REREGISTRATION ELIGIBILITY DECISION
TEBUTHIURON
LIST A
CASE 0054
ENVIRONMENTAL PROTECTION AGENCY
OJUCE OF PESTICIDE FSOGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
15 JUN
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 tebuthiuron
which includes the active ingredient tebuthiuron. 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 may also include requirements for additional data (generic) on the active
ingredient(s) 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 Linda Propst at (703) 308-8165.
Sincerely yours,
Daniel M. Barolo, 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 fDCD 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. Complete
the two response forms provided with each DCI letter by following the instructions contained
in each DCI. You must submit the response forms for each product and for each DCI
within 90 days of the date you receive the RED; otherwise, your product may be
suspended.
2. TIME EXTENSIONS AND DATA WAIVEE 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 dian 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 RED
issuance date (the cover letter 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 farther labeling guidance, refer 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; 703-487-4650).
c. Generic or Product Specific Data. Submit ail 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: (I) accept the
standard certified 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 §l58.175(e). A copy of the CSF is enclosed; follow the
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instructions on its back,
e- Certification With Respect to Citation of Data. Complete and sign this
form (EPA form 8570-29) for each product. Cite-all is not a valid option for
reregistration.
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 ALL PCI RESPONSES (90-DAY> AND APPLICATIONS
FOR REREGISTRATION (8-MQMTH RESPONSES)
By U.S. Mail;
Document Processing Desk (RED-SRRD-XXXX)* * XXXX = the
Office of Pesticide Programs (H7504C) case code for the
EPA, 401 M St. S.W. RED (see front
Washington, D.C. 20460-0001 cover of RED)
By express;
Document Processing Desk (HED-SRRD-XXXX)*
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REV1EWS-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 widiin 14 months after the
RED has been issued.
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TABLE OF CONTENTS
TEBUTHIURQN REREGISTRATION ELIGIBILITY DECISION TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
L INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile , 2
C. Estimated Usage of Pesticide 4
D. Data Requirements , , 6
E. Regulatory History 6
IH. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 8
b. Subchronic Toricity 9
c. Chronic toxicity 9
d. Carcinogenicity 10
e. Developmental Toxicity 10
f. Reproductive Toxicity 10
g. Mutagenicity 11
b. Metabolism 11
i. Reference Dose (RfD) , 12
2. Exposure Assessment 12
a. Dietary Exposure 12
b. Occupational and Residential Exposure 15
3. Risk Assessment 16
a. Dietary 16
b. Occupational and Residential 17
C. Environmental Assessment 18
4. Environmental Fate 18
a. Environmental Chemistry, Fate and Transport 18
b. Environmental Fate Assessment 21
5. Ecological Effects 22
a. Ecological Effects Data 22
(1) Terrestrial Data 22
(2) Aquatic Data . 24
(3) Non-Target Insects Data 28
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(4) Non-Target Plants Data 28
b. Ecological Effects Risk Assessment 29
IV. RISE MANAGEMENT AND REREGISTRATION DECISION 35
A, Determination of Eligibility 35
1. Eligibility Decision 36
2. Eligible and Ineligible Uses 36
B. Regulatory Position , 36
1. Tolerance Reassessment 36
2. Endangered Species Statement 38
3. Labeling Rationale/Risk Mitigation Measures 39
V. ACTIONS REQUIRED BY REGISTRANTS 42
A, Manufacturing-Use Products 42
1. Additional Generic Data Requirements 42
2. Labeling Requirements for Manufacturing-Use Products 42
B. End-Use Products 42
1. Additional Product-Specific Data Requirements 42
2. Labeling Requirements for End-Use Products 42
C. Existing Stocks 45
VI. APPENDICES . 47
APPENDIX A. Table of Use Patterns Subject to Reregistration 49
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 59
APPENDIX C. Citations Considered to be Part of the Data Base
Supporting the Reregistration of Tebutbiuron 69
APPENDIX D. List of Available Related Documents . 87
APPENDIX E 91
PR Notice 86-5 93
PR Notice 91-2 113
APPENDIX F. Combined Generic and Product Specific Data Call-In 119
Attachment 1. Chemical Status Sheets 143
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 149
Attachment 3. Generic and Product Specific Requirement Status
and Registrant's Response Forms (Form B inserts) and
Instructions 155
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 165
Attachment 5. EPA Acceptance Criteria 171
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice 185
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 187
APPENDIX G. FACT SHEET 197
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TEBUTHIURON REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Steve Jarboe
James Saulmon
Robert Torla
Margaret Cogdell
Environmental Fate and Effects Division
Arnet Jones
Paul Mastiadone
Kevin Costello
Betsy Behl
Tracy Perry
Hairy Craven
Betsy Grim
Laura Dye
Health Effects Division
Patricia McLaughlin
Steve Funk
Jeffrey Evans
Jennifer Wintersteen
Nguyen Thoa
Flora Chow
Registration Division
Edward Allen
Van Seabaugh
Special Review and, Reregistration Division
Peg Perreault
Linda Propst
Carol Stangel
Policy and Special Projects Staff
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
LUIS Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Toxicology Branch II
Chemistry Branch Reregistration Support
Occupational and Residential Exposure Branch
Science Analysis Branch
Chemical Coordination Branch
Chemical Coordination Branch
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
Jean Frane
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GLOSSARY OF TERMS AND ABBREVIATIONS
a,i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
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
GRAS Generally Recognized As Safe as designated by FDA
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, rag/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.
LD,0 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
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
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect,
TGAI Technical Grade Active Ingredient.
TMRC Theoretical Maximum Residue Contribution.
ill
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EXECUTIVE SUMMARY
Reregistration Decision
Based on the reviews of the generic data for the active ingredient tebuthiuron, the Agency
has sufficient information on the health effects of tebuthiuron and on its potential for causing
adverse effects in fish and wildlife and the environment. Based on this information, the Agency
concludes that products containing tebuthiuron for all registered uses are eligible for reregistration.
The Agency has determined that all uses of tebuthiuron, as currently registered, will not cause
unreasonable risk to humans. However, tebuthiuron may pose a significant risk to on- and off-site
endangered terrestrial, semi-aquatic, and aquatic plant species and may also have adverse effects on
other off-site nontarget plants. In addition, the Agency is concerned about the potential for ground
water contamination from registered uses of tebuthiuron.
In order to reduce both the risk to endangered and other nontarget plants and the concern for
ground water contamination, the Agency is requiring a ground water label advisory as well as label
revisions for tebuthiuron end-use products, including lower application rates and limits on the
number and frequency of applications for all registered use sites. In addition, the Agency has
initiated discussion with the registrant to identify portions of the tebuthiuron use area that are
vulnerable to ground water contamination and is requiring that this information be submitted within
4 months after the issuance of this RED. Based on the information regarding vulnerable use areas,
the registrant is also required to submit, within 4 months after the issuance of this RED, proposed
label restrictions for tebuthiuron to further reduce ground water contamination concerns.
The scientific data base is adequate to support the reregistration eligibility of all registered
uses of tebuthiuron. The Agency is, however, requiring additional product chemistry data on
preliminary analysis (Guideline 62-1) and analytical methods to verify certified limits (Guideline 62-
3); these data are considered confirmatory for the reregistration of tebuthiuron. In addition, data
pertaining to the magnitude of the residue in animal commodities (Guideline 171-4J) and residue
analytical methods for milk and animal tissues (Guideline 171-4d) remain outstanding and are due to
the Agency by 4/29/94; these data are also considered confirmatory for the reregistration of
tebuthiuron.
Background
Tebuthiuron is a relatively nonselective, soil activated herbicide registered for use to control
broadleaf and woody weeds, grasses, and brush on terrestrial feed crop sites (pastures and
rangeland) and on terrestrial non-food crop sites [airports/landing fields, industrial areas (outdoor),
non-agricultural rights-of-way/feneerows/hedgerows, non-agricultural uncultivated areas/soils, and
under newly applied asphalt and concrete]. The registered single active ingredient formulations of
tebuthiuron include granular (3 and 5%), pelleted/tableted (20 and 40%), wettable powder (80%),
water dispersible granules (dry flowable, 85%), and technical grade/solid (95%). Registered
multiple active ingredient formulations include three granular formulations (1% tebuthiuron plus one
other active ingredient, 2% tebuthiuron plus one other active ingredient, and 2% tebuthiuron plus
iv
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which represents 9% of the RfD. The subgroup most highly exposed, non-nursing infants (< 1
year), has a TMRC from all tolerances of 2.3 x 10"2 mg/kg/day, or 32% of the RfD. The children
(1-6 years) subgroup has a TMRC from all tolefgjneesiof 4,i5 x 10"2 mg/kg/day, which represents
21 % of the RfD, The chronic dietary risk from exposure to tebuthiuron (including published
tolerances on meat and milk) appears to be minimal. The OPP RfD Committee did not recommend
an acute dietary analysis. A reassessment of tolerances is also included in this document.
There is a potential for mixer/loader/applicator dermal and inhalation exposure to
tebuthiuron. Occupational risks are, however, considered to be minimal due to its low toxicity
[acute toxicity category IV by dermal route and HI by inhalation route, negative for developmental
and reproductive adverse effects, and classification as a Group D carcinogen (not classifiable as to
human carcinogenicity)].
Tebuthiuron is resistant to biological and chemical degradation under environmental
conditions. Its principal route of dissipation in the environment appears to be mobility; although
laboratory data indicate that photodegradation on soil may occur slowly, this is not likely to be a
route of dissipation in the environment. Transport to ground water (through leaching) and surface
water (following runoff) are likely as a result of tebuthiuron's persistence and low adsorption to soil.
According to the Pesticides in Ground Water Database (1992), tebuthiuron has been detected in
ground water in Texas (two wells) and California (one well). A small-scale retrospective ground-
water study conducted for the Agency in Texas indicates that tebuthiuron is persistent and mobile
and can leach to ground water. Moreover, the results of the study indicated that tebuthiuron was
persistent and mobile enough to leach at least 15 feet to the water table, then still be present above
minimum detection levels more than 4 years after the application.
Tebuthiuron is practically non-toxic to birds, fish, and aquatic invertebrates, and is slightly
toxic to mammals. Current registered uses of tebuthiuron should not pose a hazard to terrestrial or
aquatic organisms. However, phytotoxicity to on- and off-site endangered terrestrial, semi-aquatic,
and aquatic plant species as well as phytotoxicity to off-site non-target plants is a concern. When
the Agency completes its Endangered Species program, additional precautionary labeling may be
required to mitigate the risk to endangered plant species.
Accordingly, the Agency has determined that only the products containing tebumiuron as the
sole active ingredient for the uses declared eligible for reregistration will be reregistered when
acceptable labeling and product specific data are submitted and/or cited. Before reregistering each
product, 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. These data include product chemistry for each registration and acute toxicity testing.
After reviewing these data and any revised labels and finding them acceptable m accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
VI
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another active ingredient). Currently registered maximum application rates range from 2 to 16.02 Ib
ai/A, All formulations may be applied as broadcast, banded, and/or spot treatments using ground
equipment; the pelleted/tableted formulations may also be applied using aerial equipment.
Tebuthiuron was first registered by Blanco Products Company in 1974. The registration was
later transferred to DowElanco in 1989. A Registration Standard was issued in July 1987 (NTIS
$PB87-231866) for all pesticide products containing the active ingredient, tebuthiuron. This
document identified the additional generic data required to support the continued registration of the
use of tebuthiuron as an herbicide. The use patterns registered at that time included terrestrial feed,
terrestrial non-food, and aquatic non-food (ditchbanks) sites. In 1992, DowElanco (technical
producer), dropped their support of the only aquatic use site (ditchbanks); therefore, the
environmental fate and residue chemistry data required in the Registration Standard for aquatic use
sites are no longer required for tebuthiuron.
Additionally, in the Registration Standard, the Agency identified concerns about the potential
for ground water contamination by tebuthiuron and the hazard to endangered plant species from the
use of tebuthiuron on pasture and rangeland. A ground water Data-Call-in was issued for
tebuthiuron on May 24, 1988 which required a small scale retrospective ground water monitoring
study (Guideline 166-2). An additional Data-Call-in, issued July 31, 1991, required residue
chemistry studies on the magnitude of the residues in meat and milk (Guideline 171-4J); although
these data, as well as data on residue analytical methods for meat and milk remain outstanding, they
are considered confirmatory for the reregistration of tebuthiuron. With the exception of these
residue chemistry data, the Agency has now completed its review of the target data base for
tebuthiuron, including data submitted in response to the 1987 Registration Standard and subsequent
ground water Data-Call-in for tebuthiuron.
Supporting Rationales for Reregistration Decision
Acute toxicity studies indicate that tebutibiuron is moderately toxic by the oral route (toxicity
categories - in in mice and dogs, II in rats, and II in cats and rabbits), practically non-toxic by the
dermal route (Toxicity Category IV), and only slightly toxic by the inhalation route (Toxicity
Category III). Tebuthiuron is not a dermal irritant, causes only a slight irritation to the eyes
(Toxicity Category IV) 5 and is not a dermal sensitizer.
Tebuthiuron does not appear to cause any adverse developmental or reproductive effects.
Based on an acceptable carcinogeniciiy in rats and two supplemental carcinogenicity studies in mice
in which no compound-related carcinogenic effects were observed, the Health Effects Division
(HED) RfD Committee classified tebuthiuron as a Group D carcinogen (not classifiable as to human
carcinogenicity). The available data indicate that tebuthiuron does not appear to be mutagenic.
The Reference Dose (RfD) for tebuthiuron is 0,07 mg/kg/day, based on a NOEL of 7.0
mg/kg/day and an uncertainty factor of 100. The NOEL was derived from a two-generation repro-
duction study in rats which demonstrated depressed body weight gain in Fl females at 14
mg/kg/day. The TMRC for the overall U.S. population from all tolerances is 6.4 x 103 mg/kg/day,
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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 registration" before calling in data on
products and eidier reregistering products or taking "odier 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 tebuthiuron. The document consists of six sections. Section I is the introduction.
Section II describes tebuthiuron, 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 tebuthiuron. Section V discusses the
reregistration requirements for tebuthiuron. 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(s) are covered by this Reregistration Eligibility
Decision:
» Common Name; tebuthiuron
Chemical Name: N-[5-(l,l-dimethylethyl)-i,3,4-thiadiazol-2-yl]-
N,N'dimethylurea
Chemical Family: substituted urea
CAS Registry Number: 34014-18-1
OPP Chemical Code: 105501
Empirical Formula:
» Trade and Other Names: Spike (U.S.); Graslan (Australia); Herbic (Japan);
Herbec (Canada); Perflan, Bimate, Combine (Brazil,
Latin America)
Basic Manufacturer: DowElanco
B. Use Profile
The following information is on the current registered uses with an overview of use
sites and application methods. A detailed table of these uses of tebuthiuron is in Appendix
A.
For tebuthmron:
Type of Pesticide: herbicide; relatively nonselective, soil activated, readily
absorbed through plant roots
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Mode of Action: inhibits photosynthesis
Use Sites: Terrestrial Feed Crop: pastures, rangeland
Terrestrial Non-food Crop: airports/landing fields, industrial
areas (outdoor), non-agricultural rights-of-
way/fencerows/hedgerows, non-agricultural uncultivated
areas/soils, under pavement (roads/sidewalks) in areas where no
future landscaping is planned
Target Pests: broadleaf and woody weeds, grasses, and brush
Formulation Types Registered;
Single active ingredient
3.0 and 5.0% Granular
20.0 and 40.0% Pelleted/Tableted
80.0% Wettable Powder
85.0% Water Dispersible Granules (Dry Flowable)
95.0% Technical Grade/Solid
Multiple active ingredient
1.0% Granular (tebuthiuron plus one other active ingredient)
2,0% Granular (tebuthiuron plus one other active ingredient)
2.0% Granular (tebuthiuron plus another active ingredient)
Method and Rates of Application:
Granular: Apply the 3% granular at up to 16,02 Ib ai/A or the 5% granular at up to
6.0 Ib ai/A as a broadcast treatment using a spreader to airports/landing fields,
industrial areas (outdoor), nonagricultural uncultivated areas/soils, and under
pavement in areas where no future landscaping is planned. May also be applied as a
spot treatment, Reapply when needed for vegetation control.
Pelleted/Tableted: Apply up to 4,0 Ib ai/A to pasture and rangeland as a broadcast
treatment using aerial or ground equipment; reapply when needed for vegetation
control. Apply up to 6.0 Ib ai/A to industrial areas (outdoor), nonagricultural rights-
of-way/fencerows/hedgerows, and nonagricultural uncultivated areas/soils as a
broadcast treatment using aerial or ground equipment; reapply when needed for
vegetation control. May also be applied as a spot treatment.
Wettable Powder: Apply up to 6.0 Ib ai/A to airports/landing fields, industrial areas
(outdoor), nonagriculural rights-of-way/fencerows/hedgerows, nonagricultural
uncultivated areas, and under pavement in areas where no future landscaping is
planned as a soil broadcast or banded treatment using ground equipment. May also
be applied as a spot treatment using a hand-held sprayer. Reapply when needed either
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for vegetation control or to maintain bare ground.
Water dispersible granules (dry flowable): Apply up to 5.95 Ib ai/A to
airports/landing fields, industrial areas (outdoor), nonagricultural rights-of-
way/fencerows/hedgerows, nonagricultural uncultivated areas/soils, and under
pavement in areas where no future landscaping is planned as a broadcast or banded
treatment using ground equipment. May also be applied as a spot treatment using a
hand-held sprayer, Reapply when needed for vegetation control.
Use Practice Limitations:
All formulations: Do not apply to ditches used to transport irrigation or potable
water. Do not apply on or near desirable woody or herbaceous plants or in areas
where their roots may extend. Do not apply in areas where the pesticide may be
moved from the treated area by flowing water, wind, or mechanical means. Do not
apply when soil is frozen or saturated with moisture.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the usage of tebuthiuron on
an aggregate and site (crop) basis. These estimates are derived from a variety of published
and proprietary sources available to the Agency. The range of data presented accounts for
annual fluctuations in use patterns as well as the variability resulting from the use of data
from various information sources. The table below summarizes the amounts of tebuthiuron
used by site.
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ESTIMATED ANNUAL U.S. USAGE OF TEBUTHIURON
Site
Site
Acreage
Acres
Treated
Site
Treated
Lbs a,i.
Applied
(000) (000) (%) (000)
Electric utilities (*) 9,390 10-18 0,1 - 0.2 20 - 35
Pipelines (*) 2,195 4-10 0.2-0,5 8-20
Railroads (*) 1,085 15-25 1.0-2.0 45-60
Other Indus, facilities (*) 1,865 <9 <0.5 45
Roadways (*) 11,000 5-8 <0.1-0.1 10-15
Greenhs./nurseries, CA 60 NA NA 0.00 -0.05
Landscape maint,, CA NA NA NA 0.7-1.1
Raageland (**) 806,000 95 -165 0.0 -<0.1 95 - 165
Farm only —
Pastured cropland 57,820-58,675 5-40 0.0-0.1 2-8
Woodland 59,335-65,215 2-20 0.0-<0.1 1-20
Oth. pastures/rngelnd (#) 343,590 - 377,245 9-70 0.0 -<0.1 4-25
Lots, roads, etc. 25,680-28,505 2-7 0.0-<0.1 2-9
Hay except alfalfa 33,785-36,110 <1 - 10 0.0-<0.1 <1-30
Alfalfa 24,150-25,060 0-1 0.0-< 0.1 0- <1
TOTAL (##) 1,032,000-1,045,000 140-315 N/A 230-410
{*) Site acreage given is that potentially available for herbicide treatment. (**) Site acreage given is that suitable (but not
necessarily available) for grazing/browsing but generally not suitable for cultivation. Some iangeland is not available because
of other uses (e.g., hunting), environmental restrictions, etc.
(i) Other than pastured cropland and pastured woodland,
(##) Excludes farm other pastures/rangeland to avoid double counting (with most or all of this site included in above
range land).
SOURCES -
1 - US EPA Information, reports and proprietary sources
2 - CA EPA, Pesticide Use Report, Annuals 1990 and 1988
3 - US DOC/Census, 1987 Census of Agriculture, CA and US
4 - CO Pesticide Use Survey, Estimated Use 1989
5 - DowElanco, Tebuthiuron Use Document
6 - DowElanco, Market Use Specifics, 1/31/94
NOTE Ir NA = not available.
NOTE 2; Estimates are for total U.S. unless indicated otherwise. "CA", e.g., indicates that estimates are for California
only (and do not represent total U.S. site and usage).
-------
D. Data Requirements
Data requested in the July 1987 Registration Standard for tebuthiuron include studies
on product chemistry, residue chemistry, toxicology, environmental fate, and ecological
effects. These data were required to support the uses listed in the Registration Standard.
Appendix B includes all data requirements identified by the Agency for currently registered
uses needed to support reregistration.
E. Regulatory Hiitory
Tebuthiuron was first registered by Blanco Products Company in 1974. The
registration was later transferred to DowElanco in 1989. A Registration Standard was issued
in July 1987 (NTIS #PB87-231866) for all pesticide products containing the active ingredient,
tebuthiuron. This document identified the additional generic data required to support the
continued registration of the use of tebuthiuron as a herbicide. The use patterns registered at
that time included terrestrial feed, terrestrial non-food, and aquatic non-food (ditchbanks)
sites. In 1992, DowElanco (technical producer), dropped their support of the only aquatic
use site (ditchbanks); therefore, the environmental fate and residue chemistry data required in
the Registration Standard for aquatic use sites are no longer required for tebuthiuron.
Additionally, in the Registration Standard, the Agency identified concerns about the
potential for ground water contamination by tebuthiuron and the hazard to endangered plant
species from the use of tebuthiuron on pasture and rangeland. A ground water Data-Call-in
was issued for tebuthiuron on May 24, 1988 which required a small scale retrospective
ground water monitoring study (Guideline 166-2). An additional Data-Call-in, issued July
31, 1991, required residue chemistry studies on the magnitude of the residues in meat and
milk (Guideline 171-4J). This Reregistration Eligibility Decision document reflects an
assessment or reassessment of all data submitted to date in response to the Registration
Standard and subsequent Data-Call-ins for tebuthiuron.
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HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The chemical structure and physical/chemical characteristics of tebuthiuron [N-[5-(l,l-
dimethylethyI)-l,3,4-thiadiazol-2-yl]-N,N'dimethylurea] are described below:
CH
H c ' 3
CH
N—N
Empirical Formula:
Molecular Weight:
CAS Registry No,;
PC Code:
228,3
34014-18-1
105501
Color
Physical State
Melting Point
Solubility at 25c
Vapor Pressure
Oxidizing/reducing
action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
Colorless to white
Crystalline solid at 25 6C
159-161 "Cat 760 mmHg
2.5 mg/mL water, 60 mg/mL acetonitrile
70 mg/mL acetone, 170 mg/mL methanol,
20 mg/mL ethanol, 250 mg/mL chloroform,
60 mg/mL methyl cellosolve,
3,7 mg/mL benzene, and 6.1 mg/mL hexane
2x 10^mmHgat25°C
No evidence of gas evolution or temperature rise over 24 hours with
ammonium dihydrogen phosphate, potassium permanganate, or
powdered zinc
N/A
Negative in tests using 10 impacts with 8-lb hammer from 20 inches
Four years in polyethylene-lined commercial
packaging, at ambient warehouse temperatures
N/A
N/A
Noncorrosive m commercial packaging
-------
The following Product Chemistry data are required for tebutMuron technical (the Agency
considers these data confirmatory for the reregistration of tebuthiuron);
- (62-1) Preliminary Analysis: Samples must be analyzed for nitrosamine content. Additional
data are required for an impurity (CBI) listed on the CSF.
