ,PBZ),OK
TARGET(DMB),NOENDPOINT(MFD,PDM,BZO,TPR).
Potter, D. A., Spicer, P. G., Redmond, C. T., and Powell, A. J. (1994). Toxicity of
Pesticides to Earthworms in Kentucky Bluegrass Turf.
Bull.Environ.Contam.Toxicol. 52: 176-181.
EcoReference No.: 39542
Chemical of Concern:
312
-------
24DXY,AZD,BFT,BMY,CPZ,CYF,DTP,EP,FNF,FPD,FSTA1,FVL,MFD,MYC,P
RM,TEZ,TPM; Habitat: T; Effect Codes: POP: Rejection Code: LITEEVAL
CODED(AZD,FVL,BFT,CYF),OK(ALL CHEMS).
Potter, D. A., Spicer, P. G., Redmond, C. T., and Powell, A. J. (1994). Toxicity of
Pesticides to Earthworms in Kentucky Bluegrass Turf.
Bull.Environ.Contam.Toxicol. 52: 176-181.
EcoReferenceNo.: 39542
Chemical of Concern:
24DXY,AZD,BFT,BMY,CPZ,CYF,DTP,EP,FNF,FPD,FSTA1,FVL,MFD,MYC,P
RM,TEZ,TPM; Habitat: T; Effect Codes: POP: Rejection Code: LITEEVAL
CODED(MFD,AZD,FVL,BFT,CYF),OK(ALL CHEMS).
Smith, R. J. Jr. (1989). Cropping and Herbicide Systems for Red Rice (Oryza sativa)
Control. WeedTechnol. 3: 414-419.
EcoReferenceNo.: 73748
User Define 2: WASH
Chemical of Concern: MTL,TFN,PAQT,ACR,BT,MFD
Endpoint: POP; Habitat: T: Rejection Code: OK.
Storey, G. K. and Gardner, W. A. (1986). Sensitivity of the Entomogenous Fungus
Beauveria bassiana to Selected Plant Growth Regulators and Spray Additives.
Appl.Environ.Microbiol. 52: 1-3.
EcoReferenceNo.: 82489
Chemical of Concern: MFD,PBZ,FPD; Habitat: T; Effect Codes:
POP,MOR,REP; Rejection Code: LITE EVAL CODED(MFD),OK(ALL
CHEMS).
Turner, K. E., Paterson, J. A., Kerley, M. S., and Forwood, J. R. (1990). Mefluidide
Treatment of Tall Fescue Pastures: Intake and Animal Performance. J.Anim.Sci.
68: 3399-3405.
EcoReference No.: 82719
Chemical of Concern: MFD; Habitat: T; Effect Codes: PHY,BEH,GRO;
Rejection Code: LITE EVAL CODED(MFD).
Wimer, S. K., Ward, J. K., Anderson, B. E., and Waller, S. S. (1986). Mefluidide Effects
on Smooth Brome Composition and Grazing Cow-Calf Performance. J.Anim.Sci.
63: 1054-1062.
EcoReferenceNo.: 82721
Chemical of Concern: MFD; Habitat: T; Effect Codes: BCM,POP; Rejection
Code: LITE EVAL CODED(MFD).
Acceptable for ECOTOX but not OPP
-------
Agnello, A. M., Van Duyn, J. W., and Bradley, J. R. Jr. (1986). Influence of
Posternergence Herbicides on Populations of Bean Leaf Beetle, Cerotoma
trifurcata (Coleoptera: Chrysomelidae) and Corn Earworm, Heliothis zea
(Lepidoptera: Noctuidae), in Soybeans. J.Econ.Entomol. 79: 261-265.
EcoReferenceNo.: 72071
Chemical of Concern: MFD, SXD,FZFB; Habitat: T; Effect Codes: POP;
Rejection Code: NO MIXTURE(SXD,MFD,FZFB),CONTROL(ACR).
Arnold, C. E., Aldrich, J. H., and Martin, F. G. (1983). Vegetative and Flowering
Response of Peach to Mefluidide. ActHortic 137: 145-152.
EcoReferenceNo.: 44149
Chemical of Concern: MFD; Habitat: T; Effect Codes: GRO; Rejection Code:
NO ENDPOINT(MFD).
Atkin, J. C. (1984). The Use of Mefluidide to Control Grass Growth in Amenity Areas.
^^570/6:45-53.
EcoReference No.: 31485
Chemical of Concern: MFD; Habitat: T: Rejection Code: TARGET(MFD).
