United States Prevention, Pesticides EPA738-R-95-001
Environmental Protection And Toxic Substances March 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Ethalfluralin
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case ethalfluralin. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It also includes requirements for additional data
(generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Tom Myers at (703) 308-8074.
Sincerely yours,
Louis P. True Jr., Acting Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
ETHALFLURALIN
LISTB
CASE 2260
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ETHALFLURALIN REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 4
E. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic Toxicity and Carcinogenicity 9
d. Developmental Toxicity 10
e. Reproductive Toxicity 11
f. Mutagenicity 11
g. Metabolism 11
h. Reference Dose 12
2. Exposure Assessment 12
a. Dietary Exposure 12
b. Occupational and Residential 17
3. Risk Assessment 21
a. Dietary 21
b. Occupational and Residential 24
C. Environmental Assessment 24
1. Environmental Fate 24
a. Environmental Chemistry, Fate and Transport 25
b. Environmental Fate Assessment 29
2. Ecological Effects 30
a. Ecological Effects Data 30
(1) Terrestrial Data 30
(2) Aquatic Data 32
(3) Non-Target Insects Data 37
(4) Non-Target Plants Data 37
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b. Ecological Effects Risk Assessment 38
IV. Risk Management and Reregistration Decision 45
A. Determination of Eligibility 45
1. Eligibility Decision 46
2. Eligible and Ineligible Uses 46
B. Regulatory Position 46
1. Tolerance Reassessment 47
2. Risk Mitigation Measures 50
3. Endangered Species Protection 55
4. Labeling Rationale 55
V. ACTIONS REQUIRED BY REGISTRANTS 56
A. Manufacturing-Use Products 56
1. Additional Generic Data Requirements 56
2. Labeling Requirements for Manufacturing-Use Products 57
B. End-Use Products 57
1. Additional Product-Specific Data Requirements 57
2. Labeling Requirements for End-Use Products 58
C. Existing Stocks 60
VI. APPENDICES 63
APPENDIX A. Table of Use Patterns Subject to Reregistration 65
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 77
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Ethalfluralin 87
APPENDIX D. List of Available Related Documents 101
APPENDIX E 105
PR Notice 86-5 107
PR Notice 91-2 125
APPENDIX F. Generic Data Call-in 131
Attachment 1. Chemical Status Sheet 149
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 153
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 157
Attachment 4. List of Registrant(s) sent this DCI (Insert) 163
APPENDIX G. Product Specific Data Call-in 165
Attachment 1. Chemical Status Sheet 179
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 183
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 189
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Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 193
Attachment 5. EPA Acceptance Criteria 197
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
211
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 213
APPENDIX H. FACT SHEET 223
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ETHALFLURALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Gabe Patrick
Ghulam Ali
Jim Saulmon
Environmental Fate and Effects Division
Mary Frankenberry
Bill Erickson
Laura Parsons
Health Effects Division
John Redden
Pat McLauglin
Laura Morris
Steve Funk
Jennifer Wintersteen
Registration Division
Dan Kenny
Ian Blackwell
Special Review and Reregistration Division
Tom Myers
Virginia Dietrich
Policy and Special Projects Staff
Jean Frane
Office of Enforcement:
Carol Buckingham
Office of General Counsel:
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Science Analysis Branch
Fungicide-Herbicide Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Kevin Lee
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such
as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin Of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
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GLOSSARY OF TERMS AND ABBREVIATIONS
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks associated with the pesticidal use of ethalfluralin in the
United States. Ethalfluralin is a preemergence herbicide used to control a variety of annual
grasses and broadleaf weeds on agricultural sites. The scientific data base is adequate to
support the reregistration eligibility of all registered uses of ethalfluralin with the exception of
postemergence and posttransplant applications to cucurbits. Residue chemistry data to support
these specific methods of application are curreltly being reviewed by the Agency, 1995. The
Agency has determined that the uses of ethalfluralin products, labeled and used as specified in
this Reregistration Eligibility Decision Document (RED), will not cause unreasonable risk to
humans or the environment.
The Agency has classified ethalfluralin as a quantifiable Group C carcinogen, based on
increased mammary gland fibroadenomas and adenomas/fibroadenomas combined in female
rats. The Agency estimates that the incremental, upper bound dietary risk for the U.S.
population is negligible (5.7 x 10 7). This assumes anticipated residues of ethalfluralin in all
commodities except eggs, milk, fat, meat, and meat byproducts for reasons stated below. The
cancer risk to mixer/loader/applicators from ethalfluralin ranges from 1 x 10 5 to 7 x 108
depending on the product formulation, application method, and the worker task
(mixing/loading vs application). Ethalfluralin is also a developmental toxicant based on a
rabbit study. However, the Agency believes dietary exposures and those to workers wearing
proper personal protective equipment are such that the risks for these toxicological endpoints
are acceptable.
The Agency is requiring additional technical chemistry, residue chemistry (analytical
and field trial), and nitrosamine analysis data to confirm its conclusions on potential hazard
and exposure. Additionally, the Agency is requiring that tolerances for eggs, milk, fat, meat,
and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep be revoked. Due to
their low levels, it is unlikely finite residues in these commodities can be determined with
certainty. Personal protective equipment is being required to protect workers who handle and
apply the end use products and for those who may enter treated areas before the new
restricted-entry interval of 24 hours.
As currently used ethalfluralin products may pose a risk to non-endangered and
endangered freshwater fish, aquatic invertebrates, and to certain nontarget plants. The
Agency is requiring registrants to modify their product label directions so that risk reduction
will be acheived. Use modifications include: 1) prohibiting alfalfa irrigation tail waters from
entering aquatic habitats, 2) conforming to the Endangered Species Program when it takes
effect, and 3) recommending the use of a vegetative filter strip for the cucurbit uses of
ethalfluralin.
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The Agency is requiring that product specific data, revised Confidential Statements of
Formula (CSF) and revised labeling be submitted within eight months of the issuance of this
document for all products containing ethalfluralin. These data include product chemistry and
acute toxicity testing for each registration. After reviewing these data and any revised labels
and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister a product. However, those products which bear uses of this or any other a.i. which
have not been determined to be eligible for reregistration will be reregistered only when such
uses and active ingredients are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of ethalfluralin. The document consists of six sections. Section I is the
introduction. Section II describes ethalfluralin, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for ethalfluralin. Section V
discusses the reregistration requirements for ethalfluralin. Finally, Section VI is the Appendices
which support this Reregistration Eligibility Decision. Additional details concerning the Agency's
review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
B.
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade Name:
Basic Manufacturer:
Use Profile
Ethalfluralin
N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl) -benzenamine
Dinitroanaline
5523-68-6
113101
C13H14F3N304
Sonalan
DowElanco
The following is information on the currently registered uses with an overview of
use sites and application methods. This information is accurate as of September 1, 1994.
A detailed table of these uses of ethalfluralin is in Appendix A.
For: Ethalfluralin
Type of Pesticide:
Mechanism of Action:
Use Sites:
Preemergence herbicide
Inhibits cell division
Terrestrial Food Crop: Cucumber, melons, melons
(water), pumpkin, squash (summer), squash (winter)
Terrestrial Food + Feed Crop: Beans (dried-type),
peanuts (unspecified), peas (dried-type), soybeans
(unspecified), sunflower
Terrestrial Feed Crop: Alfalfa
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Target Pests: Grassy weeds: annual bluegrass, barnyardgrass,
broadleaf signalgrass, field sandbur, giant foxtail,
Italian ryegrass, johnsongrass, junglerice, large
crabgrass, shattercane, Texas panicum, wild oat,
witchgrass, woolly cupgrass;
Broadleaf weeds: black nightshade, carpetweed,
common chickweed, common lambsquarters, Florida
pursley, henbit, kochia, lanceleaf groundcherry,
redroot pigweed, Russian thistle, tarweed
fiddleneck, wild buckwheat.
Formulation Types Registered:
Single Active Ingredient
Emulsifiable concentrate~31.5-36.1% ethalfluralin
Water dispersible granules—50% ethalfluralin
Granular—10% ethalfluralin
Technical chemical—95% ethalfluralin
Method and Rates of Application:
Emulsifiable concentrate: Soil incorporate at
preplant with spreader or low pressure ground spray
at 0.75 to 1.70 Ib AI/A or at postemergence with
low pressure spray at 1.50 to 1.70 Ib AI/A; or soil
broadcast at postplant with low pressure spray at
0.75 to 1.70 Ib AI/A; or band at postemergence or
at posttransplant with low pressure ground spray at
up to 1.701b AI/A. .
Water dispersible granules: Soil incorporate at
preplant with ground equipment at 0.75 to 1.65 Ib
Al/acre.
Granular: Soil incorporate in Fall or at preplant with
spreader or at postemergence with low pressure
ground equipment at 0.75 to 1.7 Ib AI/A.
Use Practice Limitations: Do not apply to any body of water or wetland.
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C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
ethalfluralin in the U.S. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and site
(crop) basis, reflect annual fluctuations in use patterns as well as the variability in using
data from various information sources. Table 1, below, summarizes the amounts of
ethalfluralin used by site.
Table 1.
ESTIMATED ANNUAL U.S. USAGE OF ETHALFLURALIN
Site
Alfalfa
Cantaloupes
Cucumbers
Dry Beans
Dry Peas
Honeydew
Peanuts
Soybeans'1
Sunflower
Watermelon
TOTALS6
Acres
Planted/Harve
steda
(000)
24,666
131
132
1,918
172
26
1,849
58,768
2,289
251
90,202
Acres Treated11
(000)
< 247
7- 13
40-46
480 - 959
5-9
1 - 3
647 - 740
1,175 - 2,938
458 - 687
13- 25
3,073-5,667
Percent
Acres
Treated0
< 1
5 - 10
30-35
25 - 50
3- 5
5 - 10
35-40
2 - 5
20-30
5 - 10
Active Ingredient0
Ibs a.i.
(000)
10-50
3-6
30-35
500 - 1,000
4-5
4-8
350 - 400
1,000- 2,000
400 - 700
15 - 20
2,300 - 4,200f
Percentage of
Total a.i.
0.4- 1.2
0.1 -0.1
0.8- 1.3
21.7- 23.8
0.1 -0.2
0.2 -0.2
9.5- 15.2
43.5 - 47.6
16.7- 17.4
0.5 -0.7
a Three years 1989-1991 or 1990-1991 average when available is reported.
b Acres treated are calculated from the percentages given in the imediately following two
columns; The lowest limit of the ranges is zero.
c Sources: EPA Proprietary sources; RFF. Herbicide Use in the United States. December 1990;
USDA. Agricultural Chemical Usage, 1991 Field Crops Summary, March 1992; USDA.
Agricultural Chemical Usage, 1992 Field Crops Summary, March 1993; USDA. Agriculture
Chemical Usage, Vegetables, 1992 Summary, June 1993.
d Data sources indicate a declining trend in the usage of ethalfluralin.
e Usage information about pumpkin and squash is not available.
f Total a.i. would not add up exactly because of approximation.
D. Data Requirements
In addition to data requirements imposed to obtain the original registration of this
active ingredient, data were required in the reregistration Phase IV Data Call-In issued in
December of 1990. Appendix B includes all data requirements identified by the Agency
for currently registered uses needed to support reregistration.
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E. Regulatory History
Ethalfluralin is the accepted common name for N-ethyl-N-(2- methyl-2-propenyl)
-2,6-dinitro-4-(trifluoromethyl)-benzenamine. It is manufactured by DowElanco and is
marketed under the trade name Sonalan.
Ethalfluralin is a selective herbicide for the preemergence control of certain annual
grasses and broadleaf weeds. It was initially granted a conditional registration in in
November 1983 until December 1, 1985 for use on dry peas, dry beans, soybeans, and
the cucurbits vegetable group to control weeds. A risk-benefit analysis, as described in the
Federal Register v. 49, No. 2:29-33 and published concurrently, determined that the
benefits outweighed the dietary and worker carcinogenic risks for the period of the
conditional registration. Tolerances were also established at this time in a companion
notice. Subsequently, adequate data were submitted to allow full registration of
ethalfluralin and additional uses have been added since, including sunflowers seeds in 1985
and peanuts and peanut hulls in 1987.
In December of 1990 the Agency issued a Data Call-In Notice under Phase IV of
reregistration, requiring registrants to submit additional generic data to support
reregistration.
As of September 1, 1994, there are six active products containing ethalfluralin
which are registered under Section 3 of FIFRA. They consist of a 95% technical
(manufacturing use) product, two 36.1% emulsifiable concentrate end-use products, one
31.5% emulsifiable concentrate end-use product, one 50.0% water dispersible granular
end-use product, and one 10.0% granular end-use product.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Ethalfluralin [JV-ethyl-JV-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-
benzenamine] is a selective preemergence herbicide registered for use on a variety of food
and feed crops. The ethalfluralin formulations registered for use on these crops include
the granular (G), the dry flowable (DF), and the emulsifiable concentrate (EC). These
formulations may be applied preplant, postplant prior to emergence, postemergence, or
post-transplant as a soil incorporated, band, or broadcast application using ground
equipment. Ethalfluralin is only used outdoors.
Ethalfluralin [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)
benzenamine] has the following chemical structure:
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HO,,
ON,
CF_
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
C13H14F3N304
333.27
55283-68-6
113101
Ethalfluralin is a yellow crystalline solid with a melting point of 57°C.
Ethalfluralin is readily soluble in organic solvents (acetone, acetonitrile, benzene,
chloroform, hexane, methanol, methylene chloride, and xylene), and is soluble in water
at0.3ppmat25°C.
The following Technical Chemistry data are required to confirm the qualitative and
quantitative nature of technical ethalfluralin and possible impurities from the
manufacturing process:
- (61-1) Product Identity and Disclosure of Ingredients: Submitted data do not fully satisfy
the requirements of 40 CFR §158.155 (Guideline Reference No. 61-1) regarding product
identity because two compounds were incorrectly identified on the Confidential Statement
of Formula (CSF). Furthermore, the registrant must provide definitive chemical names
for all "isomers" and CAS numbers for all components.
- (62-1) Preliminary Analysis: These data do not fully satisfy the requirements of 40 CFR
§158.170 (Guideline Reference No. 62-1) regarding preliminary analysis because
preliminary analysis data on five samples from different batches of the 96% Technical,
manufactured using the current manufacturing process, must be submitted. If the
manufacturing process has changed from the one previously reviewed by the Agency in
1992, then the registrant must submit a complete description of the manufacturing process
for review (under GLN 61-2). The registrant must also indicate how the components of
a group of impurities (active ingredient isomers) were distinguished and confirm the
identification of one compound listed on the CSF from the tentative identification made
in preliminary analysis. In addition, the nitrosamine analysis must be performed using a
sample analyzed at 0, 3, and 6 months after production; only an initial analysis was
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provided. Finally, the registrant must submit preliminary analysis data for an impurity
included on the CSF dated 5/26/92.
- (62-2) Certification of Ingredients: Submitted data do not fully satisfy the requirements
of 40 CFR §158.175 (Guideline Reference No. 62-2) regarding certification of limits
because a lower certified limit must be proposed for an impurity which is pesticidally
active. We note that this compound should also be added to the label claim. In addition,
the registrant must identify which of the two manufacturing processes discussed in
preliminary analysis the proposed certified limits are intended to support.
- (62-3) Analytical method to Verify the Certified Limits: Submitted data do not fully
satisfy the requirements of 40 CFR §158.180 (Guideline Reference No. 62-3) regarding
enforcement analytical methods because complete validation data must be submitted for
the method used to determine the active ingredient. In addition, the registrant must submit
a complete description and supporting validation data for the analytical methods used to
determine the impurities.
Provided that the registrant submits the data required for guidelines 61-1,
62-1, 62-2, and 62-3, for DowElanco ethalfluralin 96% Technical, as described above and
either certifies that the suppliers of starting materials and the manufacturing process for
ethalfluralin have not changed since the last comprehensive product chemistry review or
submits a complete updated product chemistry data package, ethalfluralin is eligible for
reregistration with respect to product chemistry data requirements.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on ethalfluralin is adequate and will support
reregistration eligibility.
Table 2.
a. Acute Toxicity
TEST
Oral LDTO~rat
Dermal LDTO— rabbit
Inhalation LCTO— rat
Eye irritation— rabbit*
Dermal irritation— rabbit*
Skin sensitization— guinea pig*
RESULTS
LDTO > 5000 mg/kg
LD5n > 5000 mg/kg
LC50 >0.94mg/L
moderate
moderate to severe
sensitizer
CATEGORY
IV
IV
III
II
II
—
Note: Data pertaining to primary eye irritation, primary dermal irritation, and dermal sensitization are not required to support the
reregistration of the TGAI. These data are presented for informational purposes.
-------
An acute oral toxicity study with rats found the LD50 was greater
than 5000 mg/kg, which was toxicity category IV (MRID 41613908). An
acute dermal toxicity study with rabbits found the LD50 was greater than
5000 mg/kg. This was toxicity category IV (MRID 41613909).
An acute inhalation study with rats found the LC50 was greater than
0.94 mg/L, which was toxicity category III (MRID 41977601). An eye
irritation study with rabbits found slight to moderate corneal opacity and
edema with slight to severe iritis and irritation up to the third day,
generally followed by clearing by the seventh day. One animal retained
scattered opacity through day 7, clearing by day 14. This was toxicity
category II (MRID 41613910). A dermal irritation study with rabbits
found slight to moderate irritation and edema from 24 hours through 7 days
after 24 hour dermal treatment. There were desquamation, slight to severe
edema and irritation, with coriaceous formation, through 14 days. One
animal had epidermal fissures and bleeding by the fourteenth day. This
was toxicity category II (MRID 41613909).
A guinea pig dermal sensitization study conducted by the modified
Buehler method found no sensitization, whereas a study conducted by the
Magnusson and Kligman maximization method found ethalfluralin was
positive (MRID 00094788, ACC 070683a).
b. Subchronic Toxicity
A three month feeding study with B6C3F1 mice used doses of 0,
560, 1110, 2250, 4000, or 8000 ppm (68, 136, 285, 538, or 1205
mg/kg/day). The NOEL was 560 ppm. The LOEL was 1110 ppm based
on low bilirubin and low kidney weights in males. Higher doses showed
depressed weight gain, increased serum glutamic pyruvic transaminase
(SGPT), increased serum alkaline phosphatase, and increased relative liver
weights. (MRID 00094774)
In a second study, ethalfluralin was administered to B6C3F1 mice
for one year at dietary concentrations of 0, 100, 400, or 1500 ppm
(equivalent to 0, 12, 47.0, or 173 mg/kg/day for males; 0, 12, 49, or 184
mg/kg/day for females). The NOEL was 100 ppm. The LOEL was 400
ppm, based on increased alkaline phosphatase levels at this and the high
dose. At the high dose, there were decreased blood urea nitrogen (BUN)
and creatinine, increased SGPT, and increased relative liver weights.
(MRID 00094778)
In a third study, ethalfluralin was fed to Fisher 344 rats for one
year. The doses were 0, 100, 250, or 750 ppm in the diet (equivalent to
-------
0, 3.9, 9.7, or 28.4 mg/kg/day for males; 0, 4.9, 11.9, or 34.4 mg/kg/day
for females). The NOEL was 100 ppm. The LOEL was 250 ppm, based
on blood chemistry changes at the two higher doses, with increased relative
liver weights and decreased body weight gain at the high dose. (MRID
00094775)
The doses for the preceding study, and for the two year rat study
discussed below, were derived from a three month study in which Fischer
344 rats were fed 0, 250, 500, 1100, 2500, or 5000 ppm test material.
The NOEL was 500 ppm (29 mg/kg/day). Higher doses showed increased
liver and kidney weights, lower red blood cells (RBC), hematocrit and
hemoglobin, as well as some enzyme activity changes (MRID 00135191).
Although this is a supplemental study it provides the rationale for dose
selection in the above mentioned studies.
A three month oral study with beagle dogs had doses of 0, 6.25,
27.5, or 125/80 mg/kg/day by capsule. The systemic NOEL was 27.5
mg/kg/day. The systemic LOEL was 80 mg/kg/day (the high dose) based
on elevated alkaline phosphatase, slight fatty metamorphosis of the liver,
increased cholesterol, and increased BUN. (MRID 00135193)
In a 21 day dermal toxicity study, New Zealand white rabbits were
treated with 0 or 1000 mg/kg/day, a limit dose. No systemic effects were
found at this dose; skin effects were slight to severe dermal irritation, as
well as edema and coriaceous skin with epidermal fissures. (MRID
00145767)
c. Chronic Toxicity and Carcinogenicity
Ethalfluralin was administered to Fisher 344 rats in the diet for two
years in combined chronic toxicity and carcinogenicity replicate studies.
The doses were 0, 0.01, 0.025, or 0.075 percent in the diet (equivalent to
0, 4.2, 10.7, or 32.3 mg/kg/day). The NOEL for systemic effects was
32.3 mg/kg/day, the high dose. Mammary gland fibroadenomas were
found in dosed female rats at statistically significant incidences in the mid
and high doses. (MRID 00094776 and 92062013)
Ethalfluralin was administered to B6C3F1 mice in the diet for two
years in combined chronic toxicity and carcinogenicity replicate studies.