- (62-3) Analytical Method to Verify the Certified Limits: A validation of the method is
required.
B. Human Health Assessment
1. Toxicology Assessment
The lexicological data base on tebuthiuron is adequate and will support
reregistration.
a. Acute Toxicity
The acute toxicity data on tebuthiuron are summarized below.
TEST
(81-1) Oral LDS9 - rat
- mouse
- rabbit
- cat
- dog
(31-2) Dermal LB50 - rabbit
(81-3) Inhalation LCW - rat
(81-4) Eye irritation - rabbit*
(81-5) Dermal irritation - rabbit*
(81-6) Dermal sensitization -
guinea pig*
REStJliTS
M/F = 477/3i7 »0/kg
M/F = 528/620 mg/kg
286 ing/kg; M,F
> 200 ing /kg; H,F
> 500 mg/kgj M,t
> SOOO xng/kgj M,F
> 3.6S6 rng/1; H»F
slight irritation
nonirritating
nonsensitizing
CATEGORY
II
III
II
II
III
IV
III
IV
IV
-
Note: Data pertaining to acute eye irritation, dermal irritation, and dermal
sensitization are not required, to support the reregistration of the TGAJi. Thee
data are presented for informational purposes.
The oral LD5() values for technical tebuthiuion ranged from 387 to 477 mg/kg
in rats (toxicity category E) (MRID# 40583901) and 528 to 620 mg/kg in mice
(toxicity category III) (MRID# 00226375), suggesting that the compound has
moderate toxicity. The oral LD50 values were similar in dogs and chickens (>500
mg/kg; toxicity category III) but were lower in rabbits (286 mg/kg; toxicity
category II) and perhaps in cats (>200 mg/kg; toxicity category II) (MRID#
00226375). In these species, the adverse clinical signs of toxicity were generally
8
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referable to the central nervous system and included ataxia, anorexia, dyspnea,
hypothermia, hyperirritability, loss of righting reflex, vomiting, and tremors. In
an acute dermal rabbit study (MRID# 40583902), the LD50 for tebuthiuron was
greater than 5000 mg/kg (toxicity category IV). In an acute inhalation study in
rats (MRIDI 00155730), the LC50 value was greater than 3.696 mg/1 (toxicity
category III). Optical application of tebuthiuron to rabbits produced only slight
irritation (i.e., slight conjunctival hyperemia at one hour post-treatment) to the eyes
(toxicity category IV) (MRIDf 40583903). A primary dermal irritation study
indicated that tebuthiuron is not a skin irritant in rabbits (toxicity category IV )
(MWD# 40583902). No dermal sensitization occurred with tebuthiuron in guinea
pigs (MRIDf 40583904).
b. Subdirome Toxicity
When tebuthiuron was administered in the diet for 90 days to rats at levels of
0, 20, 50, or 125 mg/kg/day, the NOEL was 50 mg/kg/day and the LOEL was
125 mg/kg/day. The toxic effects observed in both sexes were reduced body
weight, increases in relative liver, kidney and gonad weights, and slight vacuola-
tion of pancreatic acinar cells. In addition, males also had increased relative
spleen and prostate gland weights (MRIDI 00020662).
Administration of tebuthiuron in the diet for 90 days to dogs at levels of 0,
500, 1000, or 2500 ppm resulted in a NOEL of 500 ppm (12.5 mg/kg/day). The
LOEL was 1000 ppm. (25 nig/kg/day), based upon findings of anorexia, weight
loss, increases in blood urea nitrogen and alkaline phosphatase, and increases in
spleen and thyroid gland weights (MRIW 00020663).
Dermal application of 1000 mg/kg (only dose tested) of tebuthiuron to rabbits
for 6 hours per day for 21 consecutive days resulted in slight erythema which
cleared by 7 days, and increased blood glucose values. The NOEL was less than
1000 mg/kg/day (MRID# 00149733).
c. Chronic toxicity
The required chronic toxicity study in rodents (GL# 83-1) is satisfied by a
chronic/carcinogenicity feeding study in rats (MHID i 00020714; see below under
B.l.d).
Dogs were fed tebuthiuron via capsule at doses of 0, 12.5, 25, or 50
mg/kg/day for one year. The NOEL was 25 mg/kg/day. The LOEL was 50
mg/kg/day, based on clinical signs of anorexia, diarrhea, and emesis and increases
in thrombocyte count, alanine transferase and alkaline phosphatase levels, and
weight of the liver, kidney and thyroid gland (MRID# 00146801).
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d. Carcinogenicity
In two studies of identical design, tebuthiuron was fed to 40 Harlan (Wistar-
derived) rats/sex/group of 400, 800 or 1600 ppm (20, 40 or SO mg/kg/day) for 2
years. There were 60 rats/sex/study for controls. The systemic NOEL was 40
mg/kg/day. The systemic LOEL was 80 mg/kg/day (highest dose tested), based
upon a reduction in weight gain and elevated kidney weights. No compound-
related carcinogenic effects were observed (MRIDf 00020714).
In two studies of identical design, tebuthiuron was fed to 40 Harlan ICR
mice/sex/group of 400, 800 or 1600 ppm (57, 114 or 228 mg/kg/day) for 2 years.
There were 60 mice/sex/study for controls. The systemic NOEL for mice was
1600 ppm (228 mg/kg/day, the highest dose tested). No compound-related
carcinogenic effects were observed (MRIDf 00020717). The mouse studies were
considered to be supplemental. The dose levels were judged to be inadequate for
Carcinogenicity testing. However, the Health Effects Division (HED) RfD
Committee concluded that another study would not be needed at this time because
information available from both the rat and mouse studies provide adequate
information for risk assessment purposes. Based on these studies, in which no
compound-related carcinogenic effects were observed, the HED RfD Committee
classified tebuthiuron as a Group D (not classifiable as to human Carcinogenicity)
carcinogen.
e. Developmental Toxicity
Rats were given 0, 15, 30, or 45 mg/kg/day tebuthiuron in the diet on
gestation days 6-15. The NOEL for maternal toxicity was 30 mg/kg/day. The
LOEL was 45 mg/kg/day, based upon reductions in body weight gain and food
consumption. The NOEL for developmental toxicity was 45 mg/kg/day (highest
dose tested). No compound-related developmental effects were observed (MRID#
00020803).
Rabbits were administered 0, 10, or 25 mg/kg/day tebuthiuron by gavage on
gestation days 6-18. The NOEL for rabbit maternal toxicity was greater than 25
mg/kg/day (highest dose tested). An apparent decrease in fetal weights at the 25
mg/kg/day dose level (24,8 g/fetus at 25 mg/kg/day vs. 30.0 g/fetus in controls)
was observed. The decrease is probably the result of- an increased number of
fetuses per litter (5.7 fetuses/litter in the 25 mg/kg/day group vs. 4.4 fetuses/litter
in the control group), which suggests that a NOEL for developmental toxicity is
greater than 25 mg/kg/day. Therefore, no compound-related developmental effects
were observed (MRID#s 00020644; 40776301).
f. Reproductive Toxicity
In a two-generation study in rats, the time-weighted average tebuthiuron
intake for the dietary levels 100, 200 or 400 ppm fed is 7, 14 or 28 mg/kg/day.
10
-------
The study indicated a systemic toxicity NOEL of 7 mg/kg/day . There was a
reduced rate of body weight gain in Ft females during a 101-day premating period
at higher dose levels of 14 and -28 "M^/Kgfday. The reproductive NOEL was the
highest dose tested (28 mg/kg/day) (MRIDf 00090108).
In a three-generation study in rats, both of the dietary levels that were
examined (28 and 56 mg/kg/day) produced a reduction in mean body weight gain
in Flb weanling pups. Thus, a reproductive NOEL could not be established in this
three-generation reproduction study (MRID# 00020643),
g. Mutagenicity
Results of in vitro mutagenicity studies indicate that tebuthiuron does not
appear to be mutageiric. The results of these studies are summarized in the table
below.
Mutagenicity Studies With Tebuthiuron
Study Type GL Mo. Results
Salmonella reverse gene 84-2 Negative, with or without metabolic
mutation (Ames assay) activation (HDT = 5 mg/plate) .
(MRIDtf 00141691)
Forward Gene Mutation (mouse S4-2 Negative, without metabolic activation
lymphoma 1.51787 cells) (HDT = 1000 ug/ml) .
Slightly positive (mutation index =2)
w/ metabolic activation, at e 700 ug/ml.
Cy to toxicity observed at £ 200 ug/ml.
(HDT = 800 ug/ml} , (MRID# 00145041}
Structural Chromosome 84-2 Positive at the HDT (1550 ug/ml with
Aberration in CHO cells metabolic activation; 1950 ug/ml
w/out activation) . Cy to toxicity
observed at the HDTs. (MRID# 411341-01)
Unscheduled DHA Synthesis 84-4 Negative in primary hepatocyte of
rats {HDT = 800 ug/ml; cytotoxicity
observed at 900 ug/ml) . (MRID# 407509-01)
h. Metabolism
A metabolic study of tebuthiuron was conducted in four species (rats, rabbits,
dogs, and mice), using gavage administration of single doses of radiolabelled
compound (10 or 160 mg/kg). Tebuthiuron was readily absorbed, extensively
metabolized, and rapidly excreted in all four species. A species difference
appeared to occur with mice. The total recovery of radioactivity 96 hours after
compound administration was 74% to 107% of the administered dose. At the low
dose level, most radioactivity was eliminated over 24 hours. In rats, rabbits and
dogs, elimination in the urine accounted for 84% to 95% of the dose (0,4% to
0.7% was excreted as unchanged parent compound), and elimination in the feces
11
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accounted for 1 to 31%. Biliary excretion was demonstrated in rats. Mice
eliminated less radioactivity in urine (66%, with 23% as unchanged parent
compound) and more in feces (31%) than the other three species. At least seven
major metabolites were excreted in the urine of all species. Tissue distribution
studies did not demonstrate any unusual tissue localization of metabolites. (MRID#
40849101).
In a study in lactating rats, dietary administration of radiolabelled tebuthiuron
(5 or 10 mg/kg/day; immediately postpartum for 48 hours), resulted in the
appearance of radioactive tebuthiuron and/or its metabolites in the milk at levels of
2,7 to 6.2 ppm (MRID# 00106081),
i. Reference Dose (RfD)
The RfD for tebuthiuron was determined to be 0.07 mg/kg/day based on
results of the 2-generation rat reproduction study (MRID# 00090108). The NOEL
was 7 mg/kg/day for systemic toxicity, based upon a reduction in body weight gain
at levels of 14 and 28 mg/kg/day in Fl females during a 101-day premating period.
An uncertainty factor of 100 was used; this reflects a factor of 10 for interspecies
extrapolation and a factor of 10 for intraspecies variance. A lexicological
evaluation has not been performed by the Joint FAO/WHO Meeting on Pesticide
Residues (JMPR) to establish an Acceptable Dietary Intake (ADI).
2. Exposure Assessment
a. Dietary Exposure
Plant Metabolism
The qualitative nature of the residue in grasses is adequately
understood. The residues of concern are tebuthiuron and its metabolites
1Q3(OH) [N-5-(2-hydroxy-l, 1 -dimethylethyl)-1,3s4-thiadiazol-2-yl]-N,N'-
dimethylurea], 104 [N-5-(l, l-dimethylethyl)-l ,3,4-thiadiazol-2-yl]-N-
methyluiea], and 109 [N-[5-(l,l-dimethylethyl)-l,3,4-thiadiazol-2-yl3-N*-
hydroxymethyl-N-rnethylurea]. The molecular structures of the metabolites
of concern are presented in Table A.
Animal Metabolism
The qualitative nature of the residue in milk and ruminant tissues is
adequately understood. The residues of concern in fat, meat, kidney, and
liver are tebuthiuron and its metabolites 104, 106 [N-(5-(l,l-dimethylethyl)-
l,3,4-thiadiazol-2-yl)urea], 1Q8 p-dimethylemyl-S-arnino-l^^-thiadiazole]
and 109. The terminal residues of concern in milk are tebuthiuron and its
metabolites 104, 104(OH) [N-(5-(2-hydroxy-1,1 -dimethylethyl)-1,3,4-
thiadiazol-2-yl)-N-methylurea], 106, 109, and 109(OH) [N-5-(2-hydroxy-l,l-
12
-------
dimethylethyl)-1,3,4-tMadiazol-2-yl]-N'-hydroxymethyl-N-methylmnea]. A
poultry metabolism study is not required since grasses are not considered to
be poultry feed items. The molecular structures of the metabolites of
concern are presented in Table A.
Residue Analytical Method
An adequate method is available for the enforcement of plant
commodity tolerances. A GLC method with flame photometric detection is
designated as Method II in PAM Vol. II. Tebuthiuron and metabolites 104
and 109 are thermally degraded on the GLC column and are determined as 5-
(1 J-dimethylethyl)-N-memyl-13,4-thiadiazol-2-amine; metabolite 103(OH) is
determined as 5-(2-hydroxy-l,l-dimethylethyl)-N-methyl-l,354-thiadiazol-2-
amine. The stated detection limits are 0.1 ppm for tebuthiuron and metabo-
lites 104 and 109, and 0.2 ppm for metabolite 103(OH).
A revised enforcement method for milk, to include hydrolysis steps and
the determination of metabolites 104(OH) and 109(QH), and a revised
enforcement method for animal tissues, to include hydrolysis steps and the
determination of metabolite 108, are under development by DowElanco. A
validation of these methods is required. Data are outstanding and due to the
Agency by 4/29/94. These data are considered confirmatory because an
adequate method (GC/flame photometric detector) exists to determine
tebuthiuron and some metabolites (104, 106, and 109) in milk and ruminant
tissue until a more inclusive method is submitted and validated. The existing
method is listed as Method 1 in PAM, Vol. II. The new enforcement method
is needed primarily to determine additional metabolites of lexicological
concern.
13
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Table A, The chemical structures of the metabolites of concern of tebuthiuron.
Structure
Metabolite: Chemical name
Structure
Metabolite: Chemical name
CH
CH
H
CH
OH
103 {OH): N-[5-(2-hydroxv-1,l-dimethylethyI)-
l,3,4-thiadiazol-2-yl]-N,N'-dimethylurea
N—N
108: 2-dimethytethyl-5-amino-1 ,3,4-thiadiazole
H C "'
CH
CH
H
N N
104; N-I5-(1 ,1-dimethylethyl)-1 ,3»4-thiadiazol-2-
yll-N-methylurea
N-
109: N-I5-(1,1-dimethylethyI»-1 ,3,4-thiadiazol-2-
yU-N'-hydroxymethyl-N-methylurea
CH,
H.C 3
CH
CH
HC 3
CH
H
OH
104 (OH): N-[5-(2-hydroxy-1,1-dimethylethyD-
1 ,3,4-thiadiazol-2-yl]-N-methylurea
OH
A [109 (OH)]: N-f5-(2-hydroxy-1,1-dimethylethyl}-
1,3,4-thiadia2oI-2-yI]-N'-hydroxymethyl-N-
methylurea
CH,
H 3
H
N—N o
106; N^5-n,1-dimethy!ethy!M,3,4-thiadiazol-2-
yljurea
14
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Storage Stability
Storage stability data indicate that residues of tebuthiuron and its
metabolites containing the thiadiazole moiety [103(OH), 104, and 109] are
stable in/on grass forage and hay for up to 29 months at -20° C. Storage
stability data for animal commodities remain outstanding. These data are
considered confirmatory.
Magnitude of the Residue in Plants
All data requirements for the magnitude of the residue in plants have
been evaluated and deemed acceptable-
Magnitude of the Residue in Meat, Milk, Poultry and Eggs
Data requirements pertaining to magnitude of the residue in animal
commodities remain outstanding; a feeding study with ruminants is currently
being conducted and is due to the Agency by 4/29/94. A feeding study with
poultry is not required since grasses are not considered to be a feed item of
poultry. An existing ruminant feeding study is considered inadequate because
the feeding level was only about 30% of the anticipated dietary burden and
because not all metabolites of concern were determined. However, based on
an extrapolation of the findings of that study and on the total radiolabeled
residue levels found in the nature of the residue study, it can be concluded
that total tebuthiuron residues in ruminant meat and milk are not likely to
exceed the current tolerances by a significant amount. The outstanding data
on residues in meat and milk are therefore considered confirmatory.
Confined/Field Rotational Crops
Data pertaining to confined/field rotational crops are not required.
b. Occupational and Residential Exposure
Mixer/Loader/Applicator Exposure (Pesticide Handlers)
There is a potential for handler exposure to mists and aerosols
generated during spray applications of the wettable powder and dry flowable
formulations and to dusts generated during the granular and pelleted
formulation applications. Exposure is via the dermal and inhalation route.
There is also the potential for exposure as a result of the normal mix-
ing/loading operations. Thus, tebuthiuron meets EPA's exposure criteria for
requiring mixer/loader/applicator data.
However, according to the current toxicity database, this chemical does
not meet any of EPA's acute or chronic toxicity criteria for the requirement
15
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of mixer/loader/applicator exposure monitoring data. Therefore,
mixer/loader/applicator data are not required to support the reregistration of
tebuthiuron.
Postapplication/Reentry Exposure (Workers)
The potential for postapplication exposure to tebuthiuron residue is low
because it is applied to sites where postapplication/reentry is unlikely. In
addition, since this chemical may cause adverse effects to non-target plants,
label directions contain warnings not to apply tebuthiuron to areas such as
residential lawns, landscaped areas, patios, driveways, tennis courts, and
swimming pools. Tebuthiuron does not meet EPA's exposure or toxicity
criteria for the requirement of postapplication/reentry data. Therefore,
postapplication/reentry data are not required to support the reregistration of
tebuthiuronj
3. Risk Assessment
The data available on the toxicological effects of tebuthiuron in animals are
sufficient for assessing human risks.
In acute toxicity studies, tebuthiuron is moderately toxic by the oral route (toxicity
categories = III in mice and dogs, II in rats, and II in cats and rabbits), practically non-
toxic by the dermal route (Toxicity Category IV), and only slightly toxic by the
inhalation route (Toxicity Category III). Tebuthiuron is not a dermal irritant, causes
only a slight irritation to the eyes (Toxicity Category IV), and is not a dermal sensitizer.
Tebuthiuron does not appear to cause any adverse developmental or reproductive
effects. It is classified as a Group D carcinogen (not classifiable as to human
carcmogenicity). The available data indicate that tebuthiuron does not appear to be
mutagenic.
a. Dietary
Toxicological Endpoints
The Dietary Risk Evaluation System (DKES) chronic analysis used a
Reference Dose (RfD) of 0.07 mg/kg/day, based on a NOEL of 7.0 mg/kg/day and
an uncertainty factor of 100. The NOEL was derived from a two-generation
reproduction study in rats which demonstrated depressed body weight gain in Fl
females at 14 mg/kg/day. The OPP RfD Committee did not recommend an acute
dietary analysis.
16
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Residue Data
The DUES chronic analysis used tolerance level residues and 100 percent
crop treated information to estimate the Theoretical Maximum Residue Contri-
bution (TMRC) for the overall U.S. population and 22 DKES subgroups. All
published tolerances are listed in the Tolerance Index System (TIS) and 40 CFR
§180.390. Tolerances exist for tebuthiuron use on grass hay and forage as well as
secondary residues in meat of cattle, goats, horses, and sheep and in milk. A
tolerance reduction from 20 ppm to 10 ppni was recommended for grass hay and
forage based on data showing that combined residues of tebuthiuron and its
regulated metabolites did not exceed 10 ppm on any grass forage or hay sample in
field trials conducted under label conditions. No recommendation was made for
the reassessment of the meat and milk tolerances. At this time there are no
pending tolerances for tebuthiuron.
Results
The TMRC for the overall U.S. population from all tolerances is 6.4 x 1Q~3
mg/kg/day, which represents 9% of the RfD. The recommended tolerance
reduction on grass hay and forage does not affect the TMRC since no change was
made to any meat or milk tolerances. The subgroup most highly exposed, non-
nursing infants (< 1 year), has a TMRC from all tolerances of 2.3 x 10~2
mg/kg/day, or 32% of the RfD. The children (1-6 years) subgroup has a TMRC
from all tolerances of 1.5 x 10"2 mg/kg/day, which represents 21 % of the RfD.
Conclusions/Recommendations
The dietary analysis for tebuthiuron presents a worst-case estimate of the
chronic dietary risk by using tolerance level residues and 100 percent crop treated
assumptions for all commodities. The dietary risk from exposure to tebuthiuron
(including published tolerances on meat and milk) appears to be minimal.
b. Occupational and Residential
Conclusions
As discussed above (Section B.2.b), there is a potential for mix-
er/loader/applicator dermal and inhalation exposure to tebuthiuron. Occupational
risks are, however, considered to be minimal due to its low toxicity [acute toxicity
category IV by dermal route and III by inhalation route, negative for
developmental and reproductive adverse effects, and classification as a Group D
carcinogen (not classifiable as to human carcinogenicity)].
17
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C. Environmental Assessment
4. Environmental Fate
All laboratory environmental fate data requirements necessary to support the
reregistration of tebuthiuron for the uses set forth in this RED have been satisfied.
Required terrestrial field dissipation studies (164-1 and 164-5), have not yet been
submitted; these studies are due to the Agency by 7/31/94. It is unlikely, though, that
additional information supplied by these studies would change the overall assessment of
the degradation, mobility, or accumulation of tebuthiuron in the environment. The
Agency, therefore, has sufficient information at this time to provide an overall
qualitative assessment for tebuthiuron.
a. Environmental Chemistry, Fate and Transport
Additional studies reviewed since the 1987 Registration Standard are as
follows:
Photodegradation in water
Tebuthiuron did not photodegrade in sterile aqueous buffered (pH 5) solu-
tions that were continuously irradiated for 33 days with a xenon light source at
approximately 25 °C. Tebuthiuron was the only compound identified in the
irradiated and dark control solutions at all sampling intervals. At 33 days
posttreatment, tebuthiuron comprised 96,3-97.0% and 99.7-100.1% of the
recovered radioactivity in the irradiated and dark control solutions, respectively.
(MRID 41328001)
The Agency concludes that tebuthiuron is stable to photodegradation in
water.
Aerobic soil metabolism
In a 9-month study, thiadiazole-labeled 14C tebuthiuron, at a concentration of
6 ppm in sandy loam soil incubated in darkness at 24 °C and 75% of field moisture
capacity, degraded with a half-life (calculated by the registrant) of 35.4 months.