Banko, T. J. (1985). Evaluation of Growth Regulator Effects of Embark, Atrinal, Blazer,
and Bayleton on Container-Grown Azaleas . J.Environ.Hortic. 3: 149-152.
EcoReference No.: 31450
Chemical of Concern: TDF,ACF,DKGNa,MFD; Habitat: T; Effect Codes:
GRO; Rejection Code: OK(ACF),NO ENDPOINT(TDF,TARGET-
DKGNa,MFD).
Belander, G. and Winch, J. E. (1985). Herbicides for Sod-Seeding Legumes on Shallow
Soil Pastures. Can.J.PlantSci. 65: 1049-1055.
EcoReferenceNo.: 44163
Chemical of Concern: GYP,MFD,FZFB,PAQT; Habitat: T; Effect Codes:
POP,BCM; Rejection Code: OK(ALL CHEMS),OK TARGET(MFD).
Chappell, W. E., Coartney, J. S., and Link, M. L. (1977). Plant Growth Regulators for
Highway Maintenance. Proc.South. Weed Sci.Soc. 30: 300-305.
EcoReferenceNo.: 40596
Chemical of Concern: MFD,MLH; Habitat: T; Effect Codes: GRO,REP;
Rejection Code: OK(ALL CHEMS),OK TARGET(MFD).
Elkins, D. M., Vandeventer, J. W., and Briskovich, M. A. (1977). Effect of Chemical
Growth Retardants on Turfgrass Morphology. Agron J 69: 458-461.
EcoReferenceNo.: 43015
314
-------
Chemical of Concern: MFD,MLH; Habitat: T; Effect Codes: GRO,MOR;
Rejection Code: OK(ALL CHEMS),OK TARGET(MFD).
Field, R. J. and Whitford, A. R. (1983). Response of Perennial Ryegrass, Prairie Grass,
and Browntop to the Growth Retardant, Mefluidide. Nz JExp Ag 11: 199-203 .
EcoReference No.: 44162
Chemical of Concern: MFD; Habitat: T; Effect Codes: BCM,GRO; Rejection
Code: NO ENDPOINT(ALL CHEMS).
Gerrish, J. R. and Dougherty, C. T. (1983). Tall Fescue Sward Response to Mefluidide
and Nitrogen. AgronJ75(6): 895-898.
EcoReference No.: 32345
Chemical of Concern: MFD; Habitat: T: Rejection Code: TARGET(MFD).
Griffin, J. L. and Harger, T. J. (1990). Red Rice (Oryza sativa) Control Options in
Soybeans (Glycine max). Weed Technol. 4 : 35-38.
EcoReference No.: 74045
Chemical of Concern: MTL,BT,FZFP,ACR,SXD,HFP,MFD,FZF,QZF; Habitat:
T; Effect Codes: POP; Rejection Code: NO CONTROL(TARGET-SXD,MFD).
Ivie, G. W. (1980). Fate of the Plant Growth Regulator Mefluidide [N-[2,4-Dimethyl-5-
[[(trifluoromethyl)sulfonyl]amino]phenyl]acetamide] in A Cow and Sheep.
J.Agric.FoodChem. 28: 1286-1288.
EcoReference No.: 37270
Chemical of Concern: MFD; Habitat: T; Effect Codes: PHY; Rejection Code:
NO ENDPOINT(MFD).
Marini, R. P., Byers, R. E., and Sowers, D. L. (1989). Growth Regulators and Herbicides
for Delaying Apple Fruit Abscission. Hortscience 24: 957-959.
EcoReference No.: 76104
Chemical of Concern: BZO,TPR,DMB,PBZ,DMZ,FXP,PDM,MFD; Habitat: T;
Effect Codes: GRO: Rejection Code: OK(FXP,DMZ,PBZ),OK
TARGET(DMB),NOENDPOINT(MFD,PDM,BZO,TPR).
McWhorter, C. G. and Barrentine, W. L. (1979). Weed Control in Soybeans (Glycine
max) with Mefluidide Applied Postemergence. WeedSci. 27: 42-47.
EcoReference No.: 42763
Chemical of Concern: GYP,BT,MFD,24DB; Habitat: T; Effect Codes:
POP,PHY; Rejection Code: OK(ALL CHEMS),OK TARGET(MFD).
McWhorter, C. G. and Wills, G. D. (1978). Factors Affecting the Translocation of 14C-
Mefluidide in Soybeans (Glycine max), Common Cocklebur (Xanthium
pensylvanicum) and Johnson Grass (Sorghum halapense). Weed Sci. 26: 382-388.