The doses were 0, 100, 400, or 1500 ppm in the diet (equivalent to 0,
10.3, 41.9, or 163.3 mg/kg/day). No increased incidence of neoplasms
was attributed to the treatment. The NOEL was 10.3 mg/kg/day. The mid
dose (LOEL) and high dose showed focal hepatocellular hyperplasia in both
sexes. There were increased relative liver, kidney, and heart weights in
-------
females. Some blood changes were found also, including decreased
hematocrit, hemoglobin, and erythrocyte count accompanied by increased
mean corpuscular hemoglobin concentration in high dose females. Alkaline
phosphatase values were increased at the high dose in both sexes. Body
weight gain decreased at the high dose. (MRID 00094777 and 92062016)
Beagle dogs were given 0, 4, 20, or 80 mg/kg/day orally, by
capsule, for one year. The NOEL was 4 mg/kg/day. The LOEL was 20
mg/kg/day, based on increased urinary bilirubin, variations in erythrocyte
morphology, increased thrombocyte count, and increased erythroid series
of the bone marrow. Elevated alkaline phosphatase levels were found at
the two higher doses and siderosis of the liver at the high dose (MRID
00153371 and 92062014)
The Agency's Office of Pesticide Program's Carcinogenicity Peer
Review Committee on June 8, 1994, concluded that ethalfluralin should be
classified as Group C, a possible human carcinogen, based on increased
mammary gland fibroadenomas and adenomas/fibroadenomas combined in
female rats. The tumor incidences were statistically significant at both the
mid and high dose, and were well in excess of the upper range of historical
controls. Based on a low dose extrapolation, the upperbound unit risk, Qx*
of ethalfluralin is 8.9x102 (mg/kg/day) \
d. Developmental Toxicity
Ethalfluralin was administered orally to Sprague Dawley rats at 0,
50, 250, or 1000 mg/kg/day on gestation days 6-15. The maternal NOEL
was 50 mg/kg/day. The maternal LOEL was 250 mg/kg/day, based on
decreased body weight gain and dark urine. In this study there was no
observable developmental toxicity. The developmental NOEL was 1000
mg/kg/day, the highest dose. (83-3; MRID 0015337 and 92062017)
Dutch Belted rabbits were given 0, 25, 75, 150, or 300 mg/kg/day
of ethalfluralin by gavage on gestation days 6-18. The NOELs for
maternal and developmental toxicity were 75 mg/kg/day. The maternal
LOEL at 150 mg/kg/day was based on abortions and decreased food
consumption. These effects as well as decreased weight gain, enlarged
liver, and orange urine were found at 300 mg/kg/day. In this study
developmental toxicity was observed. The developmental LOEL was 150
mg/kg/day, based on slightly increased resorptions, abnormal cranial
development, and increased sternal variants. (MRID 00129057)
10
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e. Reproductive Toxicity
A three-generation reproduction study in Fischer 344 rats gave
doses of 0, 100, 250, or 750 ppm in the diet (equivalent to 0, 5.0, 12.5,
or 37.5 mg/kg/day). The parental NOEL was 12.5 mg/kg/day. The
parental LOEL was 37.5 mg/kg/day, based on depressed mean body weight
gains in males in all generations. No treatment-related effects were noted
on reproductive parameters and the NOEL was 37.5 mg/kg/day or greater.
(MRID 00094784 and 92062019)
A seven month multigeneration bridging study was conducted with
doses of 0, 100, 250, or 750 ppm (equivalent to 0, 8, 20, or 61 mg/kg/day)
in the diet of Fischer 344 rats. The parental NOEL was 20 mg/kg/day.
The parental LOEL was 61 mg/kg/day, based on increased liver weights.
No treatment-related effects were noted on reproductive parameters and the
reproductive NOEL was equal to or greater than 61 mg/kg/day (MRID
42300301).
f. Mutagenicity
Ethalfluralin was weakly mutagenic in activated strains TA1535 and
TA100 of Salmonella typhimurium but not in strains TA1537, TA1538,
and TA98 in an Ames assay. In a modified Ames assay with Salmonella
typhimurium and Escherichia coli, ethalfluralin was weakly mutagenic in
strains TA1535 and TA100, with and without activation, and in strain TA
98 without activation, at the highest dose (MRID 00128693 and 00128694).
No mutagenicity was found in the mouse lymphoma assay for forward
mutation (MRID 00128696). Ethalfluralin did not induce unscheduled
DNA synthesis in rat hepatocytes (MRID 00128695). In Chinese hamster
ovary cells, the chemical was negative without S9 activation, but it was
clastogenic with activation (MRID 00152219).
g. Metabolism
Fischer 344 rats were treated orally with a single low dose, a single
high dose, or repeated low doses of radiolabeled ethalfluralin. Absorption
of ethalfluralin was estimated at 79-87% of the dose for all dose levels.
Ethalfluralin was rapidly and extensively metabolized, and 95% of the
chemical was excreted in urine and feces by seven days. The major route
of elimination for the radiolabel was in the feces, 50.9-63.2%, and the
levels remaining in the tissues after 72 hours were negligible. The major
metabolites in urine and feces were identified. (MRID 42822901)
11
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A study with Rhesus monkeys indicated that 2.8% of a dermal dose
was absorbed through the skin (MRID 00132820).
h. Reference Dose
The RfD was determined to be 0.04 mg/kg/day, based on a NOEL
of 4.0 mg/kg/day (altered red cell morphology, increased urinary bilirubin)
in the one-year oral dog study (MRIDs 00153371 and 92062014) discussed
above. An uncertainty factor of 100 was used to account for inter-species
extrapolation and intra-species variability. There has been no WHO RfD
determination as of yet.
Exposure Assessment
a. Dietary Exposure
Tolerances for residues in/on plants (dry beans, cucurbit vegetables
group, peanuts, peanut hulls, dry peas, soybean, and sunflower seed) and
in animal commodities (eggs, milk, and fat, meat, and meat byproducts of
cattle, goats, hogs, horses, poultry, and sheep) are expressed in terms of
ethalfluralin per se [40 CFR §180.416]. All of these tolerances are
established at 0.05 ppm and are listed in Section IV, Table 19. No
food/feed additive tolerances have been established. Adequate enforcement
methods are available for the determination of ethalfluralin residues in/on
plant and animal commodities.
GLN 171-3: Directions for use
According to the Agency's records, there are five ethalfluralin
end-use products (EPs) with food/feed uses which are registered to
DowElanco and Platte Chemical Company. Restrictions on grazing,
foraging, haying for beans, peas, soybeans, peanuts, and alfalfa must be
removed from all labels as detailed below in the discussion of guideline
171-4(k): Magnitude of the Residue in Plants.
GLN 171-4 (a): Plant Metabolism
The qualitative nature of the residue in beans and peanuts is
understood. These studies (MRID 00145955, 00094754, and 43394001)
were conducted under the registered use patterns. Sufficient radioactive
residues in/on bean and peanut commodities were obtained following
preplant soil-incorporated application of uniformly ring-labeled
[14C]ethalfluralin at ~ Ix the maximum registered rate. The major portion
12
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of the radioactivity was characterized as lignin, cellulose, and protein. The
parent, ethalfluralin, was a minor residue.
The tentatively terminal residue of concern in plants is ethalfluralin
per se] the current tolerance expression for plants is adequate. However,
before plant metabolism may be considered fully understood, an acceptable
cucurbit metabolism study must be submitted. A cucurbit metabolism study
is on-going. The cucurbit study and the outstanding raw data for the
peanut and bean studies will be considered confirmatory.
GLN 171-4 (b): Animal Metabolism
The qualitative nature of the residue in animals is adequately
understood based on acceptable poultry and ruminant metabolism studies.
In the poultry metabolism study, laying hens were dosed with uniformly
ring-labeled [14C] ethalfluralin at 10 ppm in the diet (about 200x the
maximum theoretical dietary burden) for ten consecutive days. The
maximum total radioactive residues were 0.169 ppm in eggs, 0.697 ppm
in liver, 0.070 ppm in muscle, and 0.194 ppm in skin. The parent
compound, ethalfluralin, was the major compound identified in skin, but
was a minor component in eggs, liver, and muscle. Four other
metabolites, 2,6-dinitro-4-(trifluoromethyl)phenol, N-ethyl-2,6-dinitro-4-
(trifluoromethyl)benzenamine, N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl) benzenamine , and 2 , 6-dinitro-4-
(trifluoromethyl)benzenamine, were identified; each identified metabolite
was present at j^O.05 ppm.
In the ruminant metabolism study, a lactating dairy cow was dosed
with uniformly ring-labeled [14C] ethalfluralin at 10 ppm in the diet (about
200x the maximum theoretical dietary burden) for three consecutive days.
The total radioactive residues were 0.011 ppm in fat, 0.050 ppm in kidney,
0.104 ppm in liver, 0.002 ppm in muscle, and up to 0.006 ppm in milk.
Ethalfluralin was identified in milk and fat; neither parent nor metabolites
were identified in kidney or liver.
The residue of concern in milk, eggs, and animal tissues is
ethalfluralin per se. As a result of the low levels of radiolabeled residues
found with the exaggerated (200x) feeding levels, the requirements for
animal feeding studies were waived. It was also concluded that residues of
ethalfluralin from up to lOx dietary burden would not be quantifiable
(<0.05 ppm). Therefore, according to 40 CFR 180.6(a)(3), if it is not
possible to determine finite residues with certainty, and it is unlikely there
are any residues, tolerances should not be established for eggs, milk, fat
13
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and meat byproducts of cattle, goats, hogs, horses, poultry and sheep.
Thus, these existing tolerances should be revoked.
GLN 171-4 (c) and (d): Residue Analytical Methods-Plants and Animals
Adequate residue analytical methods are available for purposes of
reregistration. Two GC methods, Method I and II, both with electron
capture detection (ECD) are listed in the Pesticide Analytical Manual
(PAM, Vol. II, Section 180.416) for tolerance enforcement. Method I is
applicable for the analysis of ethalfluralin residues in/on plant commodities
(cottonseed, cucurbits, forage legumes, peanuts, seed and pod vegetables,
and sunflower seed). Method II is applicable for tolerance enforcement of
ethalfluralin residues in animal commodities (eggs, milk, and fat, meat, and
meat byproducts of cattle, goats, hogs, horses, poultry, and sheep). The
limits of detection are 0.01 ppm and <0.01 ppm, for Method I and
Method II respectively.
The principal analytical method used for residue data collection in
plant commodities was the enforcement method, Method I. Adequate
concurrent method recoveries (70-120%) support the results of field residue
and storage stability studies that were used for tolerance reassessments.
The qualitative nature of the residue in cucurbits has not been adequately
described. If the requested data on cucurbit metabolism indicate the
presence of additional metabolites of toxicological concern, then relevant
additional analytical methods and data may be required.
Representative samples from the submitted bean and peanut
metabolism studies were not analyzed using the current enforcement
method. However, since no additional terminal residues of concern were
found in dried bean stems and peanut nutmeats and hulls, radio-validation
data will not be needed.
The FDA PESTDATA database dated August 1993 (PAM Vol. I,
Section 180.416) indicates that ethalfluralin is completely recovered
(> 80%) using multiresidue method protocols D and E (fatty and nonfatty).
GDLN 171-4 (e): Storage Stability
Storage stability studies have been conducted using fortified samples
of beans (dry), cucumbers, peanuts, peas (dry), soybean, soybean
processed commodities, and sunflower seed. Residues of ethalfluralin are
stable under frozen storage conditions (-20 C) in/on beans (dry), soybean
processed commodities, and sunflower seed for up to 6 months, in/on peas
(dry) for up to 10 months, and in/on cucumbers, peanuts, and soybean for
14
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up to 12 months. Storage stability data for soybean processed commodities
may be translated to peanut processed commodities. Storage stability data
for cucumbers may be translated to melons, pumpkin, squash (summer and
winter), and watermelon.
Additional confirmatory data indicate that ethalfluralin residues are
stable in sunflower seed stored at room temperature and then frozen,
reflecting sample handling which occurred during the sunflower seed crop
field trial study.
Samples of eggs, milk, and tissues from the poultry and ruminant
metabolism studies were analyzed within two months of sample collection.
Therefore, storage stability data to validate the results from the animal
metabolism studies are not required.
GLN 171-4 (k): Magnitude of the Residue in Plants
All data requirements for magnitude of ethalfluralin residue in
plants have been evaluated and deemed adequate except for cucurbits and
the forage and hay of various crops. To support the use on cucurbits data
from residue field trials on cucumbers, squash, and melons are required to
fulfill the data requirements. This data is currentl being reviewed by the
Agency.
The registered uses of ethalfluralin on beans (dry), peanuts, peas
(dry), soybean, and sunflower along with the established tolerances on
these commodities are supported by acceptable field residue data from trials
reflecting the maximum registered use patterns. In all cases, the residues
were < 0.01 ppm. Field trial studies for cucurbits, specifically summer
and winter squash, pumpkins, cucumbers, and melons, are being
conducted. Previous studies, not submitted by the registrants for
reregistration purposes, indicated that residues were nondetected (< 0.01
ppm) in/on squash, cantaloupe, cucumber, watermelon, and pumpkin from
postplant-preemergence surface application at rates of 1.25 - 2.5 Ibs.
a.i./acre. The similarity of the postplant-preemergence use pattern among
crops and the comparability of residue results (< 0.01 ppm) combined
with the previous field trial results provide adequate data to support the
existing tolerance of 0.05 ppm for residues of ethalfluralin in/on cucurbits
for postplant-preemergence use only until new field trial studies are
submitted within one year. The postemergence and post-transplant uses on
cucurbits are not similar to other crop use patterns. A registrant is
conducting studies to support all uses on cucurbits. At this time, without
data, the postemergence and posttransplant uses of ethalfluralin on
cucurbits is not eligible for reregistration. If data from these studies are
15
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not adequate, unsupported uses will need to be removed from product
labels.
As the result of recent changes in Table 2, Subdivision 0 (6/94),
label restrictions on grazing, haying, and foraging are generally no longer
permitted. Field trial data are required for residues of ethalfluralin in/on
alfalfa forage and hay, bean forage and hay, pea forage and hay, peanut
hay, and soybean forage and hay. These data are necessary to confirm the
adequacy of the established tolerances.
GLN 171-4 (1): Magnitude of the Residue in Processed Food/Feed
The reregistration requirements for processing studies are fulfilled.
Adequate processing studies have been conducted on the following RACs:
peanuts, soybean, and sunflower seed. Field residue data resulting from
up to 5x label rates show nondetectable (<0.01 ppm) residues of
ethalfluralin in peanuts, soybean, and sunflower seed. For the purposes of
reregistration, it is concluded that residues are not likely to concentrate in
the processed commodities of peanuts, soybean, and sunflower seed. No
food or feed additive tolerances are required.
GLN 171-4 (j) Magnitude of the Residue Meat, Milk, Poultry, and Eggs
The data requirements for magnitude of ethalfluralin residue in
meat, milk, poultry, and eggs have been waived. The results of nature of
the residue studies in poultry and ruminants, using exaggerated feeding
rates (200x) indicate that residues of ethalfluralin at levels l-10x the dietary
burden will not be quantifiable (< 0.05 ppm). Therefore, since it is not
possible to establish with certainity whether finite residues will be incurred,
but there is no reasonable expectation of finite residues (40 CFR §180.6),
the existing tolerances (expressed in terms of ethalfluralin per se) for eggs,
milk, and fat, meat, and meat byproducts of cattle, goats, hogs, horses,
poultry, and sheep should be revoked as mentioned above under GDLN
171-4(b):Animal Metabolism.
GLN 165-1 and 165-2: Confined/Field Rotational Crops
A confined rotational crop study has been submitted and deemed
adequate. In that study, radioactive residues were j^O.Ol ppm in/on
mature commodities of rotational crops (root crops, leafy vegetables, and
small grain) grown in soils that had been treated with [phenyl-
14C]ethalfluralin at Ix the maximum registered rate. Ethalfluralin at 0.01
ppm (2.3% TRR) was found in only one sample of mature barley chaff
from the 30-day plantback interval. Ethalfluralin was not identified in any
16
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other plant commodity at any plantback interval. The major metabolite,
designated as Unknown 1, was found at 0.03-0.11 ppm (18-83% TRR) and
was characterized to be polar in nature but not a potential residue of
concern. Field rotational crop studies are not required since no residues of
concern were found at significant levels in rotational crops. Furthermore,
tolerances for rotational crop commodities and plantback restrictions need
not be established.
b. Occupational and Residential
Use patterns
As stated previously, ethalfluralin is a herbicide formulated as a
granular (containing 10 percent a.i.), dry flowable (50 percent a.i.), and
as several emulsifiable concentrates (containing 31.5 percent to 36.1
percent a.i.). It is applied as a band or broadcast treatment using low-
pressure groundboom or granular spreader equipment as specified above
in Section II.B. All products containing ethalfluralin are primarily for
occupational use.
The Agency's 1992 Worker Protection Standard for Agricultural
Pesticides (WPS) established certain worker-protection requirements
(personal protective equipment, restricted entry intervals, etc.) to be
specified on the label of all products that contain uses within the scope of
the WPS. Such uses include all commercial (non-homeowner) and research
uses on farms, forests, nurseries, and greenhouses to produce agricultural
plants (including food and feed crops). Uses within scope of WPS include
uses on plants and uses on the soil or planting medium the plants are (or
will be) grown in. At this time all of the registered uses of ethalfluralin
appear to be within the scope of the WPS.
An occupational and/or residential exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators)
during use or to persons entering treated sites after application is complete.
Because ethalfluralin is classified as a Group C carcinogen, the toxicology
criteria are triggered.
Handlers (Mixers/Loaders/Applicators) Exposure
There is potential exposure to handlers during use of ethalfluralin
products. There is a concern about potential exposures arising from mixing
and loading liquid or dry flowable formulations, from loading granular
17
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formulations, and from applying with groundboom and granular spreader
equipment.
Requirements for mixer/loader/applicator (i.e., handler) exposure
studies are addressed in Subdivision U of the Pesticide Assessment
Guidelines. Mixer/loader/applicator (M/L/A) exposure data for
ethalfluralin were not required during Phase IV of the reregistration
process, since no new toxicological criteria were noted at that time. A
review of the toxicological data, summarized above, indicates that criteria
for requiring exposure data are met. An exposure assessment is required
since ethalfluralin is now classified as a quantifiable Group C carcinogen.
Surrogate and chemical specific data are available to conduct an exposure
assessment and additional data are not required.
Ethalfluralin M/L/A data for the granular formulation (Edge 5G)
were developed by the registrant for Health Canada and were also
submitted to the U.S. Pesticide Handler Exposure Database (PHED). A
limited exposure/risk assessment for handlers of all formulations and
application methods was conducted for ethalfluralin using that data and
other generic data obtained from PHED.
Based on the use-patterns and potential exposures described above,
four major exposure scenarios are identified for ethalfluralin: (1)
mixing/loading the liquid/dry flowable formulation, (2) loading the dry
(granular) formulation, (3) applying the liquid/dry flowable formulation
with a groundboom sprayer, and (4) applying the dry formulation with
granular spreader equipment. The exposure scenarios are presented in
Table 3 along with the corresponding exposure/risk assessment. Table 4
summarizes the caveats and parameters specific to each exposure scenario.
For consistency, protection factors were applied to the exposure data
reported in Table 3 to simulate personal protective equipment use of
coveralls and chemical-resistant gloves, since the actual clothing and
equipment worn by persons being monitored in the exposure studies
(described in Table 4) included long sleeves and pants or coveralls and
chemical resistant gloves or no gloves.
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Table 3. Summary Exposure/Risk Values for Ethalfluralin
Exposure Scenario
.(Scen..f).
Dermal
Exposure"
mg/lb ai
Inhalation
Exposure11
iig/lb ai .
Maximum
Label
Application
Rate0
lb/ai acre
Daily
Maxd
Treated
(acres)
Dally
Dermal
Dose6
mg/kg/day
Commercial
.Mixer/Loader/
Applicator8
Dermal
LADDf
mg/kg/day
RISK11
Mixer/Loader Exposure
Liquids/Dry
Flowable (Ground
Application) (I)
Granules (Ground
Application) (II)
0.2
0.007*
0.4
1.0
1.7
1.7
80
80
0.39
0.014
IxlO-4
6xlO-6
IxlO-5
5xlO-7
Applicator Exposure
Groundboom
Application (II)
Solid Broadcast
(Tractor) (IV)
0.02
0.0008
1.3
0.1
1.7
1.7
80
80
0.039
0.002
IxlO-5
8xlO-7
IxlO-6
7xlO-8
Dermal unit exposures are reported as the best fit mean to simulate workers wearing coveralls and chemical resistant gloves. The best fit mean is the composite
total dermal exposure based on using the geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and the median for all other
distribution types. The ethalfluralin generated mixer/loader and applicator data are reported as the geometric mean. Protection factors were used to calculate
dermal exposure values because insufficient data are available for PPE in these scenarios. Fifty percent of the total dermal exposure is assumed to be attributed
to hand exposure. Fifty percent protection factor is applied to the hand exposure for chemical resistant gloves.
Inhalation exposure values are reported as geometric means (lognormal distribution). No adjustment has been made to simulate workers wearing dust/mist
respirators. Inhalation exposure ([-ig/lb ai) is considered to be significantly less than potential dermal exposure.
Label Use Information System report and ethalfluralin labels.
Values represent the maximum area which is assumed to be used in a single day to complete treatments for each exposure scenario of concern.
Daily Dermal Dose (mg/kg/day) = Exposure (mg/lb ai) x Max. Appl. Rate (Ib ai/acre) x Max. Treated 70 kg
LADD (mg/kg/day) = Daily Dermal Dose (mg/kg/day) x (10 Work Days Per Yr/365 Days Per Year) x (35 Yrs/70 Yrs) x 0.028 (dermal absorption)
Commercial applicator is defined as an intermediate exposed individual (i.e., 10 days).
Risk = Dermal LADD (mg/kg/day) x Q{*
No protection factor necessary
19
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Table 4. Exposure Scenario Descri]
Exposure Scenario
' ' • (Seen, f) '
Data
Source.
jtions for Ethalfhu alin
Clothing Scenario"
Equipment
Standard
Assumptions'1
(8-hr work day)
Comments'1
Mixer/Loader Exposure
Jquids/Dry Flowables for
jfound Application (I)
Granules for Ground
Application (II)
PHED
Dow
Elanco
^ong Pants, Long-
sleeved Shirt, No
Cloves
single layer
:overalls, Gloves
Dpen Mixing
Dpen Mixing
80 acres
80 acres
Acceptable grades;
Dermal = 14 +
-eplicates;
nhalation = 40
-eplicates
rligh confidence in data
Acceptable dermal
grades;
nhalation grades 25 A
rnd 5C;
Dermal = 24 replicates
nhalation = 30
-eplicates
rligh confidence in data
Applicator Exposure
iroundboom Application (II)
•olid Broadcast - Tractor (V)
PHED
Dow
Elanco
^ong Pants, Long-
sleeved Shirt, No
Cloves
single layer
:overalls, No gloves
Open cab
\11 but four
-eplicates
:losed cab;
30th
:ultivator
nounted and
mll-behind
ipplicator
equipment
80 acres
80 acres
trades A, B, C;
Dermal = 6+ replicate;
nhalation = 56
-eplicates
^ow - Medium
:onfidence in data
Acceptable dermal
grades;
nhalation grades 24A
rnd 5C;
Dermal = 27 replicates
nhalation = 29
-eplicates High
:onfidence in data
8 Clothing scenario represents actual monitored exposure data. The dermal exposure values on Table 1 have been adjusted using protection factors to simulate long
pants, long-sleeved shirt and chemical resistant gloves.
b Standard Assumptions based on an 8-hour work day as estimated by the Agency.
c "Acceptable grades," as defined by the Agency's SOP for meeting Subdivision U Guidelines, are grades A and B for dermal inhalation, and grade C for hand rinse
method. All grades that do not meet the Agency's SOP are listed individually.