The degradates identified by two-dimensional TLC were N-[5-(l,l-dimethylethyl)-
13,4-thiadiazol-2-yl3-N-methylurea (compound 104), N-[5-(l»l-dimethylethyl)-
l,3,4-tMadiazol-2-yl]-N'-memylurea (compound 105), 5-(l,l-dimethylethyl)-2
methylamino-l.S^-thiadiazol (compound 107), and 5-(l,l-dimethylethyl)-2 amino-
1,3,4-thiadiazol (compound 108). The concentration of compound 104, which
accounted for 6.9% of the applied radioactivity after 9 months of incubation, ap-
peared to be increasing at the end of the experiment. (MRID 41328001)
The Agency concludes dial tebuthiuron is stable to aerobic soil metabolism
and will persist in an aerobic soil environment.
18
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Anaerobic soil metabolism
Following 30 days of aerobic incubation at 24 + 1°C and 75% of 0.33 bar
moisture capacity and 60 days under flooded conditions in a sandy loam soil,
thiadiazol-labeled 14C tebutMuron (nominal concentration 6 ppm) exhibited very
little metabolism. After 60 days of anaerobic incubation, the concentration of
parent tebuthiuron had decreased 4.7% from the concentration at initiation of
flooding. Degradates identified were N-[5-(l,l-dimethylethyl)-l,3,4-tMadiazol-2-
yl]-N-methylurea (compound 104), N-[5-(l,l-dimethylethyl)-l,3»4-thiadiazol-2-yl]-
N'-methylurea (compound 105), and N-[5-(l,l-dim.ethylethyl)-l}3,4-ihiadiazol-2-
yl]-N-methyl-N'-hydroxymethyl-urea (compound 109). (MRID 41328002)
The Agency concludes that tebuthiuron is stable to anaerobic soil metabolism
and is likely to persist in an anaerobic soil environment.
Anaerobic aquatic metabolism
Tebuthiuron degraded with a half-life (calculated by the registrant) of > 1
year in an anaerobic system containing pond water and sediment incubated for 365
days in darkness at 25.5 ± 0.8°C. During the study there was very little degrada-
tion of tebuthiuron, with 93.7% of the applied radiocarbon remaining as parent
material at day 365. Degradates were reported to comprise approximately 1.4% of
the applied radioactivity at the termination of the study. (MRID 41913101)
The Agency concludes that tebuthiuron is stable to anaerobic aquatic
metabolism and is likely to persist in an anaerobic aquatic environment.
Aerobic aquatic metabolism
Tebuthiuron did not degrade appreciably in pond water and sediment that was
incubated in darkness at 24 Ji 1°C for 4 weeks under aerobic conditions. After 4
weeks of incubation, 95.2% of the applied radioactivity was present in parent
tebuthiuron. Degradates identified by two-dimensional TLC were N-[5-(l,l-
dimethylethyl)-l,3,4-thiadiazol-2-yl]-N-methylurea (compound 104), N-[5-(l,l-
dimethylethyl)-l,3,4-thiadiazoI-2-yl]-N'-methylurea (compound 105), 5-(l,l-
dimethylethyl)-2 methylamino-i,3,4-thiadiazole (compound 107), 5-(l,l-dimethyl-
ethyl)-2 amino-l,3.4-thiadia20le (compound 108), and N-[5-(l,l-dimethylet!iyl)-
1,3,4-thiadiazol-2-yl] -N-methyl-N '-hydroxymethyl-urea (compound 109). (MRID
41372501)
The Agency concludes that tebuthiuron is stable to aerobic aquatic
metabolism and is likely to persist in water and sediment in an aerobic aquatic
environment.
19
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Bioaccumulation in fish
In a 28-day flow-through study in which bluegill sunfish were exposed to a
nominal tebuthiuron concentration of 5.0 ppm, bioconcentration factors of 1.98,
3.40, and 2.63 were reported for edible tissue, nonedible tissue, and whole fish,
respectively. Residues in the tissues consisted primarily of tebuthiuron and two
metabolites (N-[5-(l, l-dimethylethyl)-l,3,4-tMadiazol-2-yl]-N-methyl-N'-
hydroxymethyl-urea [compound 109]) and compound 103(OH), an hydroxylated
form of parent tebuthiuron). Accumulated residues depurated rapidly from fish
tissue with depuration half-lives of 0.33 and 0.51 days reported for edible and
nonedible tissue, respectively. (MRID 40819501)
Based on the study submitted and the reported octanol/water coefficient (log
K,,w = 1.79), the Agency concludes that there is slight potential for tebuthiuron
residues to accumulate in fish.
Small Scale Retrospective Ground Water Monitoring Study
A small-scale retrospective ground water monitoring study was performed on
a ranch near Sarita, Texas, that had last been treated with, tebuthiuron on March
24, 1986. The results of the study indicated that tebuthiuron was persistent and
mobile enough to leach at least 15 feet to the water table, then still be present
above minimum detection levels more than 4 years after the application.
The extensive site characterization gives a high level of confidence that this
study was performed with a reasonable "high exposure" scenario. The site is
comprised of eolian sands over fluvial deposits. Monitoring wells were installed to
avoid discontinuous, restrictive clay layers that are found at some portions of the
site.
Sampling was discontinued after data showed that, in areas where restricting
soil layers did not impede downward flow of ground water, tebuthiuron had
leached and was still present in ground water at concentrations of up to 23 parts
per billion (ppb). Twenty-three parts per billion is high compared to other
herbicides that are also ground water contaminants and applied at the same rate.
Pesticide Root Zone Modeling (PRZM) of the study site predicted that tebuthiuron
would quickly leach to the water table through sandy soils with little organic
matter. However, PRZM did not accurately predict the persistence in the soil's
unsaturated zone for tebuthiuron over time.
Soil sampling at and near the study site showed convincingly that tjebuthiuron
can persist at relatively high concentrations in soil and soil water if restrictive
layers block leaching to the ground water. (MRID 42390901)
The Agency concludes that tebuthiuron is persistent and mobile and can leach
to ground water.
20
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b. Environmental Fate Assessment
Based on acceptable eriWlSWttffiniil fate laboratory data reviewed in the 1987
Registration Standard and data submitted and reviewed subsequent to the
Registration Standard, tebuthiuron is persistent and mobile. The principal route of
dissipation appears to be transport to ground and surface water, Tebuthiuron is
stable to hydrolysis and photodegradation in water (tVi = much greater than 30
days). It has a soil photolysis half-life of 39.7 days. Tebuthiuron is metabolized
very slowly in soil under aerobic (tlA ~ 35.4 months) and anaerobic conditions
(tlA = much greater than 60 days). In aerobic and anaerobic aquatic metabolism
studies, tebuthiuron's respective half-lives were much greater than 1 month and
> 1 year. Tebuthiuron is very mobile to mobile (K^ for sand, sandy loam, loam,
and clay loam soils were 0.11, 0.62, 0.82, and 1.82, respectively). The
compound's KK was reported as 4. In addition, aged leaching data indicate that
one metabolite, N-[5-(l , l-dimethylethyl)-l ,3 ,4-thiadiazol-2-yl]-N-methylurea
(compound 104) has similar mobility to parent tebuthiuron. Terrestrial and aquatic
field dissipation studies have not been submitted, however, an interim terrestrial
field dissipation report supports the results of the laboratory studies. In California,
Nebraska, and Florida field half-lives were estimated at 1-2 years. In CA and NE,
tebuthiuron moved into the 6-12" soil depth, with small quantities detected at 12-
18" and 18-24". In a FL soil (92% sand), tebuthiuron leached to a depth of
>72". Tebuthiuron has slight potential to accumulate m fish with bioconcentration
factors of 1.98, 3.40, and 2.63 reported for edible tissue, nonedible tissue, and
whole fish, respectively. Accumulated residues depurated rapidly.
Degradation products identified in laboratory studies were N-[5-(l,l-
dimethylethyl)-l,3,4-thiadia2ol-2-yl]-N-methylurea (compound 104), N-[5-(l,l-
dimethylethyl)-l,3,4-thiadiazol-2-yl]-N'-methylurea (compound 105), 5-(l,l-
dimethylethyl)-2 methylamino-l,3,4-thiadiazol (compound 107), 5 -(1,1-
dimethylethyl)-2 armno-l,3,4-thkdiazol (compound 108), and N-[5-(l,l-
dimethylemyl)-l53,4-thiadiazol-2-yl3-N'-(hydroxymemyl)-N-me(iylurea (compound
109). After 9 months of aerobic soil incubation, compound 104 accounted for
6.9% of the applied radioactivity. This was the highest concentration of any
degradation product identified in the laboratory studies.
In summary, tebuthiuron is resistant to biological and chemical degradation
under environmental conditions. Its principal route of dissipation in the
envkonment appears to be mobility; transport to ground water (through leaching)
and surface water (solubilize in runoff) are likely to occur after the application of
tebuthiuron. Laboratory data indicate that photodegradation on soil may occur
slowly but is not likely to be a route of dissipation in the environment. Transport
to ground water (through leaching) and surface water (following runoff) are likely
as a result of tebuthiuron's persistence and low adsorption to soil. According to
the Pesticides in Ground Water Database (1992), tebuthiuron has been detected in
ground water in Texas (two wells) and California (one well). A small-scale retro-
spective ground-water study indicates that tebuthiuron is persistent and mobile and
21
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can leach to ground water. Moreover, the results of the study indicated that
tebuthiuron was persistent and mobile enough to leach at least 15 feet to the water
table, then still be present above minimum detection levels more than 4 years after
the application.
5. Ecological Effects
All ecological effect data requirements necessary to support the reregistration of
tebuthiuron 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 tebuthiuron, [Required terrestrial and aquatic field studies (124-1 and
124-2) have been waived; however, the Agency reserves the right to require these
studies, at a later date, if it is determined that a regulatory decision cannot be made in
the absence of these studies.]
a. Ecological Effects Data
The ecotoxicological data base is adequate to characterize the toxicity of
tebuthiuron to nontarget terrestrial and aquatic organisms when used on terrestrial
feed and terrestrial nonfood sites.
(1) Terrestrial Data
In order to establish the toxicity of tebuthiuron 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).
Avian Acute Toxicity
Species
Mallard duck
% Test
Material
(TGAI)
98
LD50
>20GO mg/kg
Conclusions
practically non
toxic
Based on acute toxicity data, tebuthiuron is practically non-toxic to
birds. An avian acute oral study performed on the mallard duck resulted in a
LD50 value of greater than 2000 mg/kg. (MRID 00041692)
22
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Avian Subacute Toxicity
Species
Bobwhite Quail
Mallard Duck
% Test
Material
99,1
99.1
LC50
>5113 ppm
>5093 ppm
Conclusions
practically non toxic
practically non toxic
On a subacute dietary basis, tebuthiuron is practically non toxic to
birds. Two studies, one on the mallard duck and one on the bobwhite quail
produced LCSOs >5000 ppm. (MRlDs 40601002, 40601001).
Avian Reproduction
Avian reproduction studies are required when birds may be exposed
repeatly or continuously through persistence, bioaccumulation, or multiple
applications, or if mammalian reproduction tests indicate reproductive
hazard. Tebuthiuron is a persistent herbicide; in areas of low precipitation, it
has been estimated that the time required for tebuthiuron to reach a non-
detectable level in soils from decomposition is between 3 and 7 years.
Species
Bobwhite quail
Mallard duck
% A.I.
96.4
96.4
NOEL
no repro. effect at up to 100 ppm
no repro. effect at up to 100 ppm
Two avian reproductive studies, one on the bobwhite quail and one on
the mallard duck show no effect on reproduction at dietary levels up to 100
ppm. (MRIDs 00104243, 00093690).
Toxicity to Nontargct Mammals
The available mammalian data indicate that tebuthiuron is slightly to
moderately toxic to small mammals on an acute basis.
. SPECIES
Mouse (female)
Rat (female)
Rabbit
LDM(mg/kg)
>528 < 620
387.5
286
Regarding chronic toxicity, a two-generation reproduction study with
23
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rats produced a NOEL of 100 mg/kg/day and a LOEL of 200 mg/kg/day.
(2) Aquatic Data
Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater fish, the
minimum data required on the technical grade of the active ingredient are
two freshwater fish toxicity studies. One study should use a coldwater
species (preferably the rainbow trout) and the other should use a warmwater
species (preferably the bluegill sunfish).
Species
Rainbow trout
Bluegill sunfish
% Test
Material
(TGAI)
98
98
LC50
143 ppm
106 ppm
Conclusions
practically non toxic
practically non toxic
Two 96-hour acute toxicity studies show that tebuthiuron is practically
non-toxic to fish, with LC50 values of 143 mg/1 for rainbow trout and 106
mg/1 for bluegill sunfish, (MRID 00020661)
Freshwater Fish Toxicity - Acute Studies with Formulated End-Use
Products
Formulated product testing on fish may be required when a pesticide is
applied directly to water. Since tebuthiuron is not applied directly to water,
these data are not currently required. Two fish toxicity studies using
formulated products have been submitted, however, and are discussed below
for informational purposes only.
A 96-hour LCW study performed on the fathead minnow shows that an
80% WP formulation is practically non-toxic to fish with an LC50 value of
greater than 180 ppm. (MRID 00041685)
A 96-hour LCSO study performed on the fathead minnow shows that a
20% P/T formulation is practically non-toxic to fish with an LC50 value of
greater than 180 ppm. (MRID 00041685)
Fish Early Life Stage
A fish early life stage test is required when a product is applied directly
to water or is expected to be transported to aquatic sites and 1) exposure of
24
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aquatic organisms will be continual or recurrent; or 2) the lowest LC50 is 1
mg/1 or less; or 3) the EEC in, water is equal to or greater than 0,01 of any
LC5G; or 4) if the EEC is l&s than any LC50 and the product has
reproductive effects on, or cumulative effects in aquatic organisms or has a
half-life in water greater than 4 days.
Tebuthiuron is highly soluble in water (2500 ppm) suggesting a high
potential for transport from the application site. Tebuthiuron is also stable to
photolysis and hydrolysis (tl/2 much greater than 30 days at pH 3, 6, and 9).
Pasture and rangeland are use sites which potentially allow for pesticide
transport to water.
Species
Fathead minnow
{embryo-larvae)
Rainbow trout
(embryo- larvae)
% A.I.
98
98
Results
MATC (growth) >9.3 <18
unaffected at <76 mg/1
MATC (growth & survival)
mg/1; survival
>26 <52mg/l
An early life-stage study performed with the rainbow trout shows that
survival and growth are impaired at environmental concentrations of < 52
mg/1. The MATC (Maximum Allowable Toxic Concentration) is > 26 <
52 mg/1. The fathead minnow early life-stage study shows survival to be
unaffected at concentrations as high as 76 mg/1, whereas growth is impaired
at *£ 18 mg/1. The MATC for the fathead minnow is >9.3 < 18 mg/1.
(MRIDs 00090084, 00090083).
Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a pesticide is a
freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early insiar amphipods, stoneflies, mayflies, or midges.
Species
Daphnia magna
% Test
Material
(TGAI)
99.2
LC50
297 ppm
Conclusions
practically non-toxic
There is sufficient information to characterize tebuthiuron as practically
non-toxic to aquatic invertebrates. (MRID 00041694).
25
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Aquatic Invertebrate Life Cycle
A freshwater invertebrate life-cycle test is required when a product is
applied directly to water or is expected to be transported to aquatic sites and
1) exposure of aquatic organisms will be continual or recurrent; or 2) the
lowest LC50 is 1 mg/1 or less; or 3) the EEC in water is equal to or greater
than 0.01 of any LC50; or 4) if the EEC is less than any LC50 and the product
has reproductive effects on, or cumulative effects in, aquatic organisms or
has a half-life in water greater than 4 days.
As discussed previously under fish early life stage testing requirements,
there is a high potential for transport of tebuthiuron from the application site.
Species
Daphnia magna
% A.I.
97,4
Results
MATC (growth and fecundity)
ppm
>21,8 < 44.2
An aquatic invertebrate life-cycle test performed with Daphnia magna
shows a significant reduction in growth and fecundity at >44.2 mg/1. The
MATC (Maximum Allowable Toxic Concentration) is >21.8 <44.2 ppm.
(MUD 00138700)
Estuarine/Marine Toxidty
Acute toxicity testing with estuarine and marine organisms is required
when an end-use product is intended for direct application to the
marine/estuarine environment or is expected to reach this environment in
significant concentrations. The large-scale use of tebuthiuron on rangeland
may result in exposure to the estuarine environment.
The requirements under this category include a 96-hour LC50 for an
estuarine fish, a 96-hour UCX for shrimp, and either a 48-hour embryo-
larvae study or a 96-hour shell deposition study with oysters.
Species
Eastern oyster
Pink Shrimp
% Test
Material
(TGAI)
98
98
LC50
> 180 < 320
PPm
62 ppm
Conclusions
Practically non-toxic
Slightly toxic
There is sufficient information to characterize tebuthiuron as practically
26
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non-toxic to oyster embryos and slightly toxic to pink shrimp. The guideline
requirement for testing with a marine or estuarine fish species is waived due
to the demonstrated low todcity <3*f tebuthiuron to freshwater fish as well as
marine and freshwater invertebrates, (MRID 0004168)
Field Monitoring Studies
Field monitoring studies may be required on a case-by-case basis
depending on the intended use pattern of the chemical, the toxicity to non-
target organisms, and pertinent environmental fate characteristics.
Tebuthiuron is extremely persistent in the soil, especially in areas of low
precipitation. Tebuthiuron is also highly soluble in water, suggesting a high
potential for transport from the application site. When applied over extensive
areas, as in the case of rangeland brush control, tebuthiuron would seem to
have a high potential for contamination of aquatic systems within the
watershed. For these reasons, monitoring studies measuring residues in
runoff waters, hydrosoil, and catchment ponds were required.
Instead of a single monitoring study, several studies were submitted by
the registrant. The acceptable field monitoring studies are summarized in the
following table;
Location
Boise, Idaho
Arizona
Hondo, Texas
Marietta,
Oklahoma
Application
Rale
l.Olbai/A
3.0 Ib ai/A
2.0 Ib «i/A
2.0 Ib si/A
Maximum Residues
Catchment pond = 12 ppb. Weir (runoff from entire
watershed) = 14 ppb. Spring = 7 ppb.
Weir pond = 33 ppb. Weir (renoff from entire
watershed} = 54 ppb.
Catchment pond = 70 ppb. HydrosoiJ = 70 ppb.
Catchment pond = 180 ppb (following a 7" rainfall
event). Hydrosoil = 140 ppb.
Calculated % Lost
from Watershed
1.956
0.05%
0.0855
4.53%
The initial monitoring studies show that tebuthiuron moves from the
application site through runoff. It is detectable in the runoff water and in
ponds receiving runoff from the treated watershed. Maximum residue levels
in catchment ponds ranged from 12 ppb to 70 ppb under conditions of normal
rainfall. After a single rainfall event of 7 inches, tebuthiuron levels of 180
ppb were detected in one pond. Maximum levels in hydrosoil ranged from
70 ppb - 140 ppb. (MRIDs 00090097, 00090103, 00090105, 00090106,
00090107, 00090109)
In 1982, the registrant was requested to continue monitoring water and
hydrosoil at the various study sites, especially in the catchment pond at the
Marietta, Oklahoma site. This information was considered essential in order
to better determine the long-term availability of tebuthiuron for runoff into
27
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aquatic systems and the likelihood of long-term buildup of tebuthiuron in the
hydrosoil.
In 1988, the registrant submitted supplemental information for the four
field monitoring studies which documented changes in residue levels until
1984. The Agency reviewed the supplemental information and indicated that
tebuthiuron is "a persistent herbicide with a propensity for solubilizing in
runoff water three years or longer after application," and that "tebuthiuron is
lost over time (3 years) such that the concentrations decrease to a very low
level (0,0003 ppm to undetectable)". However, residues may remain in soil
surrounding the catchments, particularly the lower soil layers. Some pellets
may not be carried to a catchment area by runoff. The studies reported
aquatic residues ranging from < 1 ppb (measured at the conclusion of the
Texas study) up to 180 ppb (measured on 5/5/81 hi the Oklahoma study) and
hydrosoil residues from < 50 ppb up to 140 ppb. (MRIDs 40640002,
40640004, 40640001, 40640003)
This series of studies, when taken together, provide adequate
environmental monitoring information and can be used to satisfy the field
monitoring data requirement (70-1). However, these studies can only be
considered valid for use patterns with a single application; they are invalid
for uses which require more than one application per year or multiple year
applications.
(3) Non-Target Insects Data
The rninimum data required to establish the acute toxicity to honey bees
is an acute contact LD50 study with the technical material.
Species
Apis Mellifera
% Test
Material
99.1
LD50
> IQOug/bee
Conclusion
Practically non-toxic j
There is sufficient information to characterize tebuthiuron as practically
non-toxic to bees. (MRID 40840401).
(4) Non-Target Plants Data
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. The above conditions apply to tebuthiuron (refer to Section
IV.B.4, Endangered Species)
28
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Aquatic plant testing is required for any herbicide applied to terrestrial
nonfood (rights-of-way) or aquatic nonfood (except residential) as in the case
of tebuthiuron. The following species should be tested: Selenastrum
capriconiutum, Lemna gibba, Skeletonema costatum, Anabaenaflos-aquae,
and a freshwater diatom.
Tier 1 toxicity data on the technical material are listed below:
Species
Seed Germination (10
species)
% A.I.
99.6
EC50
NOEL >
6 Ibs a. U Acre
Seed germination testing at the Tier II level is not required as none of
the terrestrial species tested at the maximum label rate exhibited a 25% or
greater detrimental effect as compared to the control.
The acceptable Tier II toxicity data on the technical material are listed
below:
Species
Anabaena flat -aquae
Sketetonema costatum
Navicula pelllatlosa
Lemna gibba
Setenastnun capricomutum
Seedling emergence & Vegetative
Vigor (10 species)
% AI
99.08
99.08
99.08
99,08
98
99.6
EC*
4.06 ppm (Bay 5)
0.05 ppm (Day 5)
0.081 ppm (Day 5)
0.135 ppm (Day 14)
0.05 ppm (Day 5)
ECU for radish, cabbage, cucumber and wheat = 0.05, 0.03,
0.06, 0.07 Ib ai/A
b. Ecological Effects Risk Assessment
1. Risk to Terrestrial Organisms
Avian and mammalian species will be exposed to tebuthiuron through
the consumption of insect and plant food material containing tebuthiuron
residues or by directly consuming tebuthiuron granules.
a. Acute Effects
The maximum application rate for tebuthiuron, 6 Ibs ai/A, is found on
labels for terrestrial nonfood crop use. As tebuthiuron is applied as a
pelleted or granular formulation for this use pattern, the LD^, value was
29
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chosen for the toxicity analysis because birds and mammals encounter
granules as discrete doses, The number of LDso's/sq. ft. was calculated for a
broadcast application (6 Ibs ai/A) with no soil incorporation.
mg/sq ft = appl. rate (ai Ibs/A) x 453.590 mg/lb
43,560 sq ft/acre
Single dose = mg/sq ft
LD50/sq ft LD50 mg/kg x weight of bird (kg)
mg/sq ft=6 Ibs ai/A x 453.590 mg/lb = 62.5 mg/sq ft
43,560 sq ft/acre
Single dose = 62.5 mg/sq ft = 0.03
LD50/sq ft 2,000 mg/kg x 1.082 kg (mallard)
The number of LDsos/sq ft was 0.03 for the mallard. As this number falls
below both the Restricted Use Classification (0.2 LD30s/sq ft) and the endangered
species level of concern (0.1 LDsos/sq ft), acute hazard to nontarget avian species
is not expected from a granular/pelleted application at ^ 6 Ibs a.i./A.