315
-------
EcoReferenceNo.: 29602
Chemical of Concern: MFD; Habitat: T: Rejection Code: TARGET(MFD).
Parups, E. V. and Cordukes, W. E. (1977). Growth of Turfgrass As Affected by Atrinal
and Embark. Hortscience 12: 258-259.
EcoReferenceNo.: 28947
Chemical of Concern: DKGNa,MFD; Habitat: T: Rejection Code:
TARGET(DKGNa,MFD).
Slade, J. J. and Reynolds, J. H. (1985). Plant Growth Regulator Effects on Forage Quality
of Tall Fescue and Bermudagrass. Tenn.Farm Home Sci. 134: 19-23.
EcoReferenceNo.: 44106
Chemical of Concern: EDT,CQTC,EPH,MFD; Habitat: T; Effect Codes:
GRO,BCM,POP; Rejection Code: OK(ALL CHEMS),OK
TARGET(MFD,CQTC).
Smith, R. J. Jr. (1989). Cropping and Herbicide Systems for Red Rice (Oryza sativa)
Control. WeedTechnol. 3: 414-419.
EcoReferenceNo.: 73748
Chemical of Concern: MTL,TFN,PAQT,ACR,BT,MFD; Habitat: A; Effect
Codes: POP: Rejection Code: OK(MTL,TFN,ACR,PAQT),NO
MIXTURE(MFD,BT).
Sterrett, J. P. (1979). Injection Methodology for Evaluating Plant Growth Retardants.
Weed Sci. 27: 688-690.
EcoReferenceNo.: 44029
Chemical of Concern: DKGNa,MFD; Habitat: T; Effect Codes: GRO,BCM;
Rejection Code: OK TARGET(MFD,DKGNa).
Truelove, B., Davis, D. E., and Filial, C. G. P. (1977). Mefluidide Effects on Growth of
Corn (Zea mays) and the Synthesis of Protein by Cucumber (Cucumis sativus)
Cotyledon Tissue. Weed Sci. 25: 360-363.
EcoReferenceNo.: 43005
Chemical of Concern: MFD; Habitat: T; Effect Codes: POP,GRO,BCM;
Rejection Code: OK TARGET(MFD).
MEFLUIDIDE
Papers that were excluded from ECOTOX
2001). Bolster quality efforts by developing effective PI (performance improvement)
316
-------
infrastructure. Hospital Peer Review 26: 45-47.
1996). Four TDR diseases can be "eliminated". TDK News 1-2.
1992). Pesticide chemicals manufacturing category effluent limitations guidelines,
pretreatment standards, and new source performance standards. Federal Register
57: 12560-601.
Productivity in the '90s. The outsourcing source book. The Journal Of Business
Strategy 14: 52-56.
Abert, James G. and Vancil, Ronald M. (1977). A graphical approach to determine the
economics of recovering resources from municipal solid waste. Conservation &
Recycling I: 299-300.
Abramov, V V, Mustafin, A G, larygin, V N, and Kozlov, V A (1991). Immunogenesis
and axoplasmic transport in Wistar rats. Biulleten'Eksperimental'Noi Biologii i
Meditsiny 112: 621-623.
Abramson, D (1987). Hadley Regional Medical Center embarks on laundry savings plan.
Laundry News 13: 6.
Adamczewsk, A M and Morris, S (2001). Metabolic status and respiratory physiology of
Gecarcoidea natalis, the Christmas Island red crab, during the annual breeding
migration. The Biological Bulletin 200: 321-335.
Afanas'ev, lu I and Bobova, L P (1976). Histophysiology of the thymus gland. Arkhiv
Patologii 38: 3-17.
ALEKSEEVA, M S, ELKIN, V I, and FEDOROV, V K ( COMPARATIVE GENETIC
STUDIES ON THE LABILITY OF THE NERVOUS SYSTEM IN RATS WITH
A HIGH DEGREE OF SENSITIVITY TO SOUND STIMULI AND IN WISTAR
RAT S. Zhurnal Vysshei Nervnoi Deiatelnosti Imeni IP Pavlova 14: 110-115.
Alikhanidi, Sokratis and Takahashi, Yoshimasa (2004). Pesticide persistence in the
environment - collected data and structure-based analysis. Journal of Computer
Chemistry, Japan 3: 59-70.
Amstislavskii, S la, Kachanova, I lu, Market', A L, and lakobson, G S (1997). Elevated
arterial pressure in normotensive Wistar strain rats after the transplantation of
embryos from hypertensive ISIAH strain rats. Inherited stress-induced arterial
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