Post-Application Exposure
The Agency has determined that there is potential exposure to
persons entering treated sites after application is complete, only under one
of the following conditions: (1) the application is not incorporated correctly
or (2) the entry task involves contact with the soil subsurface.
20
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The potential exposure to persons entering treated sites after
application should be minimal and does not trigger a need for dislodgeable
residue studies.
3. Risk Assessment
Toxicological Endpoints
Because ethalfluralin demonstrated developmental toxicity in rabbits
(from acute dosing), developmental toxicity is an appropriate endpoint for
acute dietary risk assessment for this chemical. The NOEL for this risk
assessment is 75 mg/kg/day from the developmental toxicity study. The
effects seen at 150 mg/kg/day LOEL were increased resorptions and
increased sternal and cranial variations. Developmental toxicity is not an
appropriate endpoint of concern for occupational/residential exposure
because the dermal absorption rate, 2.8% (from the Rhesus monkey study),
is too low to cause concern for short term exposure.
For chronic dietary exposure, ethalfluralin has a Reference Dose
(RfD) of 0.04 mg/kg body weight/day based on a NOEL of 4.0 mg/kg/ day
from the one year dog study and an uncertainty factor of 100. Additionally
for chronic exposure, ethalfluralin has been classified as a possible (Group
C) human carcinogen based on conclusions of the two year rat study. A
cancer risk assessment using the Qx* of 8.9 X 10 (mg/kg/day) is
appropriate.
a. Dietary
Food uses in this analysis include all published tolerances listed in
the Tolerance Index System (TIS) (see Table 19, below) and 40 CFR
§180.416. All established tolerances are 0.05 ppm ethalfluralin. Although
adequate data are not available for the reregistration of ethalfluralin on
cucurbits, the Agency considered the existing published tolerances for
cucurbits in its analysis, as the worst case scenario.
Currently tolerances exist for fat, meat and meat byproducts of
cattle, goats, hogs, horses, poultry, and sheep as well as milk and eggs.
Although the Agency is requiring in this document the revocation of these
tolerances for the reasons stated above, they were included in the acute,
chronic, and carcinogenic assessments, again, as a worst case assumption.
21
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Acute Exposure
The Agency's Dietary Risk Evaluation System (DRES) detailed
analysis for acute exposure evaluates individual food consumption as
reported by respondents in the USDA 77-78 Nationwide Food
Consumption Survey (NFCS) and estimates the distribution of single day
exposures through the diet for the U.S. population and certain subgroups.
The analysis assumes uniform distribution of ethalfluralin in the commodity
supply. Since developmental toxicity is the toxicological effect to which
high end exposure is being compared in this analysis, the DRES subgroup
of concern is females (13+ years) which approximates women of child-
bearing age.
The Margin of Exposure (MOE) is a measure of how closely the
high end exposure is to the NOEL (the highest dose at which no effects
were observed in the laboratory study). It is calculated as the ratio of the
NOEL to the exposure (NOEL/exposure = MOE). For substances whose
acute NOEL is based on animal studies, the Agency believes MOEs of 100
or greater represent a negligible risk to that toxicological endpoint.
In the analysis, the Theoretical Maximum Residue Contribution
(TMRC) or tolerance level residues were used to estimate the high-end
dietary exposure for the females (13+ years) subgroup. This exposure is
0.003 mg/kg/day. High end exposure was compared to the NOEL of 75
mg/kg bwt/day from the rabbit developmental study to get a high end
Margin of Exposure. The MOE for females was calculated in the attached
table and the results are as follows:
NOEL/ Exposure = 75 mg/kg/day + 0.003 mg/kg/day = 25,000
Using the given endpoints, the MOE is not of concern for the
subgroup females (13+ years) with an estimated MOE of 25000.
Chronic Exposure
The DRES chronic analysis used tolerance level residues to
calculate the Theoretical Maximum Residue Contribution (TMRC) for the
overall U.S. population and 22 population subgroups. Of these subgroups,
non-nursing infants is the most highly exposed subgroup. Refinements in
residue and percent crop treated information were considered in calculating
the Anticipated Residue Contribution (ARC) for those same population
groups. The ARC is considered the more accurate estimate of dietary
exposure. These residue values are listed in Section IV, Table 20. These
22
-------
exposure estimates were then compared to the RfD for ethalfluralin to
calculate estimates of chronic dietary risk.
Using Tolerances:
The Theoretical Maximum Residue Contribution (TMRC) (exposure
in mg/kg/day) for the overall U.S. population from published tolerances
are listed below.
Population group Exposure (mg/kg/day) %Reference Dose
U.S. population 0.000735 2
Non-nursing Infants 0.003565 9
Using Anticipated Residues:
The Anticipated Residue Contribution (ARC) for the overall U.S.
population from the published uses recommended through reregistration are
listed below.
Population group Exposure (mg/kg/day) %Reference Dose
U.S. population 0.000699 2
Non-nursing Infants 0.00347 4
The U.S. population and all the ORES subgroups have ARCs for
chronic dietary risk well below the RfD when all tolerances or anticipated
residues are considered.
Carcinogenicity Risk
The upper bound carcinogenic risk from food uses of ethalfluralin
were calculated using the following equation:
Upper Bound Cancer Risk = Dietary Exposure (ARC) x Qj*
Based on a Qx* of 0.089 (mg/kg/day) * and the anticipated residue
contribution, the upper bound cancer risk estimate for the U.S. population
is 6.2 x 10 5, contributed through all the published tolerances for
ethalfluralin. As stated above, the Agency is requiring revocation of the
tolerances for meat, milk, poultry, and eggs due to the presumption that
there are undetectable, finite residues in these food items. When the cancer
risk is calculated without these commodities' tolerances the resulting upper
23
-------
bound risk is 5.7 x 10 7, a negligible risk. Of all the ethalfluralin
commodities, cucurbits contribute the most ethalfluralin residues to the
dietary exposure and risk. Cucurbits contribute 4.8 x 10 7 to the risk
estimate of 5.7 x 107 given above. The resulting upper bound carcinogenic
risk, excluding cucurbits, would be 8.8 x 10 8.
b. Occupational and Residential
Worker carcinogenic risk for commercial M/L/A is in the range
of 7 x 108 to 1 x 10 5 as noted in Table 3 above. The worst case scenario
is for the commercial M/L using the liquid/dry flowable formulation with
ground application equipment. These workers are estimated to have an
extra cancer risk of 1 x 105. Exposure assessments for all other
mixer/loader/applicator scenarios resulted in upper bound risks of 1 x 10 6
to 7 x 108, which are considered negligible.
Worker risks were calculated as follows:
Daily Dermal Dose (mg/kg/day) = (Exposure (mg/lb ai) x Max. Appl. Rate (Ib ai/cycle) x
Max. Treated)/?!) kg
LADD (mg/kg/day) = Daily Dermal Dose (mg/kg/day) x (10 Work Days Per Yr/365 Days
Per Year) x (35 Yrs/70 Yrs) x 0.028 (dermal absorption)
Commercial applicator is defined as an intermediate exposed individual (i.e., 10 days per year
handling ethalfluralin).
Risk = Dermal LADD (mg/kg/day) x Q*
Contributions from inhalation exposure were not included in the
cancer risk assessment because this exposure is considered to be
significantly less than estimated dermal exposure. Inhalation exposure
would not significantly increase the risk estimates. Therefore, no
adjustment has been made to simulate workers wearing dust/mist
respirators.
C. Environmental Assessment
1. Environmental Fate
All laboratory environmental fate data requirements necessary to support
the reregistration of ethalfluralin for the uses set forth in this RED have been satisfied.
While the Agency has identified deficienies in some studies, as discussed below, i.e.,
photodegradation on soil and soil mobility, they provide enough information for an
overall assessment of the degradation, mobility or accumulation of ethalfluralin in the
24
-------
environment. The Agency, therefore, has sufficient information at this time to provide
an overall qualitative assessment for ethalfluralin.
a. Environmental Chemistry, Fate and Transport
Hydrolysis (GDLN 161-1)
Ethalfluralin is stable to hydrolysis at pH 3, 6, and 9.
(MRID 00094805)
Photodegradation in water (GDLN 161-2)
Ethalfluralin in pH 5 buffer solution had a photodegradation
half-life of 6.3 hours. Ethalfluralin did not degrade in the dark
controls. The major photodegradate was identified by TLC as s-
trifluoromethyl-3-nitro-l,2-benzendiamine (LY-50030; 24.4%
applied). Three other compounds were isolated at jc^ll.36% of
applied. Seven unidentified photodegradates were also detected.
(MRID 41613916)
Photodegradation on soil (GDLN 161-3)
Ethalfluralin in sandy loam soil had a photodegradation half-
life of 14.23 days. Photodegradates were tentatively identified as
s-trifluoromethyl-3-nitro-l,2-benzendiamine (LY-50030), 2-(l-
methylethenyl) -4-nitro-6-trifluoromethyl-1 H-benzimidazole (LY-
275133), and 2-methyl-7-nitro-5-trifluoromethyl-lH-benzimidazole-
3-oxide (LY-65138), all at maximums of >4.3%.
There was a problem with the dark control samples in this
study. Approximately 50% of the applied radioactivity volatilized
from the dark control samples incubated 30 days while no
radioactivity volatilized from the exposed samples. The registrant
stated that this volatile radioactivity was assumed to be ethalfluralin
since "there was no such trapping in the exposed system".
However, there was significant radioactivity evolved from the dark
controls before the half-life of ethalfluralin in the exposed system.
(MRID 41613917)
Aerobic soil metabolism (GDLN 162-1)
Ethalfluralin in sandy loam soil had a metabolism half-life
of 46 days. Parent ethalfluralin decreased from 84.4% immediately
posttreatment, 49% at 0.9 months and finally to 1.3% of the
25
-------
applied radioactivity at 9 months. Radiolabelled degradates were
identified ET-2E, ET-2M, ET-4, ET17E, ET20, ET28E, and Ml
all at maximums ranging from 0.2-3.2% of applied radioactivity at
various sampling intervals.
Ethalfluralin degradation appeared to be dependent on
microbial-mediated processes with subsequent residue incorporation
into nonlabile soil organic matter. (MRID 41613918)
Anaerobic soil metabolism (GDLN 162-2)
Ethalfluralin in sandy loam soil had a metabolism half-life
of 13.8 days; ethalfluralin declined from 65% of applied
radioactivity at the initiation of anaerobic conditions to 10% after
30 days of anaerobic incubation. Radiolabelled residues formed
mainly during aerobic incubation were identified as ET-2M, ET2E,
ET-15M, ET-17E, and ET-20 all recovered at ^0.047 ppm
ethalfluralin equivalents. During anaerobic incubation three main
degradates were formed with maximum concentrations after 30 days
of anaerobic incubation: ET-4 (0.119 ppm), Ml (0.074 ppm) and
M2 (0.076 ppm). Other minor degradates at maximums of < 0.017
ppm were ET-13E, ET-3, ET-5E, and ET-7. EthalfTuralin
degradation appeared to be dependent on microbial-mediated
processes with subsequent residue incorporation into nonlabile soil
organic matter. (MRID 41613919)
Anaerobic aquatic metabolism (GDLN 162-3)
The calculated anaerobic aquatic half-life of ethalfluralin
was approximately 38 hours. These data do not fulfill the anaerobic
aquatic metabolism data requirement because the day 0 samples
were not extracted "for several hours" and 90% of the applied
ethalfluralin had degraded prior to the extraction. This study does
not need to be repeated, however, because the acceptable anaerobic
soil metabolism study will fulfill these data requirements.
Mobility Studies
Soil mobility (Batch Equilibrium: 163-1)
The reported data indicate ethalfluralin should be immobile
in soil. Ethalfluralin has a high binding affinity on soil. Freundlich
adsorption coefficients were 11.9 ml/g in sand, 32.6 ml/g in sandy
loam soil, 53.0 ml/g in loam soil, and 97.0 ml/g in clay loam soil;
slopes were 0.954-0.984. Average (non-Freundlich) desorption
26
-------
coefficients ranged from 16.2 to 20.9 ml/g in sand, 46.7 to 66.8
ml/g in sandy loam, 71 to 117.3 ml/g in loam, and 118.6 to 146.3
ml/g in clay loam soil.
Mobility (Aged Soil Column Leaching: 163-1)
Ethalfluralin residues appear to be relatively immobile in
soil. The majority of radiolabelled residues (77% of applied) were
detected in surface 6 cm of soil. However, a small percentage of
radiolabelled residue was detected (< 7% of applied) in leachate
samples. The mobile residue was tentatively identified as ET-20.
The study provides supplemental data on mobility of "aged"
ethalfluralin residues. The data are supplemental because of
insufficient data on the identification of mobile degradates. The
study may satisfy the aged residue portion of the 163-1 data
requirement with submission of a complete explanation on the
identification of residues in leachate and soil samples. (MRID
41890102)
Mobility (Laboratory Volatility: 163-2)
The reported data indicate that volatilization of ethalfluralin
and its degradates should not be a major route of dissipation.
Radiolabelled residues volatilized (< 5% of applied ethalfluralin)
from sandy loam soil. Volatility rates of radiolabelled residue
(presumably ethalfluralin) from soil ranged from 5.65 x 104 to 1.96
x 102 ug/cm2/hr.
The study is only marginally acceptable because volatile
residues were not analyzed, but were assumed to be parent
ethalfluralin. Because ethalfluralin and its degradates are not very
volatile from soil, the Agency believes that additional data on the
volatility of ethalfluralin are not needed at this time. (MRID
42496601)
Terrestrial field dissipation
When applied at 1.5 Ib ai/A and incorporated to bare
ground, ethalfluralin dissipated from an uncropped silty clay loam
soil in Illinois with a calculated half-life of 23 days. Ethalfluralin
dissipated probably by microbially mediated degradation from an
uncropped sandy loam soil in Georgia with a calculated half-life of
28 days when applied at 1.3 Ib ai/A and incorporated. Only
"ethalfluralin residues" were analyzed because there were no major
27
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degradates of ethalfluralin; the compound splits into numerous
smaller compounds. Ethalfluralin did not leach below the 6-inch
layer at any sampling interval from either site. (MRIDs 41978101;
41613920)
Fish Bioaccumulation
Ethalfluralin accumulated in rainbow trout tissues when the
fish were incubated in flow through systems at 0.86 ng/mL for 28
days; bioconcentration factors were 1520x for edible tissues, 860x
for nonedible tissues, and 11 SOX for whole fish samples.
Ethalfluralin also depurated rapidly with an elimination half-life of
approximately 3 days when fish were held in flow-through tanks
containing pesticide-free water. (MRID 41994902)
Surface Water Data
The Agency has no data on the concentrations of
ethalfluralin in surface waters, and has not generated Estimated
Environmental Concentrations (EEC's) beyond those at the
screening level for use in the aquatic risk assessments. However,
ethalfluralin can contaminate surface water through spray drift from
ground spray application. Substantial quantities of ethalfluralin
could also be available for runoff for several weeks post-application
(aerobic soil metabolism half-life of 46 days; terrestrial field
dissipation half-lives of 23 and 28 days). However, the frequent
incorporation into soil should limit the amount applied that is
available for runoff. Although ethalfluralin may be moderately
susceptible to photodegradation on soil, its frequent incorporation
into soil should also limit its exposure to sunlight. The relatively
high soil/water partitioning of ethalfluralin (Freundlich adsorption
binding constants of 12, 33, 53, and 97; Kocs of 4103, 3976, 5000,
and 8220) indicates that a large fraction of any ethalfluralin runoff
will be via adsorption to eroding soil. However, a significant
fraction may sometimes occur via dissolution in runoff water from
the lower binding soils when high runoff water to sediment yield
ratios occur.
The persistence of ethalfluralin in surface water should be
limited by its susceptibility to rapid direct photolysis in water (half-
life of 6 hours), particularly in clear shallow water. Its rapid
anaerobic degradation (anaerobic aquatic half-life of 38 hours),
should also limit its persistence in anaerobic water and sediment.
However, its stability to abiotic hydrolysis coupled with only a
28
-------
moderate susceptibility to aerobic degradation indicate that it will
be somewhat more persistent in aerobic waters with higher light
attenuation, low microbiological activities, and high hydrological
residence times. Its relatively high soil/water partitioning indicates
that much of the ethalfluralin in surface waters will be adsorbed to
suspended and bottom sediment. Ethalfluralin has a moderate
potential for bioaccumulation bioconcentration factor = 860X -
1520X.
Groundwater Data
From the environmental fate data provided, the Agency
would not predict ethalfluralin to be a groundwater contaminant.
There are no records of detections of this chemical in groundwater.
A chemically and structurally similar compound, trifluralin (Kads
55-156 mL/g) has been detected in the groundwater in 10 of 21
states from 58 of 5590 wells tested. However, the Agency
concluded that no groundwater label advisory or management plan
was necessary for trifluralin since these detections were mostly
either unconfirmed analytically, from very shallow ground water,
or at very low levels. Because these two compounds are similar in
structure and fate parameters, the Agency concludes that
ethalfluralin is not expected to be a groundwater contaminant.
b. Environmental Fate Assessment
The data submitted to support ethalfluralin reregistration are not
complete, but provide sufficient information for a qualitative environmental
fate assessment. Based on laboratory studies, ethalfluralin is expected to
dissipate by binding to soil particles and then degrading both aerobically
and anaerobically. Freundlich Kads values ranged from 12 to 97 mL/g and
in the field ethalfluralin did not leach. Laboratory metabolism half-lives
in soil were 46 days for aerobic systems and 14 days for anaerobic systems;
field half-lives ranged 23-51 days.
There are several minor metabolites of ethalfluralin in soil systems,
but no major metabolites were recovered. Some minor metabolites
appeared to be mobile in column leaching studies.
Ethalfluralin is not expected to be a groundwater contaminant, but
there is some potential for ethalfluralin to reach surface waters on eroded
soil particles. In surface waters ethalfluralin would be expected to
photodegrade (laboratory half-life of 6 hours) and to degrade rapidly in
anaerobic sediments possibly by electrochemical reactions (anaerobic
29
-------
aquatic half-life of 38 hours). Ethalfluralin was not volatile in the
laboratory; however, no assessment of spray drift potential is possible from
the submitted data.
From the environmental fate data provided, the Agency would not
predict ethalfluralin to be a groundwater contaminant. However, a
structurally similar compound, trifluralin, has been detected in the
groundwater in 10 of 21 states. Since these two compounds are so similar
in structure and fate parameters, the Agency cannot make a more complete
assessment regarding ethalfluralin in groundwater until the groundwater
assessment of trifluralin is finished.
2. Ecological Effects
All ecological effects data requirements necessary to support the
reregistration of ethalfluralin for the uses set forth in this RED have been
satisfied. The Agency, therefore, has sufficient information at this time to
provide an overall qualitative assessment for ethalfluralin.
a. Ecological Effects Data
The ecotoxicological data base is adequate to characterize the
toxicity of ethalfluralin to nontarget terrestrial and aquatic organisms when
used on the terrestrial food and feed and nonfood sites specified in this
document.
(1) Terrestrial Data
In order to establish the toxicity of ethalfluralin to birds, the
following tests are required using the technical grade material: one
avian single-dose oral (LD50) study on one species (preferably
mallard or bobwhite quail); two subacute dietary studies (LC50) on
one species of waterfowl (preferably the mallard duck) and one
species of upland game bird (preferably bobwhite quail or ring-
necked pheasant).
Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent environmental
fate characteristics.
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure.
30
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(a) Avian Acute Toxicity
Technical ethalfluralin (94.5%) is considered to be
practically nontoxic to bobwhite quail with an acute oral LD50 of
greater than 2,000 ppm. The guideline requirement for the avian
acute oral LD50 study is fulfilled. (MRID 070677)
(b) Avian Subacute Dietary Toxicity
On a subacute dietary basis, ethalfluralin (94.5%) is
considered to be practically nontoxic to bobwhite quail and mallard
ducks with dietary LC50's of greater than 5,000 ppm. (MRID
070677)
(c) Avian Reproduction
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. Ethalfluralin is a
persistent chemical (half-life ranging from 14 to 60 days) that is
applied immediately preceding and/or during the breeding season.
Two avian reproduction studies, one with a species of waterfowl,
preferably the mallard, and one with a species of upland gamebird,
preferably the bobwhite quail, are required for the technical
material.
In two avian reproduction studies, there were no adverse
effects at 1,000 ppm, the highest dietary intake tested, from
ethalfluralin (93.5%) in the bobwhite quail or the mallard duck. A
Lowest Observed Effect Level (LOEL) could not be determined.
The guideline requirements (71-4a,b) for avian reproductive testing
are fulfilled. (MRID 070677)
(d) Toxicity to Nontarget Mammals
Oral and dermal LD50 values for ethalfluralin end-use
product formulations were obtained from data submitted to the
Agency and are tabulated below for the laboratory rat.
-------
Table 5.
Mammalian Acute Oral Toxicity Findings
Species
Rat, small mammal
tt
tt
tt
% A.I.
35.5%a
50% dry flowable
10%a
10% granules
LD50(mg/kg)
Oral
>509, <5,092
>5,000
>5,000
>5,000
LD50(mg/kg)
Dermal
>5,092
>2,000
>2,000
>5,000
Formulation type unknown
The available mammalian data indicate that ethalfluralin end-
use product formulations are slightly toxic to practically nontoxic
to small mammals on an acute oral and dermal basis.