The maximum use rate for tebuthiuron in a wettable powder form is 6 Ibs
a.i./A, After a direct application to vegetation at this use rate, the expected
residue levels on various avian food items would range from 42 to 1440 ppm.
Since tebuthiuron is considered practically nontoxic to birds on a dietary basis
(LCSO >5000 ppm), acute hazard to avian species is not expected from a wettable
powder application at <_ 6 Ibs a.i./A.
While tebuthiuron is practically nontoxic to avian species on an acute basis,
the existing data indicate that it is slightly to moderately toxic to mammals. A
rabbit, for instance, could conceivably consume enough granules to reach a lethal
acute dose. The highest percent ai granular formulation for non-cropland use is a
6% formulation. If each granule contains approximately 0.006 mg ai tebuthiuron,
a LO kg rabbit (Eastern cottontail) would have to consume 47,666 granules to
receive a lethal dose of 286 mg/kg. Therefore, use of a 6 % granular formulation
on noncropland should result in minimal hazard to small mammal species such as
the Eastern cottontail.
b. Chronic Effects
Avian reproduction studies showed no adverse effects at dietary levels up to
100 ppm. When tebuthiuron is applied directly to vegetation at the maximum use
rate for wettable powders (6 Ibs ai/A), the expected residue levels on various avian
30
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food items (42 - 1440 ppm) would exceed 100 ppm. Little is known about the
persistence of tebuthiuron on plant surfaces. However, significant chronic
exposure to birds is not expected due to the following information.
About two-thirds of the total tebuthiuron use is on rangeland and pastureland.
The maximum application rate for this use pattern is 4 Ibs ai/A/year. Actual plant
residue data for forage grasses exist for a rangeland use pattern. Residue
monitoring at test sites covering a wide range of climatic, edaphic, and
geographical conditions all showed residues in grasses to be below 20 ppm.
For rangeland and pastureland use, tebuthiuron is always applied to the
ground as a pelleted/tableted formulation and is never applied directly to
vegetation. Therefore, the residue monitoring values represent tebuthiuron that is
taken up from the soil and transported to the plant tissues. These values are
probably realistic indicators of long-term exposure to avian species. As these
residue values (20 ppm) do not exceed the NOEL of 100 ppm in the avian
reproduction studies, chronic hazard to birds is not expected,
2. Risk to Aquatic Organisms
Since tebuthiuron is practically nontoxic on an acute basis to fish and aquatic
invertebrates, none of the registered uses would result in acute effects or direct
mortality to these organisms.
Of concern, however, is the potential for chronic hazard to aquatic
organisms. Two fish early life-stage studies showed that the survival and/or
growth of fish embryo-larvae are affected at levels well below 100 ppm. A fresh
water invertebrate life-cycle test shows growth and reproductive effects also at
levels well below 100 ppm.
The maximum application rate for tebuthiuron is 6 Ib ai/A. This application
rate is for a non-cropland use and represents a worst case situation. In order to
calculate an aquatic EEC, the standard scenario of a 10 acre field running off into
a one acre waterbody was employed. Since tebuthiuron is highly soluble in water
(2300 ppm), 5 percent runoff from the treated area was assumed. With 5 percent
runoff, a total of three pounds tebuthiuron is available to enter the waterbody (6
Ibs X 10 X 0.05 = 3 Ibs). The resulting expected concentrations of tebuthiuron in
a one acre body of water of various depths are as follows;
31
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Depth of Water Concentration, ppm
6 inches 2.2
1 foot 1.1
3 feet 0.4
6 feet 0.2
These estimated aquatic concentrations are well below the MATC's for
fathead minnow (> 9.3 < 18 mg/1), rainbow trout (> 26 < 52 mg/1), and
Daphnia rnagna (> 21.8 < 44,2 mg/1). Therefore, chronic hazard to aquatic
organisms is not expected.
Field monitoring studies (3 years in duration following a single application)
reported aquatic residues ranging from < 1 ppb (measured at the conclusion of
the Texas study) up to 180 ppb (measured on 5/5/81 in the Oklahoma study) and
hydrosoil residues from < 50 ppb up to 140 ppb. The studies were performed
utilizing various application rates (1-3 Ibs a.i./A) but these rates do not reflect the
worst case. The maximum label rate for tebuthiuron is 6 Ib a.i./A, Corrected for
the maximum label rate, the minimum and maximum aquatic residues found in the
studies would be < 6 ppb and 1080 ppb, respectively. Using the same reasoning
for the hydrosoil values, the tebuthiuron residues ranged from < 300 to 840 ppb.
These values indicate that at the maximum application rate of 6 Ibs. a.i./A
tebuthiuron is not expected to pose a hazard to aquatic organisms (lowest MATC
value of >9.3 < 18 ppm for the fathead minnow) assuming a maximum of one
application per 3 years,
3. Risk to Nontarget Plants
Exposure of nontarget terrestrial and aquatic plants to tebuthiuron is based on
expected runoff from an unincorporated ground application.
Terrestrial and Semi-Aquatic Plants
Terrestrial plant EEC's are calculated by estimating the
runoff from one acre treated at the maximum application rate to
an adjacent one acre site. Semi-aquatic plant EEC's are
calculated by estimating the runoff from a 10 acre site treated at
the maximum application rate to an adjacent one acre wetland
area. For example, at a maximum ground application rate of 6.0
Ibs a.i./A (noncropland, pastureland) and anticipated 5% runoff
of applied pesticide, runoff into areas adjacent to treated sites is
expected to be 0.30 Ibs, a,i./A (see table below). Runoff into a
wetland area (i.e. moist, saturated or flooded soils) away from
treated sites is expected to be approximately 3.0 Ibs a.i./A,
32
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USE SITE
Noncrop (righ!S-
of-way.
industrial, fences)
Rangeland
(receiving >20
inches of
tain/year)
Rangeland
(receiving < 20
inches of
rain/year)
MAX. AWL.
RATECLBS
AI/A)
6.0
4.0
2,0
LEVEL OF
CONCERN1
ECa = 0.03
ECsa = 0.05
ECjs = 0.03
ECOT = 0.05
ECjj = 0.03
ECa = 0.05
TERR. PLANTS
ADJACENT TO
USE SITE
EEC2
(Ibs
ai/A)
0.30
0.20
0.10
Risk
Quot.
10.0
6.7
3,3
SEMI-AQUATIC
PLANTS Di WET
AREAS AWAY
EEC2
(tbs
ai/A)
3.0
2.0
1.0
Risk
Quot.
100
67
33
AQUATIC
PLANTS
EEC"
(ppm)
0.54
0.36
0.18
Risk
Quot
10.8
7,2
3.6
1, Levels of Concern: a) terrestrial pants -lowest EC2s value (cabbage - percent emergence and weight) = 0.03 Ibs a.i./A for seedling germination
and emergence tests; this value is compared to runoff; b) aquatic plants - lowest ECM vilue from aquatic plant studies (Selenastrum caprifomutum ECM
= 0.05 pptn).
2. EEC values are based on runoff from ground applications.
3. EEC values for aquatic plants were extrapolated from the results of environmental monitoring conducted in rangelands in the southwestern UniiKl
States. The highest observed residue from the Oklahoma site (0.18 ppm in a catchment pond after 2,0 Ibs a.i./A application to watershed) was
extrapolated for 4 and 6 Ibs a.i./A applications.
A high level of concern exists for both endangered and
nonendangered terrestrial and semi-aquatic plants if the EEC exceeds
the £€25 value for the most sensitive plant species tested or, in another
words, the risk quotient is greater than one. In the above table, the
shaded areas indicate that the high level of concern for endangered and
nonendangered terrestrial and semi-aquatic plants has been exceeded for
all use patterns,
Aquatic Plants
Environmental monitoring data were considered in order to better estimate
the aquatic plant hazard from tebuthiuron. The following table summarizes the
maximum residue values found at four study sites and the extrapolated values for
the maximum application rate (6 Ibs a.i./A):
-------
Highest Observed Tebuthiuron Concentrations in Ponds
and Extrapolated Values
Study Location
Texts
Idaho
Oklahoma
Arizona
Acreage
28.9
98
11
168
Application Rale
2 Ibs si/A
lib ai/A
2 Ibs ai/A
3 Ibs ai/A
Max. Residue Values
0.07 ppm
0.002 ppm
0.18 ppm
0.05 ppm
Extrapolated Values
for 6 Ib ai/A
0.21 ppm
0.012 ppm
0.540 ppni
0.100 ppm
Data from the Oklahoma site were used as a high exposure situation. As the
extrapolated value for this site (0,54 ppm) exceeds the EC50 values of four of the
five aquatic plant species tested, the high level of concern for aquatic plants has
been exceeded.
To further assess the potential hazard .to aquatic plants, an estimated
environmental concentration (EEC) was calculated for tebuthiuron on both
rangeland and pastureland using the models PRZM 2,0 and EXAMS 2.94. For the
rangeland scenario, a site in Oklahoma was chosen as representative of an area
receiving less than 20 inches of annual rainfall. Tebuthiuron was applied in a
pelleted form at 2 Ibs ai/A (the maximum application rate for rangeland receiving
< 20 inches of rainfall per year). For the pastureland scenario, a site in New
York was chosen as representative of an area receiving > 20 inches of rainfall per
year, Tebuthiuron was applied in a pelleted form at 6 Ibs ai/A (the maximum
application rate for a pasture receiving > 20 inches of rainfall per year). The
standard one hectare waterbody, two meters deep was used in both scenarios.
In the Oklahoma rangeland scenario, the one in ten year maximum 4-day
EEC for tebuthiuron was 0,36 ppm (range of 0.096 to 0.37 ppm). This value is
greater than both the unrefined aquatic EEC (0.183 ppm) and the results from
residue monitoring at the Oklahoma site (0.180 ppm). The New York pastureland
scenario produced a one in ten year 4-day maximum EEC of 0,92 ppm tebuthiuron
(range of 0.24 to 0.96 ppm).
In both scenarios, the one in ten year maximum EEC exceeds the ECsos for
four out of the five aquatic plant species tested. As tebuthiuron has an extremely
long half-life in aerobic soils (t1/2 — 36 mo.), 80% of the amount applied remains
one year after application and 63% of this amount remains two years after
application. Thus, even when tebuthiuron is applied every other year, its dissolved
concentration in pond water steadily increases over the 36 year simulation.
In conclusion, a high level of concern exists for both endangered and
nonendangered aquatic plants if the EEC exceeds the ECW value for the most
34
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sensitive plant species tested or, in another words, the risk quotient is greater than
one. In the above table, the shaded areas indicate that the high level of concern
for endangered and nonendangered Efuatie plants has been exceeded for all use
patterns of tebuthiuron. Successive applications of tebuthiuron will compound this
hazard due to the extremely long half-life of this chemical. Results from
environmental monitoring studies indicate that tebuthiuron is lost over time (3
years) such that concentrations decrease to a very low level (0,0003 ppm to
undetectable). Therefore, restriction of tebuthiuron applications to once every
three years may reduce the risk to nontarget plants. However, as residues may
remain in the soil surrounding catchments, there is a potential for tebuthiuron to
solubilize in runoff water three years or longer after application.
4. Risk to Endangered Species
Based on the conclusions in the preceding sections of this document, all
registered uses of tebuthiuron pose a significant risk to off-site endangered
terrestrial, semi-aquatic, and aquatic plant species. Furthermore, all endangered
plant species inhabiting certain use areas (i.e. rights-of-way and rangelands) are
likely to be jeopardized as they may receive a direct application of tebuthiuron.
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 tebuthiuron as the active ingredient. The Agency has
completed its review of these generic data, and has determined that the data are sufficient to
support reregistration of all products containing tebuthiuron. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of tebuthiuron, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of tebuthiuron and to determine that tebuthiuron can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing tebuthiuron 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 and the data identified in Appendix B. Although the Agency has found that
all uses of tebuthiuron 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
35
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support the registration of products containing tebuthiuron, 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 ingredient tebuthiuron, the
Agency has sufficient information on the health effects of tebuthiuron and on its potential for
causing adverse effects in fish and wildlife and the environment. Based on this information,
the Agency concludes that products containing tebuthiuron for all registered uses are eligible
for reregistration.
The Agency has determined that tebuthiuron products, labeled and used as specified in
this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects to
humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all registered uses of tebuthiuron are eligible for
reregistration,
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for tebuthiuron.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
The available data for grass forage and hay support a reduction in the established
tolerances from 20 ppm to 10 ppm.
The adequacy of the established tolerances for milk, and the fat, meat, and meat
byproducts of cattle, goats, hogs, horses, and sheep cannot be fully assessed until the
required feeding study is submitted and reviewed. Extrapolation of residue data from a
0.3X cattle feeding study indicates that the established meat, fat, and meat byproduct
tolerances will not be exceeded. No feeding study data are available for milk., but
results of the nature of the residue study in niminants show that established tolerance for
milk will not be exceeded. The Agency used existing tolerances to estimate risk, and
considers the feeding study confirmatory data.
Existing tolerances for the herbicide tebuthiuron and its metabolites containing the
dimethylethyl thiadiazole moiety are currently established in 40 CFR §180.390. The
reassessment of the established tolerances is summarized in Table A. below.
36
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Table A. Tolerance Reassessment Summary
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Correct Commodity
Definition
Cattle, fat
Cattle, mbyp
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Grass, hay
Grass, rangeland, forage
Horses, fat
Horses, mbyp
Horses, meat
Milk
Sheep, fat
Sheep, mbyp
Sheep, meat
2
2
2
2
2
2
20.0
20
2
2
2
0.3
2
2
2
10
10
Grass, forage
The 40 CFR tolerance expression under §180.390 should be modified as follows:
§ 180.390 Tebuthiuron; tolerances for residues.
(a) Tolerances are established for the combined residues of the herbicide tebutMuron (N-[5-
(l,l-dime%!emyl)-l,3,4-tMadiazol-2-yl-JV,^'-dimethylurea) and its metabolites N-[5-(2-
hydroxy-l,l-dimethylethyl)-l^^-thiadiazol^-yll-M^'-diinethylurea, N-[5-(l,1-dimethylethyl)-
1,3,4-tMadiazol-2-yl]-AT-niethymrea, and N-[5-(l, 1-dimethylethylH,3^-t
hydroxymethyl-JV-methylurea in or on the following agricultural commodities;
Commodity
Grass, hay
Grass, forage
Parts per
million
10
10
(b) Tolerances are established for the combined residues of the herbicide tebutMuron
(l.l-dimethylethyO-l.S^-miadiaiol^-yl-^A^'^imethylurea) and its metabolites A/-[5-(l,l-
dimethylethylH,3,4-thiadiazol-2-yl]-N-methylurea, N-[5-(l,l-dimethylethyl)-l ,3,4-thiadiazol-2-
yljurea, 2-dimethylethyl-5-amino-lJ3,4-thiadiazole, and /V-[5-(l,l-dimethylethyl)-l,3,4-
tmadiazol-2-yl]-//-hydroxymethyl-A^-methylurea in or on the following raw agricultural
commodities:
37
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Commodity
Cattle, fat
Cattle, mbyp
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Horses, fat
Horses, mbyp
Horses, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
Parts per
million
2
2
2
2
2
2
2
2
2
2
2
2
(c) A tolerance is established for the combined residues of the herbicide tebuthiuron (N-[5-
(l,l-dimethylethyl)-l,3,4-thiadiazol-2-yl-JV,]¥-dimethylurea) and its metabolites ]V-[5-(ls 1-
dimethylethyl)-!,3,4-thiadiazol-2-yl]-JV-methylurea, JV-[5-(2~hydroxy-l, l-dimethylethyl)-l,3,4-
thiadiazol-2-yll-A^methylurea, JV-[5-(l,l-dimethylethyl)-l53,4-thiadiazol-2-yl]urea, N-[5-(l,l-
dimethylethyl)-! ,3 ^-thiadiazol^-yU-JV'-hydroxymethyl-A^-dimelhylurea, and ]V-[5-(2-hydroxy-
l,l-dimethylethyl)-l,3,4-tMadiazol-2-yl]-]V''-hydroxymethyl-]V-niethylurea in or on the
following raw agricultural commodity:
Commodity
Milk
Parts per
million
0.3
Codex Harmonization
No Codex MRLs have been established or proposed for residues of tebuthiuron. Therefore, issues
of compatibility with respect to U.S. tolerances and Codex MRLs do not exist.
2. Endangered Species Statement
The Agency has concerns about the exposure of endanged plant species to
tebuthiuron as discussed above in the science assessment chapter. On July 15, 1982, the
US Fish and Wildlife Service developed a biological opinion on the proposed registration
of tebuthiuron for use in the control of woody plant species on rangeland in seven south-
western states. It was determined that this chemical was likely to jeopardize 19 listed
plant species (EPA-81-4). On September 23, 1982, the EPA requested the reinitiation of
a formal Section 7 consultation on the conditional registration for the expanded use of
tebuthiuron on pasture and rangeland in 17 additional states. USFWS determined that 10
38
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additional listed plant species were likely to be jeopardized by the expanded use of this
herbicide.
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 in the Federal Register in 1994 a
description of the program and by 1995 have available enforceable county-specific
bulletins. 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.
3. Labeling Rationale/Risk Mitigation Measures
*k
a. Worker Protection Standard
The current registered uses of tebuthiuron do not include uses associated with the
production of an agricultural plant on/in any farm, forest, nursery, or greenhouse.
Thus, tebudiiuron, as currently registered, does not fall within the scope of the Worker
Protection Standard and the 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," concerning the Agency's labeling
regulations for worker protection statements (40 CFR 156, subpart K) are not applicable
to tebuthiuron end-use products at this time.
b. Personal Protective Equipment (PPE) Requirements
The following PPE is the minimum PPE required for all persons handling
products containing tebuthiuron: long sleeved shirt, long pants, shoes and socks.
In addition, if the tebuthiuron end-use products are in Toxicity Category I, II, or
III for acute dermal toxicity or skin irritation potential, chemical-resistant or
waterproof gloves (whichever is appropriate) are required.
c. Ground Water Labeling Requirements
Based on the environmental fate assessment for tebuthiuron, the Agency
is requiring the following:
Ground Water Advisory; "This chemical is known to leach through soil
into ground water under certain conditions as a result of registered (rangeland and
39
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non-crop) uses. Use of this chemical in areas where soils are permeable, particu-
larly where the water table is shallow, may result in ground-water contamination".
"A shallow water table is defined as depth to water table of 30 feet or less.
Permeable soils include, but are not limited to sandy soils,"
Additional restrictions on the use of tebuthiuron will be required for
vulnerable use areas, given its mobility and persistence in the environment. The
Agency has initiated discussion with the registrant to identify such portions of the
tebuthiuron use area and is requiring that this information be submitted within 4
months after the issuance of this RED. The registrant should consult with EPA
and State Pesticide Agencies for additional guidance on the development of specific
soil series label information. In addition, based on the information regarding
vulnerable use areas, the registrant is required to submit, within 4 months after the
issuance of this RED, proposed label statements for tebuthiuron to further reduce
ground water contamination concerns. At that time, the Agency will consider
modifying the above label advisory.
Label Revisions: In order to reduce the concern for ground water
contamination at this time, the Agency is requiring revised labeling for tebuthiuron
end-use products, including lower application rates and limits on the number and
frequency of applications for all registered use sites. The Agency notes that
current labeling requirements for certain vulnerable use areas are more restrictive
than the requirements listed below; the current requirements for these areas must
remain on labels. Labels must be revised as follows:
Use Directions:
Granular. Pelleted/Tableted. and Water Dispersable Granules (Drv
Flowable) Formulations
For vegetation control by broadcast (aerial and ground equipment) and
banded applications: The maximum label rate and frequency of application is 1-2
Ibs ai/a once every three years for vulnerable areas (where soils are sandy and
depth to water table is shallow) as identified in the specific soil series labeling
supplement. For all other areas, may be applied one time in a 3 year period at
rates up to 4 Ib ai/A; however, no more than 6 Ib ai/A may be applied in two
consecutive treatments in any 6 year period.
Spot Treatments (hand-held equipment): May be applied at rates up to the
equivalency of 6 Ib ai/A when needed.
Wettable Powder Formulation
For vegetation control by broadcast and banded applications (ground
equipment): The maximum label rate and frequency of application is 1-2 Ibs ai/a
40
-------
once every three years for vulnerable areas (where soils are sandy and depth to
water table is shallow) as identified in the specific soil series labeling supplement.
For all other areas, may be applied 6M time in a 3 year period at rates up to 4 Ib
ai/A; however, no more than 6 Ib ai/A may be applied in two consecutive
treatments in any 6 year period.
For total vegetation control and maintainence of bare ground by broadcast
and banded applications (ground equipment): may be applied one time per year at
rates up to 4 Ib ai/A; however, no more than 6 Ib ai/A may be applied in any 3
year period.
Spot treatments (hand-held equipment): may be applied at rates up to the
equivalency of 6 Ib ai/A when needed.
d. Ecological Effects Labeling Requirements
Based on the results of aquatic/terrestrial plant testing and previous biological
opinions, there is a presumption of risk for all endangered plant species which may
be exposed to tebuthiuron. At the present time, EPA is consulting with the U.S.
Fish and Wildlife Service and other federal and state agencies to develop a
program to avoid jeopardizing the continued existence of listed species from the
use of pesticides. When this program goes into effect, endangered species
precautionary labeling will be required.
Based on the ecological effects assessment for tebuthiuron, the following
labeling is required at this time:
Environmental Hazard Statement:
Granular and Pelleted/Tableted Formulations
"In case of spills, collect, cover or incorporate granules/pellets spilled on the
soil surfaces to prevent contamination to water. Do not apply to water, or to areas
where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water when disposing of equipment washwaters or
rinsate",
Wettable Powder and Water Dispersable Granular (Dry Flowable)
Formulation
"Do not apply to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not contaminate water when
disposing of equipment washwaters or rinsate".
In addition, the Agency notes that the requirements for revised labeling
specified above under Ground Water Labeling, including lower application rates
41
-------
and limits on the number and frequency of applications, are measures that will
reduce (but not eliminate) the risks to non-target plants and the potential for ground
water contamination.
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 tebuthiuron for the above
eligible uses has been reviewed and determined to be substantially complete.
2. Labeling Requirements for Manufacturing-Use Products
The Agency has determined that current label precautions are still applicable and
are required for product reregistration if the product is to remain in compliance with
FIFRA.
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,
2. Labeling Requirements for End-Use Products
a. Compliance with the Worker Protection Standard
The current registered uses of tebuthiuron do not include uses associated with the
production of an agricultural plant on/in any farm, forest, nursery, or greenhouse.
Thus, tebuthiuron, as currently registered, does not fall within the scope of the Worker
Protection Standard and the requirements of PR Notice 93-7, "Labeling Revisions
42
-------
Required by the Worker Protection Standard (WPS)," and PR Notice 93-11,
"Supplemental Guidance for PR Notice 93-7," concerning the Agency's labeling
regulations for worker protection statements (40 CFR 156, subpart K) are not applicable
to tebuthiuron end-use products at this time.
b. Personal Protective Equipment (PPE) Requirements; Labeling
Registrants of end-use products that contain tebuthiuron must compare the personal
protective equipment requirements set forth in this section to the personal protective
equipment requirements, if any, on their current labeling and retain the more protective.