(2) Aquatic Data
(a) Freshwater Fish Toxicity
Acute toxicity - technical ethalfluralin
The minimum data required to evaluate the acute toxicity of
ethalfluralin to freshwater fish are two 96-hour LC50 freshwater fish
toxicity tests using the technical material. One test (72-la) is for
warm-water fish, preferably bluegill sunfish, and the other (72-Ic)
is for a cold-water fish, preferably rainbow trout. The acute
toxicity studies for freshwater fish are summarized below.
32
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Table 6.
Freshwater Fish Acute Toxicity Findings (Technical)
Species
Rainbow trout
Bluegill sunfish
Goldfish
%ai
100
95.46
100
95.66
100
LC50 (ppb)
37
130
32
100
260
MRID Number
070677
41613903
070677
41613902
070677a
Conclusion
very highly toxic
highly toxic
very highly toxic
highly toxic
highly toxic
Not a guideline study due to use of goldfish as the test species.
The guideline requirements for acute toxicity testing of
technical ethalfluralin with warmwater fish (72-la) and coldwater
fish (72-Ic) are fulfilled. The data indicate that technical
ethalfluralin is highly to very highly toxic to rainbow trout and
bluegill sunfish.
Acute toxicity - formulated ethalfluralin
An acute test with bluegill sunfish is required for the
formulated product, which contains an inert ingredient that may
affect toxicity.
The formulated product of ethalfluralin (36.5%) is
considered to be highly toxic to bluegill sunfish with a product LC50
of 210 ppb. The guideline requirement (72-lb) for an acute fish
toxicity test with the formulated product is fulfilled. (MRID
42176401)
Sediment study
An acute toxicity sediment study was submitted, because
ethalfluralin persists in soils and is very highly toxic to fish.
Ethalfluralin (29.9%) was mixed in soil at 1, 10, and 100 ppm; 15-
g and 50-g soil samples from each concentration were added to
separate 15-1 water chambers in which 20 bluegill sunfish (2
replicates of 10 fish each) were exposed. Fifteen grams of soil in
33
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15 liters of water was used to represent an amount that could
conceivably erode from a treated field; 50 g in 15 1 of water
provided a limit of turbidity that still permitted observations of the
test fish. The concentration of ethalfluralin in the water was
measured when fish were added to the chambers and after 96 hours.
The results of this study are summarized below.
Table 7.
Amount of ai in soil
(ppm)
1
10
100
Amount of soil
(n)
15
50
15
50
15
50
ai cone, in water (ppb)
initial (0 hrs)
<1
nr1
6
17
58
85
Final (96 hrs)
<1
<1
<1
<1
1
8.5
Mortality
1 (5%)
0
0
0
11 (55%)
20 (100%)
These data indicate that ethalfluralin released from soil
sediments can be lethal to sunfish (0-55% mortality) when
concentrations in the aqueous phase reach approximately between
17 and 58 ppb. (MRID 070677)
Chronic Toxicity - technical ethalfluralin
A fish early life stage toxicity test is required, because the
acute toxicity of ethalfluralin to daphnids is less than 1 ppm as
discussed below in part (b). The chronic fish toxicity study is
summarized below.
Table 8.
' •• • • •.• Fish Eai
•
Species
Rainbow trout
%ai
95.6
"ly Life Cyle Toxicity Findings (Technical)
Results (jig/1)
NOEL = 0.4
LOEL = 1.4
MATC1 = 0.7
MRID Number
41994901
Conclusion
See Discussion
Maximum Allowable Toxic Concentration (geometric mean)
34
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The guideline requirement (72-4a) for an early life stage
toxicity test with freshwater fish is fulfilled. The most sensitive
parameters affected in trout were larval length and weight.
(b) Freshwater Invertebrate Toxicity
Acute Toxicity - technical ethalfluralin
The minimum data requirement to establish acute toxicity to
freshwater invertebrates is a 48-hour acute study with the technical
material. Test organisms should be first instar Daphnia magna or
early instar amphipods, stoneflies, or mayflies.
Technical ethalfluralin (94%) is considered to be very highly
toxic to Daphnia magna with an EC50 of 60 ppb. The guideline
requirement for an acute toxicity study with freshwater
invertebrates (72-2) is satisfied. (MRID 070677)
Acute toxicity - formulated ethalfluralin
Acute toxicity testing with formulated ethalfluralin is
required because an end-use product contains an inert that may
affect toxicity.
The formulated product with ethalfluralin (36.5%) is
considered to be slightly toxic to Daphnia magna with a product
EC50 of 18.1 ppm. The guideline requirement (72-2b) for an acute
invertebrate toxicity study with the formulated product is fulfilled.
(MRID 42176402)
Freshwater invertebrate life cycle - technical ethalfluralin
A freshwater invertebrate life cycle toxicity test is required,
because the acute toxicity to daphnids is less than 1 ppm. The
chronic toxicity studies with an aquatic invertebrate are summarized
below:
35
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Table 9.
Freshwater Invertebrate Life Cycle Toxieity Findings
Species
Daphnia
magna
%ai
95.6
95.9
Results (ug/1)
NOEL = 67
LOEL = 162
MATC2 = 105
NOEL = 24
LOEL = 37
MATC2 = 30
MRID No.
416139071
42930101
Conclusion
See Discussion
See Discussion
reproduction was highly variable in all 5 test concentrations
Maximum Allowable Toxicant Concentration (geometric mean)
The guideline requirement (72-4b) for a life cycle toxicity
test with an aquatic invertebrate is fulfilled. Reproduction was the
most sensitive parameter affected in daphnids.
(c) Estuarine/Marine Toxicity
Acute Toxicity
Acute toxicity testing with marine/estuarine organisms is
required for ethalfluralin because of the soybean use pattern. The
acute toxicity studies for marine/estuarine organisms are
summarized below:
Table 10.
Estuarine/Marine Acute Toxicity Findings
Species
Sheeps-head
Eastern oyster
Mysid shrimp
%ai
95.46
95.46
95.93
95.46
LC50 (ppb)
240
100
170
230
MRID Number
41613904
416139051
42889801
41613906
Conclusion
Highly Toxic
Highly Toxic
Highly Toxic
shell deposition by control oysters did not meet the minimum growth standard of 2.0 mm
36
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Table 11.
The guideline requirement for acute toxicity studies with
marine/estuarine fish (72-3a), mollusks (72-3b) and shrimp (72-3c)
are satisfied. These data indicate that technical ethalfluralin is
highly toxic to sheepshead minnows, oysters, and shrimp.
(3) Non-Target Insects Data
The minimum data required to establish the acute toxicity to
Apis mellifera, honey bees, is an acute contact LD50 study with the
technical material.
Ethalflurlin (95%) is considered to be practically nontoxic
to honey bees with a LD50 of 51 ug/bee. The guideline requirement
is fulfilled. (MRID 41613914)
(4) Non-Target Plants Data
Terrestrial Plants - technical ethalfluralin
Terrestrial plant testing (seed germination, seedling
emergence and vegetative vigor) is required for herbicides which
have terrestrial nonfood/feed or aquatic nonfood (except residential)
use patterns and which have endangered or threatened plant species
associated with the site of application. In addition, these tests are
required for ethalfluralin, because the vapor pressure of the
technical-grade material exceeds 1.0 x 105mm Hg at 25°C and not
all end-use products are incorporated immediately after application.
The acceptable Tier I and II phytotoxicity studies are summarized
below.
Nontarget Terrestrial Plant Toxicity Findings
Test
Seed germination
Seedling emergence
Vegetative vigor
%ai
95.6
95.6
95.5
Results1
(Ibs ai/acre)
NOEC <1.692
EQ,S = 0.103
EQ,S = 0.314
MRID
Number
41613911
41613913
42904201
Conclusion
See Below
See Below
See Below
values are for the most sensitive of the 10 species tested (cabbage, corn, cotton, cucumber, onion, radish, sorghum,
soybean, sunflower, and wheat)
radicle length (cabbage and wheat) was the parameter affected
the parameters affected were plant height (sorghum) and plant weight (wheat)
the parameter affected was shoot dry weight (cotton)
37
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Tier I and II terrestrial plant testing is complete. The
guideline requirement (122-1) for seed germination/ seedling
emergence/vegetative vigor is satisfied.
Aquatic plants - technical ethalfluralin
Aquatic plant growth studies are required for all herbicides
for which the solubility exceeds 10 ppm. Because the solubility of
ethalfluralin in water is less than 1 ppm, these studies are not
required. However, one acceptable study has been submitted.
Ethalfluralin (95.6%) has an EC50 of 25 Jig/1. This indicates an
increasing inhibition of growth and reproduction in Selenastrum
capricornutum by increasing amounts of ethalfluralin. (MRID No.
41613912) This study is scientifically sound but is not a guideline
requirement.
b. Ecological Effects Risk Assessment
(1) Risk to Terrestrial Animals
Acute risks/spray applications
Wildlife may be exposed to ethalfluralin either by
consuming contaminated food items (e.g., seeds, fruits, insects) or
by directly ingesting granules. Contamination of vegetation is not
likely to pose a high risk within fields, because ethalfluralin is
applied before grasses and broadleaf weeds emerge. However,
some exposure might occur along field borders in some situations.
Birds also might be exposed to ethalfluralin by ingesting granules
as a source of grit.
The criterion for the determination of hazard and
presumption of unacceptable risk from exposure for acute avian and
mammalian species is a value greater than or equal to 0.5 for the
quotient of the preliminary estimated environmental concentration
(EEC) divided by the lowest LD50 value for birds and mammals—
this is known as the risk quotient (RQ).
Acute and Dietary RQ = EEC/LD50 or
EEC/LC50 > or = 0.5 for birds and mammals
38
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(a) Avian Acute Oral and Subacute Dietary Effects
Actual residue data on potential food items of birds are not
available for ethalfluralin. Based on maximum application rates,
however, estimates of expected terrestrial residues (EECs) from
spray applications can be calculated according to Hoerger and
Kenaga (1972). The residues tabulated below are the highest to be
expected from single maximum applications of 1.7 and 1.3 Ibs
ai/acre, the two highest application rates for ethalfluralin.
Table 12.
Item
Short grasses
Tall grasses
Leaves, Leafy crops
Forage and small insects
Seed pods and large insects
Seeds
Fruits
EEC (ppm)
1.7 Ibs ai/acre1
408
187
212
99
20
17
12
1.3 Ibs ai/acre2
312
143
163
75
16
13
9
1 sites: alfalfa, dry beans, cucumbers, melons, pumpkins, squash, watermelons
2 site: soybeans
Once the EECs have been estimated for the various
application rates on potential food items, acute Risk Quotient (RQ)
values can be determined as follows:
RQ = EEC/LC5
50
RQ values are then compared to the acute Levels of Concern
(LOCs):
High Risk (HR) ^0.5
Restricted Use (RU) ^0.2
Endangered Species (ES) >0.1
39
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where HR = high acute risk
RU = risk that may be mitigated by restricted use
ES = endangered species may be affected
However, all acute LOCs are assumed to be > 1 when the
LC50 values are > 5000 ppm with no treatment-related mortality at
that level.
Acute RQ values for the two highest application rates, based
on the highest residue expected (short grasses), are tabulated below
for birds.
Table 13.
Appl. rate (Ibs ai/acre)
1.71
1.32
EEC (ppm)
408
312
Risk Quotient (EEC/LC50)
0.08
0.06
Acute LOC
Risk >13
sites: alfalfa, dry beans, cucumbers, melons, pumpkins, squash, watermelons
site: soybeans
The LOC for High Risk, Restricted Use, and Endangered Species is > 1, because the LC50 values were > 5000 ppm with
no dose-related mortality.
The RQ values are far less than the acute LOC. Therefore,
no acute risks to endangered and nonendangered bird species are
presumed. RQ values based on residue levels on other potential
avian food items (seeds, insects, fruits) would be even less than
those tabulated above for short grasses. Because there is no
presumed risk at application rates of 1.7 or 1.3 Ibs ai/acre, none is
expected at the lower application rates (0.75-1.15 Ibs ai/acre).
Acute risks/granular applications
RQ values for granular applications are based on the number
of LD50s/ft2. The acute LOC values are the same as those cited for
spray applications. The LD50/ft2 is determined as follows:
LD50/ft2 = mg ai/ft2 •*• (LD50 x bird wt.)
where
mg ai/ft2 = Ibs ai/acre applied x 453,590 mg/lb •*•
43,560 fWacre
40
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For a broadcast granular application that is incorporated,
incorporation efficiency is assumed to be 85% (EPA 1992);
therefore, 15% of the granules applied are assumed to remain on
the soil surface. For the bobwhite quail, RQ values are tabulated
below for both unincorporated and incorporated applications at the
maximum application rate of 1.7 Ibs ai/acre.
Table 14.
Bobwhite quail body wt. (g)1
170
RQ (LDsns/ft2)
Uninc. appl.
< 0.052
Inc. appl.
< 0.008
LOC
Risk >12
body weight was obtained from Urban and Cook (1986)
The LOC for High Risk, Restricted Use, and Endangered Species is > 1, because the LC50 values were > 5000 ppm with
no dose-related mortality.
The RQ values tabulated above for bobwhite quail do not
exceed the acute LOC for birds. Therefore, no undue risk to avian
species is presumed from granular applications of ethalfluralin at
the present use rates.
(b) Avian Chronic Effects
Based on expected residue levels and results of avian
reproductive testing, chronic risks to birds would not be expected.
Ethalfluralin is applied only once per season. The maximum
expected residue (408 ppm on short grasses) from a single
application is well below the reproductive-effects NOEL of > 1000
ppm dietary intake. The RQ for chronic exposure is calculated as
EEC/NOEL; if the RQ > 1, the chronic LOC, a chronic risk is
presumed. For ethalfluralin, 408/1000 = 0.4; therefore, no
chronic risk is presumed based on avian reproduction.
(c) Mammalian Acute Oral and Subacute Dietary Effects
Oral and dermal LD50 values for ethalfluralin end use
product formulations were obtained from data submitted to the
Agency and were tabulated above (Table 5) for the laboratory rat.
These values (> 509 to < 5092 mg/kg for oral LD50s and > 2000
to > 5092 mg/kg for dermal LD50s) classify formulated ethalfluralin
as slightly toxic to practically nontoxic to laboratory rats on an
acute oral and dermal basis. Based on these toxicity data, low
application rates and resulting residues on vegetation and insects,
lack of food and cover in fields at treatment time (i.e., prior to
41
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Table 15.
emergence of any vegetation), and incorporation of granules,
minimal risk to mammals is anticipated from the present uses of
ethalfluralin.
(2) Risk to Aquatic Animals
Ground applications of ethalfluralin could result in a
potential risk to aquatic organisms from runoff and drift of active
ingredient. Aquatic residues in ponded waters were estimated from
the Agency's Tier I program. This program calculates
instantaneous loading in a 6-ft. deep, 1-acre pond within a 10-acre
drainage basin and estimates average residue levels after 4,21, and
56 days. Residues are based on application rate, environmental fate
data (solubility, KOC value, aerobic soil metabolism, hydrolysis,
photolysis) and depth of pesticide incorporation. The table below
provides predicted aquatic residues for applications at the maximum
rate of 1.7 Ibs ai/acre.
Type of appl.
unincorporated spray1
incorporatedspray2
incorporated granules3
Predicted aquatic residues (ppb)
Instantaneous
7.37
1.96
1.82
4 -day avg.
3.78
1.03
0.93
21-dayavg.
0.80
0.22
0.20
56-day avg.
0.30
0.08
0.07
sites: cucumbers, melons, pumpkins, squash, watermelons
sites: alfalfa, dry beans
site: dry beans
42
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LOCs and RQ values for aquatic organisms are tabulated
below for incorporated and unincorporated applications of
ethalfluralin.
Table 16.
Aquatic organism
Freshwater fish
Daphnia magna
Marine/estuarine fish
Marine/estuarine invertebrates
RQ (EEC/LCSO or EC J
Inc. granules
0.06
0.03
<0.01
0.02
Inc. spray
0.06
0.03
0.01
0.02
Uninc. spray
0.23
0.12
0.03
0.07
Acute
LOC
HR >0.5
RU >0.1
ES >0.05
Table 17.
Based on these RQ values, high acute risk to aquatic
organisms is not anticipated. However, the restricted use trigger
has been exceeded for freshwater organisms from an unincorporated
application at the present label rate of 1.7 Ibs. a.i./acre.
Endangered species triggers have been exceeded for freshwater
organisms and estuarine/marine invertebrates.
Chronic risks to aquatic organisms are assessed by
comparing 21-day and 56-day average aquatic residues to MATC
values for daphnids (30 ppb) and fish (0.7 ppb), respectively. The
chronic LOC for aquatic organisms is > 1. RQ values for spray
and granular applications at the maximum rate of 1.7 Ibs ai/acre are
tabulated below. Based on these values, no chronic risks are
presumed.
Species
Rainbow trout
Daphnia magna
RQ (EECVMATC)
Inc. granules
0.1
<0.1
Inc. spray
0.1
<0.1
Uninc. spray
0.4
<0.1
Chronic
LOC
^1
the EEC for fish is based on the 56-day average residue level, whereas for daphnids the 21-day average is assumed.
43
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(3) Risk to Terrestrial, Semi-Aquatic and Aquatic Plants
(a) Nontarget Terrestrial and Semi-Aquatic Plant Effects
Risk to terrestrial plants is assessed by comparing
phytoxicity LOCs to runoff of ethalfluralin expected from
maximum applications. Risk is assessed to plants inhabiting areas
adjacent to treated sites and to plants growing in wetter areas (i.e.,
semi-aquatic terrestrial species) farther away where channelized
runoff waters may collect. A level of concern exists for both
endangered and nonendangered terrestrial plants if runoff exceeds
the nontarget-plant EC25 values for seed germination and seedling
emergence test results.
At maximum ground-application rates of 1.7 Ibs ai/acre and
anticipated 1% runoff of active ingredient, runoff onto areas
adjacent to treated sites is expected to be about 0.02 and 0.003 Ibs
ai/acre for unincorporated and incorporated applications,
respectively (see table below). The RQs are less than 1 for both
methods of application, indicating minimal risk to nontarget plants
inhabiting dry areas adjacent to treated fields. RQs from
application rates of 1.3, 1.1, and 0.75 Ibs ai/acre would be even
less than those tabulated.
Table 18.
Type of appl.
Unincorporated3
Incorporated4
Appl. rate1
1.7
1.7
EEC1 near site
0.02
0.003
RQ2
0.2
0.03
EEC1 away from site
0.17
0.034
RQ2
1.7
0.34
Ibs ai/acre
Risk Quotient (RQ) = EEC/EC25, where the EC25 = 0.1 Ibs ai/acre [seedling emergence (sorghum, wheat)]
sites: cucumbers, melons, pumpkins, squash, watermelons
sites: alfalfa, dry beans
Runoff onto wet areas (i.e., moist, saturated, or flooded
soils) away from treated sites is expected to be about 0.17 Ibs
ai/acre for an unincorporated application. The resulting RQ of 1.7
indicates some risk to semi-aquatic terrestrial plants in the vicinity
of treated fields (cucumbers, melons, pumpkins, squash, and
watermelons). No risk to such plants is anticipated from
incorporated applications.
44
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(b) Nontarget Aquatic Plant Effects
The EC50 value for Selanastrum capricornutum is 20 ppb.
Expected aquatic residues (1.82-7.37ppb) for a 6-ft. deep pond do
not exceed this LOG; therefore, high risk is not expected.
(4) Risk to Endangered Species
For endangered avian and mammalian species the risk
quotient is a value greater than or equal to 0.1. For endangered
aquatic vertebrate and invertebrate species, the risk quotient is 0.05.
RQ = EEC/LC50 > or = 0.1 for endangered birds and mammals,
the
RQ = EEC/LC50 > or = 0.05 for endangered aquatic animals
and the
RQ = EEC/EC25 and the EEC/EC50 > or = 1 for terrestrial, semi-aquatic
and aquatic plants.
Endangered species acute LOCs have been exceeded for
freshwater organisms and estuarine/marine invertebrates from
unincorporated applications, for freshwater fish from incorporated
applications, and for plants growing in wet areas receiving
channelized runoff from treated sites (unincorporated treatments
only).
IV. Risk Management and Reregistration Decision
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing ethalfluralin active ingredients. The Agency
has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing ethalfluralin except those
labeled for postemergence and posttransplant applications to cucurbits. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of ethalfluralin, and lists the submitted studies
that the Agency found acceptable.
45
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The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of ethalfluralin and to determine that ethalfluralin, as stipulated in this
document, can be used without resulting in unreasonable adverse effects to humans and
the environment. The Agency therefore finds that all products containing ethalfluralin
except for those labeled for postemergence and posttransplant applications to cucurbits as
the active ingredient are eligible for reregistration. The reregistration of particular
products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that all uses of ethalfluralin, except those
noted above, are eligible for reregistration, it should be understood that the Agency may
take appropriate regulatory action, and/or require the submission of additional data to
support the registration of products containing ethalfluralin, if new information comes to
the Agency's attention or if the data requirements for registration (or the guidelines for
generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
ethalfluralin, the Agency has sufficient information on the health effects of
ethalfluralin and on its potential for causing adverse effects in fish and wildlife and
the environment. Therefore, the Agency concludes that products containing
ethalfluralin for all uses with the exception of the postemergence and posttransplant
uses on cucurbits are eligible for reregistration. The Agency has determined that
ethalfluralin products, labeled and used as specified in this Reregistration
Eligibility Decision document, will not pose unreasonable risks or adverse effects
to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of ethalfluralin except those
labeled for postemergence and posttransplant applications to cucurbits are eligible
for reregistration. The studies supporting these uses are currently being reviewed
by the Agency. Upon review and acceptance of these data, the Agency will
consider the uses eligible and will proceed with reregistration of products labeled
for these uses.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
ethalfluralin. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
46
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1. Tolerance Reassessment
Tolerances Listed Under 40 CFR §180.416:
The qualitative nature of the residue in beans and peanuts is tentatively
understood pending submission of additional confirmatory data. The tentative
terminal residue of concern in plants is ethalfluralin per se', the current tolerance
expression for plants is adequate. However, before plant metabolism may be
considered fully understood, an acceptable confirmatory cucurbit metabolism study
must be submitted.