For guidance in choosing which requirement is more protective, see Supplement Three
of PR Notice 93-7.
The personal protective equipment requirements, as established in this RED for
end-use products that contain tebuthiuron, are as follows:
"Applicators and other handlers must wear:
—Long sleeved shirt and long pants
-Shoes plus socles"
In addition, gloves are required if the tebuthiuron end-use products are in Toxicity
Category I, II, or III for acute dermal toxicity or skin irritation potential. The glove
statement shall be one of the following:
--"Waterproof gloves" for dry formulations or for formulations where water is the
only solvent
--"Chemical-resistant gloves" for all other formulations
See PR Notice 93-7 for additional guidance regarding glove selection.
c. Revised Labeling Regarding Application Rates and Number and
Frequency of Applications
The following maximum application rates and number and frequency of
applications must be included on labels in the Directions for Use Section for the
specified uses of tebuthiuron in order to decrease the concern for ground water
contamination and the risk to non-target plants:
Granular. Pelleted/Tableted. and Water Dispersable Granules (Dry
Flowable) Formulations
For vegetation control by broadcast (aerial and ground equipment) and
banded applications: The maximum label rate and frequency of application is 1-2
Ibs ai/a once every three years for vulnerable areas (where soils are sandy and
depth to water table is shallow) as identified in the specific soil series labeling
supplement. For all other areas, may be applied one time in a 3 year period at
43
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rates up to 4 Ib ai/A; however, no more than 6 Ib ai/A may be applied in two
consecutive treatments in any 6 year period.
Spot Treatments (hand-held equipment): May be applied at rates up the
equivalency of 6 Ib ai/A when needed.
Wettable Powder Foimulation
For vegetation control by broadcast and banded applications (ground
equipment); The maximum label rate and frequency of application is 1-2 Ibs ai/a
once every three years for vulnerable areas (where soils are sandy and depth to
water table is shallow) as identified in the specific soil series labeling supplement.
For all other areas, may be applied one time in a 3 year period at rates up to 4 Ib
ai/A; however, no more than 6 Ib ai/A may be applied in two consecutive
treatments in any 6 year period.
For total vegetation control and maintainence of bare ground by broadcast
and banded applications (ground equipment): may be applied one time per year at
rates up to 4 Ib ai/A; however, no more than 6 Ib ai/A may be applied in any 3
year period.
Spot treatments (hand-held equipment): may be applied at rates up to the
equivalency of 6 Ib ai/A when needed.
d. Other Labeling Requirements
Environmental Hazard Statement;
Granular and Pelleted/Tableted Formulations
"In case of spills, collect, cover or incorporate granules/pellets spilled on the
soil surfaces to prevent contamination to water. Do not apply to water, or to areas
where surface water is present or to intertidal areas below the mean high water
mark. Do not contaminate water when disposing of equipment washwaters or
rinsate".
Wettable Powder and Water Dispersable Granular (Dry Flowabie)
Formulation
"Do not apply to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not contaminate water when
disposing of equipment washwaters or rinsate".
Ground Water Advisory: "This chemical is known to leach through soil
into ground water under certain conditions as a result of registered (rangeland and
non-crop) uses. Use of this chemical in areas where soils are permeable, particu-
44
-------
larly where the water table is shallow, may result in ground-water contamination".
"A shallow water table is defined as depth to water table of 30 feet or less.
Permeable soils include, but are not limited to sandy soils."
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 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 tebuthiuron 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.
45
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46
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VI. APPENDICES
47
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48
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
49
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50
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Date 02/01/94
APPENDIX A - CASE 0054, [Tebuthiuron] Chemical 105501 tTebuthiuronl
Page 1
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial onlyj
Form Binimura
Maximum Soil Max. Mi*imum Dose Win. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max 3 Max or /year (days} Interv
Dse) Rate (days)
Geographic
Disaltoyed
Use
Limitations
Codes
FOOD/FEED USES
Soil broadcast treatment.. When needed., P/T NA
Aircraft.
Soil broadcast treatment., When needed,, P/T NA
Ground.
Spot soil treatment., yhen needed., By hand. P/T NA
Soil broadcast treatment., When needed,, P/T NA
Aircraft.
Soil broadcast treatment., When needed., P/T NA
Ground.
Spot soil treatment., Uhen needed., By hand. P/T NA
NOB-FOOD/NON-FEED
4 Ifa A * 1/Y
4 fb A * 1/Y
.09375 lb IK * 1/Y
sq.ft
NS NS NS
NS NS NS
NS NS NS
Ib A
lb A
1/Y NS NS NS
1/Y
,09375 Ib IK * 1/Y
sq.ft
NS NS NS
NS NS NS
Soil band treatment., When needed., Backpack DF NA
sprayer.
UP NA
Soil band treatment., When needed.. Hand DF NA
held sprayer.
Soil band treatment.. When needed..
Tank-type sprayer.
UP NA
DF NA
yp NA
Soil broadcast treatment., When needed,, DF NA
Hand held sprayer.
6 lb A * NS
5.95 lb A * NS
6 lb A * NS
5.95 lb A * NS
6 lb A * NS
5.95 lb A * NS
NS KS
NS KS
NS NS
NS NS
NS
NS
NS
NS
NS NS NS
NS NS NS
C46
C46
UP NA
6 lb A * NS
NS NS NS
C46
-------
Date 02/01/94
APPENDIX ft - CASE 0054, [Tebuthiurort] Chemical 105501 tTebuthiuron]
Page 2
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
NON-FOOD/NOW-FEED (con't>
Form
Mininum
Application
Rate
Soil broadcast treatment., When needed.,
Sprayer .
Soil broadcast treatment., yhen needed.,
Spreader.
Soil broadcast treatment.. When needed.,
Tank- type sprayer.
DF
yp
G
C
DF
UP
Spot soil treatment., When needed., Backpack DF
sprayer.
Spot sail treatment., yhen needed., By hand.
Spot soil treatment.. When needed., Hand
held sprayer.
Spot soil treatment., Mien needed.. Not on
label.
Soil band treatment., yhen needed.. Backpack
sprayer .
Soil band treatment.. When needed., Hand
held sprayer.
Soi i band treatment.. When needed.,
yp
G
DF
yp
a
SKIJJSW*:
sftWi-iS
Of
yp
DF
yp
DF
NA
Nft
NA
NA
NA
NA
NA
NA
NA .0932
NA
NA
Maximum
Application
Rates
Soil
Text
{Max
Dse)
Max.
Apps
a Max
Rate
5.95 tb A
6 tb A
16.02 Ib A
4 Ib A
5.95 Ib A
6 tb A
UC
uc
Ib IK sq.ft
UC
UC
HA UC
.36 Ib 1K sq.ft
MA
NA
HA
NA
KA
5.95 Ib A
6 Ib A
5,95 Ib A
6 Ib A
5.95 Ib A
*
*
*
*
*
*
*
*
*
*
R
*
*
*
*
*
*
*
HS
NS
NS
HS
HS
m
HS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
HaMmim Dose
/crop cycle,
or /year
NS
US
NS
NS
HS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Hin.
I nterv
(days)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
I nterv
(days)
%rn
HS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
HS
NS
NS
MS
NS
Geographic Use
Disallowed Limitations
Codes
C46
G03, QA4
C46
C4&
G03, SA4
C46
C4*
C46
Tank-type sprayer.
NA
6 Ib A * NS
NS NS
NS
C46
-------
Date 02/01/94
APPENDIX A - CASE 0054, [TebuthiuronJ Chemical 105501 [TebuthiuronJ
Page 3
SITE Application Type, Application
Timing, Application Equipment —
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
NON -FOOD/NON-FEED (con't)
Form
Minimum
Application
Rate
Soil broadcast treatment., When needed.,
Aircraft.
Soil broadcast treatment., When needed.,
Ground.
Soil broadcast treatment., When needed..
Hand held sprayer.
Soil broadcast treatment,, When needed.,
Sprayer.
Soil broadcast treatment., When needed.,
Spreader.
Soil broadcast treatment.. When needed.,
Tank- type sprayer.
Spot soil treatment., When needed., Backpack
sprayer.
Spot soil treatment., Uhen needed., By hand.
Spot soil treatment.. When needed., Hand
held sprayer.
Spot soil treatment., When needed., Mot on
P/T
P/T
DF
UP
DF
UP
G
S
DF
UP
DF
UP
G
P/T
DF
UP
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA .0932
NA . 1496
NA
NA
NA
Maximum
Application
Hates
6 Ib A
6 Ib A
5.95 Ib A
6 Ib A
5.95 Ib A
6 Ib A
16.02 Ib A
4 Ib A
5,95 tb A
6 Ib A
UC
UC
Ib 1K sq.ft
Ib 1K sej.ft
UC
UC
UC
Soil Max,
Text Apps
(Max 8 Max
Dse) Rate
* 1/Y
* 1/Y
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* 1/Y
* NS
* NS
* NS
Mix i mini Dose Min»
/crop cycle, Interv
or /year (days)
NS HS
NS NS
MS NS
HS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS HS
NS MS
NS MS
NS HS
NS MS
NS MS
m MS
Restr- Geographic
Entry Allowed
Interv
(days)
11
HS
NS
HS
MS
HS
NS
NS
NS
MS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic Use
Disallowed Limitations
Codes
C46
C46
G03, GA4
C46
C46
GQ3, GA4
C4&
label.
.36 Ib \K sq.ft *
-------
Oete 02/01/94
APPENDIX A - CASE 0054, [Tebuthiuron] Chemical 105501 tTebuthiuron]
Page 4
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
N0N-FQOO/NQN-FEED
-------
Date 02/01/94
APPENDIX A - CASE 0054, [TebuthiuronJ Chemical 105501 [TebuthiuronJ
Page 5
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
NON- FOOD/NON-FEED (con't)
Spot soil treatment,, Uhen needed,, By hand.
Spot soil treatment., When needed., Hand
held sprayer.
Spot soil treatment.. When needed., Not on
label.
Soil band treatment,. When needed,. Backpack
sprayer .
Soft band treatment., Uhen needed.. Hand
held sprayer.
Soil band treatment., When needed.,
Tank-type sprayer.
Soil broadcast treatment.. When needed..
Aircraft.
Sot! broadcast treatment.. When needed.,
Ground.
Soil broadcast treatment., yhen needed.,
Hand held sprayer.
Soil broadcast treatment., yhen needed.,
Form
Minimum
Application
Rate
Max i run Sen I
Application Text
Rates (Max
Dse)
G NA .0932 Ib 1K sq.ft *
P/1
OF
yp
G
K™sjOT
DF
yp
OF
UP
DF
WP
P/T
P/T
DF
WP
OF
NA ,1406
HA
NA
NA
.36
NA
NA
NA
MA
NA
NA
MA
NA
NA
NA
NA
Ib 1K sq.ft *
UC *
uc *
UC *
Ib 1K sq.ft *
5.95 ib ft *
6 Ib A *
5.95 Ib A. *
6 ib A *
5.95 Ib A *
6 Ib A *
6 Ib A *
6 Ib ft *
5.95 Ib A *
6 Ib A *
5.95 Ib ft *
Max. Maximum Dose Mir.
Apps /crop cycle, Inter*
3 Hax or /year (days)
Rate
iiiiiiii
MS
1/Y
NS
NS
NS
liiMiilSI
NS
NS
NS
NS
NS
NS
1/Y
1/Y
NS
NS
NS
US NS
US NS
NS NS
NS NS
MS NS
NS NS
MS NS
NS MS
NS NS
NS NS
NS NS
NS MS
NS NS
NS NS
NS NS
NS NS
Restr. Geographic Geographic Use
Entry Al lowed Disallowed Limitations
Inter v Codes
(days)
ill
MS G03, CM
NS
NS
NS C46
NS
MS
NS C46
NS
NS C46
NS
NS C46
NS
NS
NS
NS C46
NS
Sprayer.
UP NA
6 Ib A * NS
NS NS NS
C46
-------
Date 02/01/94
APPENDIX A - CASE 0054, ITebuthiuron] Chemical 105501 [TebuthiuronJ
Page 6
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
NON-FOQO/NON-FEED (can't)
Form
Soil broadcast treatment., When needed., G
Spreader .
G
Soil broadcast treatment., When needed., OF
Tank- type sprayer.
Spot soil treatment., Uhen needed.,
sprayer.
Spot soil treatment,, yhen needed.,
Spot soil treatment., yhen needed.,
held sprayer.
Spot soil treatment., Uhen needed,,
label.
Soil treatment.. Not on label,, Not
label.
yp
Backpack OF
yp
By hand. G
P/T
Hand DF
UP
Not on G
Minimum Maximum
Application Application
Rate Rates
NA
NA
NA
NA
NA
NA
NA
NA
MA
NA
NA
on 6
NA
Soil band treatment., yhen needed.,
sprayer .
Soil band treatment.. When needed..
held sprayer.
Soil band treatment., When needed.,
Backpack DF
UP
Hand DF
yp
Df
HA
HA
NA
NA
NA
16.02 Ib A
<, Ib A
5.95 Ib A
6 Ib A
UC
UC
.0932 Ib 1K sq.ft
.1406 tb IK sq.ft
UC
UC
UC
.36 Ib IK sq.ft
UC
5.95 Ib A
& Ib A
5.95 Ib A
6 Ib A
5.95 (b A
Soil
Text
(Max
Use)
li-
ft
*
*
*
*
*
*
*
It
*
*
*
*
*
*
*
*
Max.
Apps
i Max
Rate
NS
NS
NS
HS
NS
NS
HS
1/Y
NS
NS
NS
NS
NS
NS
NS
NS
HS
Maximum Dose
/crop cycle,
or /year
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Bin.
interv
(days)
NS
NS
NS
NS
NS
MS
NS
NS
NS
NS
NS
ill
NS
NS
NS
HS
NS
NS
Restr. Geographic
Entry Allowed
Interv
(days)
NS
NS
NS
NS
NS
NS
NS
HS
NS
NS
HS
NS
NS
NS
NS
NS
HS
Geographic Use
Disallowed Limitations
Codes
GQ3,
C46
C46
G03,
«S
SA4,
C46
C46
GM
GA4
GQ3
Tank-type sprayer.
yp HA
6 Ib A * NS
NS NS NS
C46
-------
Date 02/01/94
APPENDIX A
CASE 0054, [Tebuthiuron] Chemical 105501 [Tebuthiuron]
Page 7
SITE Application Type, Application
fining. Application Equipment -
Surface Type & Efficacy Influen-
cing Factor {Antimicrobial only)
HUN- FQOO/NON- FEED (con't)
Soil broadcast treatment., Uhen needed.,
Hand held sprayer.
Soil broadcast treatment., When needed..
Sprayer.
Soil broadcast treatment., When needed.,
Spreader .
Soil broadcast treatment., Uhen needed.,
Tank-type sprayer.
Spot soil treatment.. When needed., Backpack
sprayer.
Spot soil treatment., When needed., By hand.
Spot soil treatment., Uhen needed., Hand
held sprayer.
Spot soil treatment., yhen needed.. Net on
label.
Form
Hill
OF
WP
DF
UP
G
G
OF
UP
OF
UP
G
OF
UP
G
Minimun
Application
Rate
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA .0932
NA
NA
NA
.36
Max i mum
Application
Rates
5.95 Ib A
6 Ib A
5.95 Ib A
6 Ib A
16.02 Ib A
4 Ib ft
5.95 Ib A
6 tb A
UC
uc
tb IK aq.ft
UC
UC
uc
Ib 1K sq.ft
Soil Max.
Text Apps
(Max S Max
Dse) Rate
* NS
* NS
* NS
* MS
* NS
* NS
* NS
* MS
* «S
* MS
* MS
* MS
* NS
* NS
*
Maximum Dose Min.
/crop cycle, Inter*
or /year (days)
NS NS
NS SS
NS NS
NS MS
NS NS
NS NS
NS NS
m NS
NS NS
MS NS
NS NS
US NS
NS NS
NS NS
Restr. Geographic
Entry Allowed
Inter¥
(days)
NS
NS
NS
HS
NS
NS
NS
MS
NS
NS
NS
NS
NS
NS
Geographic Use
Disallowed Limitations
Codes
C46
C46
GQ3, GA4
C46
C46
G03, CA4
C46
-------
Date 02/01/94
APPENDIX A - CASE 0054, ITebgthiuron] Chemical 105501 [Tebuthiuron]
Page 8
LEGEND
HEADER ABBREVIATIONS
Max. Apps 3 Max Rate
Hin. interv (days)
Restr. Entry Interv {days}
Maximum number of Applications st Maximum Dosage Rate
Minimum Interval betyeen Applications (days)
Restricted intry Interval (days)
SOIL TiXTURE FOR MAX APP. BATE
Non-specific
C Coarse
M Hedim
f Fine
0 Others
FORMULA! ON COOES
DF WATER DISPER5ABLE GRANULES (DRV FLOUABLE)
G GRANULAR
P/T PELLETEO/TABliTED
UETTABLE POWER
ABBREV1A IONS
AN
NA
NS
UC
As Heeded
Not Applicable
Not Specified (on Label)
Unconverted due to tack of data (on label)
APPLICAT ON RATE
DCKC Dosage Can Not be Calculated
No CaLc No Calculation can be made
U PPN calculated by weight
V PPM Calcylated by volume
cut Hundred Weight
nn times {10 power -xxj; for instance,
"1.234E-04" is equivalent to ".0001234"
USE LIN!TAT IONS CODES
C46 : Do not apply through any type of irrigation system.
GQ3 : Do not graze livestock in treated areas.
GA4 : Do not feed treated forage to livestock.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TINE UNITS (HOURS,OATS, ETC.) DESCRIBED IN THE LIMITATION.
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
59
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Tebuthiuron covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Tebuthiuron in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following foimat:
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
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its flies,
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.
61
-------
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Tebuthiuron
REQUIREMENT
USE PATTERN
CITATION(S)
61-1 Chemical Identity
61-2A Start. Mat. & 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
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-16 Explodability
all
all
all
all
all
alt
all
all
all
all
all
all
all
all
all
all
all
all
all
40493801, CSF dated 3/26/93
40493801, 42720001
40493801, 41031801, 42720001
41005701
40493801, CSF dated 3/26/93
40768302, 40768303, 40768305, 41005701
40493802
40493802
40493802
40493802
40493802, 40493803
40493802
00020773
40493802
00020781
40493802
40493802, 42726201
40493804
40493804
63
-------
Data Supporting Guideline Requirements for the Reregistration of Tebuthiuron
REQUIREMENT
63-17
63-20
Storage stability
Corrosion characteristics
USE PATTERN
ail
all
CITATION(S)
40493804
40493804
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1C
72-2A
72-3B
72-3C
72-4A
72-4B
72-6
72-7B
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/M arine Toxicity -
Mollusk
Esluarine/Marine Toxicity -
Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
Aquatic Organism Accumulation
Actual Field - Aquatic Organisms
B»C
B»C
B»C
B,C
B,C
B,C
B,C
B,C
B»C
B,C
B,C
B,C
B,C
B,C
00041692
40601001
40601002
00093690
00104243
00020661
00020661
00041694
00041684
00041584
00090083, 00090084
00138700
40819501
00090097, 00090103, 00090106, 00090107,
122-1A Seed Germination/Seedling
Emergence
B,C
00090109
41066902
64
-------
Data Supporting Guideline Requirements for the Reregistration of Tebuthiuron
REQUIREMENT
123-1A
123-1B
123-2
141-1
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
USE PATTERN
B,C
B,C
B,C
B,C
CITATION©
41066901
41066901
41080401, 41080402, 41080403, 41080404
40840401
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
83-1A
83-11
83-2A
83-2B
83-3A
Acute Oral Toxicity - Rat
- Mouse/Rabbit/Cat/Dog
Acute Dermal Toxicity - Rabbit
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-
Rodent
Qncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
B,C
B»C
B,C
B»C
B,C
B,C
B,C
B,C
B»C
B,C
B,C
40583901
00226375
40583902
00155730
40583903
40583902
40583904
00020662
00020663
00149733
00020714
00146801
00020714
00020717
00020803
65
-------
Data Supporting Guideline Requirements for the Reregistration of Tehuthiuron
REQUIREMENT
83-3B
83-4
84-2A
84-2B
84-4
85-1
Developmental Toxicily - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
USE PATTERN
B,C
B,C
B,C
B»C
B,C
B»C
CITATION(S)
00020644, 40776301
00090108
00141691
41134101
00145041, 40750901
40849101, 00106081
ENVIRONMENTAL FATE
161-1
161-2
161-3
162-1
162-2
162-3
162-4
163-1
165-4
166-2
RESIDUE
171-4A
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Bioaccumulation in Fish
Ground Water - Small
Retrospective
CHEMISTRY
Nature of Residue - Plants
B»C
B,C
B,C
B»C
B,C
B,C
B,C
B,C
B,C
B»C
B
00020779
41305101
41050201
41328001
41328002
41913101
41372501
40768401
40819501
42390901
0002064S, 00020756,00020766
-------
Data Supporting Guideline Requirements tor the Reregistration of Tebuthiuron
REQUIREMENT
USE PATTERN
CITATION(S)
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method - Plants
171-4D Residue Analytical Method -
Animal
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials -
grass forage
grass hay
B
B
B
B
B
B
00020648, 00020650, 00020651, 00020652,
00020721, 00020767, 00027805, 00027810,
00041675, 00106080, 40985001, 40985002
00020656, 00020740, 00041673, 00094745,
00106080, 41196901
confirmatory data to be submitted 4/29/94
42630501 (plants); confirmatory data for
animal commodities to be submitted 4/29/94
0041673, 00106080; additional confirmatory
data to be submitted 4/29/94
00020757, 00020764, 0041671, 00094745,
42630502
00020705, 00094745, 42630502
67
-------
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Tebuthiuron
69
-------
-------
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
71
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the date from the evidence contained in the document. When the date appears
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.
72
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BIBLIOGRAPHY
MRID
CITATION
00020643 Todd, G.C.; Adams, E.R.; Owen, N.V.; et al. (1975) A Multi-generation
Reproduction Study with EL-103 in the Rat: Toxicology Report No. 2.
(Unpublished study received Jul 9, 1975 under 5G1562; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:094913-C)
00020644 Todd, G.C.; Markham, J.K.; Adams, E.R.; et al. (1975) A Teratology Study
with EL-103 in the Rabbit: Toxicology Report No. 3. (Unpublished study
received Jul 9, 1975 under 5G1562; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL;094913-D)
00020645 Rainey, D.P.; Magnussen, J.D. (1975) Metabolism of 14C EL-103 in
Sugarcane. (Unpublished study received Jul 9, 1975 under 5G1562; submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:094913-E)
00020648 Rainey, D.P.; Magnussen, J.D.; Herberg, RJ. (1975) 14C EL-103 in the
Ruminant Excretion and Tissue Residues. (Unpublished study received Jul 9,
1975 under 5G1562; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL: 094913-H)
00020650 Herberg, RJ. (1975) 14C EL-103 Milk Residue Experiment: Experiment VPR
330-766. (Unpublished study received Jul 9, 1975 under 5G1562; submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:094913-J)
00020651 Herberg, RJ. (1975) 14C EL-103 Swine Tissue Residue Study: Experiment
SW-457. (Unpublished study received Jul 9, 1975 under 5G1562; submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:094913-K)
00020652 Herberg, RJ. (1975) 14C EL-103 Chicken Tissue Residue Study: Experiment
VPR 335-766B. (Unpublished study received Jul 9, 1975 under 5G1562;
submitted by Elanco Products Co., Div, of Eli Lilly and Co., Indianapolis,
Ind.; CDL:094913-L)
00020656 Decker, O.D.; Sullivan, W.L.; Sherman, W.E. (1975) Determination of
Tebuthiuron and Metabolites in Cattle Tissues. Undated method 5801644.