The tolerances listed in 40 CFR §180.416 are for residues of ethalfluralin
per se. All tolerances are established at 0.05 ppm. Adequate enforcement
methods are available for the determination of ethalfluralin residues in/on plant and
animal commodities. Adequate field residue studies are available to ascertain the
adequacy of the established tolerances listed in 40 CFR §180.416 for beans (dry),
peanuts, peas (dry), soybean, and sunflower seed. Additional confirmatory data
are required for the postplant-preemergence application use on cucurbits
(cucumbers, melons, and squash) before the adequacy of the established tolerance
for cucurbit vegetables group may be reassessed. New data are also required for
the postemergence and posttransplant application to cucurbits. These data are not
considered confirmatory since the Agency lacks data which would allow an interim
assessment of the residues.
Adequate processing studies have been conducted on peanuts, soybean, and
sunflower seed. No food or feed additive tolerances are established or required.
The qualitative nature of the residue in animals is adequately understood
based on acceptable poultry and ruminant metabolism studies. The residue of
concern in milk, eggs, and animal tissues is ethalfluralin per se. As a result of the
exaggerated feeding levels (200x), the requirements for animal feeding studies
were waived. It was also concluded that residues of ethalfluralin from up to lOx
dietary burden would not be quantifiable (< 0.05 ppm). Therefore, the existing
tolerances for eggs, milk, and fat, meat, and meat byproducts of cattle, goats,
hogs, horses, poultry, and sheep should be revoked. A summary of ethalfluralin
tolerance reassessments is presented in Table 19.
Anticipated Residues
Anticipated residues in the various raw agricultural commodities are given
in Table 20. The calculations are based on the tolerance reassessments of Table
19 and percent crop treated data from the Agency.
47
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Table 19. Tolerance Reassessment Summary for Ethalfluralin
Commodity
Current
Tolerance
(ppm)
Tolerance Reassessment (ppm)
Comment/ Correct Commodity
Definition
Tolerances listed under 40 CFR §180.416
Beans, dry
Cattle, fat
Cattle, meat
Cattle, mbyp
Cucurbits vegetable group
Eggs
Goats, fat
Goats, meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Milk
Peanuts
Peanuts hulls
Peas, dry
Poultry, fat
Poultry, meat
Poultry, mbyp
Sheep, fat
Sheep, meat
Sheep, mbyp
Soy beans
Sunflower seed
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
Revoke
Revoke
Revoke
Additional residue data required
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
0.05
0.05
0.05
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
0.05
0.05
--
Not needed
Not needed
Not needed
Cucurbit vegetables group
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
__
Peanuts, hulls
--
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Soybean
-
48
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Table 20: Anticipated Residues of Ethalflui alin in Plant and Animal Commodities
Commodity1
Beans, dry
Cattle, fat
Cattle, meat
Cattle, mbyp
Cucurbit vegetable group
Eggs
Goats, fat
Goats, meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Milk
Peanuts
Peanut Hulls
Peas, dry
Poultry, fat
Poultry, meat
Poultry, mbyp
Sheep, fat
Sheep, meat
Sheep, mbyp
Soy beans
Sunflower seed
Reassesed
Tolerance
(ppm)
0.05
N/A
N/A
N/A
0.052
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
0.05
0.05
0.05
N/A
N/A
N/A
N/A
N/A
N/A
0.05
0.05
Field Trial
Results
(ppm)
< 0.01
-
-
-
< 0.013
-
-
-
-
-
-
-
-
-
-
-
< 0.01
< 0.01
< 0.01
-
-
-
-
-
-
< 0.01
< 0.01
Crop Treated (%
Maximum)
50
-
-
-
1004
-
-
-
-
-
-
-
-
-
-
-
40
40
5
-
-
-
-
-
-
5
30
Anticipated Residue5 (ppm)
0.01
0
0
0
0.055
0
0
0
0
0
0
0
0
0
0
0
0.008
0.008
0.001
0
0
0
0
0
0
0.001
0.006
No data to reevaluate tolerance. Existing tolerance is 0.05 ppm.
Based on 1982 field trial data NOT submitted for re registration purposes.
Cantaloupes, 10%; cucumbers, 35%; honeydew, 10%; watermelon, 10%; pumpkin and squash, unkr
Anticipated Residue = (2 X Field Trial Concentration) X (% Crop Treated), except cucurbits. For CL
the limit of detection (not the limit of quantitation), and 2 X 0.01 ppm was used to compensate for
quantitation of ^_ 0.05 ppm has been demonstrated for numerous commodities. The more conservati
trance = 0.05 ppm. The field trial concentration for all crops w
ment response and the resulting uncertainty in the limit of dete(
used for cucurbits because field trial data are required.
49
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CODEX HARMONIZATION
There are no Codex MRLs established or proposed for residues of
ethalfluralin. Therefore, there are no questions with respect to compatibility of
U.S. tolerances with Codex MRLs.
2. Risk Mitigation Measures
Dietary and Occupational\Residential
Ethalfluralin is considered a possible (Group C - quantifiable) carcinogen
and a developmental toxicant by the Agency based on the toxicology data discussed
above. The Agency has considered dietary and occupational risks for these two
endpoints. Dietary risks for carcinogenicity and developmental toxicity are
considered negligible, especially if existing residue contributions from meat, milk,
poultry, and eggs are excluded. Ethalfluralin tolerances for these commodities will
be revoked for reasons explained earlier.
Likewise, the occupational risks of these two toxicological endpoints are
low. The Agency believes risk of developmental toxicity to workers is negligible
due to the low dermal absorption of this chemical. For carcinogenicity the
estimated upper bound risks to these workers are as high as 1 x 10 5 for mixers and
loaders of liquid/dry flowable formulations applied with ground equipment. Other
worker scenarios have lower, negligible risks, equal to or less than 1 x 106. These
risk estimates assume workers wear coveralls over short pants and short shirt
sleeves (single layer protection) and chemical resistant gloves. Therefore, the
Agency is requiring at a minimum the use of coveralls and chemical resistant
gloves by workers. To further reduce worker risks as much as practical towards
negligible levels, the Agency is requiring mixers and loaders to wear coveralls
over long pants and long-sleeved shirts (double layer protection), chemical resistant
gloves and a chemical resistant apron to protect against spills or splashing. Double
layer protection should not result in heat stress to workers during mixing and
loading operations as may be the case during applications which require longer
periods of time to complete. Additionally, double layer protection is not warranted
for applicators of ethalfluralin because the Agency estimates these workers' upper
bound carcinogenic risk estimates are already negligible (10 6 or less) with single
layer protection. Additional exposure reduction measures, such as employing
closed mixing/loading systems or enclosed cabs would not be cost effective and are
not being required. These requirements and other worker protective measures,
including reentry into treated areas are discussed below and in Section V.
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Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators)
For each end-use product, PPE requirements for pesticide handlers will be
set during reregistration in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, the PPE for pesticide handlers will be established based on the
acute toxicity of the end-use product. For occupational-use products, PPE will
be established using the process described in PR Notice 93-7 or more recent EPA
guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects:
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most occupational end-
use products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that would
be designated on the basis of the acute toxicity of each end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the end-use
product.
There are special toxicological concerns (i.e., classification of ethalfluralin
as a Group C carcinogen) about ethalfluralin that warrant the establishment of
active-ingredient-based PPE requirements, as discussed above.
Handler PPE for Occupational-Use Products
WPS Uses: At this time all of the registered uses of ethalfluralin appear to be
within the scope of the Worker Protection Standard for Agricultural Pesticides
(WPS). The minimum (baseline) PPE for all end-use products containing
ethalfluralin is coveralls and chemical-resistant gloves for all handlers. The PPE
required for mixers and loaders is coveralls over long pants, and long sleeved
shirt, chemical resistant-gloves and chemical-resistant apron. Use of this PPE will
reduce potential dermal exposure and risks of carcinogenicity as discussed above
in the risk assessment, Section III.
51
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NonWPS Occupational Uses: At this time all of the registered uses of
ethalfluralin appear to be within the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS).
Handler PPE for Home-Use Products
At this time there appear to be no products containing ethalfluralin that are
intended primarily for home use.
Entry Restrictions
Entry Restrictions for Occupational-Use Products
Restricted Entry Interval: Under the Worker Protection Standard (WPS),
interim restricted entry intervals (REI) for all uses within the scope of the WPS are
established based on the acute toxicity of the active ingredient. The toxicity
categories of the active ingredient for acute dermal toxicity, eye irritation potential,
and skin irritation potential are used to determine the interim WPS REI. If one or
more of the three acute toxicity effects are in toxicity category I, the interim WPS
REI is established at 48 hours. If none of the acute toxicity effects are in category
I, but one or more of the three is classified as category II, the interim WPS REI
is established at 24 hours. If none of the three acute toxicity effects are in category
I or II, the interim WPS REI is established at 12 hours. A 48-hour REI is
increased to 72 hours when an organophosphate pesticide is applied outdoors in
arid areas. In addition, the WPS specifically retains two types of REI's established
by the Agency prior to the promulgation of the WPS: product-specific REI's
established on the basis of adequate data and interim REI's that are longer than
those that would be established under the WPS.
For occupational end-use products containing ethalfluralin as an active
ingredient, the Agency is establishing a 24-hour restricted-entry interval pertaining
to each use of the product that is within the scope of the Worker Protection
Standard for Agricultural Pesticides (WPS). This recommendation is based on
ethalfluralin being categorized as toxicity category II (moderate) for skin irritation
potential and classified as a Group C carcinogen. The Agency has found no
extenuating circumstance for retaining the 12-hour interim restricted-entry interval
placed on ethalfluralin products by PR Notice 93-7. It is noted that the 12-hour
interim WPS restricted-entry interval was established because early data indicated
that ethalfluralin was in toxicity category III for skin irritation potential.
The Agency notes that the WPS established very specific restrictions on
entry during restricted-entry intervals that involves contact with treated surfaces
and believes that these existing WPS protections are sufficient to mitigate post-
application exposures of workers who contact ethalfluralin-treated soil. The
52
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Agency also notes that if ethalfluralin has been correctly incorporated, workers
may enter the treated area during the restricted-entry interval without personal
protective equipment or any other restriction if they are performing tasks that do
not involve contact with the soil subsurface.
Early Entry PPE — Personal protective equipment requirements for persons who
must enter areas that remain under a restricted-entry interval are based on the
toxicity concerns about the active ingredient. The requirements are set in one of
two ways.
1. If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, it establishes the early-entry PPE requirements based on the
acute dermal toxicity, skin irritation potential, and eye irritation potential of the
active ingredient.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects, it may establish early-entry PPE
requirements that are more stringent than would be established otherwise.
Since ethalfluralin is classified as toxicity category II for skin irritation
potential and eye irritation potential and is categorized as a Group C carcinogen,
the PPE required for early entry is coveralls over short-sleeved shirt and short
pants, chemical-resistant gloves, chemical-resistant footwear plus socks and
protective eyewear.
Non-target Aquatic Organisms and Plants
The Agency concludes that certain uses of ethalfluralin at the maximum
application rate (1.7 Ibs. a.i./A) may result in risk of acute toxicity to freshwater
fish and invertebrates, non-target plants, and marine/estuarine invertebrates based
on the risk assessment described above in Section C.2(b). This assessment
suggests unincorporated spray applications to cucurbit and alfalfa fields may result
in aquatic residue levels that equal or slightly exceed the Agency's Restricted Use
Level of Concern (LOG) for freshwater fish and invertebrates. Also,
unincorporated applications of ethalfluralin to cucurbit fields may result in some
risks to semi-aquatic non-target plants inhabiting wet areas in the vicinity of these
fields.
This assessment also suggests that incorporated granular and spray
applications to dry bean and sunflower fields may result in aquatic residues that
slightly exceed the Agency's LOG for endangered freshwater fish species. Also
53
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unincorporated spray applications may exceed this LOG for endangered species of
freshwater fish and invertebrates and marine/estuarine invertebrates.
The following mitigation measures would likely reduce risks to
nonendangered and endangered aquatic animal and plant species.
Alfalfa: Ethalfluralin's use on alfalfa is currently limited under Special
Local Needs (FIFRA, Section 24 (c)) registrations for the states of Oregon
and Washington. Alfalfa grown in these states is irrigated by flood or
furrow irrigation practices due to low rainfall. To reduce contamination
of aquatic areas with ethalfluralin residues from treated alfalfa fields and
therefore to reduce risks to aquatic organisms, the following risk reduction
measure is required. Ethalfluralin products labeled for use on alfalfa must
include the following statement:
"For flood or furrow irrigation, do not allow the tail waters from the first
irrigation after application to enter aquatic habitats."
Dry Beans and Sunflowers: Risks of concern from ethalfluralin use on
dry beans and sunflowers are limited to endangered freshwater fish species.
Risk mitigation measures for these uses will be effected under the Agency's
Endangered Species Program discussed below.
Cucurbits: Based on the potential risks as described above from the use
of ethalfluralin on cucurbit fields all ethalfluralin products labeled for use
on cucurbits must include the following statement:
"Due to risk to plants and animals in aquatic habitats that receive run-off
containing this product, use of controls such as a vegetative buffer strip to
filter such water flow from recently treated fields is recommended."
For cucurbits, employment of a vegetative filter strip may reduce
the risk to aquatic fish, invertebrates, and plant species. However, at this
time the Agency is not imposing specific risk mitigation requirements.
Instead, the Agency is requiring that the above statement be placed on the
product labeling that alerts users to the risks and recommends controls on
runoff into aquatic habitats such as vegetative strips. In addition, the
Agency is working with the Natural Resources Conservation Service to
develop detailed guidance on vegetative filters, such as the design and
construction of different kinds of vegetative filters and an education
program for registrants and farmers. This guidance may be available in
1995. More specific requirements for the use of a vegetative filter strip
may be imposed in the future.
54
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3. Endangered Species Protection
The Agency has concerns about the exposure of threatened and endangered
plant and animal species to ethalfluralin as discussed above in the science
assessment chapter.
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks
to newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in the near future and have enforceable county-
specific bulletins available. Because the Agency is taking this approach for
protecting endangered and threatened species, it is not imposing label modifications
at this time through the RED. Rather, any requirements for product use
modifications will occur in the future under the Endangered Species Protection
Program.
Limitations in the use of ethalfluralin will be required to protect endangered
and threatened species, but these limitations have not been defined and may be
formulation specific. EPA anticipates that a consultation with the Fish and Wildlife
Service will be conducted in accordance with the species-based priority approach
described in the Program. After completion of consultation, registrants will be
informed if any required label modifications are necessary. Such modifications
would most likely consist of the generic label statement referring pesticide users
to use limitations contained in county Bulletins.
4. Labeling Rationale
In order to remain in compliance with FIFRA, it is the Agency's position
that the labeling of all registered pesticide products containing ethalfluralin must
comply with the Agency's current pesticide labeling requirements.
55
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V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of ethalfluralin for the
above eligible uses has been reviewed and determined to be substantially complete,
except for residue chemistry data to support cucurbits. Additional data are needed
to fulfill requirements for the studies listed below.
Additional confirmatory data are required to upgrade the following product
chemistry guidelines: 61-1; 62-1; 62-2; and 62-3;
Additional residue data for cucurbits are required to upgrade the following residue
chemistry guidelines: 171-4(a); 171-4(k). Confirmatory field trial data are required
for cucurbits (postplant-preemergence), and a third metabolism study is required
(cucurbits). These residue data are outstanding as well as new data to support the
postemergence and posttransplant applications on cucurbits. This residue data is
currently being reviewed by the Agency. The Agency anticipates reviewing these
data in time to allow reregistration of all end-use products labeled for use on
cucurbits.
Field trial data are required for residues of ethalfluralin in/on alfalfa hay and
forage, pea and bean hay and forage, soybean hay and forage, and peanut hay.
These data are considered confirmatory;
The Agency has concluded that residues of ethalfluralin from up to lOx dietary
burden in food-producing animals would not be quantifiable (< 0.05 ppm). This
is considered a Category 3 use (40 CFR §180.6), which states that it is not possible
to establish with certainity whether finite residues will be incurred, but there is no
reasonable expectation of finite residues. Therefore, the existing tolerances
(expressed in terms of ethalfluralin per se) for eggs, milk, and fat, meat, and meat
byproducts of cattle, goats, hogs, horses, poultry, and sheep should be revoked.
Data pertaining to the nitrosamine content are outstanding; nitrosamine analysis is
required since ethalfluralin contains a tertiary alkylamine
56
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2. Labeling Requirements for Manufacturing-Use Products
The following label statement is required on all manufacturing-use
products:
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems
must bear the following revised effluent discharge labeling statement.
"This product is toxic to fish and aquatic invertebrates. 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 Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent containing
this product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
57
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2. Labeling Requirements for End-Use Products
Worker Protection Standard
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with
the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by the primary registrant or
any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person.
Other Labeling Requirements
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other applicable
notices.
The Agency is requiring the following labeling statements to be located on
all end-use products containing ethalfluralin that are intended primarily for
occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through spray drift. Only protected handlers
may be in the area during application"
58
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Engineering Controls:
"When handlers use closed systems, enclosed cabs, or aircraft in a manner
that meets the requirements listed in the Worker Protection Standard (WPS)
for agricultural pesticides, 40 CFR 170.240 (d) (4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions exist for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing 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."
In addition, because ethalfluralin is classified as a skin sensitizer, the
Agency requires that the following statement appear on all ethalfluralin labels in
the "Hazards to Humans (and Domestic Animals) section of the Precautionary
Statements:
"This product may cause skin sensitization reactions in certain individuals."
The minimum (baseline) PPE for all end-use products containing
ethalfluralin is: coveralls and chemical-resistant gloves for all handlers.
The PPE required for mixers and loaders is coveralls over long pants, and
long-sleeved shirt, chemical-resistant gloves, and chemical-resistant apron.
The PPE required for early entry is coveralls over short-sleeved shirt and
short pants, chemical-resistant gloves, chemical-resistant footwear plus socks and
protective eyewear.
For occupational end-use products containing ethalfluralin as an active
ingredient, the Agency is establishing a 24-hour restricted-entry interval pertaining
59
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to each use of the product that is within the scope of the Worker Protection
Standard for Agricultural Pesticides (WPS).
Registrants may add the following statement to their labeling in the
Agricultural Use Requirements box immediately following the restricted entry
interval:
"Exception: if the product is soil-injected or soil-incorporated, the Worker
Protection Standard, under certain circumstances, allows workers to enter
the treated area if there will be no contact with anything that has been
treated."
Grazing, foraging, and haying restrictions must be removed from the
labels, except sunflower forage.
Environmental hazard requires the following labeling statement:
"This product is toxic to fish and aquatic invertebrates. Do not apply
directly to any body of water or to areas where surface water is present or
to intertidal areas below the mean high water mark. Do not contaminate
water when disposing of equipment washwaters or rinsate."
For application to alfalfa the following statement is required:
"For flood or furrow irrigation, do not allow the tail waters from the first
irrigation after application to enter aquatic habitats."
For application to cucurbit fields the following statement is required:
"Due to risk to plants and animals in aquatic habitats that receive run-off
containing this product, use of controls such as a vegetative buffer strip to
filter such water flow from recently treated fields is recommended."
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for effluent
discharge.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
60
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50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell ethalfluralin
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to your products.
61
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VI. APPENDICES
63
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APPENDIX A. Table of Use Patterns Subject to Reregistration
65
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Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
444444444444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
>.1 ) Page 1
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
ALFALFA
Soil incorporated treatment., EC
Postemergence., Low pressure ground sprayer.
BEANS, DRIED-TYPE
Soil incorporated treatment., Fall.,
Spreader.
Soil incorporated treatment., Preplant., Low DF
pressure ground sprayer.
Soil incorporated treatment., Preplant.,
Spreader.
NA
NA
Use Group: TERRESTRIAL FEED CROP
1.688 Ib A * NS NS NS NS NS
1.6
Ib A * NS
Ib A * NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1.7
1.5
1.3
1.65
1.5
1.3
1.688
1.5
1.313
1.688
1.5
1.313
1.7
1.5
1.3
1.7
1.5
1.3
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
F NS
M
C
F NS
M
C
F NS
M
C
F NS
M
C
F NS
M
C
F NS
M
C
NS
NS
NS OR
NS WA
NS WY
C14,
C14,
GM2, GDI
GF9
C94, CAD, GC9
C46, C94, CAD, GC9
C46, C92, C94, GC9
C46, C92, C94, GC9
C94, CAD, GC9
C94, CAD, GC9
Soil broadcast treatment., Postplant., Low
pressure ground sprayer.
1.688
1.5
1.125
Use Group: TERRESTRIAL FOOD CROP
Ib A F NS NS NS
Ib A M
Ib A C
C46, C94, CAD, GC9
Soil broadcast treatment., Postplant., Low
pressure ground sprayer.
1.688
1.5
1.125
Use Group: TERRESTRIAL FOOD CROP
Ib A F NS NS NS
Ib A M
Ib A C
C46, C94, CAD, GC9
-------
Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
444444444444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
>. 1 ) Page
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS, WATER
Soil broadcast treatment., Postplant., Low EC NA
pressure ground sprayer.
1.688
1.5
1.125
Use Group: TERRESTRIAL FOOD CROP
Ib A F NS NS NS NS
Ib A M
Ib A C
C46, C94, CAD, GC9
Soil incorporated treatment., Preplant., Low DF NA
pressure ground sprayer.
1.1
.95
.75
Use Group: TERRESTRIAL FOOD+FEED CROP
Ib A F NS NS NS NS
Ib A M
Ib A C
C46, C94, CAD, GC9
Soil incorporated treatment., Preplant., EC
Spreader.
1.125
.938
.75
1.125
.938
.75
Ib A F
Ib A M
Ib A C
Ib A F
Ib A M
Ib A C
NS NS
NS NS
C46, C92, C94, GC9
C46, C92, C94, GC9
PEANUTS (UNSPECIFIED)
Soil incorporated treatment., Preplant., Low EC
pressure ground sprayer.
Soil incorporated treatment., Preplant., EC
Spreader.