(Unpublished study received Jul 9, 1975 under 5G1562; submitted by Elanco
73
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BIBLIOGRAPHY
MRID
CITATION
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind,; CDL:094913-Q)
00020661 Todd, G.C.; Kehr, C.C.; West, H.C.; et al. (1972) The Acute Toxicity of
EL-103 in Mice, Rats, Eabbits, Cats, Dogs, Quail, Ducks, Chickens, and
Fish. (Unpublished study received Mar 13, 1973 under 1471-97; prepared in
cooperation with Bionomics, Inc., submitted by Blanco Products Co., Div. of
Eli Lilly and Co., Indianapolis, Ind.; CDL;006422-F)
00020662 Todd, G.C.; Gibson, W.R.; Kipliiiger, G.F. (1972) The lexicological
Evaluation of EL-103 in Rats for 3 Months. (Unpublished study received Mar
13, 1973 under 1471-97; submitted by Blanco Products Co., Div. of Eli Lilly
and Co., Indianapolis, Ind.; CDL; 006422-G)
00020663 Todd, G.C.; Gibson, W.R.; Kiplinger, G.F. (1972) The Toxicological
Evaluation of EL-103 in Dogs for 3 Months. (Unpublished study received
Mar 13, 1973 under 1471-97; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind,; CDL: 006422-H)
00020705 Loh, A. (1978) Residue Data on Tebuthiuron and Metabolites in Forage Grass
and Hay. (Unpublished study received Apr 6, 1978 under 1471-109;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL.-097G19-B)
00020714 Todd, G.C.; Gibson, W.R.; Hoffman, D.G.; et al. (1976) The Toxicological
Evaluation of Tebuthiuron (EL-103) in Rats for Two Years: Toxicology
Report # 7. (Unpublished study received Dec 1, 1976 under 1471-EX43;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:230139-A)
00020717 Todd, G.C.; Gibson, W.R.; Hoffman, D.G.; et al. (1976) The Toxicological
Evaluation of Tebuthiuron (EL-103) in Mice for Two Years; Toxicology
Report $ 8. (Unpublished study received Dec 1, 1976 under 1471-EX^3;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:230139-D)
00020721 Rainey, D.P, (1976) Characterization of Milk Residues from a Cow Fed
14C-Tebutbiuron. (Unpublished study received Dec 23, 1976 under
1471-EX-43; submitted by Elanco Products Co., Div, of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:237161-B)
74
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BIBLIOGRAPHY
MKID
CITATION
00020740 Macy, T.D.; Loh, A. (1977) Determination of TebufMuron and Metabolites in
Milk and Cattle Tissues. Undated method no. 5801684. (Unpublished study
received Feb 18, 1977 under 1471-109; submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:095848-C)
00020756 Rainey, D.P.; Magnussen, J.D. (1976) Metabolism of 14C Tebuthiuron in
Range Grasses: Supplemental Report. (Unpublished study received Sep 29,
1976 under 1471~EX^t3; submitted by Blanco Products Co., Div. of Eli Lilly
and Co., Indianapolis, Ind,; CDL; 095298-C)
00020757 Loh, A.; Macy, T.D. (1976) Tebuthiuron and Metabolites in Forage Grass.
(Unpublished study received Sep 29, 1976 under 1471-EX43; submitted by
Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:095298-D)
00020764 Bovey, R.W. (1975) Summary of Data. Summary of study 210135-E.
(Unpublished study received Sep 3, 1975 under 1471-EX^43; prepared by
Texas A & M Univ., submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL;Q94906-F)
00020766 Rainey, D.P.; Magnussen, J.D. (1975) Metabolism of 14C Tebuthiuron in
Range Grasses. (Unpublished study received Sep 3, 1975 under 1471-EX-43;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:094906-I)
00020767 Herberg, RJ. (1975) 14C EL-103 0.04 PPM Milk Residue Study: Experiment
VPR 343-766, (Unpublished study received Sep 3, 1975 under 1471-EX^I3;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:094906-J)
00020773 Elanco Products Company (19??) Chemical and Physical Properties: [EL-103].
(Unpublished study received Aug 16, 1977 under unknown admin, no.;
CDL:231275-A)
00020779 Mosier, J.W.; Saunders, D.G. (1976) A Hydrolysis Study on the Herbicide
Tebuthiuron. Includes undated method. (Unpublished study received Feb 18,
1977 under 1471-109; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Md.; CDL:095854-F)
75
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BIBLIOGRAPHY
MRID
CITATION
00020781 Macy, T.D.; Loh, A. (1976) N-Octanol-to-Water Partition Coefficient of
Tebuthiuron, Includes method dated Nov 1976. (Unpublished study received
Feb 18, 1977 under 1471-109; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:095854-H)
00020803 Todd, G.C.; Markham, J.K.; Adams, E.R.; et al. (1972) Eat Teratology
Study with EL-103. (Unpublished study received Mar 13, 1973 under
1471-97; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:006422-O)
00027805 Herberg, RJ. (1975) 14C EL-103 Chicken Egg Residue Experiment:
Experiment VPR 334-766. (Unpublished study received Jul 9, 1975 under
5G1562; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:094913-M)
00027810 Rainey, D.P.; Thibault, T.D. (1975?) Comments on Possible Thiadiazole Ring
Cleavage in Mammalian Systems. (Unpublished study received Apr 6, 1978
under 1471-109; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL: 097019-A)
00041671 Frank, R.; Loh, A.; Macy, T. (1976) Residue Data on Tebutbiuron and
Metabolites in Forage Grass. Includes undated method no. 5801667.
(Unpublished study received Feb 18, 1977 under 1471109; submitted by
Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:095852-D)
00041673 Day, E.W.; Decker, O.D. (1976) Residue Data on Tebuthiuron and
Metabolites in Cattle Tissue. Includes undated methods ATW and 5801661.
(Unpublished study received Feb 18, 1977 under 1471-109; submitted by
Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:095852-F)
00041675 Rainey, D.P.; Magnussen, J.D.; Herberg, R.J. (1976) Determination and
Chacterization of Radioactive Residues in Milk from a Cow Given 14C
Tebuthiuron. (Unpublished study received Feb 18, 1977 under 1471-109;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:095852-H)
00041684 Heitmuller, T.; Parrish, R. (1976) Acute Toxicity of EL-103 to Embryos of
76
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BIBLIOGRAPHY
MRID
CITATION
Eastern Oysters (j*-~ Crassostrea virginica—M), to Pink Shrimp (/i — Peoaeus
duorarum/4~), and to Fiddler Crabs Gi~-Uca pugilator—/*). (Unpublished study
received Feb 18, 1977 under 1471-109; submitted by Elanco Products Co.,
Div, of Eli Lilly and Co., Indianapolis, Ind.; CDL:095855-H)
00041690 Cline, J.C.; Thompson, C.Z.; McMahon, R.E, (1978) The Effect of Lilly
Compound 75503 (Tebuthiuron) upon Bacterial Systems Known To Detect
Mutagenic Events. (Unpublished study received Jun 1, 1978 under 1471-109;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:097101-C)
00041691 Todd, G.C.; Markham, J.K.; Owen, N.V.; et al. (1975) A Dominant Lethal
Study with EL-103 (Tebuthiuron) in the Rat: Study R-655. (Unpublished study
received Jun 1, 1978 under 1471-109; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:097101-D)
00041692 Kehr, C.C.; Hamelink, J.L.; Todd, G.C.; et al. (1978) The Acute Oral
Toxicity of Compound 75503 (EL-103) in Mallard Ducks; Study 7021-77.
(Unpublished study received Jun 1, 1978 under 1471-109; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:097102-A)
00041694 Hamelink, J.L.; Todd, G.C.; Brannon, D.R.; et al. (1978) Acute Toxicity of
Compound 75503 (EL-103) to~Daphnia magm^-: Study 5058-77. (Unpublished
study received Jun 1, 1978 under 1471109; submitted by Elanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL;097102-C)
00090083 Sauter, S.; Meyerhoff, R.D.; Todd, G.C.; et al. (1981) The Toxicity of
Tebuthiuron (EL-103, Compound 75503) in Water to Rainbow Trout (^t-Salmo
gairdneri~~/i) in a 45-day Embryo-larvae Study; Study F14580. Includes method
AM-AA-CA-JQ24-AB-7S5 dated Jan 26, 1981. (Unpublished study received
Dec 10, 1981 under 1471109; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:246375-A)
00090084 Sauter, S.; Meyerhoff, R.D.; Todd, G.C.; et al. (1981) The Toxicity of
Tebuthiuron (EL-103, Compound 75503) in Water to Fathead Minnows
(fj.— Pimephales promelas—n) in a 33-day Embryo-larvae Study: Study F08381.
Includes method AM-AA-CA-JO24-AB-755 dated Jan 26, 1981. (Unpublished
study received Dec 10, 1981 under 1471-109; submitted by Elanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:246375-B)
77
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BIBLIOGRAPHY
MRID
CITATION
00090097 Loh, A.; Magnussen, J.D. (1981) Summary of Environmental Chemistry
Studies with Tebuthiuron. Summary of studies 246373-B through 246373-E.
(Unpublished study received Dec 10, 1981 under 1471109; submitted by
Blanco Products Co., Div. of Eli Lilly and Co,, Indianapolis, Ind.;
CDL;246373-A)
00090103 Loh, A,; Meyerhoff, R.D. (1981) Summary of Tebuthiuron Soil Monitoring
and Water Runoff Experiments, (Unpublished study received Dec 10, 1981
under 1471-109; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL: 246373-G)
00090106 Loh, A.; Davis, E.A.; Helmer, J.D.; et al, (1981) Creation of Brush Grass
Mosaics in Arizona Chaparral Watershed Study with Tebuthiuron.
(Unpublished study, including published data, received Dec 10, 1981 under
1471-109; prepared in cooperation with Arizona State Univ., Rocky Mountain
Forest and Range Experiment Station, Forest Sciences Laboratory, submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:246373-J)
00090107 Loh, A.; Bjerregaard, R.S.; Eaton, BJ. (1981) Evaluation of Graslan
(Tebuthiuron) for Possible Contamination of Catchments following Application
for Rangeland Brush Control: Experiment RSB81-2, Hondo, Texas.
(Unpublished study, including published data, received Dec 10, 1981 under
1471-109; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:246373-K)
00090108 Hoyt, J.A.; Adams, E.R.; Owen, N.V.; et al. (1981) A Two-generation
Reproduction Study with Tebuthiuron (Compound 75503) in the Wistar Rat:
Studies R03780 and R08780. (Unpublished study received Dec 10, 1981
under 1471-109; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL;246374-A)
00090109 Loh, A.; Bjerregaard, R.S.; Eaton, BJ. (1981) Evaluation of Graslan
(Tebuthiuron) for Possible Contamination of Catchments following Application
for Rangeland Brash Control: Experiment RSB81-1, Marietta, Oklahoma.
(Unpublished study, including published data, received Dec 10, 1981 under
1471-109; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:246373-L)
78
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BIBLIOGRAPHY
MRID
CITATION
00093690 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report; Onegeneration
Reproduction Study—Mallard Duck: Compound 75503, Tebuthiuron: Project
No. 151-105. (Unpublished study received Jan 7, 1982 under 1471-109;
prepared by Wildlife International, Ltd., submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:246557-B)
00094745 Blanco Products Company (1982) Summary Report of Tebuthiuron Residues in
Forage Grass and Animal Tissues. Includes procedures 5801667 dated Nov
16, 1978 and 5801643 dated Apr 2, 1975. (Compilation; unpublished study
received Feb 11, 1982 under 1471109; CDL:246779-D)
00104243 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report; Onegeneration
Reproduction Study—Bobwbite Quail: Compound 75503, Tebuthiuron: Project
No. 151-104. (Unpublished study received Jan 7, 1982 under 1471-109;
prepared by Wildlife International, Ltd., submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:246557-A)
00106080 Blanco Products Co. (1982) [Residues of 14C Tebuthiuron in Milk].
(Compilation; unpublished study received Jul 15, 1982 under 1471-109;
CDL:070985-B)
00106081 Adams, E.; Magnussen, J.; Emmerson, J,; et al. (1982) Radiocarbon Levels in
the Milk of Lactating Rats Given 14C Tebuthiuron (Compound 75503) in the
Diet; Study R1378L (Unpublished study received Jul 15, 1982 under
1471-109; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL: 070985-C)
00138700 Grothe, D.; Meyerhoff, R.; Todd, G.; et al. (1983) The Toxicity of
Tebuthiuron (EL-103, Compound 75503) to Daphnia magna in a 21day Static
Renewal Full Life-Cycle study: C02882. (unpublished study received Jan 19,
1984 under 1471-109; submitted by Blanco Products Co., Div. of Eli Lilly and
Co,, Indianapolis, IN.; CDL:252491-D)
00141690 Thompson, C. (1984) The Effect of Tebuthiuron (Lilly Compound 75503) on
the Induction of Bacterial Mutation Using a Modification of the Ames Test:
Study 840410GPA655. Unpublished study prepared by Eli Lilly and Co. 27
P-
79
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BIBLIOGRAPHY
MRID
CITATION
00141691 Rexroat, M. (1984) The Effect of Tebuthiuron (Lilly Compound 75503) on the
Induction of Reverse Mutations in Salmonella (yphimurium Using the Ames
Test: Study 840326AMS655, Unpublished study prepared by Eli Lilly & Co.
28 p.
00145041 Oberly, T. (1984) The Effect of Tebuthiuron (Lilly Compound 75503) on the
Induction of Forward Mutation at the Thymidine Kinase Locus of L5178Y
Mouse Lymphoma Cells: Studies 840410MLA655; 840606MLA655;
840613MLA655, Unpublished study prepared by Eli Lilly and Co. 40 p.
00146801 Todd, G,; Means, J.; McGrath, J. (1985) The Toxicologic Evaluation of
Tebuthiuron (Lilly Compound 75503) Given Orally to Beagle Dogs for One
Year: Study D04283. Unpublished study prepared by Lilly Research
Laboratories. 348 p.
00149733 Brown, G. (1985) Subchronic (21-Day) Dermal Toxicity Study in New
Zealand White Rabbits with Technical Tebuthiuron: Study B01484.
Unpublished study prepared by Lilly Research Laboratories, 211 p.
00155730 Markey, T. (1985) The Acute Inhalation Toxicity of Technical Tebuthiuron
(EL-103, Compound 75503): Study No. R-H-023-85, Unpublished study
prepared by Lilly Research Laboratories. 15 p.
40493801 Day, E.; Hackler, R. (1988) Product Identity and Composition of Technical
Tebuthiuron: Project ID; EWD8801. Unpublished compilation prepared by
Lilly Research Laboratories. 18 p.
40493802 Saunders, D.; Hudson, J. (1988) Physical and Chemical Characteristics of
Technical Tebuthiuron: Project ID: DGS8802. Unpublished study prepared by
Lilly Research Laboratories. 9 p.
40493803 Hudson, J. (1987) Tebuthiuron Technical, Bulk Density, ... Product Chemistry
Requirement: Study No, T1H9087Q5. Unpublished study prepared by Lilly
Research Laboratories. 4 p.
40493804 Hudson, J. (1988) Tebuthiuron Technical, Part 158 Product Chemistry
Requirements for Manufacturing-Use Product: Physical and Chemical
Characteristics: Study No. T1H908707. Unpublished study prepared by Lilly
Research Laboratories. 6 p.
80
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BIBLIOGRAPHY
MRID
40583901 Negilski, D.; Hawkins, D. (1988) The Acute Toxicity of Technical
Tebuthiuron Administered Orally to the Fischer 344 Rat: Laboratory Project
ID: R06188 and R06288. Unpublished study prepared by Lilly Research
Laboratories. 27 p.
40583902 Negilski, D.; Rock, G. (1988) The Acute Dermal Toxicity and Primary
Dermal Irritation of Technical Tebuthiuron in the New Zealand White Rabbit:
Laboratory Project ID: B02088. Unpublished study prepared by Lilly
Research Laboratories. 18 p.
40601001 Negilski, D.; Grothe, D.; Meyerhoff, R. (1988) The Toxicity of Tebuthiuron
to Juvenile Bobwhite in a Five-day Dietary Study: Laboratory Project ID
AGO 188. Unpublished study prepared by Lilly Research Laboratories. 38 p.
40601002 Negilski, D.; Grothe, D.; Meyerhoff, R. (1988) The Toxicity of Tebuthiuron
to Juvenile Mallards in a Five-day Dietary Study: Laboratory Project ID
A00288. Unpublished study prepared by Lilly Research Laboratories. 38 p.
40640001 Saunders, D, (1988) Evaluation of Graslan (Tebuthiuron) for Possible
Contamination of Catchments following Application for Rangeland Brush
Control Experiment RSB81-2, Hondo, Texas: "Supplemental Report":
Laboratory Project ID: RSB81-2. Unpublished study prepared by Lilly
Research Laboratories. 16 p.
40640002 Saunders, D. (1988) Sagebrush to Grass Conversion in Southwest Idaho
Watershed Study with Tebuthiuron: "Supplemental Report": Laboratory
Project ID: MDH80-9, Unpublished study prepared by Lilly Research
Laboratories. 32 p.
40640003 Saunders, D. (1988) Supplemental Report: Study Plan VII: Evaluation of
Graslan (Tebuthiuron) for Possible Contamination of Catchments following
Application for Rangeland Brash Control, Experiment RSB81-1, Marietta,
Oklahoma: Laboratory Project ID: RSB811. Unpublished study prepared by
Lilly Research Laboratories. 20 p.
40640004 Saunders, D. (1988) Creation of Brush Grass Mosaics in Arizona Chaparral
Watershed Study with Tebuthiuron: "Supplemental Report": Laboratory
Project ID: AL-81-09. Unpublished study prepared by Lilly Research
81
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BIBLIOGRAPHY
MRID
CITATION
Laboratories. 56 p.
40768302 Day, E. (1988) Analysis and Certification of Ingredients for Tebuthiuron
Technical; Laboratory Project ID EWD8812, Unpublished study prepared by
Lilly Research Laboratories. 6 p.
40768303 Rutherford, B, (1988) Test Article Characterization of Technical Tebuthiuron
Lot Number 729AS7: Laboratory Project ID BSR87Q6, Unpublished study
prepared by Lilly Research Laboratories, 18 p,
40768304 Rutherford, B. (1988) Manufactured Product Characterization of Technical
Tebuthiuron: Laboratory project ID BSR8704, Unpublished study prepared by
Lilly Research Laboratories. 19 p.
40768305 Rutherford, B. (1988) Corporate Control Laboratory Procedure for
Tebuthiuron Technical, QA182R, ID 5857: Laboratory Project ID BSR8817.
Unpublished study prepared by Lilly Research Laboratories. 8 p.
40768401 Saunders, D.; Powers, F. (1988) Mobility of Tebuthiuron in Soil: Laboratory
Project ID DGS8808. Unpublished study prepared by Lilly Research
Laboratories. 122 p.
40776301 Negilski, D.; Higdon, G. (1988) A Supplementary Report in Support of a
Teratology Study with Tebuthiuron (EL-103, Compound 75503) in the Rabbit:
Laboratory Project ID: B-7014. Unpublished study prepared by Lilly
Research Laboratories. 9 p.
40819501 Rainey, D. (1988) [Carbon 14] Tebuthiuron Flow-through Bioaccumulation
Study in Bluegill Sunfish: Laboratory Project ID: ABC0401, Unpublished
study prepared by Division of Eli Lilly and Co. 60 p.
40840401 Hoxter, K.; Jaber, M. (1988) The Acute Contact Tbxicity of Tebuthiuron to
the Honey Bee: Wildlife International Ltd. Project No.: 151-108. Unpublished
study prepared by Wildlife International Ltd, 31 p.
40849101 Hoffman, D. (1988) A Supplementary Report in Support of General
Metabolism Studies Conducted with Tebuthiuron (EL-103, Compound 75503).
Unpublished study prepared by Lilly Research Laboratories. 44 p.
82
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BIBLIOGEAPHY
MRID
CITATION
40985001 Magnussen, J.; Rainey, D. (1989) The Nature of [Carbon 14] Tebuthiuron
Residues in Milk: Study No. ABC-0410, Unpublished study prepared by Lilly
Research Laboratories. 52 p.
40985002 Magnussen, J,; Rainey, D. (1989) Nature of [Carbon 14] Tebuthiuron
Residues in Bovine Tissue: Study No. ABC-0413. Unpublished study
prepared by Lilly Research Laboratories. 42 p.
41005701 Rutherford, B. (1989) Analytical Report on Tebuthiuron Technical Produced in
Brazil: Proj, ID BSR8820. Unpublished supplemental study prepared by Lilly
Research Laboratories. 13 p.
41031801 Day, E.; Hackler, R. (1989) Discussion of Potential N-nitroso Contaminants in
Technical Tebuthiuron: Laboratory Project ID EWD8901. Unpublished study
prepared by Lilly Research Laboratories. 7 p.
41050201 Saxena, A. (1989) Artificial Sunlight Photodegradation of [Carbon
143-Tebuthiuron on Soil: Laboratory Project ID: HLA 6237-104: Elanco
Study No.: AAC8847. Unpublished study prepared by Hazleton Laboratories
America, Inc. 95 p.
41066901 Waldrep, T. (1988) Influence of Tebuthiuron on Seedling Emergence and
Vegetative Vigor of Ten Crop Plants: Proj. ID 61988008. Unpublished study
prepared by Lilly Research Laboratories. 24 p,
41066902 Waldrep, T. (1988) Influence of Tebuthiuron on the Germination of Seeds of
Ten Crop Plants: Proj, ID 61988007. Unpublished study prepared by Lilly
Research Laboratories, lip.
41080401 Negilski, D.; Grothe, D.; Cocke, P. (1989) Toxicity of Tebuthiuron to the
Blue-Green Alga (Anabaena flos-aquae) in a Static Test System: Laboratory
Project ID J004489. Unpublished study prepared by Lilly Research
Laboratories. 44 p.
41080402 Negilski, D.; Cocke, P, (1989) Toxicity of Tebuthiuron to a Marine Diatom
(Skeletonema costatum) in a Static Test System: Laboratory Project ID
J00389. Unpublished study prepard by Lilly Research Laboratories, 43 p.
41080403 Negilski, D.; Cocke, P, (1989) Toxicity of Tebuthiuron to a Freshwater
83
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BIBLIOGRAPHY
MRID
CITATION
Diatom (Navicula pelliculosa) in a Static Test System: Laboratory Project ID
J00888. Unpublished study prepared by Lilly Research Laboratories, 47 p.
41080404 Negilski, D.; Cocke, P. (1989) Toxicity of Tebuthiuron to Duckweed (Lemna
gibba) in a Static Renewal Test System; Laboratory Project ID J00588,
Unpublished study prepared by Lilly Research Laboratories. 62 p.
41134101 Negilski, D.; Garriott, M.; Kindig, D, (1989) The Effect of Tebuthiuron
(EL-103, Compound 075503) on the in vitro Induction of Chromosomal
Aberrartions hi Chinese Hamster Ovary Cells: Project No. 89G111CTX655;
890125CTX655; 890201CAB655. Unpublished study prepared by Lilly
Research Laboratories. 49 p.
41196901 Lear, P. (1989) Multiresidue Methodology Testing of Tebuthiuron and 6 of its
Metabolites: Project ID: 132-002. Unpublished study prepared by EPL
Bio-Analytical Services, Inc. 56 p.
41305101 Saxena, A. (1989) Artificial Sunlight Photodegradation of pCarbon
14g-Tebuthiuron in a Buffered Aqueous Solution; Final Report; Lab Project
Number: HLA/6237/105. Unpublished study prepared by Hazleton
Laboratories America, Inc. 66 p.
41328001 Rainey, D. (1989) Aerobic Soil Metabolism of [carbon 14] Tebuthiuron: Lab
Project Number: ABC/0425. Unpublished study prepared by DowElanco 21
P-
41328002 Rainey, D. (1989) Anaerobic Soil Metabolism of [carbon 14] Tebuthiuron:
Lab Project Number: ABC/0426. Unpublished study prepared by DowElanco
19 p.
41372501 Rainey, D. (1989) Aerobic Aquatic Metabolism of [Carbon 14] Tebuthiuron:
Lab Project ID ABC-0446. Unpublished study prepared by DowElanco. 21
P-
41913101 Kesterson, A.; Wick, M. (1991) Anaerobic Aquatic Metabolism of
[14C]Tebuthiuron: Lab Project Number: 1332: 407, Unpublished study
prepared by PTRL East, Inc. 71 p.
42390901 Stone, C. (1992) Tebuthiron Small Scale Retrospective Groundwater Study at
84
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BIBLIOGRAPHY
MRID
CITATION
Kenedy Ranch, Sarita, Texas; Lab Project Number: 1-1208-3. Unpublished
study prepared by The Johnson Co., Inc. 678 p.
42630501 West, S.; Morgan, R,; Turner, L, (1993) Long-term Frozen Storage Stability
of Tebuthiuron and Its Major Metabolites in Grass Forage and Hay: Lab
Project Number: AAC8907. Unpublished study prepared by DowElanco. 25
P-
42630502 West, S.; Ervick, D.; Turner, L. (1993) Determination of Residues of
Tebuthiuron and Its Metabolites in Forage and Hay following Application of
Spike Herbicide to Rangeland and Pasture Grasses: Lab Project Number:
ACC8907.01. Unpublished study prepared by-DowElanco. 223 p.
42720001 Murphy, G. (1993) Tebuthiuron Product Chemistry Review: Response to
Letter from EPA's Lois A. Rossi (Rec. 3/19/92): Lab Project Number:
GLM32993: GLM32993CA. Unpublished study prepared by DowElanco. 29
P-
42726201 Murphy, G. (1993) Determination of Stability of Tebuthiuron Technical Grade
of Active Ingredient (TGAI): Lab Project Number: FOR93025. Unpublished
study prepared by DowElanco Formulation Science and Technology Lab. 9 p.
85
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APPENDIX D. List of Available Related Documents
87
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The following is a list of available documents related to Tebuthiuron. 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 Tebuthiuron 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. Tebuthiuron 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
89
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APPENDIX E. PR Notices 86-5 and 91-2
91
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PR Notice 86-5
93
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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. App1icab i1i t y
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)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill. 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
95
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. 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.
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 CPR §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.
96
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- INDEX-
Text Example
• -;- .-."•-' Page Page
A, Organization of the Submittal Package 3 17
B. Transmitta! 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) (1)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(!)) 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 admin-
istrative 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).
97
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B. Transmittal Document . «
The first item in each submittal package must be a trans-
mittal 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> (2)(B) data
call-in, §6 (a) (2) subrnittal, 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 CPR 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.
When a submittal package supports a tolerance petition
an application for a registration or an EUP, list the petition
studies first, then the balance of 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 complete-
ness, 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 Guide-
line requirement for supporting data, with some exceptions dis-
cussed 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 l. 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.
98
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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 ie plainly identified
by the study title and its position in the multi-volume sequence.
C.1 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. S a fe ty Studi e s. 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 assoc-
iated 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, 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 EIFRA
§10(d){1}(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements muat 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 inves-
tigation 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
When Required • Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
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
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d){!)(A), (B), or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10 (d) (1) (A) , (B) , or (C)
100
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D.l. 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 OH 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 if 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 pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
101
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D.2. Statements of Data Confidentiality Claims Under FIFRA
§10{d} (1) .
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)(!)(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)5 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}.
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)(1) 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 of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential 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.
102
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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. Sam-
ples of these statements are shown in Attachment 6.
E, Reference to Previously Submitted Data
DO NOT RISUBM1T 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 pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
P. 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 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.)
103
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G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 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 of 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)(1)(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 phrase "Public Docket Material -
contains no information claimed as confidential".
¥,
For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
Acting Dtrtctor,
Attachment 1
Attachment 2,
Attachment 3.
Attachment 4
Attachment 5,
Attachment 6
Attachment 7
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
104
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ATTACHMENT I
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:.
Name Signature
Company Name : ,
Company Contact: ^___
Name Phone
105
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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
January 5, 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)
106
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1){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 PIFRA §10(d)(1)(A), (B), or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
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
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 Analytical
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.
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ATTACHMENT 4
SUPPLEMENTS STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIPRA §10(d)(!)(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion 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 con-
nection 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 sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of eirnilar information in the future, and if so,
how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONflfiENTIAL ATTACHMENTS
Example l. {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 words or phrase at the
indicated volume and page references .
DELETED WORDS OR PHRASE: _ TH-hyl onA rt1r.nl _
PAGE LINE REASON FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient §10 (d) (1} (C)
12 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 FIFRfl REFERENCE
20. 2-17 Description of the quality control process §10(d)(1)(C)
Example 3. {Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER T_ This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES SEASON FOR THE DELETION FIFRA REFERENCE
20. 2-1? Description of the product manufacturing process §10(d){!)(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 -
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part ISO, and differs
in the following ways:
i.
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
FORMAT OP THE SUeMITTAL PACKAGE
Transmittal Document.
Related Administrative Materials
(*.g, , Method of Support statement, etc,)
Other materials about the subaittal
(e.g., summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement oC Confidentiality Ciains.
GLP and flagging* stateaents - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
LEGEND
Title Page of the Confidential
Attachment,
Confidential Attachment.
Supplemental Statement
of Confidentiality Ciains,
* Mian flagging requirements
are finalited.
Documents which must be submitted as
appropriate to neet established requirements.
^
Documenta submitted at subnitter's option.
111
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PR Notice 91-2
113
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FQRMULATORS,
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(1). 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 of 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
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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
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(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
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 of section 12(a)(1)(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 baaed 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.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required jto 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.
¥. 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., reregistratipn, 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 l, 1997, 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.
C-
Ann* E. Lindsay, Director
Division (H-750S
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APPENDIX F. Combined Generic and Product Specific
Data Call-in
119
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GENERIC AND PRODUCT SPECIFIC
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 A 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. Within 90 days after you receive this Notice you
must respond as set forth in Section HI below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment 3 (for both generic and product specific data), the
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. All products
are listed on both the generic and product specific DatajCall-In Response Forms. Also
included is 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 and 2070-0057 (expiration date 3-31-96).
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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:
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 ¥1 - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
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 ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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H-B. SCHEDULE FOR SUBMISSION OF DATA « • ...
You are required to submit the data or otherwise satisfy the data requirements
specified in the Requirements Status and Registrant's Response Forms (Attachment 3) within
the timeframes provided.
H-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 (Telephone
number: 703-487^1650),
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 § 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, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
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],
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcK2KB) 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 HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to
this Notice, The type of Data Call-in you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
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The appropriate responses initially required by this Notice for generic and 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
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to
satisfy the generic data requirements imposed by this Notice or (e) request a data waiver(s),
A discussion of how to respond if you choose 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 generic 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.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required
to sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (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.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your produGt(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Fonn(s). If you
choose this option, these are the only forms 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
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provisions of this Notice, which are contained in. Section IV-C,
b. 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 (Attachment
3), 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 under item 9 in the instructions for the Requirements Status and Registrant's Response
Forms. 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 Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (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, is allowed only if the product bears an amended label.
c. 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 if
the active ingredient in the product is derived exclusively from purchased, registered
pesticide products containing the active ingredient. 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, aJl of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because
of incorporation of another registered product which contains the subject active
ingredient and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this
Notice and must remain in compliance; and
(iii). 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 responding to
product specific data requirements.
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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 requirements or
are no longer in compliance with this Data Call-In Notice, the Agency will consider that both
they and you are not 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.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section HI-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-in Response Form. If you choose item 6b (agree to
satisfy the generic data requirements), you must submit the Data Call-In Response^Fonn and
the Requirements Status and Registrant's Response Form as well as any other
information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section HI-D.I. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for 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.
2. Product Specific Data Requirements
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 choose 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 HI-C.2. A discussion of
options relating to requests for data waivers is contained in Section HI-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-in
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
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each product listed on the Data Call-in Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized representative is required to
sign the first page of the Data Call-In Response Forth 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.
a. 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-In Response
Form, indicating your election of this option. Voluntary cancellation is item number 5 on
both the Generic and Product Specific Data £all-In Response Forms. If you choose this
option, you must complete both Data Call-in response forms. These are the only forms 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.
b. 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.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data
Call-In Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant'f Response Jorm. If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
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1, Generic Data
If you acknowledge on the Generic Data Cali-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic 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 you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (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. 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 hi the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If 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 of 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. This 90-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
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address of the laborstory(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 for 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 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
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
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
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registration(s)» 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 the 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 to 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 burden 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 normally will 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 axe 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
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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 "{[r]aw 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 nave 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, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to
the requirements of 40 CFR Part 160. Registrants also must 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 usually are 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 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.
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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 conforrnance 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 also should 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*1 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
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submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you select option 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 I. Developing Data - The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.I, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
in.C.I, Option 2). However, 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 snare by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section III.C.L, Option 3) apply to this option. This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.
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Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section III.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see
Section III.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instiuctions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (IILC.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
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(s) are not appropriate for your product,
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(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 low volume pesticides to be only those active ingredients 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 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 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 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;
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(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, 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.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient
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.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) 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.
(vi) 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 die testing needed to fulfill each of these data
requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
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(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, 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 in
terms of its benefits, you should provide information on any of the following factors,
as applicable to your product(s): (a) documentation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description of the beneficial impacts on
the environment of use of the active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the active ingredient 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.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement
should not apply because the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply. You also
must 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 are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B).
jf EPA determines that the data are required for vour productfs). YOU must choose a
method of meeting thejrequirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you
must submit a revised Requirements Status and Registrant's Response Form indicating
the option chosen.
2, Product Specific Data
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 HFRA, If
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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 product specific
Requireme_ois_Statu.s ancLRegistrant'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.
SECTION 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.
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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;
i. 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.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. 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
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 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
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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 generally
would 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 tlie burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. You also must 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 for which the Agency has
particular risk concerns will be determined on a 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
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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 must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and 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 Generic and Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Prevention, Pesticides
and Toxic Substances (OPPTS), EPA, will be monitoring the data being generated in
response to this Notice,
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-in Response Fonng with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
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7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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Tebuthiuron DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Tebuthiuron.
This Generic 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
Tebuthiuron. 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 Tebuthiuron 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
Tebuthiuron are contained in the Requirements Status and Registrant's Response, Attachment
C, The Agency has concluded that additional product chemistry data on Tebuthiuron are
needed. These data are needed to fully complete the reregistration of all eligible Tebuthiuron
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 Peg Perreault at (703) 308-8055.
All responses to this Notice for the generic data requirements should be submitted to:
Peg Perreault,, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Tebuthiuron
145
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TEBUTHIURON DATA CALUN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
produet(s) containing Tebuthiuron.
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 Tebuthiuron. 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), (6) a list of registrants receiving this DCI
(Attachment 6) and (7) the Cost Share and Data Compensation Forms in replying to this
Tebuthiuron 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 Tebuthiuron are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on Tebuthiuron 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 Tebuthiuron products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Tebuthiuron, please
contact Peg Perreault at (703) 308-8055.
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.
(703) 308-8069.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Sue Rathman
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: Tebuthiuron
146
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147
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
149
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Instructions For Completing
The
"Data Call-in Response Forms"
For The Generic And Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data
CalHns as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide,
and Rodenticide Act, The type of data call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-in Response"
forms must be completed.
Although the form is the same for both generic and product specific data, instructions
for completing these forms are different. Please read these instructions carefully before
filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms with a number of items. DO NOT use these forms for any other active
ingredient.
Items 1 through 4 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.
The 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, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to me Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS; This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. ON BOTH FORMS: This item identifies the type of Data Call-In. The date
of issuance is date stamped.
Item 4. ON BOTH FORMS: 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, ON BOTH FORMS: Check 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
mat request. Since this Data Call-In requires both generic and product specific
data, you must complete item 5 on both Data Call-In response forms. You do
not need to complete any item on the Requirements Status and Registrant's
Response Forms.
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
for generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed hi 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
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
152
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Generic and Product Specific Data Call-in
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. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is
for generic data 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.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM: 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."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's)
if your product is identical to another product and you qualify for a data
exemption. You must provide the EPA registration numbers of your
source(s); do 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.
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.
NOTE: Item 7a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
153
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Item 8. ON BOTH FORMS: 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 ia the space provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form hi a signed
letter that accompanies your response. 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.
154
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Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print In if*. Pleas* read carefully
Use additional sheet(a) If necessary
1. Company neM and Address
4. EPA Product
Registration
1. t wish to
cancel this
product regis-
tration volun-
tarily
6. Centric Data
the attached Instructions and supply the Information requested
2. Case f and Name
0054 Tebuthiuron
Chemical i and Name 105501
Tebuthiuron
6*. 1 MI claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration nunber listed below.
6b. I agree to satisfy Generic
Data requirements as Indicated
on th* attached form entitled
"Requirements Status and
Registrant's Response."
Form Approved
OMB No. 2070*0107
2070-0057
Approval Expires 03-31-96
on this form.
I. Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
fora entitled "Requirements
Status and Registrant's
Response."
8. Certification
1 certify that the statements made on this fora Mid all attachments are true, accurate, and complete.
1 acknowledge that any knowingly falsa or misleading statement may be punishable by fine, imprisonment
or both under applicable IBM.
Signature and Title of Conpanv's Authorized Beoftaentative
10. Name of Ccrparry Contact
7b. My product is an IUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11. Phone Nuiter
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Page 1 of 1
Unitfed States Environmental Protection Agency form Approved
Washington, D. C. 20460
WB Ho. 2070-0107
DATA CALL-IN RESPONSE EQ7Q-OOS7
Approval Empires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
155
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Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status
and Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act, The type of Data Call-in (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.
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 of uses or (2) request for a low volume/minor
use waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by
the registrant as appropriate. Items 10 through 13 must be completed by the registrant
before submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
30 minutes per response, including tune 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, Mail Code 2136, 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.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2, ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-in. The date of issuance is date stamped,
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
type of Data Call-in. The date of issuance is also date stamped. Note the
unique identifier number (ID#) assigned by the Agency. This ID number must
be used in the transmittal document for any data submissions in response to
this Data Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-In 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, Subpart c.
Item 5. ON BOTH FORMS: 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.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
158
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REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
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 crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical
Grade Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Indredient or Pute Active
Ingredient Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled
and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled
and Plant Metabolites
TEP Typical End-Use Product
TEP % Typical End-Use Product, Percent
Active Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
159
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TEP/PAI/M Typical End-Use Product or Pure Active
Ingredient and Metabolites
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or
Pure Active Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or
Pure Active Ingredient
Radiolabelled
TGAI/TEP Technical Grade Active Ingredient or
Typical End-Use Product
MET Metabolites
IMP Impurities
DEGR Degradates
* See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the date stamped on the
letter transmitting the Reregistration Eligibility Decision document, and not
from the date of receipt. However, your response to the Data Call-In itself is
due 90 days from the date of receipt.
Item 9. ON BOTH FORMS: 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.
Option 1. ON BOTH FORMS: (Developing Datal 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 the conditions for submittal of
160
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this study as outlined in the Data Call-In Notice and that I will provide
the protocols and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have entered into
an agreement with one or more registrants to develop data jointly. By
indicating
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
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.
However, for Product Specific Data, I understand that this
option is available for acute toxieity or certain efficacy data ONLY if
the Agency 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.
Option 3. ON BOTH FORMS: (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 also submitting a completed "Certification of offer to
Cost Share in the Development of Data" form, 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
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 apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-in
Notice that my product is similar enough to another product to qualify
for this option.
Option 4. ON BOTH FORMS: (Submitting Existing Data> I will submit an
existing study by the specified due date that has never before been
161
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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
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
existing data outlined in the Data Call-in Notice and I have attached the
needed supporting information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite 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.
Option 6. ON BOTH FORMS: (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. If
reviewed, I am providing the Agency's classification of the study,
However, for Product Specific Data, 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 the
Agency 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). If I cite another registrant's data, I will submit
a completed "Certification With Respect To Data Compensation
Requirements" form,
FOR THE GENERIC DATA FORM ONLY: The following three options
(Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status
and Registrant's Response Form" for generic data.
162
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product_Sj?ecific Data Call-in
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor UseJWaiver 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.
Option 9. (Request for Waiver of Data) I have read the statements concerning
data waivers other than lowvolume minor-use data waivers hi the Data
Call-In Notice and I request a waiver of the data requirement, I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice
governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate for my product. 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
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
163
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Generic and Product Specific Data Call-In
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"
form specifying 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.
Item 10.
ON BOTH FORMS:
Item 11.
Item 12,
Item 13.
ON BOTH FORMS:
ON BOTH FORMS;
ON BOTH FORMS:
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.
Enter the date of signature.
Enter the name of the person EPA should contact
with questions regarding your response.
Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this your response. 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 the Agency can ensure that its records
are correct.
164
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Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Plcass type or print In ink. Please read carefully the attached instructions and sLpply the Information requested
Use additional sheet(s) If necessary
1. Ccmpany name and Address
ft. Guideline
Requirement
Nuiter
62-1
5. Study Title
Preliminary Analysis
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V). Certification
I certify that the statements made on this form and all attachments are true, accurate, and coifilete.
I ackrwnledge that any knowingly falsa or Misleading statement may ba punishable by fine, irprisorment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
Fora Approved
OMB NO. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DC1
GENERIC
8. Time
frame
6 mos.
9. Registrant .
Response
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11. Date
IS. Phone Huiter
-------
United States Environmental Protection Agency
Washington, D. c. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPOHSE
Page i of 3
Form Approved
OMB Ho. 2070-0107
2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested en this form.
Use additional sheet(s) if necessary.
1. Conpony name and Address
SAMPLE COMPANY
HO STREET ADDRESS
NO CITYr XX OOOOO
2, Case f and Name
0054 Tebuthiuron
EPA Reg. No. NNNNNH-NMNNN
3. Date end Type of DC!
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
*. Guideline
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5. Study Title
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6. Use
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8. Time
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9. Registrant
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10. Certification
1 certify that the statements mode on this form and all attachments are true, accurate, and conptete.
I acknowledge that any knowingly false or misleading statement nay be punishable by fine, inprisonnent
or both under applicable law.
Signature and Title «f Company's Authorized Representative
11. Date
12. Name of Cenpany Contact
13, Phone Nunber
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Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS; Please type or print in iftk. Please read carefully
Use additional sheetCs) if necessary.
1. Corrpany name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
ft. Guideline
Requirement
Nuifcer
•63;— .8:':. • ^ffX-^fM
63-9
63-11
•'••': ._." :>C:x-::;::'l .t:i:t"1-;t:'
63-12 • '""'""" '
63-14
•iSSMlS--!: .V iPfyp^F;^?
63-16
63-18
63-20
g-jT™ 2 •"""•""•'"'""""•" ''•""'•"
181-3*
5, Study Title
-,
:lloiubiHtyir '•"•'• : "£.™*-ZT:*"
Vapor pressure
Octanol/watef partition (8)
•'YV':"v.~';:: ii^i;-^*-"1'"' •*; :-•- :*":::':"': :". ''-:': •'":''?, ':" : - '"' '?':''''• '•'•':'..':: ..'
.;:;:• ,;::::.i'>wBT;T:|S«.l9ff^--:-: "/.-:•"-. v'"::;^^::'^;? •• -":':-: :-£,: -- ', ••'
P" \*f
!- •,•."'-:•: ;:v:-r--.;.-£.-x-i-x. _:-:;._.-.-.; -• -. v -. •:-: .-:•. • .-.• :••:.;•?;-;• :.• .--,••• • -• ,. • •:• .••;•--. • .
Oiidizing or .reducing action CIO)
?j$Jjiiii^tffyK-;fW^
fnplodebittty (12)
Viscosity (13)
Corrosion character! ctlet
'^mmmmmmm^fm^^-
lleSt*:WTOl'6'i:S'?i1lliSMtilfelJrtWiwt;";::'i;ft5:iK^
the attached instructions and supply the information requested
2. Case ft and ttMie
0054 Tebuthluron
EPA Reg. No. NNNNNN-NNNNN
Acute darml C 1,2,3?)
lf|il|^||||yli^|i^iW|llli:!lI|li?
Acut* inhalation toxlctty-rat (3}
Initial to indicate certification as to information on this page
(full text of certification is on page one).
§
0
i
L
Progress
Reports
1
' •,':- ': . 1
2
¥:'.;":':;:-i::
3
::-;.:" •.-:' :
6. Use
Pattern
ABcisitet
ABCDEFGHIJKLMNO
A&^EFSHIjkLMNO
':':•; :' ': :-:':":-:-::;'Ji':::::-:-:.::: ivi::::::-:
ABCDEFGHIJKLMNO
ABCDEFGH I JKLMNO
KBCDEFGl
ABCbEFGHIJKLMNO
ABCblFGHijKLBWIO
Ai$\*L/,£ii;, unJuU j\Jjril*iW
ABOTEFX3HIJKiJHNb
IIJKpPgJi
|I^I|Ki|MNP:
ABCDEFGHIJKLMNO
ABCblFGHIJKLMNO
7. Test
Form Approved
OHB Ho, 2075-0107
Z070-OOS7
Approval Expires 03-31-96
on this form.
3. Date and Type of Del
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
TGfftl?/!1
TGAI/PAI
PAI
:x":::-::<": -;;•>:." V:.;.:;.;:
;-:X:X<"£:^;.x":^;:-;:;.;::
MP/EP
MP/EP
MEpiB?
MP/EP'
MP/EP
MP^/TPli-'-.-
JPUc j.-::EiX?:-:::
MP/EP
«Wf;:
MSp^i
MP/EP
MP/EP
and TGAI
,'fr f ;:;•:> :::)s.|
and TGAI
and"""TGAI
8, Time
frame
sMyisiv
8 mos.
8 mos.