1.125
.938
.75
1.125
.938
.75
Use Group: TERRESTRIAL FOOD+FEED CROP
Ib A F NS NS NS NS
Ib A M
Ib A C
Ib A F
Ib A M
Ib A C
NS NS
C46, C92, C94, GC9
C46, C92, C94, GC9
1.15
.95
.75
Ib A F
Ib A M
Ib A C
NS NS
C94, CAD, GC9
PEAS, DRIED-TYPE
Soil incorporated treatment., Preplant., Low DF NA
pressure ground sprayer.
Soil incorporated treatment., Preplant.,
Spreader.
.75
.75
Use Group: TERRESTRIAL FOOD+FEED CROP
NS NS NS NS
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
NS NS
NS NS
NS NS
NS NS
MT, CA
C46, C94, CAD, GC9
C46, C92, C94, GC9
C46, C92, C94, GC9
C94, CAD, GC9
-------
Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
444444444444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
J.I ) Page 3
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PUMPKIN
Soil broadcast treatment., Postplant.,
Ground.
1.688
1.5
1.125
Use Group: TERRESTRIAL FOOD CROP
Ib A F NS NS NS
Ib A M
Ib A C
1.688
1.5
1.125
Ib A F
Ib A M
Ib A C
1.688
1.5
1.125
Ib A F
Ib A M
Ib A C
SOYBEANS (UNSPECIFIED)
Soil incorporated treatment., Preplant., Low DF NA
pressure ground sprayer.
1.3
1.1
.75
Use Group: TERRESTRIAL FOOD+FEED CROP
Ib A F NS NS NS NS
Ib A M
Ib A C
C46, C94, CAD, GC9
Soil incorporated treatment., Preplant.
Spreader.
1.313
1.125
.75
1.313
1.125
.75
Ib A F
Ib A M
Ib A C
Ib A F
Ib A M
Ib A C
C46, C92, C94, GC9
C46, C92, C94, GC9
SQUASH (SUMMER)
Soil broadcast treatment., Postplant.,
Ground.
1.3
1.15
.75
1.688
1.5
1.125
Ib A F NS NS NS
Ib A M
Ib A C
Use Group: TERRESTRIAL FOOD CROP
Ib A F NS NS NS
Ib A M
Ib A C
C94, CAD, GC9
1.688
1.5
1.125
Ib A
Ib A
Ib A
1.688
1.5
1.125
Ib A
Ib A
Ib A
-------
Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
444444444444444444444444444444
SITE Application Type, Application
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
J.I ) Page 4
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SQUASH (SUMMER) (con't)
Use Group: TERRESTRIAL FOOD CROP (con't)
SQUASH (WINTER)
Soil broadcast treatment., Postplant.,
Ground.
SUNFLOWER
Soil incorporated treatment., Fall.,
Spreader.
Soil incorporated treatment., Preplant., Low DF NA
pressure ground sprayer.
1
1
1
1
.688
1.5
.125
.688
1.5
.125
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
F
M
C
F
M
C
Use Group
1
1
1
1
1
1
1
1
1
1
.688
1.5
.125
.688
1.5
.125
.688
1.5
.125
.688
1.5
.125
.688
1.5
.125
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
F
M
C
F
M
C
F
M
C
F
M
C
F
M
C
Use Group
1
1.7
1.5
1.3
1.1
.95
.75
.125
.938
.75
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
F
M
C
F
M
C
F
M
C
NS NS NS NS
NS NS NS NS
: TERRESTRIAL FOOD CROP
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
: TERRESTRIAL FOOD+FEED CROP
NS NS NS NS
NS NS NS NS
NS NS NS NS
C94, CAD, GC9
C46, C94, CAD, GC9
C46, C92, C94, GC9
-------
Report Run Date: 04/18/95 )
PRD Report Date: 03/10/94
Time 13:57
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
>.1 ) Page 5
SITE Application Type, Application Forir
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr.
Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SUNFLOWER (con't)
Soil incorporated treatment., Preplant.,
Spreader.
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
1.125 Ib A
.938 Ib A
.75 Ib A
F NS
M
C
C46, C92, C94, GC9
1.15 Ib A
.95 Ib A
.75 Ib A
F NS
C94, CAD, GC9
1.7 Ib A
1.5 Ib A
1.3 Ib A
F NS
M
C
C94, CAD, GC9
End Of USES ELIGIBLE FOR REREGISTRATION
-------
Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES INELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CUCUMBER
Band treatment.,
pressure ground
Band treatment.,
pressure ground
Postemergence., Low
sprayer.
Posttransplant., Low
sprayer.
Band treatment.,
pressure ground
Band treatment.,
pressure ground
MELONS, WATER
Band treatment.,
pressure ground
Band treatment.,
pressure ground
PUMPKIN
Band treatment.,
Postemergence., Low
sprayer.
Posttransplant., Low
sprayer.
Postemergence., Low
sprayer.
Posttransplant., Low
sprayer.
Postemergence., Ground.
Band treatment., Posttransplant., Ground.
SQUASH (SUMMER)
Band treatment., Postemergence., Ground.
Use Group: TERRESTRIAL FOOD CROP USES INELIGIBLE FOR REREGISTRATION
UC * NS NS NS NS NS NS NJ
UC
NS NS
NS
NS NS
NS
NJ
Use Group: TERRESTRIAL FOOD CROP USES INELIGIBLE FOR REREGISTRATION
UC * NS NS NS NS NS NS NJ
UC
NS NS
NS
NS NS
NS
NJ
Use Group: TERRESTRIAL FOOD CROP USES INELIGIBLE FOR REREGISTRATION
UC * NS NS NS NS NS NS NJ
UC
NS
NS
NS
NS NS
NS
NJ
Use Group: TERRESTRIAL FOOD CROP USES INELIGIBLE FOR REREGISTRATION
C46, C94, CAD, GC9
C46, C94, CAD, GC9
C46, C94, CAD, GC9
C46, C94, CAD, GC9
C46, C94, CAD, GC9
C46, C94, CAD, GC9
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
USES
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
INELIGIBLE
NS
NS
NS
NS
NS
NS
NS
NS
IL
KY
OH
IL
KY
OH
FOR REREGISTRATION
IL
KY
OH
OR
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
Report Run Date: 04/18/95 ) Time 13:57
PRD Report Date: 03/10/94
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
LUIS 2.1 ) Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES INELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SQUASH (SUMMER) (con't)
Band treatment., Posttransplant., Ground.
SQUASH (WINTER)
Band treatment., Postemergence., Ground.
Band treatment., Posttransplant., Ground.
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
POOD CROP
NS
NS
NS
NS
NS
NS
POOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
USES
NS
NS
NS
NS
NS
NS
USES
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
INELIGIBLE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
INELIGIBLE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOR REREGISTRATION (con't)
WA
IL
KY
OH
OR
WA
FOR REREGISTRATION
IL
KY
OH
OR
WA
IL
KY
OH
OR
WA
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
Report Run Date: 04/18/95 )
PRD Report Date: 03/10/94
Time 13:57
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
J.I ) Page
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Soil Tex. Max. Dose
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days
Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
Non-specific
C Coarse
M Medium
F Fine
O Others
FORMULATION CODES
DF WATER DISPERSIBLE GRANULES (DRY FLOWABLE)
EC EMULSIFIABLE CONCENTRATE
G GRANULAR
ABBREVIATIONS
AN
NA
NS
UC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ".0001234"
USE LIMITATIONS CODES
C14
C46
C92
C94
CAD
GC9
Grown for seed only.
Do not apply through any type of irrigation system.
For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
Runoff from treated areas may be hazardous to aquatic organisms in neighboring areas.
Do not apply directly to water or wetlands.
Do not graze or forage crop grown in treated soil or cut for hay or silage.
-------
Report Run Date: 04/18/95 )
PRD Report Date: 03/10/94
Time 13:57
APPENDIX A ) CASE 2260, [Ethalfluralin] Chemical 113101 [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dini
LUIS 2.1 ) Page 9
USE LIMITATIONS CODES (Cont.)
GF9 : Do not graze treated crop or allow hay, seeds or seed screenings from treated crop to be used for food or feed.
GM2 : Do not harvest forage or hay from treated areas.
GO1 : Do not graze or cut green forage or hay for livestock feed.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
CA
IL
KY
MT
ND
NJ
OH
OR
WA
WY
California
Illinois
Kentucky
Montana
North Dakota
New Jersey
Ohio
Oregon
Washington
Wyoming
-------
-------
APPENDIX B. Table of the Generic Data Requirements and
Studies Used to Make the Reregistration Decision
77
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case ethalfluralin covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to ethalfluralin in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
79
-------
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Ethalfluralin
REQUIREMENT
USE CITATION(S)
PATTERN
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Starting Materials & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
all Upgradable, (42042501, 42370201)
all 42042501,42779201
all 42042501
all Upgradable, (42370201)
all Upgradable, (42370201)
all Upgradable, (42370201)
all 00135194
all 00135194
all 00135194
all 00135194
Not Applicable
all 42308801
all 00135194
all 42437201
Not applicable
all 41890101
Not applicable
all 41613901,41086401,42929601
81
-------
Data Supporting Guideline Requirements for the Reregistration of Ethalfluralin
REQUIREMENT
USE
PATTERN
CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1B
72-1C
72-2A
72-2B
72-3A
72-3B
72-3C
72-4A
72-4B
122-1A
122-1B
122-2
123-1A
123-1B
Acute Avian Oral - Quail
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Tox - Mollusk
Estuarine/Marine Toxicity - Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
Seed Germination/Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Seed Germination/Seedling Emergence
Vegetative Vigor
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00094760
00094761
00094762
00094764
00094763
00135183, 41613902
42176401
00135183, 41613903
00094770
42176402
41613904
41613905, 42889801
41613906
41994901
41613907, 42930101
41613911, 41613913
42904201
41613912
41613911, 41613913
42904201
82
-------
Data Supporting Guideline Requirements for the Reregistration of Ethalfluralin
REQUIREMENT
USE CITATION(S)
PATTERN
141-1 Honey Bee Acute Contact
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity - Rabbit
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
82-1A 90-Day Feeding - Rodent
82-IB 90-Day Feeding - Dog
82-2 21-Day Dermal - Rabbit
83-1A Chronic Feeding Toxicity - Rodent
83-IB Chronic Feeding Toxicity - Dog
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
A,B 41613914
A,B 41613908
A,B 41613909
A,B 41977601
41613910
41613909
00070683
A,B 00094774, 00094775, 00094777
A,B 00135193
A,B 00145767
A,B 00094776, 00094778
A,B 00153371
A,B 00094776
A,B 00094778
A,B 00153370
A,B 00129057
A,B 00094784, 00070682, 42300301
A,B 00128693, 00128694, 00128695
A,B 00152219, 00128696
A,B 00094786
83
-------
Data Supporting Guideline Requirements for the Reregistration of Ethalfluralin
REQUIREMENT
USE CITATION(S)
PATTERN
85-1 General Metabolism
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
163-2 Volatility - Lab
164-1 Terrestrial Field Dissipation
165-4 Bioaccumulation in Fish
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method - Plants
171-4D Residue Analytical Method - Animal
171-4E Storage Stability
A,B 00094789, 00132820, 42822901
A,B 00094805
A,B 41613916
A,B 41613917
A,B 41613918
A,B 41613919
A,B 42930102
A,B 41890102, 42496601
A,B 42496601
A,B 41613920, 41978101
A,B 41994902
A,B 00145955, 43394001
data gap for cucurbits
A,B 42487801, 42487802, 42902201, 42929001
A,B PAM Vols. I and II
A,B PAM Vols. I and II
A,B 42456401, 42456402, 42456403, 42456404,
42456405, 42487801, 42487802, 42511101,
42511102, 42511103, 42511104, 42542602,
42626001
84
-------
Data Supporting Guideline Requirements for the Reregistration of Ethalfluralin
REQUIREMENT
USE CITATION(S)
PATTERN
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
Beans, dry
Peas, dry
Soybean
Beans, vines and hay
Peas, vines and hay
Soybean, forage and hay
Alfalfa, forage and hay
Cucumbers
Squash
Melons
Peanuts
Sunflower, seed
171-4L Processed Food -
Peanuts
Soybean
Sunflower, seed
A,B
A,B
Waived
41613923
42542602
42542603
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
Data Gap
42542601
41613921, 41613922
42456405
42456404
41613922
165-1
Rotational Crops (Confined)
A,B
42930103
85
-------
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Ethalfluralin
87
-------
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
89
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as (19??), 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.
90
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BIBLIOGRAPHY
MRID CITATION
DowElanco. 1991. Worker Mixer, Loader, Applicator Exposure to
Ethalfluralin. DowElanco Study No. AAC 9054.
Ethalfluralin labels (062719-00184, 062719-00120, 062719-00188).
Fisher, B. and Pettigrew, H., 1994. Memorandum dated 8/3/94 to R.
Landolt/TB II Subject: Ethalfluralin, Quantitative Risk Assessment,
Comparison of 2 Q/'s (old, 1981 vs new, 1994), from Combined Data from
Two Chronic/Oncogenicity Studies in Fischer 344 Rats, 1981.
Hoerger, F.D. and E.E. Kenaga. 1972. Pesticide residues on plants
correlation of representative data as a basis for estimation of their magnitude in
the environment. Environmental Quality, Academic Press, New York, 1:9-28.
loannov M. and van Gemert, M., 1994. Toxicology Endpoint Selection
Document for Ethalfluralin dated May 19, 1994; Memo to James Kariya, Larry
Dorsey, Esther Saito, Debra Edwards, Edward Sager, William Burnam,
George Ghali, and Caswell File.
McLaughlin, P. 1994. (Draft) Toxicology Review for Reregistration
Eligibility Document on Ethalfluralin. Memorandum revised date 7/6/94 from
McLaughlin (HED) to Chow (HED).
Telephone conversation between Tim Leighton (Versar 703-750-3000) and Ed
Day (DowElanco 317-337-3667) on 7/28/94.
U.S. EPA, 1990. Ethalfluralin OREB Phase 4 Review dated 10/26/90
reviewed by L. Morris, A. Nielsen and C. Trichilo.
U.S. EPA. 1992. Comparative Analysis of Acute Avian Risk from Granular
Pesticides. OPP Avian Granular Project Team, USEPA, Washington, D.C. 71
pp.
U.S. EPA, 1994. Label Use Information System Report for Ethalfluralin
Dated 5/26/94; (Cover Memo May 31, 1994).
Urban, DJ. and N. J. Cook. 1986. Hazard Evaluation Division Standard
Evaluation Procedure: Ecological Risk Assessment. USEPA/OPP, EPA-
540/9-85-001. 96pp.
91
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BIBLIOGRAPHY
MRID
CITATION
00094774 Adams, E.R.; Gossett, P.O.; Hoffman, D.G.; Owen, N.V.; Emmerson, J.L.;
Morton, D.M. 1978. Three Month Oral Toxicity Study of Ethalfluralin (94961;
EL-161) in Mice. Study No. M-9286. Unpublished study conducted by Lilly.
(also 070678-E)
00094775 Adams, E.R.; Owen, N.V.; Hoffman, D.G. 1979. A One-Year Dietary
Toxicity Study with Ethalfluralin (Compound 94961) in the Fisher 344 Rat.
Study No. R-257. Unpublished study conducted by Lilly, (also 070678-F)
00094776 Adams, E.R.; Owen, N.V.; Emmerson, J.L. 1981. Two-Year Dietary
Evaluation of Ethalfluralin in the Fisher 344 Rat. Study Nos. R-267, R-277.
Unpublished study conducted by Lilly, (also 070678-G, 92062013)
00094777 Adams, E.R.; Owen, N.V.; Emmerson, J.L. 1981. A One-Year Dietary
Toxicity Study with Ethalfluralin (Compound 94961) in the B6C3F1 Mouse.
Study No. M-9157. Unpublished study conducted by Lilly, (also 070679-A)
00094778 Adams, E.R. 1981. A Two-Year Dietary Evaluation of Ethalfluralin
(Compound 94961) in the B6C3F1 Mouse. Study Nos. M-9167, M-9177.
Unpublished study conducted by Lilly, (also 070680-A)
00094784 Adams, E.R.; Owen, N.V.; Emmerson, J.L. 1981. A Multi-Generation
Reproduction Study with Ethalfluralin (Compound 94961) in the Fischer 344
Rat. Study Nos R-68, R-738, R-1248. Unpublished study conducted by Lilly.
(also 070682-F)
00094786 Probst, G.S.; Neal, S.B.; Adams, E.R. 1980. The Effect of Ethalfluralin (Lilly
Compound 94961) on the Induction of DNA Repair Synthesis in Primary
Cultures of Adult Rat Hepatocytes. Study No. 791120-263. Unpublished study
conducted by Lilly, (also 0070682, 250475-C, 00128695)
00094788 Adams, E.R.; Pierson, C.L.; Arthur, B.H. 1981. Guinea Pig Sensitization
Studies of Ethalfluralin. Study Nos. G-9530, G-00379. Unpublished studies
conducted by Lilly, (also 070683-A)
00094789 Adams, E.R.; Hanasono, G.K.; Hoffman, D. 1981. Metabolism and
Disposition of Ethalfluralin in Male Wistar Rats. No study number.
Unpublished study conducted by Lilly, (also 070683-B)
92
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BIBLIOGRAPHY
MRID
CITATION
00094805 Mosier, J.W.; Sullivan, W.L.; Saunders, D.G. (1976) A Hydrolysis Study on
the Herbicide Ethalfluralin. (Unpublished study re-ceived Feb 4, 1982 under
1471-122; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:070676-D)
00128693 Thompson, C.; Adams, E.; Probst, G. 1983. The Effect of Ethalfluralin on the
Induction of Bacterial Mutation Using a Modification of the Ames Test. Study
No. 830404GPA1169. Unpublished study submitted by Lilly, (also 250475-A)
00128694 Rexroat, M.; Adams, E.; Probst, G.; et al. (1983) The Effect of Ethalfluralin
(Compound 94961) on the Induction of Reverse Mutations in Salmonella
typhimurium Using the Ames Test: Studies 830307AMS1169, 830404AMS1169
and 830425AMS1169. (Unpublished study received Jun 9, 1983 under 1471-
122; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:250475-B)
00128695 Rexroat, M.; Adams, E.; Probst, G. 1983. The Effect of Ethalfluralin
(Compound 94961) on the Induction of Reverse Mutations in Salmonella
typhimurium Using the Ames Test. Studies 830307-, 830404-, 830425-
AMS1169. Unpublished studies submitted by Lilly, (also 250475b)
00128696 Oberly, T.; Bewsey, B.; Adams, E. 1983. The Effect of Ethalfluralin
(Compound 94961) on the Induction of Forward Mutation at the Thymidine
Kinase Locus of L5178Y Mouse Lymphoma Cells. Study 830208MLA1169.
Unpublished study submitted by Lilly, (also 250475-D)
00129057 Byrd, R.; Adams, E.R.; Fisher, L.F.; et al. 1983. A Teratology Study of
Ethalfluralin Administered Orally to Butch Belted Rabbits. Study No. BO 1383.
Unpublished study conducted by Lilly, (also 250596-A)
00132820 Adams, E.R.; Bridge, T.L.; Van Lier, R.B.L. 1982. Percutaneous Absorption
of 14C-Ethalfluralin in Monkeys. Study Nos. M-6162, PO-3282. Unpublished
study conducted by Lilly, (also 072180-B)
00135191 Adams, E.; Gossett, F.; Hoffman, D; et al. 1978. Three- Month Oral Toxicity
Study of Ethalfluralin (94961, EL-161) in Rats. Study No. R936. Unpublished
study submitted by Lilly, (also 097326-E)
93
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BIBLIOGRAPHY
MRID
CITATION
00135193 Gossett, F.; Koenig, G.; Harris, P. 1974. Subacute Toxicity of EL-161
Technical Grade in Dogs. Study No. D3733. Unpublished study submitted by
Lilly, (also 097326-G)
00135194 Elanco Products Co. (1975) The Name, Chemical Identity and Composition of
the Pesticide Chemical: [Ethalfluralin]. (Compilation; unpublished study
received Aug 24, 1978 under 1471-EX-63; CDL:073327-A)
00145767 Brown, G. 1985. Subchronic (21-day) Dermal Toxicity Study in New Zealand
White Rabbits with Technical Ethalfluralin. Study No. BO 1384. Unpublished
study conducted by Lilly, (also 00257855)
00145955 Berard, D.F. (1984) Characterization of Radioactive Residues in Peanut
Nutmeats and Hulls from Plants Grown in Soil Treated with 14C Ethalfluralin.
Report No. ABC -0223. Also Radioactive residues in Bean Seeds, Pods, and
Stems from Plants Grown in Soil Treated with 14C Ethalfluralin. Report No.
ABC-0212. Unpublished study conducted and submitted by Eli Lilly and
Company, Greenfield, IN, 199 p.
00152219 Mosesso, P.; Dean, B.; Forster, R. 1985. Test Substance: Ethalfluralin.
Chromosome Aberrations in Chinese Hamster Ovary Cells (CHO) In Vitro.
Study No. 095003M02385. Unpublished study prepared by Life Science
Research Roma, (also 259342)
00153370 Robinson, K. it al. 1985. A Teratology Study of Orally Administered
Ethalfluralin (EL-161) in the Rat. Study No. 82182. Unpublished study
conducted by Bioresearch Labs, (also 260434-B, 92062017)
00153371 Adams, E.; Bernhard, N. 1985. The Toxicity of Ethalfluralin Administered
Orally to Beagle Dogs for One Year. Study No. DO 1684. Unpublished study
conducted by Lilly, (also 00262711, 260434-A, 92062014)
41086401 Carpenter, M.; Fennessey, M. (1988) Determination of the Photolysis of
[Carbon 14]-Ethalfluralin in Aqueous Solution: ABC Second Amended Final
Report #36868. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 76 p.
94
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BIBLIOGRAPHY
MRID
CITATION
41613901
41613908
41613909
41613910
41613916
41613917
41613918
41613919
41613921
Hudson, J.; Smith, C. (1990) Ethalfluralin Technical: Chemical Stability: Lab
Project Number: TIL909004. Unpublished study prepared by DowElanco. 6
P-
Adams, E.R.; Gardner, J.B.; Sites, D.L. 1990. The Acute Toxicity of
Ethalfluralin (EL-161, Compound 094961) Administered Orally to the Fischer
344 Rat. Study No. B09490. Unpublished study conducted by Lilly.
Adams, E.R.; Rock, G.L.; St. Clair, R.L. 1990. The Acute Dermal Toxicity
and Primary Dermal Irritation of Ethalfluralin (EL-161, Compound 094961) in
the New Zealand White Rabbit. Study No. BO 1390. Unpublished study
conducted by Lilly.