. :.:•:; ': ;':::. -:>'-":j::o:j:. ::
: :':;'•'.-, "•:-A-;'::>:;'J;|; '•:.;:,
8 mos.
8 mos.
ts|:ifti::|SSIi'Sti«-;:
8 mos.
8 mos.
8 mos.
:-»-:pOSV;
-5,^,;™™is;;:
8 mos.
8 mos.
9. Registrant
Response
"•:?:•• :s#f *ml
^:,-.,-,,
tt't+i-fxiy-' >:"-": • :: ';•':•:••'•;
r-;-:':-:-'«5i>::'v '•• ?:- ::' '.•••'••*'••
•_-:•/:-:- >i---:->. •- •.-, ----- -
•i>>|->;:::^::- :' ' '& : ''•
,^:;;,^,i.^^,:::;^;:;:;--:::..::
'.|:::::,:'::r':,:::::: ./:'•••:' ":•:•:• ':"•.":' -:-:•:' •:-:•
Date
-------
Page 3 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. PI ease read carefully
Use additional sheet(s) If necessary.
1 . Conpany name end Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4, Guideline
Requirement
HuAer
81-5
5, Study Title
tli* attached instruct ions and supply the Information requested
2, Case i and Name
0054 Tebuthiuron
EPA Reg. No, NNNNNN-NNNNN
Primary denw'l irritation (t,2)
:>B*r«iiv|ei^j§f:**W^ • . . :'•;.'
I
;-.V:::i
Progress
Reports
1
2
3
6, Use
Pattern
ABCDETOHIjSlNO
ABpEl|(i|EI^lpli
Initial to indicate certification M to information on this page
Cfull text of certification is on page .one).
Form Approved
OMB Ho. 2070*0107
2070-005?
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
?. Test
substance
MP/EP
«R^|Fs-:
••-•'.. ••,:-^..:
:•'• • ' ' ':: - '.-:-*-y -:|-: -
8. Time
Frame
8 mos.
9. Registrant
Response
:: 'slBP'':feP;: •
Date
-------
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFIHATIONS FOR GOIDELIHE REQUIREMENTS
Case / and Name: 0054 Tebuttiiuron
Key; HP * manufacturing-use product! EP • end-use product; provided formulators purchase their active ingredient(«} from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users ere not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TOftI = technical grade of the active ingredient; PHI = "pure" active Ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Us« Categories ley; ;
A - Terrestrial food crop 8 - Terrestrial food feed crop C • Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G * Aquatic nonfood residential H - Greenhouse food crop I * Greenhouse nonfood crop J * Forestry
K - Residential outdoor L • Indoor food H - Indoor nonfood N - Indoor Medical 0 • Indoor residential
Footnotes: CThe following not*s are referenced in column tno <5. Study Title) of th« REQUIREMENTS STATUS AND REGISTRANT'S RiSPONSE forn.l
Prod Cfi« - Regular OHM!cat
1 Requirement! pertaining to product Identity, composition, analysis, and certification of ingredients are detailed further in the following sections! *15fl-1S5 for
product Identity and ecaposttion (61-1); *156,160, 158,162, and 158.165 for description of starting materials and manufacturing process <61-2); "158.167 for
discussion of formation of Impurities C61-3); *15B.17iQ for preliminary analysis {6Z-1J; *15S.1B for certification of limits (62-2); and MSB.180 for enforeenent
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process utll suffice If the pesticide is not already under full scale production and an cyiperimental
use permit Is being taught.
1 If the pesticide ts not already under full scale production and an experimental use permit is sought, a discussion of unintentional Ingredients shall faa. submitted to
the extant this information is available.
4 To support registration of an HP or EP, uNth*f produced by an Integrated system or not, the technical grade of Active Ingredient nust be analyzed. If the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of native Ingredient must be submitted.
Data on EPs or NPs Hill be required on a csss-by-cnse basis.
5 Certified limits are not required fir inert Ingredients in products proposed for experimental use.'
A Required if technical chemical Is solid at room tenperature,
7 Required If technical chemical is liquid at roam temperature.
B Required if technical chemical Is organic and non-polar.
9 Required If test substances arc dispersibU tilth water.
10 Required If product contains an oxidizing or reducing agent.
11 Required If product contains combustible liquids.
12 Required If product Is potentially explosive.
1! Required If product Is a liquid.
14 Required if product Is an enulaif table liquid and IB to be diluted Mlth petroleum solvents.
IS Required if end-use product is liquid and is to be used around electrical equipment.
Acwt* Toxic - Regular Chemical
1 Not required If test material la a gas or highly volatile.
2 Not required If test material IB corrosive to skin or has pH less than 2 or greater than 11.5; such n product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
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Page 2 of 2
United States Environmental Protection Agency
Washington, D, C. 20460
FObTNOTIS AND KEY DEFIHATIONS FOR GUIDELIHE REQ0IKEM1ENTS
Case / and Name: 0054 Tebuthiuron
Footnotes (cont.):
3 Required If the product consists of, or infer conditions of use ufll result In, an inhatable material (e. g., gas, volatile substances, or aerosol/partfculatej,
4 Required unless repeated dermal exposure dots not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospetes, and may be required for other cholinesterase fnhlbftors and other pesticides
uMeti have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to (nltfatfon of studies,
37 Testing of the EP dilution Is required if it can be reasonably anticipated that the results of such testing my met the criteria for restriction to use by certified
applicators specified in 40 CFR 15Zv170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (n)(1).
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Attachment 4, EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
165
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EPA'S BATCHING OF TEBUTHIURON END-USE PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of end-use products containing the
active ingredient tebuthiuron, the Agency has batched products which can be considered
similar for purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological
activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder,
granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling,
etc.). Note that the Agency is not describing batched products as "substantially similar"
since some products within a batch may not be considered chemically similar or have
identical use patterns.
Batching has been accomplished using the readily available information described
above. Frequently acute toxicity data on individual end-use products has been found to
be incomplete. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual end-use product should the need
arise.
Registrants of end-use products within a batch may choose to cooperatively gener-
ate, submit or cite a single battery of six acute toxicological studies to represent ail 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
formul- ation 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 cited, the registrant
must clearly identify the material tested by its EPA registration number. If more than one
Confidential Statement Of Formula (CSF) exists for a product registration, 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
-------
168
support a batch of products, he/she must select one of the following options: Developing
Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study
(Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option
3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in
a batch, the choices are Options 1, 4, 5 or 6, However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
The following information (Table I) lists two batches (2 products each) containing
tebuthiuron.
Table I: Batched Products.
Batch No.
1
2
EPA Reg. No.
34913-9
34913-10
34913-15
34913-16
% Tebuthiuron
& Other
Active
Ingredient
3.0
5.0
(3.0)
3-(3,4 Dichloro-
phenyl)-1-1-
dimethylurea.
(1.0)
Tebuthiuron.
(6.0)
3-(3,4-Dichloro-
phenyl)-1,1-
dimethylurea.
(2.0)
Tebuthiuron.
Formulation
Type
Granular
Granular
Granular
Granular
Seven products (Table II) were either considered not to be similar for purposes of
acute toxicity or the Agency lacked sufficient information for decision making, and not
placed in any batch. Registrants of these products are responsible for meeting the acute
toxicity data requirements for each product.
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169
Table II: Products Not Batched
EPA Reg.
Number
62719-107
62719-109
62719-111
62719-121
62719-122
62719-128
62719-135
% Tebuthiuron &
Other Active
Ingredient
80.0
95.0
5,0
20.0
40.0
(4,0) Trifluralin.
(2.0) Tebuthiuron.
85.0
Formulation Type
Wettabte Powder
Technical
Granular
PeiletedfTableted
PelletedfTableted
Granular
Water Dispersable Granules
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Attachment 5. EPA Acceptance Criteria
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173
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
-------
174
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 2L 0.1% by
weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at
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.
*>•„_ 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
toxicologically significant impurities (see #3).
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175
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, 7, 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 or closure > ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0,1% (examples, nitrosamioes 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 m 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 verily 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 #9) to verily certified limits validated as to their precision and
accuracy.
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176
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; Balk density of registered products may be reported in Ibs/ft3
or Ibs/galloa,]
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
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177
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
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178
SUBDIVISION F
Guideline Study Title
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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179
81-1 Acute Oral Toxicity in the Mat
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. 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 untE 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.
-------
180
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 toxiciry of vehicle is unknown.
1. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 rag/kg).
8. Application site clipped or shaved at least 24 hours before 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 * ait supplemental and may not tie required for every study.
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181
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, cod-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 fan 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/how, 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.
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182
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 apH of <2 or >\\.5.
3,w 6 adult rabbits,
4. Dosing, instillation into the conjunctiva! sac of one eye
per animal.
5. Dose, O.I ml if a liquid; 0.1 ml or not more than 100 rog if a solid, paste or paniculate 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.
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183
81-5 Primary Derma] 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. Dosiag, 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 wirh an * are supplemental and may not be required for eveiy study.
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184
$1-6 Dermal Sensitization in the Guinea Fig
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 .>!!.5.
3. One of the 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..J 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 eveiy study.
-------
185
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
-------
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187
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
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Confidential Business Information: Dots Not Contain National Securit\
Urrtwl SMtrn in«lranni*nul Prottctton Awncy
_ Ottic»ctP«ittcicl»Proor«in«(TS 767}
JlL C DA Wwhiiwwn. DC 294IO
IP C r rA Confidential Statement of Formula
1 . Name and Address of App licant/R»9<»trent /Mwfe ZIP Codsf
3. product Nsm»
EPA USE ONLY
10, Compantntt in FormulMion A«l 11 ictvmllr mtrotutwl
into tilt totmutttian Gint commonly tcctfted ctitatictl
n«m», ff«rf» n«m«. tmlCAS mimintl
t Information {£ . 0, 1 2065)
* n
LJ BMte Formulition
i — 1 Alterntto FarmulMian
Farm Approved, OMB No, 20700060. Approval Expires 2/28/S4
e.
Piga
of
S«M Inslryciionf on Caclt
2. Namfl »nd Address of Producer (tnttuda ZIP Cade)
4. AvginrMlon N»yF Sif nature of Approving Official
19. EKhCapnptnMt
in Formulalion
i.Amourrl ». Ht^wi^i-
17 Tola
19, title
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10O%
6. Country Wh«» Fot mulaJftd
9. Flash Point/Fl3m« EnMn$«n
14. Oinrfwl Uja obiolBte. If you can pncnecapy this, please submit an additional copy. White - EPA File Copy (original) Yellow- Applicant cap*
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 857CN- 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.
e. 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 1 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.
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expire* 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 nil In blanks below.
Company Name
Product Nome
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 (FIFHA), 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
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)(lH) of FIFRA if Final agreement on ali
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nun* of Rri»{»)
Dito ef Offer
Certification:
I certify that 1 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** Auihorii»d Representative
Dale
Nam* and Till* (Plata* Type or Print)
EPA Formtt570-32 (5/91) Replaces EPA Form 8S80, which u obsolete
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195
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
"* ano4m
«••**» "»-*
Public reporting burden tor this collection ot information ii estimated to average IS minutes per response, including
time for reviewing instructions, siaichfng existing data sources, flattering and maintaining the data needed, and
completing and reviewing the coned ion of Information Send comments regarding the burden estimate or any other
aspect of this collection ct information, including suggestions for reducing this burden, to Cniel, Information Policy
Branch. PM-223, U.S. Environmental Protection Agency, 401 M St., S.W.. Washington. DC 20460; and to the Office
ot Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20S03.
Pleas* fltl In blanks below.
Company MUM
Product Mea*.
Company Number
BA K»ff. Wo.
ICerUythat:
i. For each suidy cited in support of registration or reregisiration under the Federal Insecticide, Fungicide and
Roderticbe Act
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APPENDIX G. FACT SHEET
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-S4-006
April 1994
R.E.D. FACTS
Pesticide
Reregistration
Tebuthiuron
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 hi 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 feet sheet summarizes the information in the RED for tebuthiuron.
Use Profile
Tebuthiuron is a relatively nonselective, soil activated herbicide that
acts by inhibiting photosynthesis. It is used to control broadleaf and
woody weeds, grasses and brush on feed crop sites (pasture and rangeland)
and a variety of non-food crop sites including airports/landing fields,
outdoor industrial areas, non-agricultural rights-of-way, fencerows,
hedgerows, uncultivated areas/soils, and under paved roads and sidewalks
in areas where no future landscaping is planned. Primary uses include
rangeland and near railroads and other industrial facilities.
Single active ingredient formulations include granular,
pelleted/tableted, wettable powder, water dispersible granules, and
technical grade/solid products. Three multiple active ingredient
formulations (granulars) also are registered. All formulations may be
applied as broadcast, banded or spot treatments using ground equipment.
The pelleted/tableted formulations also may be applied using aerial
equipment.
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Regulatory
History
Tebuthiuron was first registered as a pesticide in the U.S. in 1974.
EPA issued a Registration Standard for tebuthiuron in July 1987 (NTIS
#PB87-231866), which identified the potential for groundwater
contamination as well as hazards to endangered plant species from use of
tebuthiuron on pasture and rangeland, and which required additional
generic data.
In 1988, EPA issued a Ground Water Data Call-in which required a
small scale retrospective ground water monitoring study. A 1991 Data
Call-in required residue chemistry studies on residues in meat and milk.
1992, the technical producer stopped supporting the only aquatic use site
(ditehbanks).
Currently, 12 pesticide products are registered which contain the
active ingredient tebuthiuron.
In
Human Health
Assessment
Toxicity
In acute toxic ity studies, tebuthiuron is moderately toxic by the oral
route. It has been placed in Toxicity Category n for this effect hi rats,
rabbits and cats, and in Category III for mice and dogs. (Category I
indicates the greatest degree of acute toxicity and IV the least.)
Tebuthiuron is practically non-toxic by the dermal route (Toxicity Category
IV), and only slightly toxic by the inhalation route (Toxicity Category III).
The pesticide is not a dermal irritant, causes only slight irritation to the
eyes (Toxicity Category IV), and is not a dermal sensitiier.
Tebuthiuron does not appear to cause any adverse developmental or
reproductive effects. Based on an acceptable carcinogenicity study in rats
and two supplemental carcinogenicity studies in mice, in which no
compound-related carcinogenic effects were observed, tebnthiuron is
classified as a Group D carcinogen (not classifiable as to human
carcinogenicity). The available data indicate that tebuthiuron does not
appear to be mutagenic.
Dietary Exposure
Tolerances or maximum residue limits aie established for residues of
tebuthiuron on grass hay and forage; in the meat of cattle, goats, horses
and sheep; and in milk (see 40 CFR 180.390), A reduction in the grass
hay and forage tolerance from 20 pprn to 10 ppm is recommended since
residues do not typically exceed the lower value.
EPA's worst-case exposure estimates indicate that the overall U.S.
population is exposed to 9% of the Reference Dose (RfD) or amount
believed not to cause idverse effects if consumed daily over a 70-year
lifetime. Non-nursing infants (up to 1 year old) arc exposed to 32% of the
RfD, and children age 1-6 arc exposed to 21 % of the RfD. The effect of
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concern is depressed body weight gain, as observed in a rat reproduction
study.
This worst-case estimate of tebuthiurorfs chronic dietary risk assumes
that residues are at tolerance level and that 100% of all commodities are
treated. Actual exposure is less, and dietary risks are considered minimal.
Occupational and Residential Exposure
Pesticide handlers (mixers, loaders and applicators) may be exposed
to tebuthiuron during normal mixing and loading operations, to mists
during spray applications, and to dusts during application of solid
formulations. This exposure is by inhalation and to the skin. However,
tebuthiuron is of sufficiently low toxicity that exposure monitoring data are
not required. The potential for post-application exposure is low due to the
nature of the registered use sites. Again, since the pesticide is of relatively
low toxicity, post-application/reentry data are not required.
Human Risk Assessment
Although tebuthiuron is moderately toxic by the oral route, it is only
slightly toxic by inhalation and is practically non-toxic through the skin. It
is not a skin irritant or sensltizer, and causes only slight irritation to the
eyes. Tebuthiuron does not appear to cause developmental or reproductive
effects, to be mutagenic or to cause cancer.
People may be exposed to residues of tebuthiuron in meat or milk.
The dietary risk from this exposure, however, appears to be minimal.
Occupational pesticide users (mixers, loaders and applicators) also may be
exposed to tebuthiuron by inhalation and through the skin. The risks of
this exposure again are considered minimal due to the pesticide's low
toxicity,
Environmental Environmental Fate
Assessment Tebuthiuron is persistent and mobile and can leach to ground water,
as indicated by a small-scale retrospective ground water study. It is
resistant to biological and chemical degradation, and its principle route of
dissipation in the environment appears to be mobility. Transport to ground
water through leaching and to surface water through run-off are likely as a
result of tebuthiuron's persistence and low adsorption to soil, Tebuthiuron
has been detected in ground water in Texas and California. The Agency is
concerned about the potential for ground water contamination from
registered uses of tebuthiuron.
Ecological Effects
Tebuthiuron is practically nontoxic on an acute basis to birds, fish
and aquatic invertebrates, but is slightly toxic to rnarnrnals. Current
registered uses of tebuthiuron should not pose a hazard to terrestrial or
aquatic organisms. However, tebuihiuron may pose a significant risk to
on- and off-site endangered terrestrial, semi-aquatic, and aquatic plant
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species and may also have adverse effects on other off-site non-target
plants.
Ecological Effects Risk Assessment
Application of tebuthiuron to rangeland (the roost typical use pattern)
exceeds the Agency's high level of concern for nontarget terrestrial and
aquatic plants. Each application of tebuthiuron compounds this hazard due
to the pesticide's extremely long half-life. By reducing the maximum
application rates and limiting the frequency of applications to once every
three years, EPA expects to reduce the risk to non-target plants.
All registered uses of tebuthiuron pose a significant risk to off-site
endangered terrestrial, semi-aquatic and aquatic plant species. Further, all
endangered species in certain use areas, such as rangelands and rights-of-
way, are likely to be jeopardized as they may receive direct applications of
tebuthiuron. EPA may require additional labeling and use modifications
when implementing the Endangered Species Protection Program.
Additional Data
Required
EPA is requiring additional generic confirmatory data for tebuthiuron
including two product chemistry studies {Preliminary Analysis and
Analytical Methods to Verify Certified Limits). The Agency also is
requiring product-specific data including product chemistry and acute
toxicity studies, revised Confidential Statements of Formula, and revised
labeling for reregistration.
Product Labeling
Changes Required
All tebuthiuron end-use products must comply with EPA's current
pesticide product labeling requirements, and the following:
Worker Protection Standard (WPS) - The current registered uses of
tebuthiuron do not include uses associated with the production of an
agricultural plant on/in any farm, forest, nursery, or greenhouse. Thus,
tebuthiuron, as currently registered, does not fell within the scope of the
Worker Protection Standard for Agricultural Pesticides and the
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," concerning the Agency's labeling
regulations for worker protection statements (40 CFR 156, subpart K) are
not applicable to tebuthiuron end-use products at this time.
Personal Protective Equipment (PPE) Requirements
Registrants must compare the following PPE requirements with those (if
any) on their current labeling and retain the more protective. Labeling
must bear the following minimum PPE requirement:
"Applicators and other handlers must wear:
-Long sleeved shirt and long pants
-Shoes plus socks"
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In addition, gloves arc required if the product is in Toxicity Category I, II,
or III for acute dermal toxicity or skin irritation potential. The glove
statement must be one of the following:
—"Waterproof gloves" for dry formulations or for formulations where
water is the only solvent;
--"Chemical-resistant gloves" for all other formulations.
See PR Notice 93-7 for additional guidance on glove selection.
Ground Water Label Advisory - Due to its persistence and mobility in
the environment, tebuthiuron end-use products must bear the following
Label Advisory:
"This chemical is known to leach through soil into ground water
under certain conditions as a result of registered (rangeland and non-
crop) uses. Use of this chemical in areas where soils are permeable,
particularly where the water table is shallow, may result in ground-
water contamination".
"A shallow water table is defined as depth to water table of 30 feet
or less. Permeable soils include, but are not limited to sandy soils,"
Additional use restrictions will be required for areas vulnerable to ground
water contamination, once these areas are identified (within 4 months after
issuance of this RED).
Use Rates and Number of Applications - The following maximum
application rates and number and frequency of applications must be
included hi the Directions for Use section of the label, to reduce the
potential for ground water contamination and the risks to non-target plants;
* Granular. Pelleted/Tableted. and Water Dispersable Granules (Dry
Flowable) Formulations
For vegetation control by broadcast (aerial and ground equipment)
and banded applications: The maximum label rate and frequency of
application is 1-2 Ibs ai/a once every three years for vulnerable areas
(where soils are sandy and depth to water table is shallow) as
identified in the specific soil series labeling supplement. For all
other areas, may be applied one time in a 3 year period at rates up to
4 Ib ai/A; however, no more than 6 Ib ai/A may be applied in two
consecutive treatments in any 6 year period.
Spot Treatments (hand-held equipment): May be applied at rates up
to the equivalency of 6 Ib ai/A when needed.
* Wettable Powder Formulation
For vegetation control by broadcast and banded applications (ground
equipment): The maximum label rate and frequency of application is
1-2 Ibs ai/a once every three years for vulnerable areas (where soils
are sandy and depth to water table is shallow) as identified in the
specific soil series labeling supplement. For all other areas, may be
applied one time in a 3 year period at rates up to 4 Ib ai/A; however,
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no more than 6 Ib ai/A may be applied in two consecutive treatments
in any 6 year period.
For total vegetation control and maintainence of bare ground by
broadcast and banded applications (ground equipment): may be
applied one time per year at rates up to 4 Ib ai/A; however, no more
than 6 Ib ai/A may be applied in any 3 year period.
Spot treatments (hand-held equipment); may be applied at rates up to
the equivalency of 6 Ib ai/A when needed.
Other Labeling Requirements (Environmental Hazard Statement)
Granular and Pelleted/Tableied Formulations
"In case of spills, collect, cover or incorporate granules/pellets
spilled on the soil surfaces to prevent contamination to water. Do
not apply to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not
contaminate water when disposing of equipment washwaters or
rinsate".
Wetiable Powder and Water Dispersable Granular (Dry Flowable)
Formulation
"Do not apply to water, or to areas where surface water is present or
to intertidal areas below the mean high water mark. Do not
contaminate water when disposing of equipment washwaters or
rinsate".
Regulatory
Conclusion
Based on reviews of the generic data for the active ingredient
tebuthiuron, EPA has determined that tebutMuron products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, products containing tebuthiuron for all registered uses are
eligible for reregistration.
Products that contain tebuthiuron as the sole active ingredient will be
reregistered once the required confirmatory generic data, product specific
data, revised Confidential Statements of Formula and revised labeling are
received and accepted by EPA, Products which also contain other active
ingredients will be reregistered after the other active ingredients are
determined to be eligible for reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (EED) document for tebuthiuron during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register.
To obain a copy of the RED document or to submit written comments,
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please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (75Q6C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20*60, telephone
703-305-5805.
Following the comment period, the tebutMuron RED document will
be available from the National Technical Information Service (NHS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the tebuthiuron RED, or reregistration of individual products containing
tebuthiuron, 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, from 8:00 am to 6:00 pm Central
Time, Monday through Friday.
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