Adams, E.R.; Rock, G.L.; St. Clair, R.L. 1990. The Acute Ocular Irritation of
Ethalfluralin (EL-161, Compound 094961) in the New Zealand White Rabbit.
Study No. B01490. Unpublished study conducted by Lilly.
Carpenter, Mark and Melinda Fennessey. 1988. Determination of the
Photolysis Rate of 14C-Ethalfluralin in Aqueous Solution. Submitted by Eli
Lilley and Company, Greenfield, Indiana. Performed by Analytical Bio-
Chemistry Laboratories, Inc., Columbia, Missouri.
Dykes, John. 1990. Determination of the Photolysis Rate of 14C-Ethalfluralin on
the Surface of Soil. Submitted by Elli Lilly and Company, Greenfield, Indiana.
Performed by Analytical Bio-Chemistry Laboratories, Inc., Columbia,
Missouri.
Graper, L.K. 1990. Aerobic Soil Metabolism of 14C-Ethalfluralin in Sandy
Loam Soil. Submitted and performed by Dow Elanco, Plant Science Chemical
Development, Greenfield, IN.
Graper, L.K. 1990. Anaerobic metabolism of 14C-Ethalfluralin in Sandy Loam
Soil. Submitted and performed by Dow Elanco, Plant Science Chemical
Development, Greenfield, IN.
Conn, R. (1990) Magnitude of the Residue of Ethalfluralin in or on Sunflower:
Lab Project Number: MKL-003-89-12: Rpt. No. AAC-9017. Unpublished
study prepared by McKenzie Labs, Inc. 132 p.
95
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BIBLIOGRAPHY
MRID
CITATION
41613922 Conn, R. (1990) Magnitude of the Residue of Ethalfluralin in the Processed
Fractions of Sunflower: Lab Project Number: MKL-003-89-12: E8909: E8910:
Rpt. No. AAC-9044. Unpublished study prepared by McKenzie Labs, Inc.
146 p.
41613923 Conn, R. (1990) Magnitude of the Residue of Ethalfluralin in or on Dry Beans:
Lab Project Number: MKL-003-89-12: RPT. NO. AAC-9016. Unpublished
study prepared by McKenzie Labs, Inc. 201 p.
41890101 Day, E. (1991) Octanol/Water Partition Coefficient of Ethalfluralin: Lab
Project Number: EWD9104. Unpublished study prepared by Lilly Analytical
Chemistry Dept. 9 p.
41890102 Sanders, Donald G. and Fred L. Powers. 1991. Ethalfluralin Aged Soil
Leaching Study. Submitted and performed by Dow Elanco, Plant Science
Chemical Development, Greenfield, IN.
41977601 Wolff, R.; Allen, D.; Williams, er al. 1991. The Acute The Acute Inhalation
Toxicity in the Fischer 344 Rat of Technical Ethalfluralin. Lab Project
Number: R17191. Unpublished study conducted by Lilly.
41978101 Decker, O.D. 1991. Ethalfluralin dissipation study. Laboratory ID No.
AAC8712. Unpublished study performed and submitted by DowElanco,
Indianapolis, IN.
41994902 Woodburn, K.B., S.C. Hansen, T. Ball and P.C. Wilga. 1991. Ethalfluralin:
Bioconcentration in rainbow trout, Oncorhynchus mykiss. Laboratory ID No.
ES-DR-0233-3655-1. Unpublished study performed by The Environmental
Toxicology and Chemistry Research Laboratory, Dow Chemical, Midland, MI
and submitted by DowElanco, Indianapolis, IN.
42042501 Handy, P.; Reinhart, R. (1991) Product Composition of Technical
Ethalfluralin: Lab Project Number: PRH9104. Unpublished study prepared by
DowElanco, Formulation & Environ. Chem. Lab. 7 p.
42300301 Hoyt, J.A.; Owen, N.V.; Adams, E.R. 1992. A 7-Month Multigeneration
Bridging Study of Ethalfluralin (EL-161, Compound 094061) Administered in
96
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BIBLIOGRAPHY
MRID
CITATION
the Diet to Fischer 344 Rats. Study Nos. R16890, R16990. Unpublished study
conducted by Lilly.
42308801 Stolz, W. (1992) Density of Sonalan Technical: A Summary: Lab Project
Number: FOR92006. Unpublished study prepared by DowElanco. 10 p.
42370201 Handy, P. (1992) Series 62: Analysis and Certification of Ethalfluralin,
Technical Grade Active Ingredient: Lab Project Number: GH-C 2757.
Unpublished study prepared by DowElanco. 53 p.
42437201 Decker, 0. (1987) Vapor Pressure of Ethalfluralin: Lab Project Number:
ODD8721. Unpublished study prepared by Lilly Research Laboratories, lip.
42437202 Saunders, D. G. and F. L. Powers. 1987. Adsorption and Desorption of
Ethalfluralin in Soil. Submitted and performed by DowElanco, Greenfield,
Indiana.
42456401 Conn, R. (1992) Magnitude of Residue of Ethalfluralin in or on Dry Beans:
Lab Project Number: E8908: MKL-003-89-12. Unpublished study prepared by
Stewart Agricultural Research Services, Inc. in cooperation with McKenzie
Laboratories, Inc. 363 p.
42456402 Conn, R. (1992) Magnitude of Residue of Ethalfluralin in or on Sunflower: Lab
Project Number: E8909: MKL-003-89-12. Unpublished study prepared by
Stewart Agricultural Research Services, Inc. in cooperation with McKenzie
Laboratories, Inc. 295 p.
42456403 Conn, R. (1992) Magnitude of Residue of Ethalfluralin in the Processed
Fractions of Sunflowers: Lab Project Number: E8909: E8910:
MKL-003-89-12. Unpublished study prepared by Stewart Agricultural
Research Services, Inc. in cooperation with The Texas A & M University
System and McKenzie Laboratories, Inc. 161 p.
42456404 Conn, R. (1992) Magnitude of Residue of Ethalfluralin in the Processed
Fractions of Soybeans: Lab Project Number: AAC9001: MKL-006-90-12.
Unpublished study prepared by Stewart Agricultural Research Services, Inc. in
cooperation with The Texas A & M University System and McKenzie
Laboratories, Inc. 188 p.
97
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BIBLIOGRAPHY
MRID
CITATION
42456405 Conn, R. (1992) Magnitude of Residue of Ethalfluralin in the Processed
Fractions of Peanuts: Lab Project Number: AAC9002: MKL-006-90-12.
Unpublished study prepared by Stewart Agricultural Research Services, Inc. in
cooperation with The Texas A & M University System and McKenzie
Laboratories, Inc. 186 p.
42487801 Magnussen, J. (1992) Nature of [carbon 14] Ethalfluralin Residues in
Ruminants: Lab Project Number: PLN 91003. Unpublished study prepared by
DowElanco. 60 p.
42487802 Graper, L. (1992) Nature of [Carbon 14] Ethalfluralin Residues in Chickens:
Lab Project Number: MET91089. Unpublished study prepared by DowElanco.
90 p.
42496601 Kesterson, Abbe. 1992. Laboratory volatility of [14C]-ethalfluralin. Performed
by PTRL East, Inc. Submitted by DowElanco, Greenfield, Indiana.
42511101 Conn, R.; Rogers, J. (1992) Storage Stability of Ethalfluralin: Residues in
Cucumber: Lab Project Number: MKL-004-90-12. Unpublished study
prepared by McKenzie Labs, Inc. 218 p.
42511102 Conn, R.; Rogers, J. (1992) Storage Stability of Ethalfluralin: Residues in
Peanut Nutmeat: Lab Project Number: MKL-004-90-12. Unpublished study
prepared by McKenzie Labs, Inc. 218 p.
42511103 Conn, R.; Rogers, J. (1992) Storage Stability of Ethalfluralin: Residues in
Soybean Seed: Lab Project Number: MKL-004-90-12. Unpublished study
prepared by McKenzie Labs, Inc. 218 p.
42511104 Conn, R.; Rogers, J. (1992) Storage Stability of Ethalfluralin: Residues in
Soybean Processed Fractions: Lab Project Number: MKL-005-90-12.
Unpublished study prepared by McKenzie Labs, Inc. and Texas A & M
University. 124 p.
42542601 Shackelford, D.; Decker, 0.; Ervick, D. (1992) Magnitude of Residue Study of
Ethalfluralin in Peanuts: Lab Project Number: RES91048. Unpublished study
prepared by DowElanco. 105 p.
98
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BIBLIOGRAPHY
MRID
CITATION
42542602 Shackelford, D.; Decker, 0.; Ervick, D. (1992) Magnitude of Residue Study of
Ethalfluralin in Dry Peas: Lab Project Number: RES91050. Unpublished study
prepared by DowElanco. 84 p.
42542603 Shackelford, D.; Decker, 0.; Ervick, D. (1992) Magnitude of Residue Study of
Ethalfluralin in Soybean: Lab Project Number: RES91049. Unpublished study
prepared by DowElanco. 142 p.
42626001 Rutherford, B.; Griggs, R. (1993) Storage Stability of Ethalfluralin in
Sunflower Seed: Lab Project Number: RES91106. Unpublished study prepared
by DowElanco. 30 p.
42779201 Stolz, W. (1993) Technical Ethalfluralin - Beginning Materials Specification
Sheets: Lab Project Number: WS021193. Unpublished study prepared by
DowElanco. 32 p.
42822901 Eschbach, J.C.; Hackett, D. 1993. Absorption, Distribution, and Elimination of
14C-Ethalfluralin in Rats. Study No. DR-0233-3655-001. Unpublished study
conducted by Bio/dynamics.
42902201 Magnussen, J. (1992) Supplemental Data to: (Carbon 14) Ethalfluralin
Ruminant Nature of Residue Study: Lab Project Number: PLN91003:
PLN91003.01. Unpublished study prepared by DowElanco, North American
Environ. Chemi. Lab. 28 p.
42929001 Graper, L. (1992) Supplemental Data to: Nature of (Carbon 14) Ethalfluralin
Residues in Chickens: (MRID No. 42487802): Lab Project Number:
MET91089: MET91089.01. Unpublished study prepared by North American
Environmental Chemistry Lab. 39 p.
42929601 Stolz, W. (1993) Determination of the Stability of Ethalfluralin Technical to
Selected Metals and Metal Ions at Elevated Temperatures: Lab Project Number:
FOR93036. Unpublished study prepared by DowElanco. 10 p.
42930102 Lawrence, B, S.G. Mobley, and A. Kesterson. 1993. Anaerobic aquatic
metabolism of [14C]ethalfluralin. PTRL Project ID: 650. Unpublished study
performed by PTRL East, Richmond, KY and submitted by DowElanco,
Indianapolis, IN.
99
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42930103 O'Neal, S.; Johnson, T. (1993) A Confined Rotational Crop Study with
(Carbon 14)-Ethalfluralin: Lab Project Number: 576: 1509. Unpublished study
by PTRL East, Inc. 312 p.
43394001 Berard, D. (1994) Supplemental Data for (carbon 14) Ethalfluralin Nature of
Residue Studies in Peanuts and Beans: Lab Project Number: ABC-0212.01:
ABC-0223.01: 0212.01/ABC-0223.01. Unpublished study prepared by
DowElanco North American Environ. Chemistry Lab. 49 p.
100
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APPENDIX D. List of Available Related Documents
101
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The following is a list of available documents related to ethalfluralin. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for ethalfluralin and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Ethalfluralin RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
103
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APPENDIX E. PR Notices 86-5 and 91-2
105
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PR Notice 86-5
107
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tPROl WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of pesticides.
Subject: Standard format for data submitted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental Protection Agency (EPA) in a
standard format. This Notice also provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA to satisfy data
requirements for granting or maintaining pesticide registrations, experimental use permits,
tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
are defined in FIFRA §10(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.
OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
109
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, which applies only to data
submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be altered, these samples are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be altered to reflect the
submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
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Claims (other than those based on FIFRA §10(d)(l)) 8 14
D. 5 Good Laboratory Practice Compliance Statement 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then be bound separately.
Submitters sometimes provide additional materials that are intended to clarify,
emphasize, or otherwise comment to help Product Managers and reviewers better understand
the submittal.
- If such materials relate to one study, they should be included as an appendix to that
study.
- If such materials relate to more than one study (as for example a summary of all
studies in a discipline) or to the submittal in general, they must be included in the
submittal package as a separate study (with title page and statement of confidentiality
claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted--i.e., a registration application, petition, experimental
use permit (EUP), §3(c)(2j(B) data call-in, §6(aj(2) submittal, or a special review; the
transmittal date; and a list of all individual studies included in the package in the order of their
appearance, showing (usually by Guideline reference number) the data requirement(s)
addressed by each one. The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be included in the transmittal
document as well, if it is known to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data submittal package supporting a
registration application should be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data submittal package supporting a
petition for tolerance or an application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions) or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.
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When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance or the studies. Within
these two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding studies on page 9.)
Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page. In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either of the following:
- Include the total number of pages in the complete study on each page (i.e., 1 of 250,
2 of 250, ...250 of 250).
- Include a company name or mark and study number on each page of the study, e g ,
Company Name-1986-23. Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification, because they address
Guidelines of broader than normal scope or for other reasons.
a. Safety Studies. Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end use product and covered by
a single title page, may be bound together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data within a submittal package
submitted in support of an end-use product produced from registered manufacturing-use
products should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical product, other
manufacturing-use product, an experimental use permit, an import tolerance petition, or an
end-use product produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range for biorational pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,
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151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial pesticide would cover
Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4 are extremely
broad in scope; studies addressing residue chemistry requirements must thus be defined at a
level below that of the Guideline code. The general principle, however, of limiting a study to
the report of a single investigation still applies fully. Data should be treated as a single study
and bound separately for each analytical method, each report of the nature of the residue in a
single crop or animal species, and for each report of the magnitude of residues resulting from
treatment of a single crop or from processing a single crop. When more than one commodity
is derived from a single crop (such as beet tops and beet roots) residue data on all such
commodities should be reported as a single study. When multiple field trials are associated
with a single crop, all such trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in the list below, in the order
indicated. (Also see Page 17.) Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the page number of this notice
where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
I, (B).or(C)
Example
Page 12
Page 13
Page 16
If CBI is claimed under FIFRA
§10(d)(l)(A), (B),or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
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D.I. Title Page
A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement (s) addressed by the study.
c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers. (Supplements submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).
g. Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
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D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 1 of X on the title page. Each passage confined to the Confidential Attachment
must be associated with a specific cross reference to the page(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list of the points to address in such a statement is included in Attachment 4
on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims must be signed and dated
and must include the typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory work subject to GLP
requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
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microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies Required - All submittal packages except those associated with a
Registration Standard or Special Review (See Part G below) must be provided In three
complete, identical copies. (The proposed regulations specified two copies; three are now
being required to expedite and reduce the cost of processing data into the OPP Pesticide
Document Management System and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard or Special Review
must be provided in four copies, from one of which all material claimed as CBI has been
excised. This fourth copy will become part of the public docket for the RS or SR case. If no
claims of confidentiality are made for the study, the fourth copy should be identical to the
other three. When portions of a study submitted in support or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
Do not close up or paraphrase text remaining after this excision.
Mark the fourth copy plainly on both its cover and its title page with the phi
"Public Docket Material - contains no information claimed as confidential".
ihrase
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V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+ Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+ Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-pondence with Project
Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
Vol n Title of nth study in the submittal (Guideline No.)
* Applicants commonly provide this information in a tran-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Signature Name
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should note that it is OPP
policy that no permanent tolerance, temporary tolerance, or request for an
emergency exemption incorporating an analytical method, can Be approved
unless the applicant waives all claims of confidentiality for the analytical
method. These analytical methods are published in the FDA Pesticide Analyt-
ical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which
confidentiality claims have been made, to the submitter, to obtain the
confidentiality waiver before they can be processed.
ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
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For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:
• Identify specifically by page and line number (s) each portion of the study for
which you claim confidentiality.
• Cite the reasons why the cited passage qualifies for confidential treatment.
• Indicate the length of time—until a specific date or event, or permanently—for
which the information should be treated as confidential.
• Identify the measures taken to guard against undesired disclosure of this
information.
• Describe the extent to which the information has been disclosed, and what
precautions have been taken in connection with those disclosures.
• Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
• If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
• If you assert that the information in voluntarily submitted, indicate whether you
believe disclosure of this information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PARAGRAPH(S) :
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
• Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
:—":' _. *""} . Supplemental Statement
i..-(•-"'' j of Confidentiality Claims
• ' * When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91 -2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient (s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expected to be present in their
product at the end or the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed in connection with a
product's registration, represent the amounts of an ingredient that may legally be present 40
CFR 158.1/5. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10 (b). In this respect the
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis (i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must be changed to
nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4 (a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, to comply with this Notice. Such applications should
note "Conversion to Nominal Concentrations on the application form. These
types Or amendments will not be handled as "Fast Track" applications but will
be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Generic Data Call-in
131
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.m
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
„ ^t& OFFICE OF
• PR01 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet,
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments 1
through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
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Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-in Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of products
containing this active ingredient(s). You have been sent this Notice because you have product(s)
containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant s Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR s 15o. Normally,
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the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from OECD, 1750 Pennsylvania Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a) (6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-In(s), or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately respond
to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due
to failure to comply with this Notice are presented in Section IV-A and IV-B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Noticed Please note that the company's authorized
representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial
any subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active
ingredient (s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form
indicating your election of this option. Voluntary cancellation is item number b
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on the Data Call-in Response Form. If you choose this option, this is the only form
that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are contained
in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you wish
to amend your registration to delete uses, you must submit the Requirements Status
and Registrant's Response Form, a completed application for amendment, a copy
of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant
for registration of a product is exempt from the requirement to submit or cite
generic data concerning an active ingredient(s) if the active ingredient(s) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient (s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-in Response Form, Attachment 2 and all supporting documentation. The
Generic Data Exemption is item number 6a on the Data Call-in Response Form.
If you claim a generic data exemption you are not required to complete the
Requirements Status and Registrant s Response Form. Generic Data Exemption
cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with this
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Data Call-in Notice, the Agency will consider that both they and you are not in
compliance and will normally initiate proceedings to suspend the registrations of
both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various options
available to satisfy the data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Caii-ln Response Form, it you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or '(), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below
with information in parentheses to guide registrants to additional instructions provided in
this Section. The options are:
1. I will generate and submit data within the specified time frame (Developing
Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1, Developing Data —
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and in
the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
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Pesticide Assessment Guidelines (PAG), and be in conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. It you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission or data.
A progress report must be submitted for each study within 90 days from the
date you are required to commit to generate or undertake some other means to
address that study requirement, such as making an offer to cost-share or agreeing
to share in the cost of developing that study. A 90-day progress report must be
submitted for all studies. This 9T)-day progress report must include the date the
study was or will be initiated and, for studies to be started within 12 months of
commitment, the name and address of the laboratory(ies) or individuals who are
or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing tor the submission of
completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by
this Notice and intend to seek additional time to meet the requirement(s), you must
submit a request to the Agency which includes: (1) a detailed description of the
expected difficulty and (2) a proposed schedule including alternative dates for
meeting such requirements on a step-by-step basis. You must explain any technical
or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide the
name of the registrant who will be submitting the data. You must also provide
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EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the
terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of
the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration^), although you do not comply with the
data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of
a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data.
In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant s receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or
failing agreement to be bound by binding arbitration as provided by FIFRA section
3(c) (2) (B) (iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required by
this Notice by submitting a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form committing to develop and submit the data
required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for some
other reason is subject to suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame.
In such cases, the Agency generally will not grant a time extension for submitting
the data.
Option 4, Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance
of this Notice. Do not use this option if you are submitting data to upgrade a
study. (See Option 5).
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You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that
the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be done
in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation
of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact
transcript may be substituted for the original source as raw data. Raw data
may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term "specimens", according to 40
CFR 160.3(7), means "any material derived from a test system for
examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control information,
pursuant to the requirements of 40 CFR Part 160. Registrants must also
certify at the time of submitting the existing study that such GLP
information is available for post-May 1984 studies by including an
appropriate statement on or attached to the study signed by an authorized
official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
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protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is in the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing
study you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated
as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
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Option 6, Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as 'core-guideline" or ' core minimum.'
For ecological effects studies, the classification generally would be a rating of
"core." For all other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option you must provide the
MRID number of the study you are citing and, if the study has been reviewed by
the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed! copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement^) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(cj (2) (A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume pesticides
only those active ingredient (s) whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use
waiver the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the pesticide, and the
exposure and risk from use of the pesticide. If an active ingredient (s) is used for
both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient (s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to requests
for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not registered
in this country but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information by year for
each of the past five years.
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b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product (s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting the
testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active ingredient (s).
h. A description of the importance and unique benefits of the active
ingredient (s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient (s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts on
the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant s Response FofrrTThis option may be used if you believe that a
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particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must also
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s), you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days ot your receipt ot the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing studies
or offers, arrangements, or arbitration on the sharing of costs or the
formation of Task Forces, failure to comply with the terms of an agreement
or arbitration concerning joint data development or failure to comply with
any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the
cost of developing data and provided proof of the registrant's receipt of
such offer, or failure of a registrant on whom you rely for a generic data
exemption either to:
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a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form; of,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
The grounds for suspension include, but are not limited to, failure to meet any of the
following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies. Such
requirements include, but are not limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation or any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced or
included in this Notice or contained in PR 86-5. All studies must be submitted in
the form of a final report; a preliminary report will not be considered to fulfill the
submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3 (c) (2) (B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
produces) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
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should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an ' existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their sale, distribution, and use. Unless you meet
this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, ana should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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ETHALFLURALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing ethalfluralin.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point or contact tor inquiries pertaining to the reregistration of ethalfluralin.
This attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the
Generic Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's
Form (Attachment 2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms in
replying to this ethalfluralin Generic Data Callln (Attachment F). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for ethalfluralin
are contained in the Requirements Status and Registrant's Response Attachment C. The Agency
has concluded that additional product chemistry data on ethalfluralin are needed. These data are
needed to fully complete the reregistration of all eligible ethalfluralin products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Tom Myers at (703) 308-o074.
All responses to this Notice for the generic data requirements should be submitted to:
Tom Myers, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Ethalfluralin
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by
the registrant as appropriate Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St , S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-in Notice), and
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incorporate that product into all your products, you may complete this item
for all products listed on this form If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants Response Form that indicates how
you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant s Response Form that indicates how you will satisfy those
requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion or uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223,
U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and to the
Office of Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
submitted in connection with the study. As noted in Section III of the Data Call-In
Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and Registrant's
Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
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D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
0.
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP_*
TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
DEGR
*See: guideline comment
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient
and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
Degradates
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
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the conditions for submittal of this study as outlined in the Data Call-in
Notice and that I will provide the protocol and progress reports required in
item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data Jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-in Notice.
4. (Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option,
I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In Notice
and I have attached the needed supporting information along with this
response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching an
identification or the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
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modified by the Agency in writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-in
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
ofyour product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all ofyour products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
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Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
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in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-in(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the first page of the Data Call-In
Response Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person (s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-
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In Response Form, indicating your election of this option. Voluntary cancellation is item number
b on the Data Call-In Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response .Form. Deletion of a use(s) and the iow volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
1) I will generate and submit data within the specified time frame (Developing Data)
2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
3) I have made offers to cost-share (Offers to Cost Share)
4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1 Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
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submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c) (2) (B) (iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
Notice by submitting a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form committing to develop and submit the data required by this Notice.
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In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
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study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of~how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or ' core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete Justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
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8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEP TABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
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the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 3D day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment Z and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person (s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Peter Caulkins, Acting Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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ETHALFLURALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing ethalfluralin.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
ethalfluralin. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this ethalfluralin Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for ethalfluralin are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on ethalfluralin are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible ethalfluralin products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of ethalfluralin, please contact
Tom Myers at (703) 3W-8074.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Bruce Kapner, (703) 308-8013
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Ethalfluralin
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in me Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
187
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
188
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
189
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed "
Certification of offer to Cost Share in the Development Data" form. I am including
a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the require data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-in Notice (Section III-
C.l.) apply as well.
191
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4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of my receipt of the Agency's written decision, submit
a revised "Requirements Status chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
192
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
193
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EPA'S BATCHING OF PRODUCTS CONTAINING ETHALFLURALIN AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXIC1TY 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 reregistration of products containing the active ingredient ethalfluralin
(Benzenamine, N-ethyl-N-[2-methyl-2-propenyl]-2,6-dinitro-4-[trifluoromethyT|-[9CI]) the Agency
has batched products which can be considered similar in terms of acute toxicity. Factors considered
in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar '
since some products within a batch may not be considered chemically similar or have identical use
patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6j.
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.
195
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Table 1 displays the batches for the active ingredient Ethalfluralin.
Table 1
Batch
1
2
Registration
Number
62719-184
ND90000200
ND91000200
34704-610
62719-120
IL91000300
KY93000100
OH91000400
OR91000400
OR91000800
WA91000500
WA92000900
WY92000400
Percent Active Ingredient
ethalfluralin ... 10.00%
ethalfluralin ... 10.00%
ethalfluralin ... 10.00%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
ethalfluralin ... 36.1%
Form
granular
granular
granular
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
Table 2 lists the products the Agency was unable to batch. These products were considered not to
be similar to other products in terms of acute toxicity. The registrant of these products is
responsible for meeting the acute toxicity data requirements for these products.
Table ?..
Registration Number
62719-132
62719-139
62719-188
Percent Active Ingredient
ethalfluralin ... 95%
ethalfluralin ... 50%
ethalfluralin ... 31.5%
Form
powder
powder
liquid
196
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Attachment 5. EPA Acceptance Criteria
197
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
199
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and
for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present "af < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically
significant impurities~(see #3).
200
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, Y, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
all impurities present at > 0.1%.
2. Degree of accountability!^ closure _>_ ca 98%.
3. Analyses conducted for certain trace toxiclmpurities at lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in 19) to verify certified limits validated as to their precision and accuracy.
201
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in ° C
Any observed decomposition reported
63-6 Boiling Point
Reported in ° C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
202
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SUBDIVISION F
Guideline Study Tide
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
204
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
205
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
206
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
207
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
208
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.~ Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
209
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
211
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
213
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-------
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
217
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United States Environmental Protection Agency
^^ P™r^J\ Washington, DC 20460
^S&r'W^fjL CERTIFICATION OF OFFER TO COST
^^IH| M\ SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
20700057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
5322
'""ilLlli"
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. SencTcomments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodentipide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay cpmpensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wi
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
with regard to the registration or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
221
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APPENDIX H. FACT SHEET
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-002
January 1995
R.E.D. FACTS
Ethalfluralin
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 2260, ethalfluralin.
Ethalfluralin is a selective herbicide used for the preemergence control
of annual grasses and broadleaf weeds in certain food and feed crops.
Marketed under the trade name Sonalan, ethalfluralin may be used in
growing a variety of grain, seed, and cucurbit crops. The greatest amounts
of ethalfluralin are used in growing soybeans, dry beans, and sunflower
seeds. Granular, dry flowable, and emulsifiable concentrate formulations
are registered. Products may be applied preplant, postplant prior to
emergence, postemergence, or post-transplant as a soil incorporated, band,
or broadcast application using ground equipment.
Ethalfluralin is used only outdoors, in agriculture—no residential uses
are registered. Use practice limitations prohibit applying ethalfluralin to
any body of water or wetland.
Ethalfluralin was conditionally registered as a herbicide for use on dry
peas, dry beans, soybeans, and cucurbits, from November 1983 until
December 1, 1985. EPA determined that ethalfluralin's benefits outweighed
its cancer risks during that time period. Tolerances, or maximum residue
limits in food and feed commodities, were established. Later, data were
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Human Health
Assessment
submitted that allowed full registration of ethalfluralin, and several new uses
were added.
In December 1990, EPA issued a data call-in notice under phase IV of
the accelerated reregistration program. At present, six products are
registered containing the active ingredient ethalfluralin including one
technical (manufacturing use) product and five end-use products.
Toxicity
Ethalfluralin causes moderate eye irritation and moderate to severe
skin irritation, and has been placed in Toxicity Category II (the second-
highest of four acute toxicity categories) for these effects. It also is a skin
sensitizer. Ethalfluralin otherwise is of relatively low acute toxicity. It has
been placed in Toxicity Category III for inhalation effects, and Toxicity
Category IV for oral and dermal effects.
Subchronic toxicity studies using mice and rats resulted in changes in
liver and kidney weights, decreased weight gain, and changes in blood and
enzyme activity. A study using beagle dogs resulted in changes in the liver,
blood and cholesterol. A study using rabbits resulted in severe skin
irritation.
A chronic toxicity and carcinogenicity study using rats resulted in
mammary gland tumors in female rats at mid and high doses. EPA
concluded on June 8, 1994, that ethalfluralin should be classified as a Group
C, possible human carcinogen, based on the results of that study. A second
study in mice caused liver cell, blood and enzyme changes, as well as
increased liver, kidney and heart weights in females, and decreased body
weight gain. A study using beagle dogs resulted in changes in the blood,
bone marrow, enzymes and liver.
Although a developmental toxicity study in rats did not show effects, a
study using rabbits resulted in maternal effects (abortions and decreased
food consumption), and developmental toxicity effects including increased
resorptions, abnormal skull development, and variations in the sturnum.
No treatment-related effects were noted on reproduction parameters in
two reproductive toxicity studies using rats. Ethalfluralin was weakly
mutagenic in two types of mutagenicity studies but negative for mutagenicity
in two other studies.
Dietary Exposure
People may be exposed to residues of ethalfluralin through the diet.
Tolerances or maximum residue limits have been established for
ethalfluralin residues in/on plants (dry beans, cucurbit vegetables, peanuts,
peanut hulls, dry peas, soybeans, and sunflower seeds) and in animal
commodities (eggs, milk, and the fat, meat, and meat byproducts of cattle,
goats, hogs, horses, poultry, and sheep). (Please see 40 CFR 180.416.)
All of these tolerances are established at 0.05 parts per million (ppm).
Ethalfluralin residues are not likely to concentrate in processed food, so no
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food or feed additive tolerances are established or required. Residues were
not found in rotational crops so relevant tolerances need not be established.
EPA has assessed most existing ethalfluralin tolerances. Additional
confirmatory data are required for the postplant-preemergence application
use of ethalfluralin on cucurbits (cucumbers, melons, and squash) to
reassess the adequacy of the tolerances established. New data also are
required for the postemergence and posttransplant applications to cucurbits.
These data are not considered confirmatory, however, since EPA lacks data
which would allow an interim assessment of the residues. Thus, at this
time, the postemergence and posttransplant uses of ethalfluralin on cucurbits
are not eligible for reregistration. If data from cucurbit studies currently
underway are not adequate, these uses will have to be removed from
ethalfluralin product labels.
In addition, ethalfluralin tolerances for animal commodities must be
revoked. Ethalfluralin residues in animals at up to ten times the usual
dietary burden are not quantifiable. If it is not possible to determine finite
residues with certainty, and if it is unlikely that there are any residues, the
Agency's policy is not to establish tolerances, or to revoke existing ones.
Finally, since label restrictions on grazing, haying, and foraging
generally are no longer permitted, such restrictions for beans, peas,
soybeans, peanuts and alfalfa must be removed from all ethalfluralin labels.
EPA has assessed the dietary risk posed by ethalfluralin. In its
analysis, the Agency included the existing tolerances for cucurbits (though
adequate data are not available for reregistration) and animal commodities
(though these tolerances must be revoked), to reflect a worst case scenario.
The upper bound dietary risk estimate for the U.S. population is 6.2 x
10 5 based on all the published tolerances for ethalfluralin. However, EPA
is revoking the tolerances for meat, milk, poultry, and eggs, based on the
presumption that there are undetectable, finite residues in these food items.
When cancer risk is calculated without these tolerances, the upper bound
dietary risk is 5.7 x 10 7, a negligible risk.
For the overall U.S. population, chronic exposure from all existing
ethalfluralin tolerances represents 2% of the Reference Dose (RfD), or
amount believed not to cause adverse effects if consumed daily over a 70-
year lifetime. The Anticipated Residue Contribution (ARC), a more
accurate estimate of dietary exposure which takes into account percent of
crop treated and other chemical- and use-specific information, still
represents only 2% of the RfD for the overall population. For the most
highly exposed subgroup, non-nursing infants, chronic exposure from all
existing tolerances represents 9% of the RfD, while the ARC is only 4% of
the RfD. Therefore, chronic dietary risk appears to be minimal.
Acute exposure to the subgroup of greatest concern, females age 13
and older (women of childbearing age), results in a Margin of Exposure
(MOE) of 25,000 for developmental toxicity. EPA believes MOEs of 100
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or greater represent a negligible risk for that toxicological endpoint.
Therefore, acute dietary risk to ethalfluralin is not of concern.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders and
applicators) may be exposed to ethalfluralin during applications to
agricultural crops. Because ethalfluralin is a possible human carcinogen,
EPA assessed exposure and risk to workers in four major exposure
scenarios. While workers in three of the scenarios have risks that are
considered negligible, commercial mixers/loaders using the liquid/dry
flowable formulation with ground application equipment are estimated to
have an extra cancer risk of 1 x 10 5.
To mitigate this worker risk, EPA is requiring use of minimum,
baseline personal protective equipment (PPE), including coveralls and
chemical resistant gloves, by all ethalfluralin handlers. To further reduce
their risks, mixers and loaders must wear coveralls over long pants and
long-sleeved shirts—a double layer of protection—as well as chemical
resistant gloves and a chemical-resistant apron to protect against spills or
splashing.
Post-application exposure to ethalfluralin should be minimal, as long
as the pesticide is applied and incorporated into soil correctly, or unless the
task involves contact with the soil subsurface. EPA is requiring a 24-hour
restricted entry interval (REI), strengthening the interim 12-hour REI
established by the Worker Protection Standard (WPS). However, if
ethalfluralin has been incorporated correctly, workers may enter the treated
area during the REI without PPE, if they are performing tasks that do not
involve contact with the soil surface. When contact with the soil surface is
necessary, early entry workers must wear appropriate PPE including
coveralls over a short-sleeved shirt and short pants, chemical-resistant
gloves, chemical-resistant footwear plus socks, and protective eyewear.
Human Risk Assessment
Ethalfluralin causes moderate eye and skin irritation but otherwise is
of relatively low acute toxicity. However, it causes mammary gland tumors
and is classified as a quantifiable Group C, possible human carcinogen.
Ethalfluralin also is a developmental toxicant.
Although people may be exposed to residues of ethalfluralin through
the diet, both acute and chronic dietary risks appear to be minimal. Risks to
handlers (mixers/loaders/applicators) are of concern, but are being reduced
by requiring minimum, baseline PPE for all handlers plus additional PPE
for mixers and loaders. A more stringent, 24-hour REI is being imposed,
as is early entry PPE.
Environmental Environmental Fate
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AsSGSSITIGnt Although the data submitted for reregistration are not complete, EPA
has sufficient information at this time to provide an overall qualitative
assessment for ethalfluralin.
Ethalfluralin is expected to dissipate by binding to soil particles and
then degrading both aerobically and anaerobically. In the field, ethalfluralin
did not leach, and it is not expected to contaminate ground water. Because
ethalfluralin is structurally similar to trifluralin, which has been detected in
ground water in 10 of 21 states, EPA cannot make a complete assessment of
ethalfluralin until its assessment of trifluralin is finished.
There is some potential for ethalfluralin to reach surface waters on
eroded soil particles. In surface waters, it is expected to photodegrade and
to degrade rapidly in anaerobic sediments by electrochemical reactions.
Ethalfluralin was not volatile in the laboratory; however, no assessment of
its spray drift potential is possible from the submitted data.
Ecological Effects
Technical ethalfluralin is practically nontoxic to bobwhite quail on an
acute oral basis, and to bobwhite quail and mallard ducks on a subacute
dietary basis. It does not appear to cause reproductive effects in birds.
Ethalfluralin end-use products are practically nontoxic to slightly toxic
to small mammals on an acute oral and dermal basis. Technical
ethalfluralin also is practically nontoxic to honey bees.
Technical ethalfluralin is highly to very highly toxic to rainbow trout
and bluegill sunfish. The formulated product also is highly toxic to bluegill
sunfish. Since ethalfluralin persists in soils and is very highly toxic to fish,
an acute toxicity sediment study was submitted. This study shows that
ethalfluralin released from soil sediments can be lethal to sunfish when
concentrations in water reach 17 to 58 parts per billion (ppb). In an early
life stage toxicity test with freshwater fish, ethalfluralin affected larval
length and weight in trout.
In invertebrate toxicity studies, technical ethalfluralin is very highly
toxic and the formulated product is slightly toxic to Daphnia magna on an
acute basis. In a life cycle study using daphnids, reproduction was the most
sensitive parameter affected. Ethalfluralin is highly toxic to
marine/estuarine fish, mollusks, and shrimp on an acute basis.
In terrestrial plant studies, ethalfluralin affected parameters including
radicle length, plant height and weight, and shoot dry weight (in cotton).
Ecological Effects Risk Assessment
Wildlife may be exposed to ethalfluralin either by consuming
contaminated food items (such as seeds, fruit, or insects), or by ingesting
granules. Birds, for example, may ingest granules as a source of grit.
However, no acute or chronic risks to endangered or nonendangered birds
are expected to occur from eating food items, and no undue risk is expected
from granular applications. Minimal risk to mammals is anticipated from
the present ethalfluralin uses.
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Ground applications of ethalfluralin could result in potential risks to
aquatic organisms from runoff and drift. Although neither high acute risk
nor chronic risk to aquatic organisms is anticipated, the restricted use
trigger has been exceeded for freshwater organisms, and endangered species
triggers are exceeded for freshwater organisms and estuarine/marine
invertebrates.
For unincorporated applications, some risk is posed to nontarget semi-
aquatic plants in the vicinity of treated fields. However, no risk to plants is
posed from soil-incorporated applications. High risk to nontarget aquatic
plants is not expected.
Endangered species levels of concern are exceeded for freshwater
organisms and estuarine/marine invertebrates from unincorporated
applications; for freshwater fish from incorporated applications; and for
plants growing in wet areas receiving channelized runoff from treated sites
(from unincorporated applications). Limitations may be imposed on the use
of ethalfluralin to protect threatened and endangered species when EPA
implements the Endangered Species Protection Program, later in 1995.
Risk Mitigation
Since ethalfluralin is considered a possible human carcinogen and a
developmental toxicant, EPA is requiring the following risk mitigation
measures, as discussed earlier:
O To reduce risks to workers, require all handlers to use minimum,
baseline PPE, and require mixers and loaders to use additional PPE, as
specified in the RED. Extend the REI from 12 to 24 hours and require
early entry PPE, as detailed in the RED document.
O To reduce risks to freshwater fish, invertebrates, and certain nontarget
plants from unincorporated granular and spray applications:
° Prohibit alfalfa irrigation tail waters from entering aquatic habitats.
° Recommend use of runoff controls such as vegetative buffer strips
to filter water flow from recently treated cucurbit fields before it
reaches aquatic habitats. EPA and the Natural Resources
Conservation Service are developing guidance on such vegetative
filters, and the Agency may require their use in the future.
° Require compliance with the Endangered Species Protection
Program, when it goes into effect.
Additional Data
Required
EPA is requiring the following generic studies for ethalfluralin to
confirm its regulatory assessments and conclusions:
Additional generic product chemistry studies;
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Product Labeling
Changes Required
Additional residue chemistry studies, confirmatory and new field trial
data, and a third metabolism study for cucurbits (due by May 31,
1995);
Field trial data for alfalfa hay and forage, pea and bean hay and
forage, soybean hay and forage, and peanut hay;
Nitrosamine content and analysis studies.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
All ethalfluralin end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Worker Protection Standard
Personal Protective Equipment (PPE) Requirements
Products containing ethalfluralin may contain more stringent PPE, but
in no case may require less stringent PPE than the following requirements.
Producers must compare the PPE requirements in this section with those on
current labeling and retain the more protective.
Handler PPE for Occupational Use Products - For all uses of
ethalfluralin, which are within the scope of the WPS, the minimum or
baseline PPE required for pesticide handlers (mixers, loaders, and
applicators) is:
° coveralls, and
° chemical-resistant gloves.
The PPE required for mixers and loaders is:
° coveralls over long pants and long-sleeved shirt;
° chemical-resistant gloves; and
° chemical-resistant apron.
Early Entry PPE - The PPE required for early entry is:
° coveralls over short-sleeved shirt and short pants;
° chemical-resistant gloves;
° chemical-resistant footwear plus socks; and
° protective eyewear.
Entry Restrictions
WPS Uses - A 24-hour restricted entry interval (REI) is required for
all currently registered ethalfluralin uses, all of which are within the scope
of the Worker Protection Standard (WPS).
Registrants may add the following statement to their labeling in the
Agricultural Use Requirements box immediately following the restricted
entry interval:
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"Exception: If the product is soil-injected or soil-incorporated,
the Worker Protection Standard, under certain circumstances,
allows workers to enter the treated area if there will be no
contact with anything that has been treated."
Other Labeling Requirements
Grazing, foraging and haying restrictions must be removed from
ethalfluralin labels, except sunflower forage.
Directions for Use - The labels of all ethalfluralin end-use products must be
revised to bear the following statements under this section:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through spray drift. Only protected
handlers may be in the area during application."
Engineering Controls:
"When handlers use closed systems, enclosed cabs, or aircraft in a
manner that meets the requirements listed in the Worker Protection
Standard (WPS) for Agricultural Pesticides, 40 CFR 170.240(d) (4-6),
the handler PPE requirements may be reduced or modified as
specified in the WPS."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions exist for washables, use detergent and hot water.
Keep and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"Users should remove clothing 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 - Because ethalfluralin is classified as a skin
sensitizer, the Agency requires that the following statement appear on all
labels in the Hazards to Humans and Domestic Animals section of these
statements:
"This product may cause skin sensitization reactions in certain
individuals."
Environmental Hazard - The labels of all ethalfluralin end-use products
must bear the following statement under this section:
"This product is toxic to fish and aquatic invertebrates. Do not apply
directly to any body of water or to areas where surface water is
present, or to intertidal areas below the mean high water mark. Do
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not contaminate water when disposing of equipment washwaters or
rinsate."
For application to alfalfa, the following statement is required:
"For flood or furrow irrigation, do not allow the tail waters from the
first irrigation after application to enter aquatic habitats."
For applications to cucurbit fields, the following statement is required:
"Due to risk to plants and animals in aquatic habitats that receive run-
off containing this product, use of controls such as a vegetative buffer
strip to filter such water flow from recently treated fields is
recommended."
Effluent Discharge Statements - All end-use and manufacturing-use
products that may be contained in an effluent discharged to the waters of the
U.S. or municipal sewer systems must bear the following labeling
statement:
"This product is toxic to fish and aquatic invertebrates. 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 Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local
sewage treatment plant authority. For guidance contact your State
Water Board or Regional Office of the EPA."
The use of currently registered products containing ethalfluralin, in
accordance with labeling amended to reflect the risk mitigation measures
imposed by this RED, generally will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products,
except postemergence and posttransplant applications to cucurbits, are
eligible for reregistration.
EPA is unable to make a reregistration eligibility decision regarding
the postemergence and posttransplant uses of ethalfluralin on cucurbits
because the Agency does not yet have the residue chemistry data required to
support these uses. A registrant is conducting the required studies, which
are due to the Agency by May 31, 1995. Once EPA reviews and accepts
the studies, these cucurbit uses also will be considered eligible for
reregistration.
Ethalfluralin products will be reregistered once the required product
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
For MOTG EPA is requesting public comments on the Reregistration Eligibility
Infnrmatinn Decision (RED) document for ethalfluralin during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
Regulatory
Conclusion
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obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-
5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV., or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the ethalfluralin RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the ethalfluralin RED, or reregistration of individual products containing
ethalfluralin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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